Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening

BACKGROUND:  In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The f...

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Veröffentlicht in:Transfusion (Philadelphia, Pa.) Pa.), 2003-10, Vol.43 (10), p.1452-1459
Hauptverfasser: Tobler, Leslie H., Stramer, Susan L., Lee, Stephen R., Masecar, Barbara L., Peterson, Jon E., Davis, E. Anne, Andrews, William E., Brodsky, Jaye P., Kleinman, Steven H., Phelps, Bruce H., Busch, Michael P.
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container_end_page 1459
container_issue 10
container_start_page 1452
container_title Transfusion (Philadelphia, Pa.)
container_volume 43
creator Tobler, Leslie H.
Stramer, Susan L.
Lee, Stephen R.
Masecar, Barbara L.
Peterson, Jon E.
Davis, E. Anne
Andrews, William E.
Brodsky, Jaye P.
Kleinman, Steven H.
Phelps, Bruce H.
Busch, Michael P.
description BACKGROUND:  In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The first study evaluated the differential performance in a cross‐section of screened whole‐blood donors after implementation of HCV 3.0 EIA; the second study evaluated the differential performance of HCV 3.0 EIA in plasma donors acutely infected with HCV, identified during routine Abbott HCV 2.0 EIA and HCV NAT (using Roche Ampliscreen plate assay) donor screening. STUDY DESIGN AND METHODS:  The first study evaluated HCV 3.0 EIA repeat‐reactive donations from four US blood centers, identified during the first 5 months of HCV 3.0 EIA implementation. HCV EIA repeat‐reactive donations confirmed by RIBA HCV 3.0 SIA were retested using both Ortho HCV Version 2.0 ELISA Test System and Abbott HCV 2.0 EIA. All EIA‐discordant donations were tested by polymerase chain reaction (PCR). In the second study, Abbott HCV 2.0 EIA‐nonreactive, HCV PCR‐positive donors were enrolled in a follow‐up study in which the index and follow‐up samples were re‐evaluated by HCV 3.0 EIA. RESULTS:  In the first study, of 292,459 donations, 501 (0.17%) confirmed HCV 3.0 EIA‐reactive donations were identified; 15 (0.005%) were nonreactive by Ortho HCV 2.0 EIA and were all HCV RNA negative. In the second study, Ortho HCV 3.0 EIA retesting of Abbott HCV 2.0 EIA‐nonreactive, RNA‐positive index donations identified 16 (23%) as 3.0 EIA reactive. In 42 panels with a discordant time of seroconversion, HCV 3.0 EIA sero‐conversion preceded HCV 2.0 EIA in all cases (p < 0.001). Two donors with HCV 3.0 EIA‐reactive index donations never seroconverted by HCV 2.0 EIA during 160 to 180 days of follow‐up. CONCLUSION:  These studies demonstrate that HCV 3.0 EIA compared to HCV 2.0 EIA can better detect 1) remote nonviremic HCV infections, 2) acute infection, and 3) HCV antibodies in cases of atypical seroconversion.
doi_str_mv 10.1046/j.1537-2995.2003.00521.x
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Anne ; Andrews, William E. ; Brodsky, Jaye P. ; Kleinman, Steven H. ; Phelps, Bruce H. ; Busch, Michael P.</creator><creatorcontrib>Tobler, Leslie H. ; Stramer, Susan L. ; Lee, Stephen R. ; Masecar, Barbara L. ; Peterson, Jon E. ; Davis, E. Anne ; Andrews, William E. ; Brodsky, Jaye P. ; Kleinman, Steven H. ; Phelps, Bruce H. ; Busch, Michael P.</creatorcontrib><description>BACKGROUND:  In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The first study evaluated the differential performance in a cross‐section of screened whole‐blood donors after implementation of HCV 3.0 EIA; the second study evaluated the differential performance of HCV 3.0 EIA in plasma donors acutely infected with HCV, identified during routine Abbott HCV 2.0 EIA and HCV NAT (using Roche Ampliscreen plate assay) donor screening. STUDY DESIGN AND METHODS:  The first study evaluated HCV 3.0 EIA repeat‐reactive donations from four US blood centers, identified during the first 5 months of HCV 3.0 EIA implementation. HCV EIA repeat‐reactive donations confirmed by RIBA HCV 3.0 SIA were retested using both Ortho HCV Version 2.0 ELISA Test System and Abbott HCV 2.0 EIA. All EIA‐discordant donations were tested by polymerase chain reaction (PCR). In the second study, Abbott HCV 2.0 EIA‐nonreactive, HCV PCR‐positive donors were enrolled in a follow‐up study in which the index and follow‐up samples were re‐evaluated by HCV 3.0 EIA. RESULTS:  In the first study, of 292,459 donations, 501 (0.17%) confirmed HCV 3.0 EIA‐reactive donations were identified; 15 (0.005%) were nonreactive by Ortho HCV 2.0 EIA and were all HCV RNA negative. In the second study, Ortho HCV 3.0 EIA retesting of Abbott HCV 2.0 EIA‐nonreactive, RNA‐positive index donations identified 16 (23%) as 3.0 EIA reactive. In 42 panels with a discordant time of seroconversion, HCV 3.0 EIA sero‐conversion preceded HCV 2.0 EIA in all cases (p &lt; 0.001). Two donors with HCV 3.0 EIA‐reactive index donations never seroconverted by HCV 2.0 EIA during 160 to 180 days of follow‐up. CONCLUSION:  These studies demonstrate that HCV 3.0 EIA compared to HCV 2.0 EIA can better detect 1) remote nonviremic HCV infections, 2) acute infection, and 3) HCV antibodies in cases of atypical seroconversion.