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Serology-based tests for COVID-19

Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered. Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response. In contrast, the RT-PCR tests currently being used globally to diagnose cases of COVID-19 can only indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently recovered. These tests can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus.

The Johns Hopkins Center for Health recently released a report detailing considerations for a national strategy on serology testing, including actions for leaders and areas for continued research. You can find this report here.

This page serves to provide up to date information on serology tests that are in development or available for use. Importantly, many of these tests have been approved for research use only, which indicates that they are not yet approved for use as a public health diagnostic tool or for at-home diagnosis. Some of these tests may move forward to approval for diagnostic use, while others may be appropriate for research only.

Disclaimer
This website is updated twice weekly, and only includes tests for which data and documentation is available and for which their stated intended use aligns with their FDA (or relevant national regulatory body) status. This site does not include tests that are in subsection IV.D of the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, as these have not been approved by the FDA and may not have indicated to the FDA that they are pursuing EUA approval. This site is not intended to be used as a reference for funding or grant proposals. Non-inclusion in this list should not be interpreted as judgment on validity or legitimacy of tests. If you do not see your test on this list, but would like it to be considered, please fill out the following form. Submission does not guarantee inclusion on this site.

Note on sensitivity and specificity data
Here we list the manufacturer-reported sensitivity and specificity data, where available. A highly sensitive test should capture all true positive results. A highly specific test should rule out all true negative results. These measures are not independently validated by the Johns Hopkins Center for Health Security. If a sensitivity or specificity is not listed, it was not listed/available at the time of posting. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description.

It should also be noted that the terms “sensitivity” and “specificity” may not appear in the manufacturers’ information sheets, but rather these values are often reported as “positive percent agreement” and “negative percent agreement.” The FDA recommends that manufacturers use these terms to indicate that a non-reference standard was used when evaluating the test.

This page was last updated on October 16, 2020.

This resource was created and is updated by Amanda Kobokovich, MPH, Rachel West, PhD, and Gigi Gronvall, PhD.

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  1. Description of types of serology assays (RDT, ELISA, neutralization, etc.), including uses and benefits
  2. Tests that have been approved for diagnostic use in the United States
  3. Tests that have been approved for diagnostic use in other countries
  4. Tests that have been approved for research or surveillance purposes only
  5. Tests that are still in development

 

Description of types of serology assays

Rapid diagnostic test (RDT): This is typically a qualitative (positive or negative) lateral flow assay that is small, portable, and can be used at point of care (POC). These tests may use blood samples from a finger prick, saliva samples, or nasal swab fluids. RDTs are often similar to pregnancy tests, in that the test shows the user colored lines to indicate positive or negative results. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM), or viral antigen. In some cases, it can be beneficial to measure baseline (before infection) of IgG and IgM titers.

Enzyme-linked immunosorbent assay (ELISA): This test can be qualitative or quantitative and is generally a lab-based test. These tests usually use whole blood, plasma, or serum samples from patients. The test relies on a plate that is coated with a viral protein of interest, such as Spike protein. Patient samples are then incubated with the protein, and if the patient has antibodies to the viral protein they bind together. The bound antibody-protein complex can then be detected with another wash of antibodies that produce a color or fluorescent-based readout. In the context of COVID-19, these tests most frequently test for patient antibodies (IgG and IgM).

Neutralization assay: This test relies on patient antibodies to prevent viral infection of cells in a lab setting. Neutralization assays can tell researchers if a patient has antibodies that are active and effective against the virus, even if they have already cleared the infection. These tests require whole blood, serum, or plasma samples from the patient. Neutralization assays depend on cell culture, a lab-based method of culturing cells that allow SARS-CoV-2 growth (like VeroE6 cells). When virus and cells are grown with decreasing concentrations of patient antibodies, researchers can visualize and quantify how many antibodies in the patient serum are able to block virus replication. This blocking action can happen through the antibody binding to an important cell entry protein on the virus, for example.

Chemiluminescent immunoassay: This test is typically quantitative, lab-based, and uses whole blood, plasma, or serum samples from patients. A variation of this test can use magnetic, protein-coated microparticles, known as a chemiluminescent microparticle immunoassay. The test relies on mixing patient samples with a known viral protein, buffer reagents, and specific enzyme-labeled antibodies that allow a light-based, luminescent read-out. Any antibodies in the patient sample that react to the viral protein will form a complex. Then, (secondary) enzyme-labeled antibodies are added that bind to these complexes.  This binding induces a chemical reaction that produces light. The amount of light (radiance) emitted from each sample is then be used to calculate the number of antibodies present in a patient sample. This test can look for multiple types of antibodies, including IgG, IgM, and IgA.

Type of testTime to resultsWhat it tells usWhat it cannot tell usFigure
Rapid diagnostic test (RDT)10-30 minutesThe presence or absence (qualitative) of antibodies against the virus present in patient serum.The amount of antibodies in the patient serum, or if these antibodies are able to inhibit virus growthRDT figure
Enzyme linked immunosorbent assay (ELISA)2-5 hoursThe presence or absence (quantitative) of antibodies against the virus present in patient serum.If the antibodies are able to inhibit virus growth.ELISA figure
Neutralization assay3-5 daysThe presence of active antibodies in patient serum that are able to inhibit virus growth ex vivo, in a cell culture system.It may miss antibodies to viral proteins that are not involved in replication.PRNT figure
Chemiluminescent immunoassay1-2 hoursThe presence or absence (quantitative) of antibodies against the virus present in the patient serum.If the antibodies are able to inhibit virus growth.CLIA figure

 

 

Tests that have been approved for diagnostic use in the United States

Country of developmentUS/China
Type of Serological TestRDT
Authors/CompanyCellex Inc.
DescriptionRDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. The sensitivity is 93.8% and specificity is 95.6%, when tested at 2 Chinese hospitals in a total of 128 COVID19 positive patients, and 250 COVID19 negative patients (as detected by RT-qPCR).
Sensitivity93.8%
Specificity95.6%
Phase of developmentApproved by FDA for EUA on diagnostics, has CE approval
Proposed releaseavailable for purchase by research labs/healthcare providers (product number 5513)
DateApril 1, 2020

 

Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyChemBio
DescriptionThis test detects IgM and IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Sensitivity and specificity values were not released.
Sensitivity 
Specificity 
Phase of  developmentApproved for EUA by the FDA
Proposed releaseApril 14, 2020
DateApril 15, 2020

 

Country of developmentUSA
Type of Serological TestELISA
Authors/CompanyMount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
DescriptionThis test detects, qualitatively, IgG present in the serum of patients. The ELISA based method uses a 1:50 dilution of human serum that is flowed over a plate coated with the spike protein receptor binding domain (RBD). Sensitivity and specificity are not yet available.
Sensitivity 
Specificity 
Phase of  developmentApproved for EUA by the FDA
Proposed releaseApril 15, 2020
DateApril 16, 2020

 

Country of developmentUSA
Type of Serological TestChemiluminescent immunoassay
Authors/CompanyOrtho-Clinical Diagnostics, Inc.
DescriptionThis test detects IgG and is designed to be used with VITROS Immunodiagnostic Products and the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems. Sensitivity was approximately 87.5% and specificity is approximately 100%.
Sensitivity 
Specificity 
Phase of  developmentApproved for EUA by the FDA
Proposed releaseCurrent
DateApril 24, 2020

 

Country of developmentUSA
Type of Serological TestELISA
Authors/CompanyDiaSorin Inc.
DescriptionThis test is designed to run on the LIAISON XL analyzer and detects IgG specific to recombinant spike protein subunits 1 and 2 (S1 and S2). Specificity was approximately 98%. Sensitivity was approximately 90% on samples obtained 5-15 days post-symptom onset. For samples taken greater than 15 days post-symptom onset, the sensitivity was approximately 97%.
Sensitivity90-97%
Specificity98%
Phase of  developmentApproved for EUA by the FDA
Proposed releaseCurrent
DateApril 24, 2020

 

Country of developmentUSA
Type of Serological TestChemiluminescent microparticle immunoassay (CMIA)
Authors/CompanyAbbott Laboratories Inc.
DescriptionThis is an update to the EUA received 4/26/2020, for the ARCHITECT i SARS-CoV-2 IgG and Alinity i SARS-CoV-2 IgG assays. This test detects IgG by measuring antibody-antigen binding in terms of relative light units (RLU). It is intended to be used with the ARCHITECT i1000SR and i2000SR systems, as well as the Abbott Alinity i system. Sensitivity and specificity were determined on the Architect system, with 122 positive clinical samples and 1070 negative samples (including non-COVID respiratory illnesses). Sensitivity was stratified by time post symptom onset.
Sensitivity0% (0-3 days), 25% (3-7 days), 86.4% (8-13 days), and 100% (14+ days)
Specificity99.63%
Phase of  developmentReceived EUA by the FDA (most recently revised on 9/18/2020)
Proposed releaseCurrent
DateApril 26, 2020

 

Country of developmentUS
Type of Serological TestModified ELISA
Authors/CompanyBio-Rad
DescriptionThe Platelia SARS-CoV-2 Total Ab assay measures IgM, IgG, and IgA antibodies to SARS-CoV-2. The target antigen is recombinant nucleocapsid protein, coupled with peroxidase that provides the read-out. Human serum or plasma samples are required.The sensitivity and specificity are not yet known, though it appears the readout of the assay may be quantiative or qualitative.
Sensitivity98%
Specificity99%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateApril 29, 2020

 

Country of developmentUS
Type of Serological TestMicrosphere immunoassay
Authors/CompanyWadsworth Center, New York State Department of Health
DescriptionThis test assays for total antibodies (IgG, IgM, and IgA) in human serum samples. The test uses full-length recombinant nucleocapsid protein from SARS-CoV-1 (it is stated that the sequence is similar enough to use the other virus' N protein-90% homologous). The test should be run with a Luminex FlexMap dual laser cytometer.
SensitivityNot stated
Specificity93-100%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateApril 30, 2020

 

Country of developmentUS/Switzerland
Type of Serological Testelectro-chemiluminescence immunoassay (ECLIA)
Authors/CompanyRoche
DescriptionThe test couples chemiluminescence immunoassay technology with an electric pulse that allows for rapid quantifiation of captured antigen-antibody complexes from patient serum samples. The target antigen is the viral N protein.The test assays for IgM and IgG, and takes about 18 minutes. The test should be run on the Elecsys Anti-SARS-CoV-2 on the cobas e 411, cobas e 601, cobas e 602, or cobas e 801 analyzers. Sensitivity was determined from 204 samples, and specificity from 5,272 negative samples.
SensitivityFrom 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100%
Specificity99.81%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateMay 2, 2020

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyEuroimmun AG
DescriptionThe Euroimmun AG IgG ELISA assay uses the viral S1 region of the spike protein to quantify IgG antibodies present in serum samples. Sensitivity and specificity were determined compared to onset of symptoms in PCR positive and negative samples. Sample sizes varied over time.
SensitivityFrom 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation
Specificity100% by NCI validation
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateMay 4, 2020

 

Country of developmentUS/China
Type of Serological TestRDT
Authors/CompanyHealgen Scientific LLC
DescriptionThis is a lateral flow assay based test, that uses human venous whole blood, plasma from anticoagulated blood, or serum to detect IgG and IgM antibodies. The test takes approximately 10 minutes, and is a qualitative test for presence of antibodies. The antigen target is not stated. Sensitivity was determined from 90 positive clinical samples, and specificity from 101 negative clinical samples from two testing sites in China. The test was also independently validated, with sensitivity of 100% and specificity of 97.5%.
Sensitivity96.7% (IgG),86.7 % (IgM), 96.7% combined
Specificity98% (IgG), 99% (IgM), 97% combined
Phase of  developmentReceived EUA and CE/IVD, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 1, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThis CLIA based assay uses the Atellica platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was from 250 clinical positive samples, with times since PCR positivity listed. Specificity was determined from 1091 samples, including 98 pregnant women.
Sensitivity60.7% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).
Specificity99.82%%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent, their website states that there are already over 20,000 analyzers installed, and there should be mass availability.
DateJune 1, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThis CLIA based assay uses the ADVIA Centaur platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was determined using 262 clinical samples, with times listed post PCR postivity. Specificity was from 1589 people, including 100 pregnant women.
Sensitivity65.1% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).
Specificity99.81%%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent, their website states that there are already over 20,000 analyzers installed, and there should be mass availability.
DateJune 1, 2020

 

