2021
DOI: 10.3390/healthcare9091124
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Updated Clinical Evaluation of the CLUNGENE® Rapid COVID-19 Antibody Test

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,… Show more

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Cited by 4 publications
(4 citation statements)
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“…The CLUNGENE ® test has been previously studied, including the use of the test in the offices of general practitioners, evaluating the presence of antibodies in convalescent plasma donors, and how the test performs at a point of care facility. [18][19][20][21][22][23][24][25][26] The test employs 1 drop (; 10 mL) of whole blood added to a well followed by 2 drops of buffer. Results are available in 15 minutes.…”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…The CLUNGENE ® test has been previously studied, including the use of the test in the offices of general practitioners, evaluating the presence of antibodies in convalescent plasma donors, and how the test performs at a point of care facility. [18][19][20][21][22][23][24][25][26] The test employs 1 drop (; 10 mL) of whole blood added to a well followed by 2 drops of buffer. Results are available in 15 minutes.…”
Section: Methodsmentioning
confidence: 99%
“…The specificity of the assay has been reported as 100%, the sensitivity has been reported at 96.77% with no false-positive results due to infections or vaccinations unrelated to the SARS-CoV-2 virus. 27 For the present analysis, a test was considered positive if IgM, IgG, or both antibodies were present.…”
Section: Methodsmentioning
confidence: 99%
“…The CLUNGENE ® Test was commercially available in the United States under an FDA-approved Emergency Use Authorization (EUA201121) and Europe (CE Mark reference 02PBJ267 dated 9 March 2020) [ 57 ]. The CLUNGENE ® Test has been previously studied, including the use of the test in the offices of general practitioners, evaluating the presence of antibodies in convalescent plasma donors, and how the test performs at a point-of-care facility [ 58 , 59 , 60 , 61 ]. This LFA can detect specific SARS-CoV-2 antibodies and differentiate between IgG and IgM antibody classes [ 50 , 62 ].…”
Section: Methodsmentioning
confidence: 99%
“…The COVID-19 is cause by SARS-CoV-26; an enveloped RNA virus that causes respiratory, enteric, hepatic and neurological diseases 7 8. Clinical and diagnostic tools for care developed rapidly but implementation within local communities was challenging 9–13. Hospital diversions, long waits and other delays led to negative health consequences 14.…”
Section: Introductionmentioning
confidence: 99%