Laboratory Evaluation Links Some False-Positive COVID-19 Antigen Test Results Observed in a Field Study to a Specific Lot of Test Strips

Alyssa M Carter; Alexander Viloria Winnett; Anna E Romano; Reid Akana; Natasha Shelby; Rustem F Ismagilov

doi:10.1093/ofid/ofac701

Laboratory Evaluation Links Some False-Positive COVID-19 Antigen Test Results Observed in a Field Study to a Specific Lot of Test Strips

Open Forum Infect Dis. 2023 Jan 5;10(1):ofac701. doi: 10.1093/ofid/ofac701. eCollection 2023 Jan.

Authors

Alyssa M Carter¹, Alexander Viloria Winnett¹, Anna E Romano¹, Reid Akana¹, Natasha Shelby¹, Rustem F Ismagilov¹

Affiliation

¹ Chemistry and Chemical Engineering, California Institute of Technology, Pasadena, California, USA.

Abstract

During a household-transmission field study using COVID-19 antigen rapid diagnostic tests (Ag-RDT), a common test strip lot was identified among 3 participants with false-positive results. In blinded laboratory evaluation, this lot exhibited a significantly higher false-positive rate than other lots. Because a positive Ag-RDT result often prompts action, reducing lot-specific false positives can maintain confidence and actionability of true-positive Ag-RDT results.

Keywords: COVID-19; Quidel QuickVue; diagnostics; false positive; faulty lot; lateral flow test.