Country of developmentUS
Type of Serological TestECLIA (electrochemiluminescence immunoassay)
Authors/CompanyRoche Diagnostics
DescriptionElecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay “ECLIA” and is intended for use on cobas e immunoassay analyzers.
Sensitivity84%
Specificity63%
Phase of  developmentReceived EUA and CE/IVD, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 2, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyVibrant America Clinical Labs
DescriptionThe Vibrant COVID-19 Ab assay is a chemiluminescence immunoassay (CLIA) intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum or Dry Blood Spot (DBS) using fingerstick blood specimen collected by their health care provider.
Sensitivity98.1%
Specificity98.6%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 4, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyHangzhou Biotest Biotech Co., Ltd
DescriptionThis RDT tests for IgM and IgG in patient whole blood, serum, or plasma. The target antigen is recombinant spike protein receptor binding domain. Results should only be read after 10 minutes of incubation, but before 20 minutes. Clinical samples used for internal validation were from 3 different sites in China. Sensitivity and specificity presented here are for overall measures, though the company provides information for days 1-7 post symptoms, 8-14, and days 15+. Sensitivity and specificity were determined from 320 positive and 210 negative samples. Sensitivity increases after day 8 post symptom onset.
Sensitivity92.5% (IgM), 91.56% (IgG)
Specificity98.1% (IgM), 99.52% (IgG)
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 4, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThe Dimension Vista COV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension Vista COV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology.
Sensitivity97.3%
Specificity99.8%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 8, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThe Dimension EXL CV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension EXL CV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and a biotinylated S1 RBD antigen.
Sensitivity97.3%
Specificity99.8%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 8, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyInBios International, Inc.
DescriptionThe SCoV-2 Detect™ IgG ELISA is a qualitative immunoassay for the detection of IgG antibodies targeting SCoV-2 related antigens. Diluted serum specimens are added to antigencoated wells and incubated. After incubation and washing, human antibodies targeting SARS-CoV-2 antigens remain bound to the plate surface. Secondary antibody conjugated to horseradish peroxidase (HRP) targeting human IgG is then added to each well. After incubation, the ELISA wells are washed once again before a tetramethylbenzidine (TMB) substrate is added. An acidic stopping solution is finally used to stop the reaction and the degree of enzymatic turnover of the substrate is determined by absorbance measurement at 450 nanometers.
Sensitivity97.8%
Specificity98.9%
Phase of  developmentReceived EUA, available for purchase by healthcare professionals and researchers.
Proposed releaseCurrent
DateJune 10, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyEmory University
DescriptionThis test detects IgG antibodies specific to a recombinant receptor binding domain (RBD) of the spike protein. It should be run on the BioTek 800 TS Absorbance Reader. Sensitivity was determined from 231 positive samples, and specificity from 388 negative samples--including samples taken prior to the pandemic and rRT-PCR negative health care workers during the pandemic. These results were stratified based on days post-positive rRT-PCR.
Sensitivity73% (days 0-7), 100% (days 8-14), 100% (days 14+)
Specificity97.7% (prior to pandemic), 94.4% (PCR negative HCW)
Phase of  developmentReceived EUA by the FDA
Proposed releaseCurrent, Emergency use of this test is limited to the Emory Medical Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
DateJune 15, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyBiohit Healthcare (Heifei) Co. Ltd.
DescriptionThis test detects IgM and IgG through immunchromatography. It is not intended for use early in infection, with optimal performance after 15 days post symptom onset. The target antigen is recombinant N-protein. Specificity was determined from 186 negative samples (including 78 samples positive for other respiratory diseases), and sensitivity was determined from 197 serum samples.
Sensitivity33% (IgM, days 1-7), 56.6% (IgG days 8-14), 83.% (IgM days 8-14), 96.2% (IgG days 15+), 97.7% (IgM days 15+)
Specificity99.46% (IgM), 100% (IgG)
Phase of  developmentReceived EUA by the FDA
Proposed releaseCurrent
DateJune 18, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyHangzhou Laihe Biotech Co., Ltd
DescriptionThis test is a lateral flow assay/colloidal gold method to detect IgG and IgM antibodies. The target antigen is the S1 region of the spike protein. They used 178 positive samples to determine sensitivity, stratified by day since symptom onset. They determined specificity from 349 negative samples, 239 of which were from patients with non-SARS-CoV-2 coronavirus infections. The test was also independently validated by the NCI, and found 96.7% IgM sensitivity, 100% IgG sensitivity, and 98.8% specificity.
Sensitivity100% (IgM, 0-6 days), 0% (IgG, 0-6 days); 85.7% (IgM, 7-14 days), 76% (IgG, 7-14 days); 99.25% (IgM, 14+ days), 98.5% (IgG, 14+ days)
Specificity99.43%
Phase of  developmentReceived EUA by the FDA
Proposed releaseCurrent
DateJune 19, 2020

 

Country of developmentUS
Type of Serological TestChemiluminescent immunoassay/indirect sandwich immunoassay
Authors/CompanyBabson Diagnostics
DescriptionThis test is a CLIA based assay that detects IgG antibodies. The target antigen is the S1 region of the spike protein. The test should be run on the Siemens Atellica IM platform. Sensitivity was determined from 34 positive samples, stratified by time post symptom onset and 2 of which were asymptomatic individuals. Specificity was determined from 100 individuals.
Sensitivity66.7% (8-14 days), 100% (15+ days), 100% (asymptomatic)
Specificity100%
Phase of  developmentReceived EUA by the FDA
Proposed releaseCurrent, but only to be used at Babson Diagnostics
DateJune 23, 2020

 

Country of developmentUS
Type of Serological TestChemiluminescent immunoassay
Authors/CompanyBeckman Coulter, Inc.
DescriptionThis is a two step CLIA that uses the target antigen of the receptor binding domain of S1 of the spike protein. It detects IgG in patient samples. Sensitivity was determined using 192 positive clinical samples, stratified by time since symptom onset. Specificity was determined from 1400 samples collected before December 2019.
Sensitivity75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days)
Specificity100%
Phase of  developmentReceived EUA by the FDA
Proposed releaseCurrent
DateJune 26, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyInBios International, Inc.
DescriptionThis kit specifically tests for IgM present in patient serum. The target antigen is not stated. Samples for testing should only be taken between 7 days to 64 days post symptom onset. Samples taken before 12 days post-symptom onset that test negative should be re-tested using a second, molecular method. Samples, taken after 12 days post symptom onset, that are negative should also be tested for IgG. Sensitivity was determined from 120 positive clinical samples, and specificity from 95 negative samples. Sensitivity presented is overall sensitivity, but the company does list varied sensitivity stratified by time post symptom onset. In general, the greater number of days post symptom onset, the more sensitive the assay.
Sensitivity92.5%
Specificity98.5%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateJune 30, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyAssure Biotech (Hangzhou Co, Ltd.)
DescriptionThis test's EUA was updated on September 23,2020. The updates include that the test can now be used with fingerstick samples, and in point-of-care settings.This lateral flow assay tests for both IgM and IgG in patient serum. The target antigens are recombinant Nucleocapsid protein and Spike protein (S1 region). Sensitivity was determined from 61 positive clinical samples, and specificity from 105 negative samples. The company also provides sensitivity stratified by time post symptom onset, though the overall sensitivity is presented here. Overall, the kit had highest sensitivity with venous whole blood. The kit has also been independently validated by the NCI, as presented by the manufacturer. Combined IgG/IgM sensitivity was 100%, and specificity was 98.8%.
Sensitivity95.1%
Specificity100%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateSeptember 23, 2020, original was July 6, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyDiazyme Laboratories, Inc.
DescriptionThe Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit is an indirect chemiluminescence immunoassay. The light signal is measured by the DZ-lite 3000 Plus Chemiluminescence Analyzer as relative light units (RLUs), which is evaluated against the established cutoff to determine the final result. The product contains a Low and a High Calibrator to execute calibration operation.
Sensitivity91.7%
Specificity97.4%
Phase of  developmentReceived EUA
Proposed releaseCurrent
Date7/8/2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.
DescriptionThis is a lateral flow assay that detects total antibody to the RBD region of the spike protein of SARS-CoV-2. Sensitivity was determined from 132 positive clinical cases, and specificity from 271 negative cases. They also post sensitivity and specificity stratified by time since symptom onset.The test has been independently validated by several institutions, including the NCI which found a sensitivity of 100% and specificity of 98.8%.
Sensitivity94.7
Specificity98.9
Phase of  developmentReceived EUA and CE mark.
Proposed releaseCurrent
DateJuly 10, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.
DescriptionThe WANTAI SARS-CoV-2 Ab Rapid Test is a lateral flow assay for the qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, lithium heparin, and sodium citrate), and venous whole blood. NCI cross-validation studies reported sensitivity of 100% and specificity of 98.8%.
Sensitivity94.7%
Specificity98.9%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateJuly 10, 2020

 

Country of developmentFinland
Type of Serological TestRDT
Authors/CompanySalofa Oy
DescriptionThe SiennaTM-Clarity COVIBLOCKTM COVID-19 IgG/IgM Rapid Test Cassette is a membrane-based lateral flow immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma (dipotassium EDTA, sodium citrate, sodium heparin) and venous whole blood (dipotassium EDTA, sodium citrate, sodium heparin). NCI cross-validation studies reported sensitivity of 90% for IgM and 93.3% for IgG and specificity of 100% for IgM and 98.8% for IgG.
Sensitivity100% for IgM and IgG
Specificity100% for IgM and IgG
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateJuly 13, 2020

 

Country of developmentUS
Type of Serological TestRDT
Authors/CompanyMegna Health, Inc.
DescriptionThis is a lateral flow assay RDT that tests for IgM and IgG to SARS-CoV-2 nucleocapsid protein. Sensitivity was determined from 126 positive clinical samples, and specificity was determined from 285 negative samples. They present a combined (IgM and IgG) sensitivity, but also stratify by isotype and time since symptom onset. They also present independent NCI validation results, with combined sensitivity of 100% and specificity of 95%.
SensitivityIgM: 73.81%
IgG, 73.81
Combined: 90.5%
SpecificityIgM: 99.7%
IgG:99.3%
Combined: 98.9%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateJuly 17, 2020

 

Country of developmentUS
Type of Serological TestFluorescent microbead-based immunoassay (FMIA)
Authors/CompanyLuminex
DescriptionThis is a multiplexed, bead based assay that tests for antibodies against the nucleocapsid protein, the receptor binding domain of spike, and the S1 subunit of spike protein. The test should be run using the Luminex® xMAP technology and works with Luminex 200, MAGPIX, and FLEXMAP 3D System. This test is specific for IgG. Sensitivity was determined from 112 serum samples, stratified by time since symptom onset. Specificity was from 309 negative serum samples. They also tested plasma sensitivity, stratified by time (n=46). They validated sensitivity and specificity on all platforms suitable for the test.
SensitivitySerum: 71% (days 0-7), 71.4% (8-14 days), 96.2% (14+ days); Plasma: 100% (0-7 days), 82% (8-14 days), 96.6% (14+ days)
SpecificitySerum: 100%, Plasma: 99.2%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateJuly 16, 2020

 

Country of developmentSouth Korea
Type of Serological TestRDT
Authors/CompanyAccess Bio, Inc.
DescriptionThis is a lateral flow assay that detects IgM and IgG to recombinant nucelocapsid and spike RBD antigens of SARS-CoV-2. Sensitivity was determined from 64 positive clinical samples, and specificity from 182 negative samples. The company also stratifies by time post symptom onset, though most samples were from 15 days onward. This test has also been validated by the NCI, and the combined (IgG/IgM) sensitivity is 100%, and specificity is 97.5%.
Sensitivity96.7% (IgG); 89% (IgM); 98.44% (combined)
Specificity99.45% (IgM); 99.45%(IgG); 98.9% (combined)
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateJuly 24, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyXiamen Biotime Biotechnology Co., Ltd
DescriptionThis is a lateral flow assay that detects IgM and IgG against SARS-CoV-2 (specific antigen not stated). This has only been authorized for use with potassium EDTA plasma, serum or potassium EDTA venous whole blood. In testing for cross-reactivity with other samples from patients with non-SARS-CoV-2 infections, there was no cross-reactivity found. They provide sensitivity and specificity stratified by time post symptom onset (presented here) and time post positive PCR. Sensitivity was determined from 120 positive clinical samples, and specificity from 315 clinical samples. The manufacturer also did a longitudinal study to determine time of seroconversion. The test was also validated by the NCI, with a combined sensitivity of 100% and specificity of 96.2%.
SensitivityIgG: 46.38% (days 0-7), 67.65% (days 7-14), 100% (days 14+); IgM: 55% (days 0-7), 94% (days 7-14), 100% (days 14+)
Specificity99.23%%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateJuly 24, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThis is a chemiluminescent immunoassay to detect IgG in patient samples, using the ADVIA Centaur XP or XPT platforms. The target antigen is the RBD of the S1 domain of the spike protein. This assay provides a semi-quantitative (meaning an estimate/relative amount of antibodies) readout within about 25 minutes. Sensitivity and specificity were determined using 189 positive clinical samples and 1831 negative samples. Both measures were stratified by time post symptom onset.
Sensitivity53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days)
Specificity99.9%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateJuly 31, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanySiemens Healthcare Diagnostics Inc.
DescriptionThis is a chemiluminescent immunoassay to detect IgG in patient samples, using the Atellica platform. The target antigen is the RBD of the S1 domain of the spike protein. This assay provides a semi-quantitative (meaning an estimate/relative amount of antibodies) readout within about 25 minutes. Sensitivity and specificity were determined using 197 positive clinical samples and 1841 negative samples. Both measures were stratified by time post symptom onset.
Sensitivity56% (0-6 days), 92%(7-14 days), 100% (14+ days)
Specificity99.9%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateJuly 31, 2020

