Evaluation of COVID-19 IgG/IgM Rapid Test from Orient Gene Biotech

J Clin Microbiol. 2020 Jun 9;JCM.01233-20. doi: 10.1128/JCM.01233-20. Online ahead of print.

Abstract

While the COVID-19 pandemic has peaked in many countries already, the current challenge is to assess population immunity on large scale. Many serological tests are available and require urgent independent validation. Here we report performance characteristics of Orient Gene (OG) COVID-19 IgG/IgM Rapid Test Cassette compare it Abbott SARS-CoV-2 IgG immunoassay (ASIA). Patients (n=102) with a positive SARS-CoV-2 RT-PCR were tested. They were asymptomatic (n=2), had mild (n=37) or severe symptoms requiring hospitalization in medical (n=35) or intensive care unit (n=28). Specificity was evaluated on 42 patients with previous viral and parasitic diseases as well as high level of rheumatic factor. Sensitivity of OG was 95.8% (CI95% 89.6-98.8) for samples collected ≥10 days after onset of symptoms which was equivalent to sensitivity of ASIA of 90.5% (IC95% 82.8-95.6). OG uncovered 6 false negative of ASIA, of which two had only IgM with OG. Specificity was 100% (CI95% 93.4-100) with both tests on samples including patients infected with endemic coronavirus. Overall, OG performance characteristics indicate that the test is suitable for routine use in clinical laboratories and performance is equivalent to immunoassay. Testing OG on a larger asymptomatic population may be needed to confirm these results.