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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 June 2, 2020.

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

Navigation:

  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/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/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 TestRDT
Authors/CompanyAutobio Diagnostics Co. Ltd. (jointly with Hardy Diagnostics)
DescriptionThis test detects IgM and IgG via lateral flow assay. IgM test line sensitivity was approximately 95.7%. IgG test line sensitivity was approximately 99%. Specificity for both IgM and IgM were reported around 99%.
Sensitivity95.7% (IgM) and 99% (IgG)
Specificity99% (both IgM and IgG)
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 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/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
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/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 postive).
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 postive).
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

 

 

Tests that have been approved for diagnostic use in other countries

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 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
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 

 

 

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 TestChemiluminescent immunoassay
Authors/CompanyBabson Diagnostics
DescriptionThe primary chemiluminescent assay is to detect IgG against SARS-CoV-2. The company has reported that 440 samples can run per hour, per analyzer, using the Atellica platform.
Sensitivity93.2%
Specificity100%
Phase of  developmentNot FDA approved, in development
Proposed releaseIn development, though the company has stated that they plan to provide tests to the Austin, TX area healthcare workers and retailers, as well as researchers, first.
DateApril 30, 2020

 

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

 

 

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

 

 

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