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Serology tests for COVID-19

Serology testing for SARS-CoV-2 continues to be in high demand because it can help to better quantify the total number of cases of COVID-19 to date. This type of testing is valuable because it can identify those who may have been asymptomatic and recovered. Serology tests measure the levels of specific antibodies in the blood, revealing whether a person has been exposed to a particular pathogen by looking at their immune response. 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 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 provides up-to-date information on serology tests that have received emergency use authorization (EUA) available for use. These tests are not approved for diagnosis of acute, active SARS-CoV-2 infection, but may indicate previous exposure to the virus. Negative results do not rule out prior or current infection. Active infection should be diagnosed using an antigen or molecular diagnostic test.

 

Disclaimer

This list is updated twice weekly, and only includes tests that have received a US Food and Drug Administration EUA. It only includes tests for which data and documentation is available and for which their stated intended use aligns with their regulatory status. This site is not intended to be used as a reference for funding or grant proposals. Noninclusion in this list should not be interpreted as judgment on validity or legitimacy of tests.

 

Note on sensitivity and specificity data

The manufacturer-reported sensitivity and specificity data is listed, 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 in the extended versions of the tables.

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 US FDA recommends that manufacturers use these terms to indicate that a non-reference standard was used when evaluating the test.

 

More information on serology tests:

 

This page was last updated on September 21, 2021.

Tests that have been authorized for use

Download the complete list of tests authorized for use (xlsx). Included in the complete list are descriptions and phase of development.

