December 8, 2020

A SARS-CoV-2 Coronavirus nucleocapsid protein antigen-detecting lateral flow assay

Grant, Ben; Anderson, Caitlin; Garing, Spencer; Alonzo, Luis; Williford, John; Baughman, Ted; Glukhova, Veronika; Boyle, David; Weigl, Bernhard; Nichols, Kevin

Inexpensive, simple, rapid diagnostics are necessary for efficient detection, treatment and mitigation of COVID‑19. Currently, the primary diagnostic tool being utilized is reverse transcription polymerase chain reaction (RT-PCR). RT-PCR delivers results with good sensitivity and excellent specificity, but is expensive, prone to access challenges and is often slowed by transport to centralized testing laboratories. Antigen-based assays are inexpensive and can be rapidly mass-produced and deployed, with lateral flow assays (LFAs) being the most common inexpensive antigen test. To date, few antigen-detecting LFAs for COVID-19 have been commercialized. Herein, we present an open source LFA using commercially available antibodies and materials for the detection of SARS-CoV-2. Using an optical reader with comparable sensitivity to a visual read, the LFA yielded a Limit of Detection (LOD) of 23 TCID/mL (95% CI of 9.1 to 37 TCID/mL), equivalent to 1.4×10 copies/mL (95% CI of 5.5×10 to 2.3×10 copies/mL) irradiated virus in pooled nasal matrix. This LOD meets the criteria suggested by WHO for diagnosis of acute SARS-CoV-2 infection in a point of care format. A clinical evaluation and further testing is ongoing.5050545

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