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अमूर्त

Expanded Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

Christopher C. Lamb, Fadi Haddad, Christopher D. Owens, Alfredo Lopez-Yunez, Marion Carroll, Jordan Moncrieffe

Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool [1]. 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 using the CLUNGENE^® Rapid Test: 1. An expanded Point-of-Care (POC) study at two clinical sites 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: Specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%). 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 provides results within 15 minutes without high complexity laboratory instrumentation.