select ad.sno,ad.journal,ad.title,ad.author_names,ad.abstract,ad.abstractlink,j.j_name,vi.* from articles_data ad left join journals j on j.journal=ad.journal left join vol_issues vi on vi.issue_id_en=ad.issue_id where ad.sno_en='82167' and ad.lang_id='9' and j.lang_id='9' and vi.lang_id='9' Expanded Clinical Evaluation of the CLUNGENEandreg; Rapid CO | 82167
జర్నల్ ఆఫ్ క్లినికల్ అండ్ సెల్యులార్ ఇమ్యునాలజీ

జర్నల్ ఆఫ్ క్లినికల్ అండ్ సెల్యులార్ ఇమ్యునాలజీ
అందరికి ప్రవేశం

ISSN: 2155-9899

నైరూప్య

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.

నిరాకరణ: ఈ సారాంశం కృత్రిమ మేధస్సు సాధనాలను ఉపయోగించి అనువదించబడింది మరియు ఇంకా సమీక్షించబడలేదు లేదా ధృవీకరించబడలేదు.
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