Evaluation of a new rapid test kit to detect hepatitis C virus infection

•A new rapid kit, SD Bioline HCV had sufficient sensitivity and specificity for screening of HCV infection.•SD Bioline HCV had similar ability of early detection during window period compared to EIA.•SD Bioline HCV showed almost perfect agreement with RIBA. This study investigated the performance ch...

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Veröffentlicht in:Journal of virological methods 2013-11, Vol.193 (2), p.379-382
Hauptverfasser: Kim, Myeong Hee, Kang, So Young, Lee, Woo In
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Kang, So Young
Lee, Woo In
description •A new rapid kit, SD Bioline HCV had sufficient sensitivity and specificity for screening of HCV infection.•SD Bioline HCV had similar ability of early detection during window period compared to EIA.•SD Bioline HCV showed almost perfect agreement with RIBA. This study investigated the performance characteristics and diagnostic usefulness of a new rapid device test (RDT) for HCV (SD Bioline, Korea). A total of 200 specimens were used in this study and to assess cross-reactivity, five hepatitis B surface antigen (HBsAg) positive, five anti-hepatitis B surface antibody (anti-HBs) positive, five rheumatoid factor (RF) positive, and six samples from multiple myeloma patients were tested. The early detection capability of the test was assessed using seroconversion panels. Sensitivity and specificity were calculated compared with a recombinant immunoblot assay (RIBA). Sixty-six cases were positive by the RIBA, while 52 cases were positive using the new RDT. The sensitivity and specificity of the new RDT were 78.8% (95% CI: 71.2–86.8%) and 100%, respectively. The kappa value for the agreement between the new RDT and RIBA results was 0.831 (95% CI: 0.746–0.916). The early detection capability of the new RDT and a HCV EIA were similar, with the same window period. The new RDT did not cross-react with HBsAg, anti-HBs, RF and immunoglobulins. In conclusion, the SD Bioline HCV RDT has superior sensitivity and specificity than the GENEDIA® HCV Rapid LF that is used in Korea. This assay can be used for HCV screening, especially in small hospitals, without the financial burden of expensive equipment.
doi_str_mv 10.1016/j.jviromet.2013.07.005
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The early detection capability of the new RDT and a HCV EIA were similar, with the same window period. The new RDT did not cross-react with HBsAg, anti-HBs, RF and immunoglobulins. In conclusion, the SD Bioline HCV RDT has superior sensitivity and specificity than the GENEDIA® HCV Rapid LF that is used in Korea. 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The early detection capability of the new RDT and a HCV EIA were similar, with the same window period. The new RDT did not cross-react with HBsAg, anti-HBs, RF and immunoglobulins. In conclusion, the SD Bioline HCV RDT has superior sensitivity and specificity than the GENEDIA® HCV Rapid LF that is used in Korea. This assay can be used for HCV screening, especially in small hospitals, without the financial burden of expensive equipment.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-HCV</subject><subject>antibodies</subject><subject>Child</subject><subject>cross reaction</subject><subject>Female</subject><subject>Hepacivirus - immunology</subject><subject>hepatitis B antigens</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C Antibodies - blood</subject><subject>Hepatitis C virus</subject><subject>hospitals</subject><subject>Humans</subject><subject>Immunochromatography - methods</subject><subject>immunoglobulins</subject><subject>Male</subject><subject>Middle Aged</subject><subject>myeloma</subject><subject>patients</subject><subject>Rapid device test</subject><subject>RIBA</subject><subject>screening</subject><subject>Sensitivity and Specificity</subject><subject>seroconversion</subject><subject>Young