 

Country of developmentChina
Type of Serological TestELISA
Authors/CompanyBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.
DescriptionThe WANTAI SARS-CoV-2 Ab ELISA test is an ELISA based assay, detecting IgM and IgG reactive to the spike protein receptor binding domain. Sensitivity was determined from 235 positive samples, and specificity from 501 negative samples stratified by time since symptom onset. The test was also validated by the NCI, finding a sensitivity of 96.7% and specificity of 97.5%.
Sensitivity55.4% (0-7 days), 84.8% (7-14 days), 98.7% (15+ days)
Specificity98.6%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateAugust 5, 2020

 

Country of developmentFrance
Type of Serological TestEnzyme linked fluorescent assay (ELFA)
Authors/CompanybioMérieux SA
DescriptionThe VIDAS SARS-CoV-2 IgG measures IgG antibody to the S1 unit of the spike protein. This system is completely automated, and provides a fluorescent readout that correlates to titers of antibody present in the patient sample. Sensitivity was determined from 120 positive clinical samples, and specificity from 989 negative samples. The positive samples were stratified by time since symptom onset, and only 17 were from 15 days onward.
Sensitivity49% (0-7 days), 100% (7-14 days), 100% (15+days)
Specificity99.9%%
Phase of  developmentReceived EUA, has CE mark.
Proposed releaseCurrent
DateAugust 6, 2020

 

Country of developmentFrance
Type of Serological TestEnzyme linked fluorescent assay (ELFA)
Authors/CompanybioMérieux SA
DescriptionThe VIDAS SARS-CoV2 IgM measures IgM antibody to the S1 unit of the spike protein. The system is completely automated, and provides a fluorescent readout that correlates to titers of antibody present in the patient sample. Sensitivity was determined from 111 positive clinical samples, stratified by time, and 308 negative clinical samples. Only 20 samples were from after 7 days post symptom onset. 91 were from 0-7 days.
Sensitivity53.8% (0-7 days), 100% (7-14 days), 100%(15+)
Specificity99.4%%
Phase of  developmentReceived EUA, has CE mark.
Proposed releaseCurrent
DateAugust 6, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyDiazyme Laboratories, Inc.
DescriptionThe Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit detects IgM specific to SARS-CoV-2. The test uses a recombinant virus antigen, though it is not stated which protein is used. The manufacturer recommends that the kit be used at least 15 days post symptom onset. Sensitivity was determined from 155 positive clinical samples, and specificity from 302 negative samples. Sensitivity was stratified by time post symptom onset (108 samples were from after 15 days).
Sensitivity26.1% (0-7 days); 83.3% (7-14 days), 94.4% (15+days)
Specificity98.3%
Phase of  developmentReceived EUA
Proposed releaseCurrent
DateAugust 17, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyBioCheck, Inc.
DescriptionThe BioCheck SARS-CoV-2 IgG and IgM Combo Test is a CLIA based assay that detects antibodies specific to the S1 region of spike protein. The assay, which uses special casettes, should be run on the MS-Fast Automated Chemiluminescent Immunoassay Analyzing System. Sensitivity was determined from 110 positive clinical samples, and specificity from 143 negative samples. Sensitivity was further stratified by time post symptom onset.
Sensitivity100% (0-7 days, IgM); 93.8% (7-14 days, IgM); 88.9% (15+days, IgM); 100% (0-7 days, IgG); 100%(7-14 days, IgG); 100% (15+days, IgG)
Specificity97.2% (IgM), 100% (IgG)
Phase of  developmentReceived EUA and CE mark
Proposed releaseCurrent
DateAugust 17, 2020
 

 

Country of developmentCanada
Type of Serological TestRDT
Authors/CompanyBiocan Diagnostics Inc.
DescriptionBiocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Rapid Test is a lateral flow chromatographic immunoassay. The T2 line is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-SARS-CoV-2, the T1 line is pre-coated with reagents for the detection of IgM anti-SARS-CoV-2. The sensitivity was determined from 30 positive clinical samples and specificity from 79 negative samples.
SensitivityIgG: 93.3% IgM: 90%
SpecificityIgG: 96.2% IgM: 98.7%
Phase of  developmentReceived FDA EUA and CE mark
Proposed releaseCurrent
DateAugust 25, 2020

 

Country of developmentTaiwan/China
Type of Serological TestRDT
Authors/CompanyTBG Biotechnology Corp.
DescriptionThe TBG SARS-CoV-2 IgG / IgM Rapid Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human serum and plasma. Manufacterer reported sensitivity and specificity was determined from 56 positive samples and 482 negative samples. The test was also validated by the NCI, finding a sensitivity of IgG 93.3%/ IgM 93.3% and specificity of IgG 96.2%/ IgM 95.0%.
SensitivityIgG: 96.4% IgM: 87.5%
Specificity99.8%
Phase of  developmentReceived FDA EUA and CE mark, NCI validation studies complete
Proposed releaseCurrent
DateAugust 31, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyUniversity of Arizona Genetics Core for Clinical Services
DescriptionThe COVID-19 ELISA pan-Ig Antibody Test is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of total antibodies (including IgA, IgG, and IgM) to SARS-CoV-2 in human serum. Sensitivity and specificity was determined from 40 positive samples and 320 negative samples.
Sensitivity97.5%
Specificity99.1%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent, testing is limited to University of Arizona Genetics Core for Clinical Services
DateAugust 31, 2020

 

Country of developmentSouth Korea
Type of Serological TestRDT
Authors/CompanySugentech Inc.
DescriptionThe SGTi-flex COVID-19 IgG is a colloidal gold based lateral flow assay, specific for IgG to SARS-CoV2. The test strip is within a cassette, and the results can be read by eye within about 15 minutes. The assay detects IgG specific to the SARS-CoV-2 nucleocapsid and RBD of the spike protein. This test can use human serum, plasma, or whole blood samples. Sensitivity was determined from 185 positive clinical samples and stratified by time post symptom onset, and specificity from 234 negative clinical samples. The test was also validated by the NCI, with a sensitivity of 96.7%, and a specificity of 100%.
Sensitivity41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days)
Specificity99.15%
Phase of  developmentReceived FDA EUA, CE mark, Korea MFDS Product license, and Brazil ANVISA certified
Proposed releaseCurrent
DateSeptember 3, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyBioCheck, Inc.
DescriptionThe BioCheck SARS-CoV-2 IgG Antibody Test Kit uses an indirect method to determine the presence of SARS-CoV-2 IgG antibodies in a human serum. In the cassette, the SARS-CoV-2 IgG antibodies in a patient serum sample bind to biotinylated SARS-CoV-2 S1 antigens. Excess streptavidin coated magnetic beads bind with high affinity to biotinylated SARS-CoV-2 S1 antigen to form complexes. A luminescent substrate is added, and the enzymes in the complexes catalyze the luminescent substrate to form unstable excited state intermediates. When the excited intermediates return to the ground state, photons are emitted. The number of photons produced is positively correlated with the level of SARS-CoV-2 IgG antibodies in the sample.
Sensitivity100%
Specificity100%
Phase of  developmentReceived FDA EUA and CE mark
Proposed releaseCurrent
DateSeptember 9, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyBioCheck, Inc.
DescriptionThe BioCheck SARS-CoV-2 IgM Antibody Test Kit uses an indirect method to determine the presence of SARS-CoV-2 IgM antibodies in a human serum. In the cassette, the SARS-CoV-2 IgM antibodies in a patient serum sample bind to biotinylated SARS-CoV-2 S1 antigens. Excess streptavidin coated magnetic beads bind with high affinity to biotinylated SARS-CoV-2 S1 antigen to form complexes. A luminescent substrate is added, and the enzymes in the complexes catalyze the luminescent substrate to form unstable excited state intermediates. When the excited intermediates return to the ground state, photons are emitted. The number of photons produced is positively correlated with the level of SARS-CoV-2 IgM antibodies in the sample.
Sensitivity96.2%
Specificity97.2%
Phase of  developmentReceived FDA EUA and CE mark
Proposed releaseCurrent
DateSeptember 9, 2020

 

Country of developmentChina
Type of Serological TestCLIA
Authors/CompanyShenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE)
DescriptionThe MAGLUMI 2019-nCoV IgM/IgG assay uses a capture chemiluminescent immunoassay to detect IgM and IgG antibodies to SARS-CoV-2 recombinant spike and nucleocapsid proteins. This test should be run on the MAGLUMI 2000 platform. IgM and IgG are measured in two separate cassettes, though the results are displayed in a single report. Sensitivity was determined using 264 positive clinical samples, stratified by time. The manufacturer provides separate IgG and IgM sensitivity, though the combined sensitivity is presented here. Specificity was determined from 226 negative samples.
Sensitivity43.8% (0-7 days), 93.4% (8-14 days), 100% (15+ days)
Specificity98.67%
Phase of  developmentReceived EUA, and CE mark
Proposed releaseCurrent
DateSeptember 14, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyJiangsu Well Biotech Co., Ltd.
DescriptionThe Orawell IgM/IgG Rapid Test is a lateral flow immunoassay intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum and acid citrate dextrose (ACD) plasma. The test was also validated by the NCI, with a sensitivity of 100%, and a specificity of 94.8%.
Sensitivity97.1%
Specificity100%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateSeptember 23, 2020

 

Country of developmentSwitzerland
Type of Serological Testsolid-phase photometric immunoassay
Authors/CompanyQuotient Suisse SA
DescriptionThe MosaiQ COVID-19 Antibody Magazine detects IgM and IgG in patient serum samples, and operates using a microarray to detect antibodies. The test must be run on the high-throughput, MosaiQ instrument intended for use in central laboratories. The target antigen is the Spike protein. The test may detect antibodies as soon as 7 days post-PCR positivity. Sensitivity was determined using 30 positive clinical samples (15 were from days 8-14 post PCR positivity, and 15 from 15+ days), and specificity using 400 negative samples. An independent validation study did include samples from 0-7 days post PCR positivity (n=5), 8-14 days (n=9), and 15+days (n=86). Sensitivity was 100%, except after 15+ days, where it was 93%.
Sensitivity100%
Specificity99.8%
Phase of  developmentReceived EUA, and CE mark
Proposed releaseCurrent
DateSeptember 25, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyDiaSorin, Inc.
DescriptionThe method for qualitative determination of specific IgM to SARS-CoV-2 is an indirect chemiluminescence immunoassay (CLIA). SARS-CoV-2 spike receptor binding domain (RBD) antigen is used for coating magnetic particles (solid phase). The light signal, and hence the amount of isoluminol-antibody onjugate, is measured by a photomultiplier as relative light units (RLU) and indicates the presence or absence of antibodies to SARS-CoV2 present in calibrators, samples or controls. Sensitivity and specificity was determined with 81 positive and 2473 negative samples.
Sensitivity92.6%
Specificity99.3%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateSeptember 29, 2020

 

Country of developmentUS
Type of Serological Testimmunofluorescence assay
Authors/CompanyNanoEntek America, Inc.
DescriptionThe FREND™ cartridge utilizes micro-fluidics lateral flow technology where the analyte of interest in the sample forms immune complexes while moving through the fluidics pathway in the cartridge. A specimen is added to sample dilution tube and mixed. A well-mixed sample of 35 μL is transferred to the sample inlet of a single use FREND™ COVID-19 total Ab cartridge. The cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The FREND™ System is a bench-top fluorescence reader containing a touchscreen user interface. Sensitivity and specificity was determined with 33 positive and 12 negative samples.
Sensitivity100%
Specificity100%
Phase of  developmentReceived FDA EUA and CE mark
Proposed releaseCurrent
DateSeptember 29, 2020

 

Country of developmentUS
Type of Serological TestRDT
Authors/CompanyNirmidas Biotech, Inc.
DescriptionThis test uses the principle of colloidal gold immunochromatography, and capture method to detect COVID-19 (SARS-CoV-2) IgM and IgG antibodies in human serum and plasma. When the sample contains COVID-19 (SARS-CoV-2) IgM / IgG antibody and the concentration is greater than or equal to the minimum detection limit, the antibody binds to the S1 and RBD subunits of spike protein immobilized in test region M / test region G and captured by the secondary antibody to produce a red reaction line.
SensitivityIgM: 97.1%
IgG: 100%
Specificity94.8%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateSeptember 29, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyThermo Fisher Scientific
DescriptionThe OmniPATH COVID-19 Total Antibody ELISA Test detects IgG, IgM, and IgA antibodies. The ELISA can be run manually, or using the Dynex AGILITY automated ELISA workstation.The target antigen is recominant spike protein. Sensitivity was measured using 91 positive clinical samples, stratified by time post symptom onset. Specificity was measured using 162 negative samples. The test was also validated by the NCI, finding a sensitivity of 96.7% and specificity of 97.5%.
Sensitivity19% (0-7 days), 76.7% (8-14 days), 100% (15+days)
Specificity100%
Phase of  developmentReceived FDA EUA and CE mark
Proposed releaseCurrent
DateOctober 2, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyZEUS Scientific, Inc.
DescriptionThe ZEUS ELISA SARS-CoV-2 IgG Test System is an indirect, antibody capture enzyme-linked immunosorbent assay designed to detect IgG class antibodies to SARSCoV-2 (novel 2019 Coronavirus) in human serum or plasma collected in CLIA certified laboratories. The wells of the plastic microwell strips are coated with a mixture of recombinant S1 receptor binding domain (RBD) viral protein and recombinant nucleoprotein as the antibody capture antigens. Sensitivity and specificity were determined from 28 positive and 214 negative samples.
Sensitivity100%
Specificity99.1%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateOctober 6, 2020

