A SARS-CoV-2 Coronavirus Nucleocapsid Protein Antigen-Detecting Lateral Flow Assay Article Swipe

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Antigen Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Detection limit Virology Molecular biology Coronavirus disease 2019 (COVID-19) Reverse transcription polymerase chain reaction Antibody Chemistry Medicine Biology Immunology Messenger RNA Gene Chromatography Internal medicine Disease Biochemistry Infectious disease (medical specialty)

Ben D Grant , Caitlin E. Anderson , Spencer Garing , Luis F. Alonzo , John R. Williford , Ted A. Baughman , Veronika Glukhova , David S. Boyle , Bernhard H. Weigl , Kevin P. Nichols ·

YOU? · · 2020 · Open Access · · DOI: https://doi.org/10.26434/chemrxiv.12794825 · OA: W4230339771

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 TCID50/mL (95% CI of 9.1 to 37 TCID50/mL), equivalent to 1.4x105 copies/mL (95% CI of 5.5x104 to 2.3x105 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.