Published January 30, 2023 | Version Published + Supplemental Material
Journal Article Open

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

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.

Attached Files

Published - ofac701.pdf

Supplemental Material - ofac701_supplementary_data.pdf

Files

ofac701.pdf

Files (507.3 kB)

Name Size Download all
md5:2c1716cccecfe2021915a6e0f123c979
337.9 kB Preview Download
md5:f3101239a9d910c5dccc5ed24b5c9ac1
169.5 kB Preview Download

Additional details

Identifiers

PMCID
PMC9887260
Eprint ID
118971
Resolver ID
CaltechAUTHORS:20230130-263514000.2

Related works

Describes
10.22002/fmz6a-0x036 (DOI)

Funding

Ronald and Maxine Linde Center for New Initiatives
Jacobs Institute for Molecular Engineering for Medicine
UCLA

Dates

Created
2023-01-30
Created from EPrint's datestamp field
Updated
2023-07-05
Created from EPrint's last_modified field

Caltech Custom Metadata

Caltech groups
COVID-19, Jacobs Institute for Molecular Engineering for Medicine, Division of Biology and Biological Engineering (BBE)