 

Country of developmentUS
Type of Serological Testphotonic ring immunoassay (PRI)
Authors/CompanyGenalyte, Inc
DescriptionThe Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 is a qualitative assay to detect IgG and IgM antibodies specific to SARS-CoV-2. The photonic ring immunoassay uses silicon photonics to multiplex several antigens on a small chip. This allows for simultaneous detection of a variety of antibodies to different viruses. This assay can detect antibodies to SARS-CoV-2 nucleocapsid, full length spike, S1, S2, and RBD subunits. It also detects antibodies to the spike protein of the common coronaviruses, 229E, OC43, and HKU1, and to the nucleoprotein of NL63. Further, it can detect antibodies to influenza A H1 and H3 proteins, the S1 subunit of MERS, and the nucleoprotein of SARS-CoV-1. However, the test only reports positivity/negativity for SARS-CoV-2. The test must be run on the Maverick platform, and a proprietary algorithm analyzes the signal to determine test results. This table depicts the sensitivity and specificity measures for SARS-CoV-2 only. Sensitivity was determined using 338 positive clinical samples, stratified by time post sympto onset. Specificity was determined from 862 negative samples.
Sensitivity66.7% (0-7 days); 90.91% (8-14 days); 96.1% (15+ days)
Specificity97.7%%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateOctober 8, 2020

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyBeckman Coulter
DescriptionThe Access SARS-CoV-2 IgM assay detects IgM to the RBD of the spike protein of SARS-CoV-2 . The test should only be run on samples 8 days to 30 days post symptom onset. Sensitivity was determined using 173 positive clinical samples, and specificity using 1400 negative samples. Sensitivity is presented here for samples 8 days or more post symptom onset.
Sensitivity91.7%(8-14 days); 98.3%(15+ days)
Specificity99.9%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateOctober 8, 2020

 

Country of developmentUS
Type of Serological TestCMIA
Authors/CompanyAbbott Laboratories Inc.
DescriptionThe AdviseDx SARS-CoV-2 IgM test can be run on the Alinity i or Architect platforms, with separate instructions for use for each. This test should only be run with samples 15 days to 30 days post symptom onset. Sensitivity presented here is only for 15 days or more post-symptom onset. Sensitivity was determined using 40 positive clinical samples (for each platform), and specificity was determined using 2965 (Architect) and 2985 (Alinity) negative samples.
Sensitivity95%
Specificity99.56%
Phase of  developmentReceived FDA EUA
Proposed releaseCurrent
DateOctober 9, 2020

 

 

Tests that have been approved for diagnostic use in other countries

Country of developmentSingapore
Type of Serological TestNot explicity stated, though their "gold standard" is a neutralization assay
Authors/CompanySingapore/ Wang Lab
DescriptionThe Wang lab developed two tests. One, which has about 90% sensitivity, is rapid and uses recombinant viral proteins to detect reactive antibodies. The second is their "gold standard" and utilizes a viral neutralization assay but takes 3-5 days.
Sensitivity90%
Specificity 
Phase of developmentDeployed in Singapore
Proposed releaseNot stated
DateMarch 1, 2020

 

Country of developmentUS/China
Type of Serological TestRDT, solid phase immunochromatographic assay
Authors/CompanyAytu Biosciences/Orient Gene Biotech
DescriptionThe (COVID-19) IgG/IgM Rapid Test will assay patient antibodies to SARS-CoV-2 from blood or plasma samples.
Sensitivity87.9% (IgM) and 97.2% (IgG)
Specificity100% for IgG and IgM
Phase of developmentCE approved, used in China in clinical settings, awaiting FDA approval
Proposed releaseShipments should be ready by early April
DateMarch 10, 2020

 

Country of developmentUS/China
Type of Serological TestProprietary
Authors/CompanyScanWell Health/INNOVITA
DescriptionThis kit is for detection of IgG and IgM for SARS-CoV-2 in the blood, taking only 15 minutes, and is an at-home test.
Sensitivity87.3%
Specificity100%
Phase of developmentCleared by China's National Medical Products Administration (NMPA), and pending approval by US FDA
Proposed release6-8 weeks (May 1 to May 15), depending on FDA approval date
DateMarch 20, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyMayoClinic/University of Minnesota
DescriptionMayoClinic is developing an ELISA to test for antibodies to SARS-CoV-2. The types of antibodies are not stated, nor is sensitivity or specificity.
Sensitivity 
Specificity 
Phase of  developmentClinical
Proposed releaseApril 6, 2020
DateApril 1, 2020

 

Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyAdvaite
DescriptionRapCov Rapid COVID-19 Test is an in vitro diagnostic test for IgM and IgG antibodies. In a study with 18 healthy and 18 COVID-19 positive patients, the sensitivity was 89% and specificity was 100%. It should be noted that "specificity" was only performed on healthy patient samples, not patient samples from related viruses. Further testing is necessary to validate the test. It is currently being used to study community prevalence in Chester County, PA. https://advaite.com/press-release/advaite-deploys-covid-19-rapid-antibody-test-kits-to-chester-county-and-collaborates-with-pennsylvania-companies-to-scale-up-manufacturing/
Sensitivity 
Specificity 
Phase of  developmentResearch use only (IVD), not approved for diagnostic use. This company was not found on any FDA categorization of tests
Proposed releaseApril 2020
DateApril 6, 2020

 

Country of developmentSwitzerland
Type of Serological TestMIRA - Multiplexed Immuno-Refractive Assay
Authors/CompanyQuotient
DescriptionAn antibody microarray running on the CE marked MosaiQ instrument. The test looks for both IgM and IgM. Time to initial results is 35 minutes and the machine can process 1000 microarrays in an eight hour shift.
Sensitivity100%
Specificity99.8%
Phase of  developmentCE/IVD; in process of applying for FDA EUA
Proposed releaseCurrently available in Europe; manufacturing capacity of 30M per year rate in 2020, 60M per year within 18 months
DateMay 1, 2020

 

Country of developmentUnited Kingdom
Type of Serological TestRDT
Authors/CompanyEdinburgh Genetics
DescriptionColloidal gold lateral flow assay for the detection of IgM and IgG antibodies in human serum, plasma or whole blood
Sensitivity100%
Specificity98.7%
Phase of  developmentReceived CE/IVD
Proposed releaseCE/IVD usage in Europe
Date 

 

Country of developmentMexico
Type of Serological TestRDT
Authors/CompanyKabla Clinical Diagnostics
DescriptionColloidal gold lateral flow assay for the detection of IgM and IgG antibodies in human serum, plasma or whole blood. In collaboration with Certum Diagnostics.
Sensitivity99.9% (IgG) 85% (IgM)
Specificity98% (IgG) 96% (IgM)
Phase of  developmentReceived CE/IVD, emergency use authorized in Mexico, Brazil, and other countries
Proposed releaseCurrent
Date 

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyRingbio
DescriptionThe kit is based on immunochromatographic assay, to detect COVID-19 IgG & IgM antibody in serum / plasma / blood. Sensitivity and specificity was calculated from 132 clinical samples.
SensitivityIgM: 89.4%
IgG: 97.9%
SpecificityIgM: 97.7%
IgG: 97.7%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
Date5/28/2020

 

Country of developmentSpain
Type of Serological TestDouble Recognition ELISA
Authors/CompanyIngenasa (via Gold Standard Diagnostics)
DescriptionThe INgezim COVID assays use the SARS-CoV-2 nucleoprotein (N protein) as the antigen for the detection of antibodies to SARS-CoV-2. This test can use serum or plasma samples. The test uses SARS-CoV-2 recombinant N protein as a coating and conjugate. Sensitivity and specificity were determined using 116 positive samples and 249 negative samples.
Sensitivity98.3%
Specificity99.2%
Phase of  developmentReceived CE mark; undergoing FDA EUA review
Proposed releaseCurrent
Date 

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyGold Standard Diagnostics
DescriptionThe GSD SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum and plasma.
SensitivityIgG: 100% (>12 days)
IgM: 44% (>12 days)
IgA: 88.9% (>12 days)
SpecificityIgG: 100%
gM: 99%
IgA: 100%
Phase of  developmentReceived CE mark; undergoing FDA EUA review
Proposed releaseCurrent
Date 

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyVIROTECH Diagnostics GmbH (via Gold Standard Diagnostics)
DescriptionThe VIROTECH SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum.
SensitivityIgG:100% (>12 days)
IgM: 77.8% (>12 days)
IgA: 77.8% (>12 days)
SpecificityIgG: 100%
IgM: 100%
IgA: 100%
Phase of  developmentReceived CE mark; undergoing FDA EUA review
Proposed releaseCurrent
Date 

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyNovaTec Immundiagnostica GmbH (via Gold Standard Diagnostics)
DescriptionThere are 3 NovaLisa tests for COVID-19 IgG, IgM, and IgA. The ELISA tests can use serum or plasma samples.
SensitivityIgG: 100% (>12 days)
IgM: 40% (>12 days)
IgA: 88.9% (>12 days)
SpecificityIgG: 99.3%
IgM: 100%
IgA: 98.3%
Phase of  developmentReceived CE mark; undergoing FDA EUA review
Proposed releaseCurrent
Date 

 

Country of developmentSpain
Type of Serological TestRDT
Authors/CompanyIngenasa (via Gold Standard Diagnostics)
DescriptionINgezim® COVID 19 CROM qualitatively determines the total antibodies (IgG, IgA, and IgM) specific to SARS-CoV2 virus N in a single blood, serum or plasma sample by using nucleoprotein (N protein) as an antigen for detection of antibodies to the virus. Sensitivity and specificity were determined using 286 positive samples and 146 negative samples.
Sensitivity90.7%
Specificity99.3%
Phase of  developmentReceived CE mark; undergoing FDA EUA review
Proposed releaseCurrent
Date 

 

Country of developmentUK
Type of Serological TestELISA
Authors/CompanyErba Mannheim (IgG test)
DescriptionThe ErbaLisa COVID-19 IgG Enzyme Immunoassay (ELISA) kit for the detection of IgG antibodies to SARS-CoV-2 in human serum. The total incubation time is 50 min at room temperature with a simple one step serum dilution.
Sensitivity98.3%
Specificity98.1%
Phase of  developmentReceived CE mark, FDA Notification status (not yet EUA)
Proposed releaseCurrent
Date 

 

Country of developmentUK
Type of Serological TestELISA
Authors/CompanyErba Mannheim (IgM test)
DescriptionThe ErbaLisa COVID-19 IgM Enzyme Immunoassay (ELISA) kit for the detection of IgM antibodies to SARS-CoV-2 in human serum.The total incubation time is 50 min at room temperature with a simple one step serum dilution.
Sensitivity100%
Specificity90%
Phase of  developmentReceived CE mark, FDA Notification status (not yet EUA)
Proposed releaseCurrent
Date 

 

Country of developmentUS
Type of Serological TestDried blood spot
Authors/CompanyPerkinElmer
DescriptionThe PerkinElmer® GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit has been designed to run dried blood samples on the fully automated and high throughput screening GSP® instrument, as well as serum/plasma on a manual time-resolved fluorescence reader, e.g. VICTOR2™ D instrument.
Sensitivity96.2%
Specificity98.7%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
Date 

 

Country of developmentUS
Type of Serological TestCLIA
Authors/CompanyPerkinElmer
DescriptionThe SuperFlex™ Anti-SARS-CoV-2 IgG kit product is an immunoassay intended for qualitative detection of anti-SARS-CoV-2 IgG in human serum, plasma (EDTA, sodium citrate) and venous whole blood on Automated chemiluminescence analyzer. The test is performed using superparamagnetic microparticles together with direct chemiluminescence technology to detect anti-SARS-CoV-2 IgG.
Sensitivity90.3%
Specificity100%
Phase of  developmentReceived CE mark
Proposed release 
DateCurrent

 

