Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection
Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the pe...
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Veröffentlicht in: | Journal of clinical virology 2010-05, Vol.48 (1), p.15-17 |
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creator | Lee, S.R Yearwood, G.D Guillon, G.B Kurtz, L.A Fischl, M Friel, T Berne, C.A Kardos, K.W |
description | Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. Conclusions The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection. |
doi_str_mv | 10.1016/j.jcv.2010.02.018 |
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Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. Conclusions The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/j.jcv.2010.02.018</identifier><identifier>PMID: 20362493</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Allergy and Immunology ; Antibodies ; Biological and medical sciences ; Diagnosis ; Fundamental and applied biological sciences. Psychology ; HCV ; Hepatitis C - diagnosis ; Hepatitis C Antibodies - analysis ; Hepatitis C Antibodies - blood ; Hepatitis C Antigens ; Hepatitis C virus ; Human viral diseases ; Humans ; Immobilized Proteins ; Immunoenzyme Techniques - methods ; Infectious Disease ; Infectious diseases ; Medical sciences ; Microbiology ; Miscellaneous ; Point-of-Care Systems ; Rapid ; Reagent Kits, Diagnostic ; Sensitivity and Specificity ; Viral diseases ; Viral hepatitis ; Virology</subject><ispartof>Journal of clinical virology, 2010-05, Vol.48 (1), p.15-17</ispartof><rights>Elsevier B.V.</rights><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c469t-f5e9aef5bd64f615af1d6629e981332bf43478e5ccebfc744001c7727d7aab8f3</citedby><cites>FETCH-LOGICAL-c469t-f5e9aef5bd64f615af1d6629e981332bf43478e5ccebfc744001c7727d7aab8f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jcv.2010.02.018$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22686403$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20362493$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lee, S.R</creatorcontrib><creatorcontrib>Yearwood, G.D</creatorcontrib><creatorcontrib>Guillon, G.B</creatorcontrib><creatorcontrib>Kurtz, L.A</creatorcontrib><creatorcontrib>Fischl, M</creatorcontrib><creatorcontrib>Friel, T</creatorcontrib><creatorcontrib>Berne, C.A</creatorcontrib><creatorcontrib>Kardos, K.W</creatorcontrib><title>Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. Conclusions The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection.</description><subject>Allergy and Immunology</subject><subject>Antibodies</subject><subject>Biological and medical sciences</subject><subject>Diagnosis</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>HCV</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C Antibodies - analysis</subject><subject>Hepatitis C Antibodies - blood</subject><subject>Hepatitis C Antigens</subject><subject>Hepatitis C virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immobilized Proteins</subject><subject>Immunoenzyme Techniques - methods</subject><subject>Infectious Disease</subject><subject>Infectious diseases</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Miscellaneous</subject><subject>Point-of-Care Systems</subject><subject>Rapid</subject><subject>Reagent Kits, Diagnostic</subject><subject>Sensitivity and Specificity</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><subject>Virology</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkk-L1TAUxYM4OOPTD-BGshE39pl_TRqEAXmMOjDgQl25CGl646T2NTVpH8y3N-U9FVzMZJNcOOfk5peL0AtKtpRQ-bbf9u6wZaTUhG0JbR6hC9ooXtVaqsflzBtZyZqzc_Q0554QWnOhnqBzRrhkQvML9P3qYIfFziGOOHpscbJT6N7gKYZxrqKvnE2AZ8gz7uAQHGAfE55vAXfB_hhjDnn13cJUMuZS7HAYPbg18Bk683bI8Py0b9C3D1dfd5-qm88fr3fvbyonpJ4rX4O24Ou2k8JLWltPOymZBt1QzlnrRWm6gdo5aL1TQpR3OKWY6pS1beP5Br0-5k4p_lpKq2YfsoNhsCPEJRslJFFK6PphJeeNJrwg3CB6VLoUc07gzZTC3qY7Q4lZ4ZveFPhmhW8IMwV-8bw8pS_tHrq_jj-0i-DVSWCzs4NPdnQh_9Mx2UhBVt27ow4KtUOAZLILMDroQipoTRfDvW1c_ud2QxhDufAn3EHu45LG8h2GmlwM5ss6JeuQUFKWJpr_BjK7tiU</recordid><startdate>20100501</startdate><enddate>20100501</enddate><creator>Lee, S.R</creator><creator>Yearwood, G.D</creator><creator>Guillon, G.B</creator><creator>Kurtz, L.A</creator><creator>Fischl, M</creator><creator>Friel, T</creator><creator>Berne, C.A</creator><creator>Kardos, K.W</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7U9</scope><scope>H94</scope></search><sort><creationdate>20100501</creationdate><title>Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection</title><author>Lee, S.R ; Yearwood, G.D ; Guillon, G.B ; Kurtz, L.A ; Fischl, M ; Friel, T ; Berne, C.A ; Kardos, K.W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c469t-f5e9aef5bd64f615af1d6629e981332bf43478e5ccebfc744001c7727d7aab8f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Allergy and Immunology</topic><topic>Antibodies</topic><topic>Biological and medical sciences</topic><topic>Diagnosis</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>HCV</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis C Antibodies - analysis</topic><topic>Hepatitis C Antibodies - blood</topic><topic>Hepatitis C Antigens</topic><topic>Hepatitis C virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immobilized Proteins</topic><topic>Immunoenzyme Techniques - methods</topic><topic>Infectious Disease</topic><topic>Infectious diseases</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Miscellaneous</topic><topic>Point-of-Care Systems</topic><topic>Rapid</topic><topic>Reagent Kits, Diagnostic</topic><topic>Sensitivity and Specificity</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, S.R</creatorcontrib><creatorcontrib>Yearwood, G.D</creatorcontrib><creatorcontrib>Guillon, G.B</creatorcontrib><creatorcontrib>Kurtz, L.A</creatorcontrib><creatorcontrib>Fischl, M</creatorcontrib><creatorcontrib>Friel, T</creatorcontrib><creatorcontrib>Berne, C.A</creatorcontrib><creatorcontrib>Kardos, K.W</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lee, S.R</au><au>Yearwood, G.D</au><au>Guillon, G.B</au><au>Kurtz, L.A</au><au>Fischl, M</au><au>Friel, T</au><au>Berne, C.A</au><au>Kardos, K.W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2010-05-01</date><risdate>2010</risdate><volume>48</volume><issue>1</issue><spage>15</spage><epage>17</epage><pages>15-17</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>Abstract Background Despite considerable evolution in the quality of laboratory-based testing for detection of HCV, the availability of rapid, point-of-care tests may increase diagnoses by increasing opportunities for testing outside of traditional laboratory settings. Objectives We evaluated the performance of a new, rapid HCV test that can be used with venous blood, finger stick blood, serum, plasma, or oral fluid and compared it to FDA-approved laboratory methods. Study design HCV positive subjects as well as subjects at low risk for HCV were tested with the rapid test using all 5 specimen types and results compared to FDA-approved laboratory methods. In addition, performance was assessed in commercially available seroconversion panels. Results Sensitivity and specificity of the rapid test was equivalent to laboratory EIA and performance was comparable across all 5 specimen types. Conclusions The OraQuick® HCV Rapid Antibody Test appears suitable as an aid in the diagnosis of HCV infection.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>20362493</pmid><doi>10.1016/j.jcv.2010.02.018</doi><tpages>3</tpages></addata></record> |
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subjects | Allergy and Immunology Antibodies Biological and medical sciences Diagnosis Fundamental and applied biological sciences. Psychology HCV Hepatitis C - diagnosis Hepatitis C Antibodies - analysis Hepatitis C Antibodies - blood Hepatitis C Antigens Hepatitis C virus Human viral diseases Humans Immobilized Proteins Immunoenzyme Techniques - methods Infectious Disease Infectious diseases Medical sciences Microbiology Miscellaneous Point-of-Care Systems Rapid Reagent Kits, Diagnostic Sensitivity and Specificity Viral diseases Viral hepatitis Virology |
title | Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection |
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