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Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test
BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral flu...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Korean Society for Laboratory Medicine
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646192/ https://www.ncbi.nlm.nih.gov/pubmed/23667844 http://dx.doi.org/10.3343/alm.2013.33.3.184 |
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author | Cha, Young Joo Park, Quehn Kang, Eun-Suk Yoo, Byung Chul Park, Kyoung Un Kim, Jin-Wook Hwang, Yoo-Sung Kim, Myung Hee |
author_facet | Cha, Young Joo Park, Quehn Kang, Eun-Suk Yoo, Byung Chul Park, Kyoung Un Kim, Jin-Wook Hwang, Yoo-Sung Kim, Myung Hee |
author_sort | Cha, Young Joo |
collection | PubMed |
description | BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings. |
format | Online Article Text |
id | pubmed-3646192 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | The Korean Society for Laboratory Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-36461922013-05-10 Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test Cha, Young Joo Park, Quehn Kang, Eun-Suk Yoo, Byung Chul Park, Kyoung Un Kim, Jin-Wook Hwang, Yoo-Sung Kim, Myung Hee Ann Lab Med Original Article BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings. The Korean Society for Laboratory Medicine 2013-05 2013-04-17 /pmc/articles/PMC3646192/ /pubmed/23667844 http://dx.doi.org/10.3343/alm.2013.33.3.184 Text en © The Korean Society for Laboratory Medicine. http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Cha, Young Joo Park, Quehn Kang, Eun-Suk Yoo, Byung Chul Park, Kyoung Un Kim, Jin-Wook Hwang, Yoo-Sung Kim, Myung Hee Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title | Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title_full | Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title_fullStr | Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title_full_unstemmed | Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title_short | Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test |
title_sort | performance evaluation of the oraquick hepatitis c virus rapid antibody test |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646192/ https://www.ncbi.nlm.nih.gov/pubmed/23667844 http://dx.doi.org/10.3343/alm.2013.33.3.184 |
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