Country of developmentUK
Type of Serological TestRDT
Authors/CompanyAbingdon Health
DescriptionThe “AbC-19TM Rapid Test” uses a small drop of blood from a finger-prick, and shows results in 20 minutes.The test detects IgG antibodies to SARS-CoV-2. Sensitivity and specificity were determined using 203 positive samples and 450 negative samples.
Sensitivity98%
Specificity99.6%
Phase of  developmentReceived CE mark
Proposed releaseCurrent, roll-out by the end of August
DateJuly 30. 2020

 

Country of developmentUS
Type of Serological TestRDT
Authors/CompanyNOWDiagnostics
DescriptionThe ADEXUSDx® COVID-19 Test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies to deliver accurate and reliable results in 15 minutes with no buffers, reagents, or additional equipment. The test uses a drop of fingerstick blood to obtain results.
Sensitivity95.6%
Specificity98.5%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
Date 

 

Country of developmentSweden
Type of Serological TestRDT
Authors/CompanyZetaGene Ltd.
DescriptionThe ZetaGene COVID-19 Rapid IgM IgG Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum or plasma (EDTA, citrate) specimens from patients suspected of COVID-19 infection by a healthcare provider.
Sensitivity95%
Specificity97%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
Date 

 

Country of developmentSingapore
Type of Serological TestELISA
Authors/CompanyRestalyst
DescriptionThe COVID19N-REAAD test assays for IgG antibodies to SARS-CoV-2 nucleocapsid protein. The sensitivity was determined from 56 positive clinical samples and specificity from 331 negative samples.
Sensitivity98.2%
Specificity100%
Phase of  developmentReceived CE mark and provisional authorization from the Singapore Health Sciences Authority
Proposed releaseCurrent
DateAugust 25, 2020

 

Country of developmentUK
Type of Serological TestRDT
Authors/CompanyMologic/Visitect
DescriptionThe lateral flow assay developed by Mologic (also under the name Visitect) detects IgG, IgA, and IgM to SARS-CoV-2. The company stated that the test will be used in primary care settings.
SensitivityNot available
SpecificityNot available
Phase of  developmentReceived CE Mark, validated by London School of Tropical Medicine and Hygiene, St. George's, and the University of London.
Proposed releaseAccording to a press release, the company can produce up to 100,000 tests per week.
Date 

 

Country of developmentCanada
Type of Serological TestELISA
Authors/CompanyVictory Square
DescriptionThe VS Health’s Safetest Covid-19 IgG /IgM detects antibodies using an ELISA method. There is not currently a product insert or description available beyond the press release.
Sensitivity93.3%
Specificity98.7%
Phase of  developmentReceived CE mark and Brazilian Anvisa approval.
Proposed releaseCurrent
DateSeptember 14, 2020

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyImmunodiagnostik
DescriptionIDK® anti-SARS-CoV-2 IgM is an enzyme-linked immunosorbent assay (ELISA) for qualitative measurement of IgM antibodies against the novel coronavirus SARSCoV-2 in human serum or EDTA plasma. The assay is an in vitro diagnostic medical device and is intended to be used by professional users in a laboratory environment. This ELISA can be performed manually or using an automated platform.
Sensitivity95%
Specificity97.6%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
DateAugust 25, 2020

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyImmunodiagnostik
DescriptionIDK® anti-SARS-CoV-2 IgG is an enzyme-linked immunosorbent assay (ELISA) for qualitative measurement of IgG antibodies against the novel coronavirus SARS-CoV-2 in human serum or EDTA plasma. The assay is an in vitro diagnostic medical device and is intended to be used by professional users in a laboratory environment. This ELISA can be performed manually or using an automated platform.
Sensitivity100%
Specificity99.1%
Phase of  developmentReceived CE mark
Proposed releaseCurent
DateAugust 25, 2020

 

Country of developmentGermany
Type of Serological TestELISA
Authors/CompanyMediagnost
DescriptionMediagnost Anti-SARS-CoV-2 ELISA is a highly specific Enzyme Immunoassay for the detection of IgG antibodies directed against SARS-CoV-2-S1 Receptor Binding Domain (RBD) in human blood.
Sensitivity95.3%
Specificity98.6%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
DateJuly 7, 2020

 

Country of developmentUK
Type of Serological TestRDT
Authors/CompanySureScreen
DescriptionThe test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies.
Sensitivity97.8%
Specificity99.6%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
Date 

 

Country of developmentSwitzerland
Type of Serological TestECLIA
Authors/CompanyRoche
DescriptionThe Elecsys Anti-SARS-CoV-2 S test is a quantitative immunoassay to detect patient IgG antibodies against the SARS-CoV-2 spike protein. The test should be run on Roche cobas e analyzers. Sensitivity was determined using 5,991 positive clinical samples, and specificity using 1423 negative samples. This test differs from the Elecsys Anti-SARS-CoV-2 test (granted EUA in June) in that it detects antibodies specific to the Spike protein (rather than the nucleocapsid), and is quantitative rather than qualitative.
Sensitivity99.98%
Specificity98.8%
Phase of  developmentReceived the CE mark
Proposed releaseCurrent
DateSeptember 18, 2020

 

Country of developmentSingapore
Type of Serological TestRDT
Authors/CompanyMP Biomedicals Asia Pacific
DescriptionMP Diagnostics ASSURE® SARS-CoV-2 IgG/IgM Rapid Test is a immunochromatographic test which uses immobilized mouse antihuman IgG and IgM antibodies for capturing IgG and IgM antibodies in the human serum, plasma or whole blood with anticoagulants. The presence of IgG and IgM antibodies against SARS-CoV-2 are detected by the colloidal gold-labeled SARSCoV-2 recombinant proteins. Sensitivity and specificity were determined from 6 positive and 170 negative clinical samples.
Sensitivity100%
Specificity99.4%
Phase of  developmentReceived CE mark and Singapore Health Sciences Authority provisional authorization
Proposed releaseCurrent
DateJuly 21, 2020

 

Country of developmentUK
Type of Serological TestELISA
Authors/CompanyNovacyt/Microgen Bioproducts
DescriptionThe Microgen Bioproducts SARS-CoV-2 IgG EIA test detects IgG in patient plasma and serum. The test was validated on 112 positive clinical samples and 1561 negative samples. The test can be performed manually, but has the potential to be automated.
Sensitivity99.4%
Specificity100%
Phase of  developmentReceived CE mark
Proposed releaseCurrent
DateSeptember 28, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyThermo Fisher Scientific
DescriptionThe EliA SARS-CoV-2-Sp1 IgG test is a quantitative test specific for IgG antibodies. The test can run up to 60 samples per hour, and must be run on the Thermo Scientific Phadia 250 platform. Sensitivity and specificity were not available at the time of writing.
Sensitivity 
Specificity 
Phase of  developmentReceived CE mark
Proposed releaseCurrent
DateOctober 12, 2020

 

Country of developmentCanada
Type of Serological TestRDT
Authors/CompanybioLytical
DescriptionThe INSTI COVID-19 antibody assay is a rapid, lateral flow based test that takes 1 minute until results are readable by eye. The test requires a fingerprick blood sample. No sensitivity or specificity data was yet available.
Sensitivity 
Specificity 
Phase of  developmentReceived CE mark
Proposed releaseCurrent
DateOctober 15, 2020

 

 

Tests that have been approved for research or surveillance purposes only

Country of developmentUS
Type of Serological TestRDT
Authors/CompanyBioMedomics
DescriptionThis assay detects patient antibodies, IgG and IgM, on a lateral flow assay. It uses a recombinant viral antigen, though it does not state the specific antigen. The test is a 3 line read-out, one line for a control, one line to detect IgM, and one to detect IgG. Three lines indicates the patient has both IgG and IgM. Sensitivity was measured from 397 positive patients, and specificity from 128 negative patients.
Sensitivity88.6%
Specificity90.63%
Phase of developmentUnder development
Proposed releaseBD has stopped selling the kit, as it is not approved under the new FDA serology test guidelines. They are planning to resubmit the test for a new EUA once they have validated the second generation version of the test.
DateMay 12, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyCreative Diagnostics
DescriptionKit DEIASL019 detects patient IgG for SARS-CoV-2, and uses the whole virus lysate as the antibody binding target. The reported sensitivity and specificity are 100% (from 16 and 30 samples, respectively). The DEIA2020 kit only tests for patient IgG that reacts to N protein.
Sensitivity100%
Specificity100%
Phase of developmentNot approved for diagnostic use; for research use only
Proposed releaseavailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateMarch 20, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyEagle Biosciences
DescriptionThis company has two kits, one (KTR-1032) which targets patient IgG, and one (KTR-1033) that targets IgM. The target antigen is an "HRP-labeled-COVID-19 antigen." Sensitivity was determined from 30 positive patients, and specificity was determined from 54 negative patients.
Sensitivity100%
Specificity100%
Phase of developmentResearch use only, CE/IVD outside the US
Proposed releaseavailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateDate not given

 

Country of developmentChina/US
Type of Serological TestRDT, immunofluorescence, colloidal gold
Authors/CompanyBioEasy/Shenzhen BioEasy Biotechnology Co.
DescriptionThere are three tests: 1) the 2019 nCoV Ag test, which assays sputum or nasal swabs for SARS-CoV-2 antigens and gives a fluorometric read out, 2) the 2019-nCoV Ag GICA test, which uses colloidal gold, and 3) the 2019 nCoV IgG/IgM GICA rapid test which assays for patient antibodies to the virus from blood samples
Sensitivity 
Specificity 
Phase of developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateDate not given

 

Country of developmentGermany
Type of Serological TestELISAs
Authors/CompanyEuroimmun AG
DescriptionThis company has two tests, including EI 2606-9601 A, which tests for patient IgA, and EI 2606-9601 G, which tests for patient IgG. The target antigens were not stated, nor were specificity or sensitivity of tests.
Sensitivity 
Specificity 
Phase of developmentResearch use only, CE/IVD in EU
Proposed releaseCE/IVD in the EU
DateMarch 12, 2020

 

Country of developmentGermany
Type of Serological TestRDT, lateral flow assay
Authors/CompanyPharmACT
DescriptionThis RDT tests for IgM and IgG of patients, with 92-98% sensitivity in later stages of the infection (day 11-24) with 100% sensitivity.
Sensitivity92-98%
Specificity100%
Phase of developmentResearch use only
Proposed releaseAppears available for purchase by research labs/healthcare providers, but no clear approvals
DateDate not given

 

Country of developmentChina
Type of Serological TestNot listed
Authors/CompanySnibe Co
DescriptionThe company provides two tests the 2019-nCoV IgG , and 2019-nCoV IgM tests. The test is a chemiluminescent immunoassay (CLIA). It has been clinically tested in China, though the exact specificity and sensitivity was not stated.
Sensitivity 
Specificity 
Phase of developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateFeb. 19, 2020

 

Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanySanuo Biotech
DescriptionThe SARS-Cov-2 Antibody Test strip tests for patient IgG and IgM. The press release did not disclose sensitivity or specificity of the test.
Sensitivity 
Specificity 
Phase of developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateMarch 12, 2020

 

Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanyBioTime
DescriptionThe SARS-CoV-2 IgG/IgM kit tests for patient antibodies to the virus from blood or plasma samples. There is no reported sensitivity or specificity.
Sensitivity 
Specificity 
Phase of developmentOnly approved for in vitro diagnostic use
Proposed releaseavailable for purchase by research labs/healthcare providers
DateDate not given

 

Country of developmentThe Republic of Korea
Type of Serological TestRDT
Authors/CompanyGenBody
DescriptionGenBody FIA COVID-19 IgM/IgG (COVI025)
Sensitivity 
Specificity 
Phase of developmentResearch use only, CE/IVD in EU
Proposed releaseCE/IVD in the EU
DateMarch 2, 2020

 

Country of developmentUnited Kingdom
Type of Serological TestRDT
Authors/CompanyMologic
DescriptionSeems to be an RDT (probably to IgM and IgG). No description was given, other than they received 1 million pounds investment from the UK government.
Sensitivity 
Specificity 
Phase of  developmentThey are validating now with Liverpool Trop Med and St. Georges, London
Proposed releaseDate not given
DateMarch 29, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyLivzon Diagnostics
DescriptionRDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2.
Sensitivity 
Specificity 
Phase of  developmentResearch use only, CE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers
DateDate not given

 

Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyConfirm Biosciences
DescriptionThis RDT detects IgM and IgG, though the target antigen is unclear. Sensitivity appears to be 93.8%, and sensitivity is 99.1%, in 704 samples tested. The location of the trial was not disclosed.
Sensitivity93.1%
Specificity99.1%
Phase of  developmentResearch use only, not approved by the FDA
Proposed releaseAvailable for purchase by research labs/healthcare providers
DateApril 15, 2020

 

Country of developmentUK
Type of Serological TestELISA
Authors/CompanyAdams et al (Liverpool School of Tropical Medicine and Hygiene)
DescriptionThe authors developed an in-house ELISA, with recombinant SARS-CoV-2 trimeric spike protein. They were testing for IgM and IgG, against RT-qPCR. They found, in 31 samples, there was 100% sensitivity for IgG after 10 days post symptom onset.
Sensitivity100%
Specificity 
Phase of  developmentResearch use only
Proposed releaseNot stated
DateApril 20 2020

