Inexpensive, simple, rapid diagnostics are necessary for efficient detection, treatment, and mitigation of COVID-19. Assays for SARS-CoV2 using reverse transcription polymerase chain reaction (RT-PCR) offer good sensitivity and excellent specificity, but are expensive, slowed by transport to centralized testing laboratories, and often unavailable. Antigen-based assays are inexpensive and can be rapidly mass-produced and deployed at point-of-care, with lateral flow assays (LFAs) being the most common format. While various manufacturers have produced commercially available SARS-Cov2 antigen LFAs, access to validated tests remains difficult or cost prohibitive in low-and middle-income countries. Herein, we present a visually read open-access LFA (OA-LFA) using commercially-available antibodies and materials for the detection of SARS-CoV-2. The LFA yielded a Limit of Detection (LOD) of 4 TCID 50 /swab of gamma irradiated SARS-CoV-2 virus, meeting the acceptable analytical sensitivity outlined by in World Health Organization target product profile. The open-source architecture presented in this manuscript provides a template for manufacturers around the globe to rapidly design a SARS-CoV2 antigen test.
【초록키워드】 COVID-19, Treatment, SARS-CoV-2, SARS-CoV2, antibody, detection, SARS-CoV-2 virus, RT-PCR, diagnostics, Antigen, lateral flow, reverse transcription polymerase chain reaction, polymerase chain reaction, point-of-care, sensitivity, specificity, Mitigation, reverse transcription, Swab, analytical sensitivity, Health Organization, Chain Reaction, World Health Organization, Transport, Template, manuscript, TCID, while, offer, polymerase chain, produced, globe, provide, outlined, 【제목키워드】 SARS-CoV-2 coronavirus, nucleocapsid protein, lateral flow,