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

United Biomedical, Inc. · SARS-COV-2 ELISA
Panel 2 · Negative · Truth: Negative
2020-06-17PlasmaSample C0098
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. · WANTAI SARS-CoV-2 Ab ELISA
Panel 2 · Negative · Truth: Negative
2020-07-02PlasmaSample C0121
MOKOBIO Biotechnology R&D Center, INC. · SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay
Panel 2 · HIV+ · Truth: Negative
2020-08-03PlasmaSample C0089
Euroimmun · SARS-COV-2 ELISA (IgG)
Panel 1 · Negatives · Truth: Negative
2020-04-21SerumSample C0012
Genobio Pharmaceutical Co. Ltd · Virusee® COVID-19 IgM/IgG Lateral Flow Assay
Panel 2 · Positive · Truth: Positive
2020-07-09SerumSample C0152
Accudiagnostics · Covid-19 IgM/IgG Test Kit
Panel 1 · HIV+ · Truth: Negative
2020-04-27PlasmaSample C0155
BioMedomics, Inc. · BioMedomics COVID-19 IgM-IgG Rapid Test
Panel 2 · HIV+ · Truth: Negative
2020-06-02PlasmaSample C0150
Guangzhou Wondfo Biotech Co., Ltd. · COVID-19 One Step, COVID-19 Test (Immunochromatography Assay)
Panel 2 · Negative · Truth: Negative
2020-08-06PlasmaSample C0004
Predictive Laboratories, Inc. · Assurance AB COVID-19 IgM/IgG Rapid Antibody Test
Panel 2 · HIV+ · Truth: Negative
2020-08-21PlasmaSample C0018
Boditech Med Incorporated · iChroma COVID-19 Ab
Panel 2 · Positive · Truth: Positive
2020-08-21SerumSample C0145
NanoEntek Inc · FREND™ COVID-19 IgG/IgM Duo test
Panel 2 · Negative · Truth: Negative
2020-08-19PlasmaSample D0086
CTK Biotech, Inc. · OnSite COVID-19 IgG/IgM Rapid Test
Panel 2 · Positive · Truth: Positive
2020-07-21SerumSample D0104
Roche Diagnostic Corporation · Elecsys Anti-SARS-CoV-2
Panel 2 · Negative · Truth: Negative
2020-08-26SerumSample D0128
Invenio Medical Inc. · COVID-19 IgG/IgM Ab Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-06SerumSample C0081
Invenio Medical Inc. · COVID-19 IgG/IgM Ab Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-06SerumSample C0120
Zeus Scientific, Inc. · Zeus ELISA SARS-CoV-2 Total Antibody Test System
Panel 3 · Negative · Truth: Negative
2021-02-05PlasmaSample C0101
NOWDiagnostics, Inc. · ADEXUSDx COVID-19 Test
Panel 3 · Negative · Truth: Negative
2021-03-04PlasmaSample C0005
Teco Diagnostics · Scanwell SARS-CoV-2 IgM & IgG Rapid Test
Panel 2 · Negative · Truth: Negative
2021-03-22PlasmaSample C0199
Bio-Rad · Platelia SARS-CoV-2 Total Ab
Panel 3 · Negative · Truth: Negative
2021-05-04PlasmaSample D0085
Top Biotech Sdn. Bhd. · Top Rapid COVID-19 Rapid Antibody IgG/IgM Test Kit
Panel 3 · Negative · Truth: Negative
2020-09-28PlasmaSample D0178

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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.