 

Country of developmentUS
Type of Serological TestRDT
Authors/CompanyAbcam
DescriptionThe Abcam Novel Coronavirus IgM Antibody Detection Kit detects IgM specific to the SARS-CoV-2 nucleocapsid protein. Their Novel Coronavirus IgG Antibody detects IgG specific to the nucleocapsid protein as well. Specificity and sensitivity are not stated.
Sensitivity 
Specificity 
Phase of  developmentAvailable for purchase by healthcare/research professionals. Not approved by the FDA. Under section IV.D
Proposed releaseCurrent
DateApril 21, 2020

 

Country of developmentUS
Type of Serological TestNot stated
Authors/CompanyAdvanced Diagnostics Laboratory, National Jewish Health
DescriptionThis test can test for IgG or IgM to SARS-CoV-2, and was developed in-house. The assay specificity and sensitivity were not stated.
Sensitivity 
Specificity 
Phase of  developmentResearch use only. Not yet authorized by the FDA, but in th EUA application process
Proposed releaseCurrent
DateApril 24, 2020

 

Country of developmentCanada
Type of Serological TestRDT
Authors/CompanyArtron
DescriptionThis test is an RDT that detects IgG and IgM to SARS-2-CoV. The target antigen is not stated. The sensitivity is 93.4% and the specificity is 97.7%, in testing over 180 positive samples and over 500 negative samples. The kit was also recently used in a study (https://www.medrxiv.org/content/10.1101/2020.04.22.20075564v1.full.pdf) on IgM and IgG antibodies in COVID-19 patients. After 2 weeks, IgM was detected 95.8% in positive cases, and IgG was detected in 62.5% of cases.
Sensitivity93.4%
Specificity97.7%
Phase of  developmentNot FDA authorized (subsection IV.D). For research use only
Proposed releaseCurrent
DateApril 27, 2020

 

Country of developmentUS
Type of Serological TestChemiluminescent immunoassay
Authors/CompanyBioCheck
DescriptionThe BioCheck MS-FAST system and SARS-CoV-2 chemiluminescence-based tests can process blood, serum, or plasma samples in 30 minutes to detect IgM and IgG antibodies.
Sensitivity 
Specificity 
Phase of  developmentApplying for FDA EUA
Proposed releaseAvailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateApril 15, 2020

 

Country of developmentGermany
Type of Serological TestRDT
Authors/CompanyAlphaBiolabs
DescriptionThe Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect both early and late marker IgG/IgM antibodies in human finger-prick blood samples.
Sensitivity99.9% IgM and 91.8% IgM
Specificity99.5% IgG and 99.2% IgM
Phase of  developmentCE approved
Proposed releaseAvailable for purchase by research labs/healthcare providers, CE approved
Date 

 

Country of developmentUS
Type of Serological TestProtein microarray
Authors/CompanyKrishnamurthy et al.
DescriptionThis group worked to improve upon ELISA based methods with a protein microarray that allows for multiplexing (pooling) of samples. Dried blood spots were found to be usable for this type of test. For the study, they had 158 positive samples and 1418 negative. Overall sensitivity was varied, and sensitivity/specificity reported here is reflective of when all antigens and all antibodies were combined. There was no cross-reactivity to antibodies to other coronaviruses.
Sensitivity98.1%
Specificity98.6%
Phase of  developmentResearch use only
Proposed releaseNot stated
DateMay 5, 2020

 

Country of developmentUS
Type of Serological TestNeutralizing antibodies
Authors/CompanyVyriad, Inc./Regeneron
DescriptionThe test relies on a pseudovirus that has been engineered to express the SARS-CoV-2 spike glycoprotein on its surface. Human serum samples are then analyzed for neutralizing antibody titers. The type of cell in which this is tested was not stated in the press release.
Sensitivity 
Specificity 
Phase of  developmentUnder internal validation and submitted for EUA.
Proposed releaseExpected to be available in CLIA certified labs by late May
DateMay 12, 2020

 

Country of developmentUS
Type of Serological TestChemiluminescence immunoassay
Authors/CompanyAccelerate Diagnostics/BioCheck
DescriptionThe test is called BioCheck MS-FAST.This test is run on the BioCheck platform to rapidly detect IgM and IgG to SARS-CoV-2 in patient serum samples. The test takes about 30 minutes.
Sensitivity 
Specificity 
Phase of  developmentUnder development, submitted for EUA
Proposed release 
Date 

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyUniversity of Kentucky
DescriptionThe University of Kentucky College of Medicine FCIM lab is developing an ELISA assay for detection of antibodies to SARS-CoV-2 in patient samples. The target antigen is the spike protein. While the sensitivity and specificity were unavailable, the researchers state that the test is accurately identifying positive COVD-19 cases and did not react to negative samples.
Sensitivity 
Specificity 
Phase of  developmentUnder development
Proposed release 
DateMay 11, 2020

 

Country of developmentUS
Type of Serological TestSingle molecule array (Simoa)
Authors/CompanyNorman et al
DescriptionThis group used single molecule array assay to measure total antibodies to SARS-CoV-2. The Simoa protocol has shown, in other cases, 1000-fold improvement in sensitivity over standard ELISA, and it allows analysis of multiple types of antibodies and antigens at once. The target antigens are Spike Protein, S1 subunit, Receptor Binding Domain (RBD), and Nucleocapsid protein.
SensitivityFirst week of infection, 86%; second week of infection and onward, 100%
Specificity100%
Phase of  developmentPreclinical
Proposed releaseNot stated
DateMay 5, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyVitalant/UCSF
DescriptionIt appears that Vitalant (a blood donation company) and UCSF have teamed up to make an in-house antibody test for SARS-CoV-2. It is an ELISA based assay, though they have not disclosed which antibodies are detected.
Sensitivity 
Specificity 
Phase of  developmentIn development
Proposed releaseDate not given
DateMarch 31, 2020

 

Country of developmentSpain
Type of Serological TestELISA
Authors/CompanyColavita et al./Diesse Diagnostica
DescriptionResearchers developed an ELISA to detect IgA, IgG, and IgM from serum samples of patients. The test, ENZY-WELL SARS-CoV-2 ELISA, uses native viral protein (but does not specify which protein). Sensitivity and specificity were determined from 200 positive and 353 negative clinical samples. Sensitivity was optimal in samples obtained greater than 10 days after symptom onset.
Sensitivity92.5% (IgG), 93.6% (IgA), 87% (IgM)
Specificity91.7% (IgG) , 97.9% (IgA), 88% (IgM)
Phase of  developmentResearch use only, CE/IVD approved
Proposed release 
Date 

 

Country of developmentUS
Type of Serological TestModified neutralization assay
Authors/CompanyGenscript
DescriptionThis test uses a pseudovirus expressing the RBD of the spike protein to assay the ability of antibodies to block virus interaction with ACE2 receptors. This is not a traditional neutralization assay, in that it does not require live cells. It is a "blocking ELISA" assay. Essentially, if there is an antibody that blocks interaction of the RBD with ACE2, then there is no color change. A lack of neutralizing antibodies results in a color change. Sensitivity was determined from 60 clinical samples, and specificity from 97 negative clinical samples.
Sensitivity93%
Specificity100%
Phase of  developmentResearch use only; currently has CE/IVD approval (EU) and HSA approval (Singapore)
Proposed release 
DateMay 26, 2020

 

Country of developmentRepublic of Korea
Type of Serological TestLateral flow assay (RDT)
Authors/CompanyGenBody Inc.
DescriptionLateral flow assay for SARS-CoV-2 IgM and IgG. Results can be read within 10 minutes. Samples can be serum, plasma, or whole blood
Sensitivity91.7%
Specificity95.2%
Phase of  developmentCE/IVD
Proposed releaseCurrently licensed for use in Brazil and Australia in addition to CE/IVD status
Date 

 

Country of developmentRepublic of Korea
Type of Serological Testfluorescence immunoassay
Authors/CompanyBoditech Med Inc.
DescriptionThis test is intended to be used with the company's accompanying AFIAS-6 or AFIAS-1 analyzer machine. Results from SARS-CoV-2 IgM and IgM can be read in 10 minutes. Blood can either be whole plasma or finger-stick specimens.
Sensitivity95.8%
Specificity96.7%
Phase of  developmentCE/IVD
Proposed releaseCurrently licensed for use in Brazil in addition to CE/IVD status
DateMarch 30, 2020

 

Country of developmentUK
Type of Serological TestRDT
Authors/CompanyBBI Solutions
DescriptionThe AbC-19 is an RDT, lateral flow assay that detects IgM and IgG. The test is designed for at-home use. Sensitivity was determined from 203 positive samples, and specificity from 450 negative samples. They used the EuroImmun assay as their standard. Further validation will be performed after MHRA approval at Ulster University.
Sensitivity98.03%
Specificity99.6%
Phase of  developmentReceived CE mark
Proposed releaseThe test is still under validation with the MHRA, but the test is designed for at-home use. The test is available for commercial distribution for use by research professionals.
DateJuly 30, 2020

 

Country of developmentUS
Type of Serological Testmodified ELISA
Authors/CompanyPromega
DescriptionLumit™ Dx Immunoassay, a SARS-CoV-2-specific protein fragment is labeled with the two subunits of the NanoBiT® Luciferase (Lumit™ Dx CoV-2-SmBiT and Lumit™ Dx CoV-2-LgBiT). When these labeled proteins are incubated with a serum or plasma sample that contains SARS-CoV-2 antibodies, the proteins bind to the antibody, bringing the SmBiT and LgBiT subunits in close proximity to form an active luciferase. A bright luminescent signal is generated following the addition of the Lumit™ Dx Detection Reagent and detected using a luminescent-capable microplate reader. Unlike conventional ELISA assays, the Lumit™ Dx SARS-CoV-2 Immunoassay requires no wash steps. Sensitivity and specificity were determined using 107 positive samples and 31 negative samples.
Sensitivity93.5%
Specificity100%
Phase of  developmentPending FDA EUA, NCI validation ongoing
Proposed releaseTest available for purchase by CLIA labs in the US, but still awaiting EUA
Date 

 

Country of developmentSouth Korea
Type of Serological TestRDT
Authors/CompanyCelltrion
DescriptionCelltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is an in vitro diagnostic test based on an immunochromatographic assay. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibodies of the novel Coronavirus (COVID-19) in human whole blood, plasma or serum. Sensitivity and specificity were determined using 50 positive samples and 75 negative samples.
SensitivityIgG: 92% IgM: 96%
SpecificityIgG: 100% IgM: 98.7%
Phase of  developmentPending FDA EUA, NCI validation ongoing
Proposed releaseBy the third week of August 2020 in the US
Date 

 

 

Tests that are still in development

Country of developmentUS
Type of Serological TestCRISPR-based lateral flow assay
Authors/CompanyBroughton et al (Mammoth Biosciences)
DescriptionUsing a CRISPR-Cas12 based method, they can specifically detect virus RNA for the E and N genes. This is called the DETECTR assay, and does not assay for patient antibodies, but the presence of viral RNA. The CRISPR-Cas12 RNA targeting is followed by isothermal amplification of the target, resulting in a visual readout with a fluorophore.This was 90% sensitive and 100% specific.
Sensitivity90%
Specificity100%
Phase of developmentPre-clinical
Proposed releaseIn development
DateMarch 10, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyCDC
DescriptionThe CDC is currently using an ELISA based test, with a target antigen of whole Spike (S) protein. Sensitivity was determined from 99 patients, and specificity from over 500 patients, some of whom had other coronavirus infections. They found that using a 1:100 dilution of human serum was optimal. Sera samples from patients with SARS-CoV-1 or MERS-CoV did yield a positive result, but all other sera positive for other coronaviruses did not cross react.
Sensitivity96%
Specificity99%
Phase of developmentNot EUA approved, Research use only
Proposed releaseCurrently released for research use only
DateMay 27, 2020

 

Country of developmentNetherlands
Type of Serological TestELISA
Authors/CompanyOkba et al
DescriptionModifying existing beta version ELISA kits (EUROIMMUN Medizinische Labordiagnostika AG) for IgG or IgA, and an in-house ELISA kit, they coated plates with recombinant S1 domain of the spike protein. The commercially available kits are not yet approved for use. They found that the kits were sensitive and specific for the S1 region of SARS-CoV-2, looking at 45 samples overall.
Sensitivity 
Specificity 
Phase of developmentPre-clinical
Proposed releaseNot stated
DateMarch 20, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyJiangsu bioPerfectus technologies
DescriptionThis company has two tests, the PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit and the PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit. The IgM/IgG test assays for patient antibodies to the virus from a blood sample, while the Ag Rapid test assays for SARS-CoV-2 antigen from nasal swab samples.
Sensitivity 
Specificity 
Phase of developmentDeveloped, awaiting approval
Proposed releaseAppears available for purchase by research labs/healthcare providers in China, but no clear approvals
DateMarch 3, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyKlein lab, JHSPH
DescriptionThey have adapted an ELISA, based on Amanat et al 2020, that tests for IgG and IgM to the full length Spike protien and to the receptor binding domain (RBD). They are now working to get a mucosal IgA ELISA working. So far, they are using the kit to test samples from Johns Hopkins Hospital.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot given, but being used for research use
DateApril 6, 2020

