Journal of Clinical and Cellular Immunology
Open Access
ISSN: 2155-9899
ISSN: 2155-9899
Alivio Medical Center, Indianapolis, IN, USA
Research
Expanded Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test
Author(s): Christopher C. Lamb, Fadi Haddad, Christopher D. Owens, Alfredo Lopez-Yunez, Marion Carroll and 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 c.. View More»