Name of TestManufacturerType of testSensitivitySpecificity
SGTi-flex COVID-19 IgGSugentech Inc.RST41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days)99.2%
Rapid COVID-19 IgM/IgG Combo Test KitMegna Health, Inc.RSTIgM: 73.81%, IgG, 73.81, Combined: 90.5%IgM: 99.7%, IgG:99.3%, Combined: 98.9% 
QUANTA Flash SARS-CoV-2 IgGInova Diagnostics, Inc. ChLIA66.7% (0-7 days), 61.5% (7-14 days), and 100% (15+ days)99.90%
Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody TestQuanterix Corporationparamagnetic microbead-based sandwich ELISA45.2% (0-7 days), 87.5% (7-14 days), and 100% (15+ days)99.2%%
MidaSpot COVID-19 Antibody Combo Detection KitNirmidas Biotech, Inc.RST76.9% (7-14 days), 100% (15+ days)100.00%
COVID-19 Self-Collected Antibody Test SystemSymbiotica, Inc.Home collection, ELISA100% (8-14 days), 100% (15+ days)98.00%
Dimension EXL SARS‑CoV‑2 IgG (CV2G)Siemens Healthcare Diagnostics Inc.ChLIA61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days)100.00%
Dimension Vista SARS‑CoV‑2 IgG (COV2G)Siemens Healthcare Diagnostics Inc.ChLIA61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days)100.00%
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent PackOrtho Clinical DiagnosticsChLIA80% (0-8 days), 100% (8+ days)100%
SCoV-2 Detect IgM ELISAInBios International, Inc.ELISA93%99%
Access SARS-CoV-2 IgG IIBeckman Coulter, Inc. ELISA81.8% (0-7 days), 95.8% (8-14 days), 98.9% (15+ days)100%
T-Detect COVID TestAdaptive Biotechnologies Corporationmultiplex PCR, NGS97.10%99%
AdviseDx SARS-CoV-2 IgG IIAbbott Laboratories Inc.CMIAARCHITECT: 49.33% (0-7 days), 82.6% (7-14 days), 98.1% (15+ days);
Alinity I: 49.33% (0-7 days), 80.43% (7-14 days), 98.1% (15+ days)
99.55% (both ARCHITECT and Alinity I)
IDS SARS-CoV-2 IgGImmunodiagnostic Systems LtdChLIA60.9% (0-7 days), 80.% (7-14 days), 97.6% (15+ days)100%
UBI SARS-CoV-2 ELISAUnited Biomedical, Inc.ELISA38.5% (0-7 days), 79.5% (7-14 days), 100% (15+ days)100.00%
EliA SARS-CoV-2-Sp1 IgG TestPhadia ABFluoroenzyme Immunoassay15.4% (0-7 days), 58.2% (7-14 days), 97.6% (15+ days)99.40%
RapCov Rapid COVID-19 TestADVAITE, Inc.RST90.00%95.20%
Sign COVID-19 IgG/IgM Rapid Test CassetteHangzhou Laihe Biotech Co., LtdRST100% (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)99.43%
ACON SARS-CoV-2 IgG/IgM Rapid TestACON Laboratories, Inc.RST100% (0-7 days), 100% (8-14 days), 100% (15+ days)95.90%
Innovita 2019-nCoV Ab Test (Colloidal Gold)Innovita (Tangshan) Biological Technology Co., Ltd.RST(For combined IgG/IgM) 95.6% (8-14 days), 100% (15+ days)98.03%
LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)Hangzhou Laihe Biotech Co., LtdRST100% (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)99.43%
 (ARCHITECT and Alinity i systems)Abbott Laboratories Inc.Chemiluminescent microparticle immunoassay (CMIA)43% (3-7 days); 78.9% (8-14 days); 100% (15+ days)99.60%
Elecsys Anti-SARS-CoV-2 S (semi-quantitative)RocheEChLIA90.6% (0-7 days), 87% (8-14 days), 96.6% (15+days)100.0%
COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody KitKantaro Biosciences LLCELISA100% (0-7 days), 100% (7-14 days), 98.87% (15+ days)99.6%
Orawell IgM/IgG Rapid TestJiangsu Well Biotech Co., Ltd.RST97.1%100.0%
BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative TestXiamen Biotime Biotechnology Co., LtdRSTIgG: 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+)99.23%%
Access SARS-CoV-2 IgMBeckman CoulterChLIA91.7%(8-14 days); 98.3%(15+ days)99.9%
cPass SARS-CoV-2 Neutralization Antibody Detection KitGenScript USA, Inc.Modified ELISA100.0%100.0%
Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)Siemens Healthcare Diagnostics Inc.ChLIA91.3% (7-13 days), 100% (15+ days)99.8%
Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Inc.ChLIA91.3% (7-13 days), 100% (15+ days)99.8%
CareStart COVID-19 IgM/IgGAccess Bio, Inc.RST96.7% (IgG); 89% (IgM); 98.44% (combined)99.45% (IgM); 99.45%(IgG); 98.9% (combined)
Platelia SARS-CoV-2 Total Ab assayBio-Rad Modified ELISA98%99%
Q-Plex SARS-CoV-2 Human IgG (4 Plex)Quansys Biosciences, Inc. ELISA100% (0-7 days, n=4), 100% (8-14 days, n=13), 95.2% (15+days, n=22)99.70%
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent PackOrtho-Clinical Diagnostics, Inc.ChLIA83% (12-15 days), 100% (15 days+) 
Elecsys Anti-SARS-CoV-2RocheEChLIAFrom 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100%99.81%
LIAISON SARS-CoV-2 S1/S2 IgGDiaSorin Inc.ChLIA90% (8-14 days), 97% (15+ days)98%
Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Heifei) Co. Ltd.RST33% (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+)99.46% (IgM), 100% (IgG)
MosaiQ COVID-19 Antibody MagazineQuotient Suisse SAsolid-phase photometric immunoassay100.0%99.8%
