Point-Of-Care clinical evaluation of the Clungene^® SARS-CoV-2 virus IgG/IgM 15-minute rapid test cassette with the Cobas^® Roche RT-PCR platform in patients with or without Covid-19

Background: Coronavirus disease 2019 (Covid-19) remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness results. We hypothesize that rapid 15-minute Point-Of-Care serological test evaluate past infection complements diagnostic testing for Covid-19 significantly enhances availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene ® lateral flow immunoassay (LFI) compared Cobas Roche real-time polymerase chain reaction (RT-PCR) Arm 1: Thirty-five (35) subjects confirmed RT-PCR were tested twice: prior 14 days following symptom onset once between 12 70 days. 2: Thirty (30) 12-70 post onset. 3: negative 1–10 date. Results: Specificity by 100% (95% CI, 88.4%–100.0%); meaning there positive agreement day 7 antibody negative. In 7–12 RT-PCR, combined sensitivity IgM IgG 58.6% 38.9%–76.5%). 13–70 90.5% 80.4%–96.4%). Conclusion: The is useful tool individuals an adaptive immune response severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) indicating infection. Providing results within 15 minutes without any laboratory instrumentation or specialized software has added value increasing availability patients who have been symptomatic more than 1 week Performance characteristics are optimal after 13 specificity 90% 100%, respectively. Statement novelty: Formal controlled clinical studies tests limited. This demonstrates utility minute potential expanded use where vaccination