 

Country of developmentChina
Type of Serological TestELISA
Authors/CompanyZhang et al
DescriptionThis group developed an in-house ELISA testing for patient antibodies (IgM and IgG) to the SARSr-CoV Rp3 nucleocapside (N) protein. They found that on day 5, 81% of patients were positive for IgM and 100% were positive for IgG (of 16 COVID-19 positive patients).
Sensitivity81% (IgM) and 100% (IgG)
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot given
DateFebruary 17, 2020

 

Country of developmentChina
Type of Serological TestChemiluminescence immunoassay
Authors/CompanyQian et al
DescriptionUsing a fully automated chemiluminescent assay on a YHLO Biotech analyzer, Qian and colleagues processed the serum of patients with or without COVID-19 at 10 hospitals. They tested for IgM and IgG to the nucleocapsid and spike proteins (both recombinant). Clinical sensitivity (in over 500 samples) of IgM was 85.88% and to IgG 96.62%, relative to rRT-qPCR. They used over 900 samples from patients with diseases other than COVID-19, as well as over 500 non-hospitalized (healthy) patient samples to determine specificity. They found the test to be 97.33% for hospitalized patients.
Sensitivity85.6% (IgM) and 96.62% (IgG)
Specificity99.49% (IgM) and 99.1% (IgG)
Phase of  developmentPre-clinical development
Proposed releaseNot stated
DateApril 21, 2020

 

Country of developmentChina
Type of Serological TestChemiluminescent immunoassay
Authors/CompanyMa et al.
DescriptionThis lab based chemiluminescent assay detects IgM, IgG, and IgA (all serum) against the SARS-CoV-2 nucleocapsid and spike receptor binding domains. Using samples from 87 positive patients, they found that sensitivity was improved when using the RBD rather than the N protein. RBD based test results were used for sensitivity and specificity.
Sensitivity98.6% (IgA), 96.8% (IgM), and 96·8% (IgG)
Specificity98.1% (IgA), 92.3% (IgM), and 99·8% (IgG).
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateApril 22, 2020

 

Country of developmentUSA
Type of Serological TestMicrofluidic ELISA
Authors/CompanyOptofluidic Bioassay
DescriptionThis startup, based out of the University of Michigan, has a microfluidic chip that allows rapid ELISA assays. The chip can utilize a variety of reagents, so companies that have developed target viral antigens and anti-IgM or IgG antibodies could adapt their assay for use on this chip. The test only takes 15 minutes, and requires a few drops of blood. Sensitivity and specificity were not listed, but will likely depend on the reagents used.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateApril 26, 2020

 

Country of developmentHong Kong/US
Type of Serological TestELISA, micro-neutralisation (MN) and plaque reduction neutralisation tests (PRNT)
Authors/CompanyPerera et al.
DescriptionPerera and colleagues sought to create a sensitive ELISA, matched with a novel microneutralization assay. They also performed plaque reduction neutralization assays. The MN assay has the advantage of higher throughput, though results take 4 days. The MN and PRNT assays had significant agreement, validating the MN assay. This shows not only antibody titers, but the neutralizing capability. Several sensitivities were recorded at different time points during the assay. The sensitivities listed here are from 11-18 days post symptom onset, from 14 samples.
Sensitivity92.8% (IgM) and 71.4% (IgG) measured by ELISA; 64% were positive in the MN assay; 92.8% were positive in the PRNT assay
Specificity100% in MN assay
Phase of  developmentPre-clinical
Proposed releaseNot listed
DateApril 23, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyMcDade et al.
DescriptionThis group sought to improve ELISA based methods by using dried blood spots, rather than serum samples from venipuncture, for detection of antibodies to SARS-CoV-2. The receptor binding domain of the spike protein was used as a target. They found that both blood spiked with viral antigen, as well as with 9 PCR-positive patient samples, there was a significant signal difference relative to negative samples.
Sensitivity 
Specificity 
Phase of  developmentPreclinical
Proposed releaseNot stated
DateMay 5, 2020

 

Country of developmentFrance
Type of Serological TestIndirect immunofluorescence assay
Authors/CompanyColson et al.
DescriptionThis indirect immunofluorescence test was developed in order to detect three types of antibodies in patient samples. They validated the test using 888 COVID-19 positive patient samples, and 200 negative patient samples as controls. There was limited reactivity in patients with non-SARS-CoV-2 coronavirus infection.
Sensitivity 
Specificity100% for IgA; 98.6% for IgM; and 96.3% for IgG
Phase of  developmentPre-clinical
Proposed release 
DateMay 12, 2020

 

Country of developmentFrance
Type of Serological TestChemiluminescence immunoassay
Authors/CompanyRosado et al.
DescriptionIn studying antibody profiles of COVID-19 patients, the researchers developed an assay to detect antibodies to SARS-CoV-2. IgG and IgM antibodies to four SARS-CoV-2 Spike (S) antigens: spike trimeric ectodomain (Stri), its receptor-binding domain (RBD), spike subunit 1 (S1), and spike subunit 2 (S2) could be detected.
Sensitivity96.1
Specificity99.1
Phase of  developmentPre-clinical
Proposed release 
DateMay 11, 2020

 

Country of developmentGermany
Type of Serological TestFlow cytometry
Authors/CompanyLapuente et al.
DescriptionFlow cytometric assay to determine SARS-CoV-2 spike protein specific antibodies (IgM and IgM) in serum samples
Sensitivity100%
SpecificityNot specified
Phase of  developmentPre-clinical
Proposed release 
DateMay 13, 2020

 

Country of developmentFrance
Type of Serological TestIndirect immunofluorescence assay
Authors/CompanyEdouard et al.
DescriptionDetects SARS-CoV-2-specific IgM, IgG, and IgA antibodies through fluoresence readouts of diluted serum samples with inactivated antigen
SensitivityNot specified
Specificity100% for IgA, 98.5% for IgM, and 95.9% for IgG.
Phase of  developmentPre-clinical
Proposed release 
DateMay 12, 2020

 

Country of developmentSingapore/US
Type of Serological TestRDT
Authors/CompanySingapore-MIT Alliance for Research and Technology (SMART)
DescriptionResearchers are developing a paper based RDT that can use saliva or nasal swab samples for an easy to use diagnostic. This RDT is being developed with funding support from the National Medical Research Council (NMRC) to develop a rapid test to detect antibodies against the S and N proteins. This is a collaborative effort between SMART, Nanyang Technological University (NTU), and Massachusetts Institute of Technology (MIT).
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateMay 19, 2020

 

Country of developmentUS
Type of Serological TestNanosensor
Authors/CompanyPourmand Lab
DescriptionNader Pourmand (UC Santa Cruz) recently received funding to apply his nanosensor biotechnology for use in diagnostics for COVID-19 along with Pinpoint Science. The sensor chip would be fabricated by Analog Devices. This technology would be a point-of-care, rapid test. The nanosensor technology relies on changes in electric current through the nanopipette in the system. In the nanopipette opening, there are viral proteins to which patient antibodies can attach. If there are these complexes, this will disrupt an electric current passed through the pore. So far, they have found that sensitivity is far greater (100 times) in this system than in conventional methods such as ELISA, detecting as low as 1 femtogram per milliliter.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated, though sensor chips will be available by April 2020. They are proposing to apply for EUA by September 2020.
DateMay 14, 2020

 

Country of developmentUS
Type of Serological TestChemiluminescent immunoassay
Authors/CompanyPrandad et al.
DescriptionResearchers at Johns Hopkins University and Emory University developed a bead-based immunoassay to detect IgM, IgG, and IgA antibodies in the saliva of patients. This would be far less invasive in sample collection. The researchers also investigated which viral protein would be optimal for use in this diagnostic. They compared 33 saliva samples with 206 serum samples that were positive, and 134 saliva and 112 serum samples that were negative. There were 28 matched samples, in which IgG and IgM were strongly correlated in saliva and serum. The highest sensitivity and specificity were with the Genscript N protein, and Mt. Sinai RBD (S) protein, after 10 days post symptom onset.
Sensitivity100% (Genscript N protein, IgG), 61% (IgA), 65% (IgM)
Specificity98-100% (IgG, IgA, and IgM)
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateMay 26, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyKlumpp-Thomas et al. (NIH)
DescriptionResearchers at the NIH developed a highly specific ELISA that can use fresh and dried blood samples. The target antigens are full length Spike protein, and the RBD of Spike protein, to increase specificity. The test can detect IgG, IgM, and IgA. Sensitivity was determined from 14 positive controls, while specificity was from 100 samples.
Sensitivity100%
Specificity100% (IgG), 100% (IgM), 99% (IgA)
Phase of  developmentPre-clinical
Proposed releasenot stated
DateMy 27, 2020

 

Country of developmentThe Netherlands
Type of Serological TestMultiplex bead-based immunoassay
Authors/CompanyHartog et al.
DescriptionThis test detects IgG specific to the spike S1 protein, spike RBD, and N protein by incubating serum with pre-coated microbeads that fluoresce upon antigen-antibody binding. Each target antigen was incubted to bind on their own specific beads and then patient serum was added to allow for binding to occur. Results were read by a Luminex reader.
Sensitivity90.9%-98.8%
Specificity100%
Phase of  developmentPre-clinical
Proposed releaseNot stated, work pre-published in pre-print
DateJune 20, 2020

 

Country of developmentUS
Type of Serological TestModified ELISA, surface plasmon resonance (SPR)
Authors/CompanyWistar Institute
DescriptionThis is a surrogate neutralization assay, utilizing ELISA and SPR to test for antibodies able to block the interaction between ACE2 and viral spike protein. In both assays, the interaction between patient antibodies and viral spike protein leads to a colorimetric/refraction readout if ACE2 interaction is blocked. This can measure levels of neutralizing antibodies without a BSL-3 setting. Sensitivity and specificity were not listed.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releasenot stated
DateJune 20, 2020

 

Country of developmentUK
Type of Serological TestELISA
Authors/CompanyFaustini et al.
DescriptionThis group from the University of Birmingham developed an in-house ELISA and surface plasmon resonance system to detect IgM, IgA, and IgG antibodies. They used the S1 region, RBD, N protein, and full length spike glycoprotein as target antigens. They also used a truncated version of humane ACE2 protein for surface plasmon resonance. They found that the trimeric Spike glycoprotein was optimal for antibody detection.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releasenot stated
DateJune 18, 2020

 

Country of developmentUS
Type of Serological TestMass spectrometry (CyTOF)
Authors/CompanyGeanon et al.
DescriptionThis group used an adapted mass cytometry system, CyTOF, to look at immune cells and cytokine profiles of patients. This assay uses Fluidigm MaxPar Direct Immune Profiling Assay (MDIPA), a dry tube 30-marker immunophenotyping panel, and SmartTube Proteomic Stabilizer,.They did find that the sample preparation can negatively impact the detection of antibodies, as well as chemokines like reduced staining index for CD25 and CD127, which are typical of CD4+ T cells. But, if the SmartTube prep is performed after staining the cells with MDIPA, then the samples are well preserved. They found that this method could allow you to use small blood samples from patients to essentially track how the immune system was reacting--through immune cell development and immune signaling molecules.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releasenot stated
DateJune 28, 2020

 

Country of developmentIsrael
Type of Serological TestElectrochemiluminescent assay
Authors/CompanyMunitz et al.
DescriptionThis research group developed an ECLIA to detect IgM, IgA, and IgG antibodies to the spike protein RBD and to the nucleoprotein (N). Using a combined IgM, IgA, and IgG detection, the specificity and sensitivity were increased in 96 positive and 190 negative individuals. This was all after 14 days or more post symptom onset.
Sensitivity100%
Specificity95%
Phase of  developmentPre-clinical
Proposed releasenot stated
DateJune 30, 2020

 

Country of developmentIsrael
Type of Serological TestElectrochemiluminescent assay
Authors/CompanyMunitz et al.
DescriptionThis research group developed an ECLIA to detect IgM, IgA, and IgG antibodies to the spike protein RBD and to the nucleoprotein (N). Using a combined IgM, IgA, and IgG detection, the specificity and sensitivity were increased in 96 positive and 190 negative individuals. This was all after 14 days or more post symptom onset.
Sensitivity100%
Specificity94.9%
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateJune 30, 2020

 

Country of developmentCanada
Type of Serological TestNeutralization assay
Authors/CompanyAbe et al.
DescriptionThis is a surrogate neutralization assay, using ELISA based methods to quantify patient antibodies that can block virus protein interaction with the human ACE2 receptor. Instead of using an anti-human antibody that is coupled to a reporter, they use a recombinant version of hACE2 with a reporter. Then, they can see if it binds. Essentially, the less ACE2 binding, the better neutralization. Sensitivity and specificity were not stated.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateJuly 11, 2020