Adult</subject><issn>0166-0934</issn><issn>1879-0984</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMFuGyEQhlHUKHadvELKsRdvYWFhubWy0jpSpB6SnBHLzra49uIC6yhv37Ec95oTI_H9M78-Qm45qzjj6sum2hxCijsoVc24qJiuGGsuyJy32iyZaeUHMkdQ4SzkjHzMecOQ0EJckVktWs11o-ZkfXdw28mVEEcaB-roCC80uX3oaYFc6J9QaIm0hwK-0N-wR7SETFcUz0-ZhnHAD0xfk8vBbTPcvL0L8vz97mm1Xj78_HG_-vaw9MLUZdkL6TojnHK1qHljBGt6Jb0BA50clNcDq6HVWvGhazrVNlq12Na0ra-1xNCCfD7t3af4d8KKdheyh-3WjRCnbLkUolZGSomoOqE-xZwTDHafws6lV8uZPVq0G3u2aI8WLdMWHWHw9u3G1O2g_x87a0Pg0wkYXLTuVwrZPj_iBoWKFZfqePvriQB0cQiQbPYBRg99SCjM9jG81-If26CO3g</recordid><startdate>20131101</startdate><enddate>20131101</enddate><creator>Kim, Myeong Hee</creator><creator>Kang, So Young</creator><creator>Lee, Woo In</creator><general>Elsevier B.V</general><scope>FBQ</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></search><sort><creationdate>20131101</creationdate><title>Evaluation of a new rapid test kit to detect hepatitis C virus infection</title><author>Kim, Myeong Hee ; Kang, So Young ; Lee, Woo In</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c392t-d34ab93a6a232159305d64c9e9eb4f6c7f02e87761fb5b685768238988c274a23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-HCV</topic><topic>antibodies</topic><topic>Child</topic><topic>cross reaction</topic><topic>Female</topic><topic>Hepacivirus - immunology</topic><topic>hepatitis B antigens</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis C Antibodies - blood</topic><topic>Hepatitis C virus</topic><topic>hospitals</topic><topic>Humans</topic><topic>Immunochromatography - methods</topic><topic>immunoglobulins</topic><topic>Male</topic><topic>Middle Aged</topic><topic>myeloma</topic><topic>patients</topic><topic>Rapid device test</topic><topic>RIBA</topic><topic>screening</topic><topic>Sensitivity and Specificity</topic><topic>seroconversion</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Myeong Hee</creatorcontrib><creatorcontrib>Kang, So Young</creatorcontrib><creatorcontrib>Lee, Woo In</creatorcontrib><collection>AGRIS</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><jtitle>Journal of virological methods</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Myeong Hee</au><au>Kang, So Young</au><au>Lee, Woo In</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a new rapid test kit to detect hepatitis C virus infection</atitle><jtitle>Journal of virological methods</jtitle><addtitle>J Virol Methods</addtitle><date>2013-11-01</date><risdate>2013</risdate><volume>193</volume><issue>2</issue><spage>379</spage><epage>382</epage><pages>379-382</pages><issn>0166-0934</issn><eissn>1879-0984</eissn><abstract>•A new rapid kit, SD Bioline HCV had sufficient sensitivity and specificity for screening of HCV infection.•SD Bioline HCV had similar ability of early detection during window period compared to EIA.•SD Bioline HCV showed almost perfect agreement with RIBA. 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The early detection capability of the new RDT and a HCV EIA were similar, with the same window period. The new RDT did not cross-react with HBsAg, anti-HBs, RF and immunoglobulins. In conclusion, the SD Bioline HCV RDT has superior sensitivity and specificity than the GENEDIA® HCV Rapid LF that is used in Korea. This assay can be used for HCV screening, especially in small hospitals, without the financial burden of expensive equipment.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>23871756</pmid><doi>10.1016/j.jviromet.2013.07.005</doi><tpages>4</tpages></addata></record>
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source MEDLINE; ScienceDirect Journals (5 years ago - present)
subjects Adolescent
Adult
Aged
Aged, 80 and over
Anti-HCV
antibodies
Child
cross reaction
Female
Hepacivirus - immunology
hepatitis B antigens
Hepatitis C - diagnosis
Hepatitis C Antibodies - blood
Hepatitis C virus
hospitals
Humans
Immunochromatography - methods
immunoglobulins
Male
Middle Aged
myeloma
patients
Rapid device test
RIBA
screening
Sensitivity and Specificity
seroconversion
Young Adult
title Evaluation of a new rapid test kit to detect hepatitis C virus infection
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