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

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

Abstract

During a household-transmission field study using COVID-19 antigen rapid diagnostic tests (Ag-RDT), a common test strip lot was identified among three 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.

Additional Information

© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. We thank the study participants for making this work possible. We thank Study Coordinators Saharai Caldera for suggesting the laboratory evaluation and both Saharai and Hannah Davich for removing lot 152000 from circulation in the study. We thank Taikun Yamada, John Raymond B. Reyna, Paolo Piatti and Yap Ching Chew for performing and verifying the validity of RT-qPCR results as previously reported. Finally, we thank all the case investigators and contact tracers at the Pasadena Public Health Department and Caltech Student Wellness Services for their efforts in study recruitment and their work in the pandemic response. This work was supported by the Ronald and Maxine Linde Center for New Initiatives at the California Institute of Technology and the Jacobs Institute for Molecular Engineering for Medicine at the California Institute of Technology. A UCLA DGSOM Geffen Fellowship to AVW. Data Availability: The data underlying the results presented in the study are available at CaltechDATA at: https://doi.org/10.22002/fmz6a-0x036. Alyssa M. Carter and Alexander Viloria Winnett contributed equally to this manuscript.

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