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Testing Trackers

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 March 30, 2022.

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 Test Manufacturer Type of test Sensitivity Specificity
SGTi-flex COVID-19 IgG Sugentech Inc. RST 41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days) 99.2%
Rapid COVID-19 IgM/IgG Combo Test Kit Megna Health, Inc. RST IgM: 73.81%, IgG, 73.81, Combined: 90.5% IgM: 99.7%, IgG:99.3%, Combined: 98.9% 
QUANTA Flash SARS-CoV-2 IgG Inova Diagnostics, Inc.  ChLIA 66.7% (0-7 days), 61.5% (7-14 days), and 100% (15+ days) 99.90%
Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test Quanterix Corporation paramagnetic microbead-based sandwich ELISA 45.2% (0-7 days), 87.5% (7-14 days), and 100% (15+ days) 99.2%%
MidaSpot COVID-19 Antibody Combo Detection Kit Nirmidas Biotech, Inc. RST 76.9% (7-14 days), 100% (15+ days) 100.00%
COVID-19 Self-Collected Antibody Test System Symbiotica, Inc. Home collection, ELISA 100% (8-14 days), 100% (15+ days) 98.00%
Dimension EXL SARS‑CoV‑2 IgG (CV2G) Siemens Healthcare Diagnostics Inc. ChLIA 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) 100.00%
Dimension Vista SARS‑CoV‑2 IgG (COV2G) Siemens Healthcare Diagnostics Inc. ChLIA 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) 100.00%
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack Ortho Clinical Diagnostics ChLIA 80% (0-8 days), 100% (8+ days) 100%
SCoV-2 Detect IgM ELISA InBios International, Inc. ELISA 93% 99%
Access SARS-CoV-2 IgG II Beckman Coulter, Inc.  ELISA 81.8% (0-7 days), 95.8% (8-14 days), 98.9% (15+ days) 100%
T-Detect COVID Test Adaptive Biotechnologies Corporation multiplex PCR, NGS 97.10% 99%
AdviseDx SARS-CoV-2 IgG II Abbott Laboratories Inc. CMIA ARCHITECT: 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 IgG Immunodiagnostic Systems Ltd ChLIA 60.9% (0-7 days), 80.% (7-14 days), 97.6% (15+ days) 100%
UBI SARS-CoV-2 ELISA United Biomedical, Inc. ELISA 38.5% (0-7 days), 79.5% (7-14 days), 100% (15+ days) 100.00%
EliA SARS-CoV-2-Sp1 IgG Test Phadia AB Fluoroenzyme Immunoassay 15.4% (0-7 days), 58.2% (7-14 days), 97.6% (15+ days) 99.40%
RapCov Rapid COVID-19 Test ADVAITE, Inc. RST 90.00% 95.20%
RightSign COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Laihe Biotech Co., Ltd RST 100% (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 Test ACON Laboratories, Inc. RST 100% (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., Ltd RST 100% (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) Roche EChLIA 90.6% (0-7 days), 87% (8-14 days), 96.6% (15+days) 100.0%
COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit Kantaro Biosciences LLC ELISA 100% (0-7 days), 100% (7-14 days), 98.87% (15+ days) 99.6%
Orawell IgM/IgG Rapid Test Jiangsu Well Biotech Co., Ltd. RST 97.1% 100.0%
BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test Xiamen Biotime Biotechnology Co., Ltd RST IgG: 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 IgM Beckman Coulter ChLIA 91.7%(8-14 days); 98.3%(15+ days) 99.9%
cPass SARS-CoV-2 Neutralization Antibody Detection Kit GenScript USA, Inc. Modified ELISA 100.0% 100.0%
Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) Siemens Healthcare Diagnostics Inc. ChLIA 91.3% (7-13 days), 100% (15+ days) 99.8%
Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) Siemens Healthcare Diagnostics Inc. ChLIA 91.3% (7-13 days), 100% (15+ days) 99.8%
CareStart COVID-19 IgM/IgG Access Bio, Inc. RST 96.7% (IgG); 89% (IgM); 98.44% (combined) 99.45% (IgM); 99.45%(IgG); 98.9% (combined)
Platelia SARS-CoV-2 Total Ab assay Bio-Rad  Modified ELISA 98% 99%
Q-Plex SARS-CoV-2 Human IgG (4 Plex) Quansys Biosciences, Inc.  ELISA 100% (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 Pack Ortho-Clinical Diagnostics, Inc. ChLIA 83% (12-15 days), 100% (15 days+)  
Elecsys Anti-SARS-CoV-2 Roche EChLIA From 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100% 99.81%
LIAISON SARS-CoV-2 S1/S2 IgG DiaSorin Inc. ChLIA 90% (8-14 days), 97% (15+ days) 98%
Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit Biohit Healthcare (Heifei) Co. Ltd. RST 33% (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 Magazine Quotient Suisse SA solid-phase photometric immunoassay 100.0% 99.8%
