Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE ® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two studies were performed by using the CLUNGENE ® Rapid Test. (1) An expanded Point-of-Care (POC) study at two clinical sites was conducted to evaluate 99 clinical subjects: 62 positive subjects and 37 negative subjects were compared to RT-PCR, PPA, and NPA (95% CI). Sensitivity was calculated from blood-collection time following symptom onset. (2) A cross-reactivity study was performed to determine the potential for false-positive results from other common infections. Results: The specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4–100.0%). The sensitivity of subjects with confirmed positive COVID-19 by RT-PCR was 96.77% (95% CI, 88.98–99.11%). In the cross-reactivity study, there were no false-positive results due to past infections or vaccinations unrelated to the SARS-CoV-2 virus. Conclusion: There is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. The CLUNGENE ® Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.
【저자키워드】 COVID-19 serology, COVID-19 antibody testing, COVID-19 immunity, CLUNGENE®, 【초록키워드】 COVID-19, vaccination, healthcare professionals, POC, Infection, Test, diagnostic, Diagnosis, RT-PCR, Laboratory, cross-reactivity, sensitivity, specificity, infections, COVID-19 infection, Rapid, COVID-19 antibody, utility, Predictive, symptom onset, 95% CI, subject, positive, positive COVID-19, cassette, effective, shown, performed, evaluate, evaluated, conducted, was performed, calculated, provide, determine, false-positive result, the SARS-CoV-2 virus, 【제목키워드】 COVID-19, Test, clinical, Rapid,