Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test
Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE<sup>®</sup> SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two st...
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| Format: | Article |
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MDPI AG
2021-08-01
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| Series: | Healthcare |
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| Online Access: | https://www.mdpi.com/2227-9032/9/9/1124 |
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| author | Christopher C. Lamb Fadi Haddad Christopher Owens Alfredo Lopez-Yunez Marion Carroll Jordan Moncrieffe |
| author_facet | Christopher C. Lamb Fadi Haddad Christopher Owens Alfredo Lopez-Yunez Marion Carroll Jordan Moncrieffe |
| author_sort | Christopher C. Lamb |
| collection | DOAJ |
| description | Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation. |
| first_indexed | 2024-03-10T07:37:22Z |
| format | Article |
| id | doaj.art-0add96adfc4f423785f1220f6f989f21 |
| institution | Directory Open Access Journal |
| issn | 2227-9032 |
| language | English |
| last_indexed | 2024-03-10T07:37:22Z |
| publishDate | 2021-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Healthcare |
| spelling | doaj.art-0add96adfc4f423785f1220f6f989f212023-11-22T13:17:16ZengMDPI AGHealthcare2227-90322021-08-0199112410.3390/healthcare9091124Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody TestChristopher C. Lamb0Fadi Haddad1Christopher Owens2Alfredo Lopez-Yunez3Marion Carroll4Jordan Moncrieffe5Weatherhead School of Management, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH 44106, USAFellow of the Infectious Disease Society of America (IDSA), 4040 Wilson Boulevard, Suite 300, Arlington, VA 22203, USAAlivio Medical Center, Indianapolis, IN 46219, USAAlivio Medical Center, Indianapolis, IN 46219, USAMedComp Sciences, LLC, 20503 MacHost Road, Zachary, LA 70791, USAMedComp Sciences, LLC, 20503 MacHost Road, Zachary, LA 70791, USABackground: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.https://www.mdpi.com/2227-9032/9/9/1124COVID-19 antibody testingCOVID-19 immunityCOVID-19 serologyCLUNGENE<sup>®</sup> |
| spellingShingle | Christopher C. Lamb Fadi Haddad Christopher Owens Alfredo Lopez-Yunez Marion Carroll Jordan Moncrieffe Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test Healthcare COVID-19 antibody testing COVID-19 immunity COVID-19 serology CLUNGENE<sup>®</sup> |
| title | Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test |
| title_full | Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test |
| title_fullStr | Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test |
| title_full_unstemmed | Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test |
| title_short | Updated Clinical Evaluation of the CLUNGENE<sup>®</sup> Rapid COVID-19 Antibody Test |
| title_sort | updated clinical evaluation of the clungene sup r sup rapid covid 19 antibody test |
| topic | COVID-19 antibody testing COVID-19 immunity COVID-19 serology CLUNGENE<sup>®</sup> |
| url | https://www.mdpi.com/2227-9032/9/9/1124 |
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