</description><identifier>ISSN: 0041-1132</identifier><identifier>EISSN: 1537-2995</identifier><identifier>DOI: 10.1046/j.1537-2995.2003.00521.x</identifier><identifier>PMID: 14507279</identifier><identifier>CODEN: TRANAT</identifier><language>eng</language><publisher>Oxford, UK and Malden, USA: Blackwell Science Inc</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Blood Donors ; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis ; Hepatitis C - diagnosis ; Hepatitis C Antibodies - blood ; Human viral diseases ; Humans ; Immunoenzyme Techniques ; Infectious diseases ; Medical sciences ; RNA, Viral - blood ; Transfusions. Complications. 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Anne</creatorcontrib><creatorcontrib>Andrews, William E.</creatorcontrib><creatorcontrib>Brodsky, Jaye P.</creatorcontrib><creatorcontrib>Kleinman, Steven H.</creatorcontrib><creatorcontrib>Phelps, Bruce H.</creatorcontrib><creatorcontrib>Busch, Michael P.</creatorcontrib><title>Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening</title><title>Transfusion (Philadelphia, Pa.)</title><addtitle>Transfusion</addtitle><description>BACKGROUND:  In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The first study evaluated the differential performance in a cross‐section of screened whole‐blood donors after implementation of HCV 3.0 EIA; the second study evaluated the differential performance of HCV 3.0 EIA in plasma donors acutely infected with HCV, identified during routine Abbott HCV 2.0 EIA and HCV NAT (using Roche Ampliscreen plate assay) donor screening. STUDY DESIGN AND METHODS:  The first study evaluated HCV 3.0 EIA repeat‐reactive donations from four US blood centers, identified during the first 5 months of HCV 3.0 EIA implementation. HCV EIA repeat‐reactive donations confirmed by RIBA HCV 3.0 SIA were retested using both Ortho HCV Version 2.0 ELISA Test System and Abbott HCV 2.0 EIA. All EIA‐discordant donations were tested by polymerase chain reaction (PCR). In the second study, Abbott HCV 2.0 EIA‐nonreactive, HCV PCR‐positive donors were enrolled in a follow‐up study in which the index and follow‐up samples were re‐evaluated by HCV 3.0 EIA. RESULTS:  In the first study, of 292,459 donations, 501 (0.17%) confirmed HCV 3.0 EIA‐reactive donations were identified; 15 (0.005%) were nonreactive by Ortho HCV 2.0 EIA and were all HCV RNA negative. In the second study, Ortho HCV 3.0 EIA retesting of Abbott HCV 2.0 EIA‐nonreactive, RNA‐positive index donations identified 16 (23%) as 3.0 EIA reactive. In 42 panels with a discordant time of seroconversion, HCV 3.0 EIA sero‐conversion preceded HCV 2.0 EIA in all cases (p &lt; 0.001). Two donors with HCV 3.0 EIA‐reactive index donations never seroconverted by HCV 2.0 EIA during 160 to 180 days of follow‐up. CONCLUSION:  These studies demonstrate that HCV 3.0 EIA compared to HCV 2.0 EIA can better detect 1) remote nonviremic HCV infections, 2) acute infection, and 3) HCV antibodies in cases of atypical seroconversion.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Blood Donors</subject><subject>Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis C Antibodies - blood</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunoenzyme Techniques</subject><subject>Infectious diseases</subject><subject>Medical sciences</subject><subject>RNA, Viral - blood</subject><subject>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0041-1132</issn><issn>1537-2995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkFFv0zAQxy0EYmXwFZBf4C2Z7YvtWOJlqtatYgJpKt2j5TgXlJLGxU5H9-1J12h73dOdzr__-fQjhHKWc1aoi03OJehMGCNzwRjkjEnB88MbMnt-eEtmjBU84xzEGfmQ0oYxJgzj78kZLyTTQpsZWSy3O-cHGhp6M1_TcRO9Wl7SiJ0b2gekQ3iai2keelp1IdRZHfoQafIRsW_73x_Ju8Z1CT9N9Zz8Wlyt5jfZ7c_r5fzyNvMFCJ5pBwClqbAuuK94IxTzSihVG-NVpV2NAovxSIcGlWMGGimgBFXWlecAHs7J19PeXQx_95gGu22Tx65zPYZ9slpqrpiCESxPoI8hpYiN3cV26-Kj5cweHdqNPaqyR1X26NA-ObSHMfp5-mNfbbF-CU7SRuDLBLjkXddE1_s2vXCSm1IaPnLfTty_tsPHVx9gV3eLsRnj2SnepgEPz3EX_1ilQUt7_-PawvfV3Vrer-0C_gMrCZdx</recordid><startdate>200310</startdate><enddate>200310</enddate><creator>Tobler, Leslie H.