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

Christopher C Lamb; Fadi Haddad; Christopher Owens; Alfredo Lopez-Yunez; Marion Carroll; Jordan Moncrieffe

doi:10.3390/healthcare9091124

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

Healthcare (Basel). 2021 Aug 30;9(9):1124. doi: 10.3390/healthcare9091124.

Authors

Christopher C Lamb^{1

2

3}, Fadi Haddad^{4

5

6}, Christopher Owens⁷, Alfredo Lopez-Yunez⁷, Marion Carroll⁸, Jordan Moncrieffe⁸

Affiliations

¹ Weatherhead School of Management, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH 44106, USA.
² Silberman College of Business, Fairleigh Dickinson University, 1000 River Rd., Teaneck, NJ 07666, USA.
³ BioSolutions Services LLC, 92 Irving Avenue, Englewood Cliffs, NJ 07632, USA.
⁴ Fellow of the Infectious Disease Society of America (IDSA), 4040 Wilson Boulevard, Suite 300, Arlington, VA 22203, USA.
⁵ Fadi Haddad, MD, Inc., 8860 Center Dr. Suite 320, La Mesa, CA 91942, USA.
⁶ Sharp Grossmont Hospital, 5555 Grossmont Center Dr., La Mesa, CA 91942, USA.
⁷ Alivio Medical Center, Indianapolis, IN 46219, USA.
⁸ MedComp Sciences, LLC, 20503 MacHost Road, Zachary, LA 70791, USA.

Abstract

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.

Keywords: CLUNGENE®; COVID-19 antibody testing; COVID-19 immunity; COVID-19 serology.