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

Doctorspot Technologies Inc, · COVID-19 SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)
Panel 3 · Negative · Truth: Negative
2020-10-02PlasmaSample C0026
Artron Laboratories, Inc. · OTO-Artron COVID-19 IgG/IgM Antibody Test
Panel 3 · Positive · Truth: Positive
2020-10-21SerumSample D0268
InBios International, Inc. · InBios SCoV-2 Detect IgM/IgG Rapid Test
Panel 3 · Negative · Truth: Negative
2020-10-09PlasmaSample D0145
Acon Biotech (Hangzhou) Co., LTD · Acon SARS-CoV2 IgG/IgM Rapid Test
Panel 2 · Negative · Truth: Negative
2020-11-02PlasmaSample C0019
MP Biomedicals Asia Pacific Pte. Ltd. · MP Diagnostics Assure SARS-CoV-2 IgG/IgM Rapid Test
Panel 3 · HIV+ · Truth: Negative
2020-10-29PlasmaSample C0182
Salofa Oy · Sienna COVID-19 IgG/IgM Rapid Test Cassette (whole blood/serum/plasma)
Panel 2 · Negative · Truth: Negative
2020-06-09PlasmaSample C0140
Tianjin New Bay Bioresearch C. #1 · Quik Pac II COVID-19 IgG & IgM Test
Panel 2 · Negative · Truth: Negative
2020-06-10PlasmaSample C0156
GenBody Inc. · GenBody COVID-19 IgM/IgG
Panel 2 · Negative · Truth: Negative
2020-06-11SerumSample D0173
BTNX Inc · COVID-19 IgG/IgM Test Cassettes (Whole Blood/Serum/Plasma)
Panel 2 · Positive · Truth: Positive
2020-06-12SerumSample C0187
AutoBio Diagnostics Co., LTD · Anti-SARS-CoV-2 Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-24SerumSample D0011
Bio-Rad · Platelia SARS-CoV-2 Total Ab
Panel 2 · Negative · Truth: Negative
2021-06-07SerumSample D0173
Euroimmun Medizinische Labordiagnostika AG · EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
Panel 4 · Negative · Truth: Negative
2021-07-09PlasmaSample D0162
LumiraDX UK Ltd · LumiraDx SARS-CoV-2 Ab Test
Panel 3 · Negative · Truth: Negative
2022-07-27PlasmaSample C0137
Xiamen Biotime Biotechnology Co., Ltd. · Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Panel 2 · Positive · Truth: Positive
2020-05-29SerumSample C0153
Cellex, Inc. · Cellex qSARs-CoV-2 IgG/IgM Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-08SerumSample C0081
Chemtron Biotech, Inc. · Rapid COVID-19 IgM/IgG Antibody Screen Test
Panel 1 · Negatives · Truth: Negative
2020-05-08PlasmaSample C0098
Euroimmun · SARS-COV-2 ELISA (IgA)
Panel 1 · Negatives · Truth: Negative
2020-04-21PlasmaSample C0117
GP Getein Biotech, Inc. · One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)
Panel 1 · Positives · Truth: Positive
2020-05-08SerumSample C0136
Atlas-Link (Beijing) · Nova COVID-19 IgG/IgM Antibody Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-04-27SerumSample C0158
Sugentech, Inc. · Sugentech SGTi-flex COVID-19 IgM/IgG
Panel 2 · Negative · Truth: Negative
2020-05-28PlasmaSample C0193

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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.