</creator><creator>Stramer, Susan L.</creator><creator>Lee, Stephen R.</creator><creator>Masecar, Barbara L.</creator><creator>Peterson, Jon E.</creator><creator>Davis, E. 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Transfusion reactions. Cell and gene therapy</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tobler, Leslie H.</creatorcontrib><creatorcontrib>Stramer, Susan L.</creatorcontrib><creatorcontrib>Lee, Stephen R.</creatorcontrib><creatorcontrib>Masecar, Barbara L.</creatorcontrib><creatorcontrib>Peterson, Jon E.</creatorcontrib><creatorcontrib>Davis, E. Anne</creatorcontrib><creatorcontrib>Andrews, William E.</creatorcontrib><creatorcontrib>Brodsky, Jaye P.</creatorcontrib><creatorcontrib>Kleinman, Steven H.</creatorcontrib><creatorcontrib>Phelps, Bruce H.</creatorcontrib><creatorcontrib>Busch, Michael P.</creatorcontrib><collection>Istex</collection><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><jtitle>Transfusion (Philadelphia, Pa.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tobler, Leslie H.</au><au>Stramer, Susan L.</au><au>Lee, Stephen R.</au><au>Masecar, Barbara L.</au><au>Peterson, Jon E.</au><au>Davis, E. Anne</au><au>Andrews, William E.</au><au>Brodsky, Jaye P.</au><au>Kleinman, Steven H.</au><au>Phelps, Bruce H.</au><au>Busch, Michael P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening</atitle><jtitle>Transfusion (Philadelphia, Pa.)</jtitle><addtitle>Transfusion</addtitle><date>2003-10</date><risdate>2003</risdate><volume>43</volume><issue>10</issue><spage>1452</spage><epage>1459</epage><pages>1452-1459</pages><issn>0041-1132</issn><eissn>1537-2995</eissn><coden>TRANAT</coden><abstract>BACKGROUND:  In 1996, the Ortho HCV Version 3.0 ELISA Test System (HCV 3.0 EIA) was licensed in the United States for donor screening but was neither mandated nor universally implemented. Data from two studies comparing the differential performance of HCV 3.0 EIA and HCV 2.0 EIA are presented. The first study evaluated the differential performance in a cross‐section of screened whole‐blood donors after implementation of HCV 3.0 EIA; the second study evaluated the differential performance of HCV 3.0 EIA in plasma donors acutely infected with HCV, identified during routine Abbott HCV 2.0 EIA and HCV NAT (using Roche Ampliscreen plate assay) donor screening. STUDY DESIGN AND METHODS:  The first study evaluated HCV 3.0 EIA repeat‐reactive donations from four US blood centers, identified during the first 5 months of HCV 3.0 EIA implementation. HCV EIA repeat‐reactive donations confirmed by RIBA HCV 3.0 SIA were retested using both Ortho HCV Version 2.0 ELISA Test System and Abbott HCV 2.0 EIA. All EIA‐discordant donations were tested by polymerase chain reaction (PCR). In the second study, Abbott HCV 2.0 EIA‐nonreactive, HCV PCR‐positive donors were enrolled in a follow‐up study in which the index and follow‐up samples were re‐evaluated by HCV 3.0 EIA. RESULTS:  In the first study, of 292,459 donations, 501 (0.17%) confirmed HCV 3.0 EIA‐reactive donations were identified; 15 (0.005%) were nonreactive by Ortho HCV 2.0 EIA and were all HCV RNA negative. In the second study, Ortho HCV 3.0 EIA retesting of Abbott HCV 2.0 EIA‐nonreactive, RNA‐positive index donations identified 16 (23%) as 3.0 EIA reactive. In 42 panels with a discordant time of seroconversion, HCV 3.0 EIA sero‐conversion preceded HCV 2.0 EIA in all cases (p &lt; 0.001). Two donors with HCV 3.0 EIA‐reactive index donations never seroconverted by HCV 2.0 EIA during 160 to 180 days of follow‐up. CONCLUSION:  These studies demonstrate that HCV 3.0 EIA compared to HCV 2.0 EIA can better detect 1) remote nonviremic HCV infections, 2) acute infection, and 3) HCV antibodies in cases of atypical seroconversion.</abstract><cop>Oxford, UK and Malden, USA</cop><pub>Blackwell Science Inc</pub><pmid>14507279</pmid><doi>10.1046/j.1537-2995.2003.00521.x</doi><tpages>8</tpages></addata></record>
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subjects Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Blood Donors
Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis
Hepatitis C - diagnosis
Hepatitis C Antibodies - blood
Human viral diseases
Humans
Immunoenzyme Techniques
Infectious diseases
Medical sciences
RNA, Viral - blood
Transfusions. Complications. Transfusion reactions. Cell and gene therapy
Viral diseases
Viral hepatitis
title Impact of HCV 3.0 EIA relative to HCV 2.0 EIA on blood-donor screening
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