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.
【초록키워드】 COVID-19, pandemic, SARS-COV-2 infection, Infection, diagnostic, Symptom, Symptoms, lateral flow, RT-qPCR, Rapid test, nasopharyngeal, Signs and symptoms, Rapid, Clinical signs, WHO, Rapid tests, Predictive, Adult patients, reagents, minimum, positive, Clinical sign, Result, nare, Adult patient, meet, 【제목키워드】 lateral flow, clinical, antigen detection,