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

Biocan Diagnostics Inc · Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
Panel 3 · Positive · Truth: Positive
2020-12-01SerumSample D0344
Nirmidas Biotech, Inc. · MidaSpot COVID-19 Antibody Combo Detection Kit (NBPC-0007)
Panel 3 · Negative · Truth: Negative
2020-12-10PlasmaSample C0198
Zeus Scientific, Inc. · Zeus ELISA SARS-CoV-2 Total Antibody Test System
Panel 3 · Negative · Truth: Negative
2021-02-05PlasmaSample D0025
NOWDiagnostics, Inc. · ADEXUSDx COVID-19 Test
Panel 3 · Positive · Truth: Positive
2021-03-04SerumSample D0493
Teco Diagnostics · Scanwell SARS-CoV-2 IgM & IgG Rapid Test
Panel 2 · Negative · Truth: Negative
2021-03-22PlasmaSample D0142
Bio-Rad · Platelia SARS-CoV-2 Total Ab
Panel 3 · Negative · Truth: Negative
2021-05-04PlasmaSample D0170
Aurora Biomed Inc · COVID-19 IgG/IgM Rapid Test
Panel 1 · Positives · Truth: Positive
2020-05-08SerumSample C0038
Aurora Biomed Inc · COVID-19 IgG/IgM Rapid Test
Panel 1 · Negatives · Truth: Negative
2020-05-08SerumSample C0072
Artron Laboratories, Inc. · OTO-Artron COVID-19 IgG/IgM Antibody Test
Panel 3 · Negative · Truth: Negative
2020-10-21PlasmaSample C0004
InBios International, Inc. · InBios SCoV-2 Detect™ IgG Rapid Test
Panel 3 · Positive · Truth: Positive
2020-10-09SerumSample D0209
Acon Biotech (Hangzhou) Co., LTD · Acon SARS-CoV2 IgG/IgM Rapid Test
Panel 2 · HIV+ · Truth: Negative
2020-11-02PlasmaSample C0089
MP Biomedicals Asia Pacific Pte. Ltd. · MP Diagnostics Assure SARS-CoV-2 IgG/IgM Rapid Test
Panel 3 · Negative · Truth: Negative
2020-10-29PlasmaSample D0166
Salofa Oy · Sienna COVID-19 IgG/IgM Rapid Test Cassette (whole blood/serum/plasma)
Panel 2 · Negative · Truth: Negative
2020-06-09PlasmaSample D0145
Tianjin New Bay Bioresearch C. #1 · Quik Pac II COVID-19 IgG & IgM Test
Panel 2 · Positive · Truth: Positive
2020-06-10SerumSample D0161
GenBody Inc. · GenBody COVID-19 IgM/IgG
Panel 2 · Negative · Truth: Negative
2020-06-11PlasmaSample D0184
BTNX Inc · COVID-19 IgG/IgM Test Cassettes (Whole Blood/Serum/Plasma)
Panel 2 · Positive · Truth: Positive
2020-06-12SerumSample D0205
AutoBio Diagnostics Co., LTD · Anti-SARS-CoV-2 Rapid Test
Panel 2 · Negative · Truth: Negative
2020-06-24PlasmaSample D0015
Bio-Rad · Platelia SARS-CoV-2 Total Ab
Panel 2 · Negative · Truth: Negative
2021-06-07PlasmaSample D0184
Euroimmun Medizinische Labordiagnostika AG · EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
Panel 4 · Positive · Truth: Positive
2021-07-09SerumSample D0396
LumiraDX UK Ltd · LumiraDx SARS-CoV-2 Ab Test
Panel 3 · Positive · Truth: Positive
2022-07-27SerumSample D0326

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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.