AdviseDx SARS-CoV-2 IgM (ARCHITECT and Alinity i systems) Abbott Laboratories Inc. CMIA 95% 99.6%
Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 Genalyte, Inc photonic 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 System ZEUS Scientific, Inc. ELISA 100% 99.1%
OmniPATH COVID-19 Total Antibody ELISA Test Thermo Fisher Scientific ELISA 19% (0-7 days), 76.7% (8-14 days), 100% (15+days) 100%
Nirmidas Biotech, Inc. Nirmidas Biotech, Inc. RST IgM: 97.1%
IgG: 100%
94.80%
FREND COVID-19 total Ab NanoEntek America, Inc. immunofluorescence assay 100.0% 100.0%
DiaSorin LIAISON SARS-CoV-2 IgM Assay DiaSorin, Inc. ChLIA 92.60% 99.3%
Assure COVID-19 IgG/IgM Rapid Test Device Assure Biotech (Hangzhou Co, Ltd.) RST 95% 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/IgG Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE) ChLIA 43.8% (0-7 days), 93.4% (8-14 days), 100% (15+ days) 98.67%
BioCheck SARS-CoV-2 IgM Antibody Test Kit BioCheck, Inc. ChLIA 93.7%(8-14 days), 88.9% (15+ days) 97.2%
BioCheck SARS-CoV-2 IgG Antibody Test Kit BioCheck, Inc. ChLIA 100% 100%
COVID-19 ELISA pan-Ig Antibody Test University of Arizona Genetics Core for Clinical Services ELISA 97.5% 99.1%
TBG SARS-CoV-2 IgG / IgM Rapid Test Kit TBG Biotechnology Corp. RST IgG: 96.4%
IgM: 87.5%
99.8%
Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Biocan Diagnostics Inc. RST IgG: 93.3%
IgM: 90%
IgG: 96.2%
IgM: 98.7%
BioCheck SARS-CoV-2 IgG and IgM Combo Test BioCheck, Inc. ChLIA 100% (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 Kit Diazyme Laboratories, Inc. ChLIA 26.1% (0-7 days); 83.3% (7-14 days), 94.4% (15+days) 98.30%
VIDAS SARS-CoV-2 IgM bioMérieux SA Enzyme linked fluorescent assay (ELFA) 53.8% (0-7 days), 100% (7-14 days), 100%(15+) 99.4%%
VIDAS SARS-CoV-2 IgG bioMérieux SA Enzyme linked fluorescent assay (ELFA) 49% (0-7 days), 100% (7-14 days), 100% (15+days) 99.9%%
WANTAI SARS-CoV-2 Ab ELISA Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. ELISA 55.4% (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. ChLIA 56% (0-6 days), 92%(7-14 days), 100% (14+ days) 99.9%
ADVIA Centaur SARS-CoV-2 IgG (COV2G) Siemens Healthcare Diagnostics Inc. ChLIA 53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days) 99.9%
xMAP SARS-CoV-2 Multi-Antigen IgG Assay Luminex Fluorescent 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 Cassette Salofa Oy RST 100% for IgM and IgG 100% for IgM and IgG
WANTAI SARS-CoV-2 Ab Rapid Test Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. RST 94.7% 98.9%
Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit Diazyme Laboratories, Inc. ChLIA 92% 97%
Access SARS-CoV-2 IgG Beckman Coulter, Inc. ChLIA 75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days) 100%
Babson Diagnostics aC19G1 Babson Diagnostics ChLIA/indirect sandwich immunoassay 66.7% (8-14 days), 100% (15+ days), 100% (asymptomatic) 100%
SARS-CoV-2 RBD IgG test Emory University ELISA 73% (days 0-7), 100% (days 8-14), 100% (days 14+) 97.7% (prior to pandemic), 94.4% (PCR negative HCW)
SCoV-2 Detect IgG ELISA InBios International, Inc. ELISA 97.8% 98.9%
RightSign COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Biotest Biotech Co., Ltd RST 96.3% (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 Assay Vibrant America Clinical Labs ChLIA 98.1% 98.6%
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific LLC RST 96.7% (IgG),86.7 % (IgM), 96.7% combined 98% (IgG), 99% (IgM), 97% combined
Atellica IM SARS-CoV-2 Total (COV2T) Siemens Healthcare Diagnostics Inc. ChLIA 60.7% (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. ChLIA 65.1% (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 AG ELISA From 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation 100% by NCI validation
New York SARS-CoV Microsphere Immunoassay for Antibody Detection Wadsworth Center, New York State Department of Health Microsphere immunoassay Not stated 93-100%
COVID-19 ELISA IgG Antibody Test Mount Sinai Laboratory  ELISA    
qSARS-CoV-2 IgG/IgM Rapid Test Cellex Inc. RST 93.80% 95.60%
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