AdviseDx SARS-CoV-2 IgM (ARCHITECT and Alinity i systems)Abbott Laboratories Inc.CMIA95%99.6%
Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2Genalyte, Incphotonic ring immunoassay (PRI)66.7% (0-7 days); 90.91% (8-14 days); 96.1% (15+ days)97.7%%
ZEUS ELISA SARS-CoV-2 IgG Test SystemZEUS Scientific, Inc.ELISA100%99.1%
OmniPATH COVID-19 Total Antibody ELISA TestThermo Fisher ScientificELISA19% (0-7 days), 76.7% (8-14 days), 100% (15+days)100%
Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection KitNirmidas Biotech, Inc.RSTIgM: 97.1%
IgG: 100%
94.80%
FREND COVID-19 total AbNanoEntek America, Inc.immunofluorescence assay100.0%100.0%
DiaSorin LIAISON SARS-CoV-2 IgM AssayDiaSorin, Inc.ChLIA92.60%99.3%
Assure COVID-19 IgG/IgM Rapid Test DeviceAssure Biotech (Hangzhou Co, Ltd.)RST95%100%
SARS-CoV-2 IgG (ARCHITECT and Alinity i)Abbott Laboratories Inc.Chemiluminescent microparticle immunoassay (CMIA)0% (0-3 days), 25% (3-7 days), 86.4% (8-13 days), and 100% (14+ days)99.63%
MAGLUMI 2019-nCoV IgM/IgGShenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE)ChLIA43.8% (0-7 days), 93.4% (8-14 days), 100% (15+ days)98.67%
BioCheck SARS-CoV-2 IgM Antibody Test KitBioCheck, Inc.ChLIA93.7%(8-14 days), 88.9% (15+ days)97.2%
BioCheck SARS-CoV-2 IgG Antibody Test KitBioCheck, Inc.ChLIA100%100%
COVID-19 ELISA pan-Ig Antibody TestUniversity of Arizona Genetics Core for Clinical ServicesELISA97.5%99.1%
TBG SARS-CoV-2 IgG / IgM Rapid Test KitTBG Biotechnology Corp.RSTIgG: 96.4%
IgM: 87.5%
99.8%
Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody TestBiocan Diagnostics Inc.RSTIgG: 93.3%
IgM: 90%
IgG: 96.2%
IgM: 98.7%
BioCheck SARS-CoV-2 IgG and IgM Combo TestBioCheck, Inc.ChLIA100% (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)97.2% (IgM), 100% (IgG)
Diazyme DZ-Lite SARS-CoV-2 IgM CLIA KitDiazyme Laboratories, Inc.ChLIA26.1% (0-7 days); 83.3% (7-14 days), 94.4% (15+days)98.30%
VIDAS SARS-CoV-2 IgMbioMérieux SAEnzyme linked fluorescent assay (ELFA)53.8% (0-7 days), 100% (7-14 days), 100%(15+)99.4%%
VIDAS SARS-CoV-2 IgGbioMérieux SAEnzyme linked fluorescent assay (ELFA)49% (0-7 days), 100% (7-14 days), 100% (15+days)99.9%%
WANTAI SARS-CoV-2 Ab ELISABeijing Wantai Biological Pharmacy Enterprise Co., Ltd.ELISA55.4% (0-7 days), 84.8% (7-14 days), 98.7% (15+ days)98.6%
Atellica IM SARS-CoV-2 IgG (COV2G)Siemens Healthcare Diagnostics Inc.ChLIA56% (0-6 days), 92%(7-14 days), 100% (14+ days)99.9%
ADVIA Centaur SARS-CoV-2 IgG (COV2G)Siemens Healthcare Diagnostics Inc.ChLIA53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days)99.9%
xMAP SARS-CoV-2 Multi-Antigen IgG AssayLuminexFluorescent microbead-based immunoassay (FMIA)Serum: 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)Serum: 100%, Plasma: 99.2%
Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test CassetteSalofa OyRST100% for IgM and IgG100% for IgM and IgG
WANTAI SARS-CoV-2 Ab Rapid TestBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.RST94.7%98.9%
Diazyme DZ-Lite SARS-CoV-2 IgG CLIA KitDiazyme Laboratories, Inc.ChLIA92%97%
Access SARS-CoV-2 IgGBeckman Coulter, Inc.ChLIA75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days)100%
Babson Diagnostics aC19G1Babson DiagnosticsChLIA/indirect sandwich immunoassay66.7% (8-14 days), 100% (15+ days), 100% (asymptomatic)100%
SARS-CoV-2 RBD IgG testEmory UniversityELISA73% (days 0-7), 100% (days 8-14), 100% (days 14+)97.7% (prior to pandemic), 94.4% (PCR negative HCW)
SCoV-2 Detect IgG ELISAInBios International, Inc.ELISA97.8%98.9%
Sign COVID-19 IgG/IgM Rapid Test CassetteHangzhou Biotest Biotech Co., LtdRST96.3% (8-14 days), 94.9% (15+ days) (IgM);  91.6% (8-14 days), 96.2% (15+ days) (IgG)98.1% (IgM), 99.52% (IgG)
Vibrant COVID-19 Ab AssayVibrant America Clinical LabsChLIA98.1%98.6%
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)Healgen Scientific LLCRST96.7% (IgG),86.7 % (IgM), 96.7% combined98% (IgG), 99% (IgM), 97% combined
Atellica IM SARS-CoV-2 Total (COV2T)Siemens Healthcare Diagnostics Inc.ChLIA60.7% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).99.82%%
ADVIA Centaur SARS-CoV-2 Total (COV2T)Siemens Healthcare Diagnostics Inc.ChLIA65.1% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).99.81%%
Anti-SARS-CoV-2 ELISA (IgG)Euroimmun AGELISAFrom 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation100% by NCI validation
New York SARS-CoV Microsphere Immunoassay for Antibody DetectionWadsworth Center, New York State Department of HealthMicrosphere immunoassayNot stated93-100%
COVID-19 ELISA IgG Antibody TestMount Sinai Laboratory ELISA  
qSARS-CoV-2 IgG/IgM Rapid TestCellex Inc.RST93.80%95.60%