 

Country of developmentUS
Type of Serological TestNeutralization assay
Authors/CompanySuhandynata et al.
DescriptionThis neutralization assay uses a pseudovirus for detection of neutralizing antibodies in patient samples. They developed the assay for both SARS-CoV-2 and SARS-CoV-1. This pseudovirus also has a firefly luciferase reporter, so the infection rate of HeLa cells (that express hACE2) can be measured by luciferase quantification.
Sensitivity96.6%
Specificity98.8%
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateJuly 11, 2020

 

Country of developmentUS
Type of Serological TestSurrogate neutralization assay
Authors/CompanyZheng et al.
DescriptionThey made a pseudovirus neutralization assay using murine leukemia virus capsids and a modified minimal MLV genome encoding firefly luciferase for quantification. They did not present a sensitivity or specificity, but this would allow for a neutralization assay in a BSL2 environment.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateJuly 18, 2020

 

Country of developmentUS
Type of Serological TestBiolayer interferometry immunosorbent assay (BLI-ISA)
Authors/CompanyDzimianski et al.
DescriptionThis is a novel serology assay. This biolayer interferometry immunosorbent assay (BLI-ISA) tests antigen levels, antibody levels, and isotypes all in a point of care format (and only takes 20 minutes). This assay essentially depends on interference of light passage between two layers, a reference and biosensor layer. If molecules bind the biosensor, then the wavelength shifts and the optical fiber can detect it. This is often used to measure binding kinetics. They do not present sensitivity or specificity.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateJuly 19, 2020

 

Country of developmentGermany
Type of Serological TestSurrogate neutralization assay
Authors/CompanyBosnjak et al.
DescriptionThis is an ELISA-based surrogate neutralization assay. They found NAbs in the sera of mildly (90%) and severely infected (100%) patients (n=44). Their test also correlated well to a pseudovirus neutralization assay.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
Date 

 

Country of developmentChina
Type of Serological TestQuantum dot lateral flow assay
Authors/CompanyLiu et al.
DescriptionThey developed a a quantum-dot lateral flow immunoassay strip (QD-LFIA) based portable fluorescence smart-phone system for detection of specific IgM/IgG to SARS-CoV-2 in human serum samples. This is an easy to use, point of care, 15 minute assay. They validated it with 97 positive clinical samples and 450 negative samples. Rather than colorimetric, the read out is fluorescent and requires a laser-based "strip reader." The paper has a figure on how it works.
Sensitivity99%
Specificity99.7%
Phase of  developmentPre-clinical
Proposed releasenot states
DateJuly 24, 2020

 

Country of developmentChina
Type of Serological TestPseudovirus neutralization assay
Authors/CompanyNie et al.
DescriptionThis test is a pseudovirus-based neutralization assay for evaluation of anti-viral measures for SARS-CoV-2, which would be used to evaluate the inhibition of viral attachment and entry mediated by the S protein. Neutralization was measured by the reduction in luc gene expression.
SensitivityNot stated
SpecificityNot stated
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in peer-reviewed literature
DateMarch 24, 2020

 

Country of developmentUS
Type of Serological TestELISA
Authors/Company
Stadlbauer et al.
DescriptionThis test is a two‐stage ELISA in which the first stage includes relatively high‐throughput screening of samples in a single serum dilution against the RBD. This is followed by a second stage in which positive samples from the first stage undergo a confirmatory ELISA against the full‐length spike protein.
SensitivityNot stated
SpecificityNot stated
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in peer-reviewed literature
DateApril 17, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyChen et al.
DescriptionLateral flow immunoassay that uses a recombinant nucleocapsid phosphoprotein and self-prepared lanthanide-doped polysterene nanoparticles to detect anti-SARS-CoV-2 IgG in human serum. After the sample is run on the strip, it is read on a fluorescence reader to confirm results.
Sensitivity100%
Specificity87.5%
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in peer-reviewed literature
DateMay 19, 2020

 

Country of developmentChina
Type of Serological TestRDT
Authors/CompanyChen et al.
DescriptionLateral flow immunoassay that uses a recombinant nucleocapsid phosphoprotein and self-prepared lanthanide-doped polysterene nanoparticles to detect anti-SARS-CoV-2 IgG in human serum. After the sample is run on the strip, it is read on a fluorescence reader to confirm results.
Sensitivity100%
Specificity87.5%
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in peer-reviewed literature
DateMy 19, 2020

 

Country of developmentBrazil
Type of Serological TestELISA
Authors/CompanyHuergo et al.
DescriptionThis test is a bead-based ELISA, which the authors found to be more sensitive in regard to dilution of patient serum (in a single sample) than other commercially available ELISA tests. This can be used for IgM and IgG antibodies, the target antigen is the nucleocapsid protein, and it only takes 12 minutes to run. They had 6 positive clinical samples, and 26 negative samples, to determine sensitivity and specificity. This assay seems optimal for low-titer antibody samples, as it can detect antibodies even in highly diluted samples.
Sensitivity100%
Specificity100%
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in pre-print literature
DateJuly 29, 2020

 

Country of developmentGermany
Type of Serological Testsurrogate neutralization assay
Authors/CompanyBosnjak et al
DescriptionThis study focused on creating a novel surrogate neutralization assay to measure the neutralizing antibodies present. It is essentially a modified ELISA that tests blocking of hACE2:Spike interactions. They found that it correlated well with a pseudovirus neutralization assay.
Sensitivitynot listed
Specificitynot listed
Phase of  developmentPre-clinical
Proposed releaseNot stated, though it was used in the recent study led by Behrens et al involving seroprevalence of healthcare workers.
DateJuly 14, 2020

 

Country of developmentUS
Type of Serological Testelectrochemical impedance-based sensing (EIS)
Authors/CompanyRashed et al.
DescriptionThis test uses rapid label-free electrochemical signals to detect the binding activity of SARS-CoV-2 antibodies to the SARS-CoV-2 RBD. The test uses ACEA Biosciences’ 16-well plate xCELLigence system (a commercially available impedance sensing platform). The test returns quantitative results and provided comparable results against a standard ELISA.
SensitivityNot stated
SpecificityNot stated
Phase of  developmentPre-clinical
Proposed releaseNot stated; published in peer-reviewed literature
Date 

 

Country of developmentUS
Type of Serological Testneutralization assay
Authors/CompanyOguntuyo et al
DescriptionThey made a new version of a virus neutralization assay, CoV2pp, which consists of manufactured pseudotyped particles. They did this so that you could get an efficient measure of Ab neutralization, without needed BSL3. They compared their assay to true neutralization, and modified ELISAs, and found a good correlation. They validated the test, and also had 3 other labs validate it. They also made sure to have the late and early pathways of ACE2 interaction represented in cell culture. Importantly, these CoV2pp particles can be manufactured at scale so that you can do a lot of testing (150,000 per week).
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releasenot stated
DateAugust 17, 2020

 

Country of developmentUS
Type of Serological TestDried blood spot
Authors/CompanyLiu et al.
DescriptionResearchers obtained discarded newborn dried blood spots from Yale New Haven Hospital and then adapted a standardized Solid Phase ELISA Serology Assay for detecting anti-SARS-CoV-2 antibody for use on the newborn DBS. Recombinant SARS CoV-2 S1 protein (ACROBiosystems #S1N-C52H3) was used as the antigen. Anti-SARS-CoV-2 IgG was measured in all samples, and IgM was measured in DBS where the IgG result was positive.
Sensitivitynot stated
Specificitynot stated
Phase of  developmentPre-clinical
Proposed releasenot stated
DateAugust 16, 2020

 

Country of developmentIndia
Type of Serological Testbio-layer Interferometry
Authors/CompanyLokireddy et al.
DescriptionOnCovid total antibody (IgG/IgM/IgA) assay uses BLI platform to detect antibodies against SARS-CoV-2 using Spike S1 subunit and Nucleocapsid protein. This method can use finger-stick blood and does not require additional steps such as washing, incubation, substrate addition etc. The authors state that the biosensors can be reused up to 50 times. OnCovid uses virus specific ligands immobilized on the sensor and the patient plasma containing the antibodies is used as an analyte. The interference pattern of white light by the biosensor is taken in real time and the calculated binding rate is then correlated with standard to quantify the real amount antibody present in the given biological samples.
Sensitivity100%
Specificity100%
Phase of  developmentPre-clinical
Proposed releasenot stated
DateAugust 17, 2020

 

Country of developmentJapan
Type of Serological TestChemiluminescence reduction neutralization test (CRNT)
Authors/CompanyTani et al.
DescriptionThis is a pseudovirus neutralization assay, that detects neutralizing antibodies present in patient serum specific to the spike protein of SARS-CoV-2. The pseudovirus is vesicular stomatitis virus, which has been engineered to express Spike protein (full length and truncated) as well as a luciferase reporter. Before infection with pseudovirus, cells were incubated with convalescent patient serum. The cells were then incubated with pseudovirus for 24 hours and luciferase activity was then read. Results correlated well with IFA microscopy studies.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releasenot stated
DateAugust 21, 2020

 

Country of developmentGermany
Type of Serological TestPooled flow cytometry
Authors/CompanyNessler et al.
DescriptionThis test, developed at the University of Goettingen allows pooled serology testing. This is a cell based assay, and requires flow cytometry to measure the antibodies present.The protocol specifies that this is pooled testing of up to 24 patient samples, coupled with a testing algorithm that identified that two-step pooling (of fixed pool sizes) is optimal. The test detects antibodies specific to the S1 region of spike protein. They validated their assay using the Abbott and Euroimmun assays (both of which have EUA approval). They also used a pseudovirus neutralization assay to better understand the types of antibodies detected, finding that 21/23 samples that were positive for antibodies also had neutralizing activity. Currently, this is a purely lab-based assay in pre-clinical development. Sensitivity was not stated, though there was a correlation between their results and Abbott (r=0.87) and Euroimmun (r=0.71)
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateSeptember 4, 2020

 

Country of developmentUS
Type of Serological Testaerosol jet nanoparticle electrochemical sensor
Authors/CompanyAzahar-Ali et al
DescriptionThis assay seems to be a novel serology test that can detect antibodies interacting with a coated electrode within seconds, and quickly re-load the electrode via a pH change. According to the authors, Aerosol Jet (AJ) nanoparticle 3D printing is a technique that allows a fine, aerosolized coating of electrodes. Their kit is called the 3D Printed COVID-19 Test Chip (3DcC) platform. Basically, interactions of patient antibodies and viral antigen cause a change in the electrochemical measurement. This allows a really sensitive measurement, as low as 1 pM of antibodies. It is not clear what kind of sample this would need.
Sensitivity 
Specificity 
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateSeptember 13, 2020

 

Country of developmentCanada
Type of Serological TestELISA
Authors/CompanyHuynh et al
DescriptionThis assay is an ELISA that they developed to detect IgA, IgM, and IgG in patients. They used 10 positive clinical samples and 4 negative. Sensitivity is 95-98%, and most samples (11/14) corresponded with the Euroimmun/Abbott assay results.
Sensitivity95-98%
Specificitynot stated
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateSeptember 13, 2020

 

Country of developmentAustralia
Type of Serological TestELISA
Authors/CompanyHicks et al.
DescriptionUsing an ELISA-based approach to that combines data 62 about IgG responses to both the Nucleocapsid and Spike-receptor binding domain antigens, 63 we show that near-optimal sensitivity and specificity can be achieved.
SensitivityNot stated
SpecificityNot stated
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateSeptember 9, 2020

 

Country of developmentUS
Type of Serological TestMicrosphere-based immunoassay
Authors/CompanyCameron et al.
DescriptionThis pre-print details a surrogate neutralization assay, called Luminex FLEXMAP 3D system (Flex3). This multiplex assay is microsphere-based, and detects antibodies to 3 different SARS-CoV-2 antigens: Spike, RBD, and Nucleocapsid. The assay can also use soluble ACE2 to determine the potential neutralization capability of antibodies. Sensitivity was determined using 188 positive clinical samples, stratified by time since symptom onset. Specificity was determined from 213 samples. Sensitivity listed here is for 21 days or more, though all are listed in the pre-print. Specificity was 100%, as they used the pre-pandemic samples to establish background signal.
Sensitivity97.3%
Specificity100%
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateOctober 6, 2020

 

Country of developmentUK
Type of Serological TestHaemagluttination assay
Authors/CompanyTownsend et al
DescriptionThis study, led by the University of Oxford, developed a haemagluttination assay to detect antibodies to the RBD section of the spike protein. The test can be run in a point of care setting, and reagents can be lyophilized for ease of transport. Sensitivity was determined from 98 positive samples, and specificity from 199 negative samples.
Sensitivity90%
Specificity99%
Phase of  developmentPre-clinical
Proposed releaseNot stated
DateOctober 6, 2020

 

 

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