Devices · openFDA

COVID-19 serology test evaluations

Independent evaluations of COVID-19 antibody tests: each sample's known result against the test's result. 13,420 records; openFDA updated it 2026-11-13. About this dataset

Records

Xiamen Biotime Biotechnology Co., Ltd. · Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Panel 2 · Negative · Truth: Negative
2020-05-29PlasmaSample C0179
Euroimmun · SARS-COV-2 ELISA (IgG)
Panel 1 · Negatives · Truth: Negative
2020-04-21SerumSample C0034
Healgen · COVID-19 IgG/IgM Rapid Test Cassette
Panel 1 · Negatives · Truth: Negative
2020-04-21SerumSample C0146
Healgen · COVID-19 IgG/IgM Rapid Test Cassette
Panel 1 · HIV+ · Truth: Negative
2020-04-21PlasmaSample C0197
GP Getein Biotech, Inc. · One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Panel 1 · Negatives · Truth: Negative
2020-05-08SerumSample C0139
Atlas-Link (Beijing) · Nova COVID-19 IgG/IgM Antibody Rapid Test
Panel 1 · Positives · Truth: Positive
2020-04-27SerumSample C0161
Sugentech, Inc. · Sugentech SGTi-flex COVID-19 IgM/IgG
Panel 2 · HIV+ · Truth: Negative
2020-05-28PlasmaSample C0182
Wondfo · SARS-CoV-2 Antibody Test (Lateral Flow Method)
Panel 1 · Negatives · Truth: Negative
2020-04-21SerumSample C0002
Hangzhou Laihe Biotech Co., Ltd. · Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Panel 2 · Negative · Truth: Negative
2020-06-10SerumSample D0131
Guangzhou Fenghua Bioengineering Co., Ltd. · SARS-COV-2 IgM/IgG Combo Rapid Test Kit
Panel 2 · Positive · Truth: Positive
2020-06-04SerumSample D0022
MEDsan GmbH · MEDsan biological health solutions, MEDsan COVID-19 IgM/IgG Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-01SerumSample D0047
Zhuhai Livzon Diagnostics Inc · Livzon IgM/IgG Diagnostic Kit for IgM/IgG Antibody to Coronovirus (SARS-Cov-2) Lateral Flow
Panel 2 · Negative · Truth: Negative
2020-06-03PlasmaSample C0065
RayBiotech · Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit (Colloidal Gold Method)
Panel 2 · Negative · Truth: Negative
2020-06-01PlasmaSample D0086
Assure Tech. (Hangzhou) Co., Ltd. · FaStep Rapid Diagnostic Test Coronavirus Disease 2019/ (COVID-2019) IgG/IgM Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-10PlasmaSample C0105
Fisher Diagnostics · OmniPATH COVID-19 Total Antibody ELISA Test
Panel 3 · Positive · Truth: Positive
2020-09-01SerumSample D0455
Shenzhen JetMay Care Limited · COVID-19 IgM & IgG Test
Panel 3 · Negative · Truth: Negative
2020-09-25PlasmaSample D0170
EUROIMMUN Medizinische Labordiagnostika AG · Anti-SARS-CoV-2-NCP ELISA (IgM)
Panel 3 · Negative · Truth: Negative
2020-09-18PlasmaSample D0077
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. · WANTAI SARS-CoV-2 Ab Rapid Test
Panel 2 · HIV+ · Truth: Negative
2020-06-16PlasmaSample C0099
Jiangsu Well Biotech Co, Ltd. · COVID-19 IgM/IgG Rapid Test (Colloidal gold)
Panel 2 · Positive · Truth: Positive
2020-06-23SerumSample C0053
InBios International Inc. · SCoV-2 Detect™ IgG ELISA
Panel 2 · HIV+ · Truth: Negative
2020-06-16PlasmaSample C0197

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.