Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2021
2021
Historique:
received:
28
06
2021
accepted:
04
08
2021
entrez:
17
8
2021
pubmed:
18
8
2021
medline:
26
8
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 34403456
doi: 10.1371/journal.pone.0256352
pii: PONE-D-21-19695
pmc: PMC8370603
doi:
Substances chimiques
Antigens, Viral
0
RNA, Viral
0
Types de publication
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0256352Déclaration de conflit d'intérêts
No authors have competing interests.
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