Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays.

Autor: Bachman CM; Global Health Labs, Inc, Bellevue, Washington, United States of America., Grant BD; Global Health Labs, Inc, Bellevue, Washington, United States of America., Anderson CE; Global Health Labs, Inc, Bellevue, Washington, United States of America., Alonzo LF; Global Health Labs, Inc, Bellevue, Washington, United States of America., Garing S; Global Health Labs, Inc, Bellevue, Washington, United States of America., Byrnes SA; Global Health Labs, Inc, Bellevue, Washington, United States of America., Rivera R; Global Health Labs, Inc, Bellevue, Washington, United States of America., Burkot S; Global Health Labs, Inc, Bellevue, Washington, United States of America., Ball A; Global Health Labs, Inc, Bellevue, Washington, United States of America., Stafford JW; Global Health Labs, Inc, Bellevue, Washington, United States of America., Wang W; Global Health Labs, Inc, Bellevue, Washington, United States of America., Banik D; Global Health Labs, Inc, Bellevue, Washington, United States of America., Keller MD; Global Health Labs, Inc, Bellevue, Washington, United States of America., Cate DM; Global Health Labs, Inc, Bellevue, Washington, United States of America., Nichols KP; Global Health Labs, Inc, Bellevue, Washington, United States of America., Weigl BH; Global Health Labs, Inc, Bellevue, Washington, United States of America., Dewan P; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2021 Aug 17; Vol. 16 (8), pp. e0256352. Date of Electronic Publication: 2021 Aug 17 (Print Publication: 2021).
DOI: 10.1371/journal.pone.0256352
Abstrakt: Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW® and Sofia®). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms ≤7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia®, BinaxNOW ™, and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia®, and 82% (73% - 88%) BinaxNOW™. The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.
Competing Interests: No authors have competing interests.
Databáze: MEDLINE
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