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 2026-09-26. About this dataset

Records

Invenio Medical Inc. · COVID-19 IgG/IgM Ab Rapid Test
Panel 1 · Positives · Truth: Positive
2020-05-06SerumSample C0010
MP Biomedicals Asia Pacific Pte. Ltd. · MP Diagnostics Assure SARS-CoV-2 IgG/IgM Rapid Test
Panel 3 · Negative · Truth: Negative
2020-10-29PlasmaSample C0005
Biocan Diagnostics Inc · Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
Panel 3 · Negative · Truth: Negative
2020-12-01PlasmaSample C0140
Nirmidas Biotech, Inc. · MidaSpot COVID-19 Antibody Combo Detection Kit (NBPC-0007)
Panel 3 · Negative · Truth: Negative
2020-12-10PlasmaSample D0085
Zeus Scientific, Inc. · Zeus ELISA SARS-CoV-2 Total Antibody Test System
Panel 3 · Negative · Truth: Negative
2021-02-05PlasmaSample D0129
Advaite Inc. · ADVAITE RapCOV Rapid COVID-19 Test
Panel 3 · Negative · Truth: Negative
2020-10-06PlasmaSample C0133
Plexense, Inc. · ACCEL ELISA COVID-19
Panel 3 · HIV+ · Truth: Negative
2020-10-09PlasmaSample C0182
Aurora Biomed Inc · COVID-19 IgG/IgM Rapid Test
Panel 1 · Positives · Truth: Positive
2020-05-08SerumSample C0119
Aurora Biomed Inc · COVID-19 IgG/IgM Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-08SerumSample C0165
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 C0199
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 D0154
Assure Tech. (Hangzhou) Co., Ltd. · FaStep Rapid Diagnostic Test Coronavirus Disease 2019/ (COVID-2019) IgG/IgM Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-10SerumSample D0173
Hangzhou Laihe Biotech Co., Ltd. · Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Panel 2 · Negative · Truth: Negative
2020-06-10PlasmaSample C0196
Jiangsu Dablood Pharmaceutical Co. Ltd · COVID-19 IgM/IgG One Step Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-04SerumSample D0011
NOWDiagnostics, Inc. · ADEXUSDx COVID-19 Test
Panel 3 · Negative · Truth: Negative
2021-03-04PlasmaSample C0199
Access Bio, Inc. · CareStart EZ COVID-19 IgM/IgG
Panel 3 · Negative · Truth: Negative
2021-05-04PlasmaSample C0137
Guangzhou Wondfo Biotech Co., Ltd. · Wondfo SARS-CoV-2 Antibody Test
Panel 2 · Negative · Truth: Negative
2021-06-07SerumSample D0027
LumiraDx UK Ltd · Modified LumiraDx SARS-CoV-2 Ab Test
Panel 4 · Negative · Truth: Negative
2021-06-17PlasmaSample C0041
Euroimmun Medizinische Labordiagnostika AG · EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
Panel 2 · Negative · Truth: Negative
2021-08-13PlasmaSample C0065
Cellex, Inc. · Cellex qSARs-CoV-2 IgG/IgM Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-08SerumSample C0158

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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.