Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays.
PLoS One
; 16(8): e0256352, 2021.
Article
in English
| MEDLINE | ID: covidwho-1360648
ABSTRACT
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Immunoassay
/
SARS-CoV-2
/
COVID-19
/
Antigens, Viral
Type of study:
Diagnostic study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
PLoS One
Journal subject:
Science
/
Medicine
Year:
2021
Document Type:
Article
Affiliation country:
Journal.pone.0256352
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