High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan
Nationwide nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) of blood donated voluntarily after serological screening was implemented on July 1st 1999 for transfusion and plasma fractionation by the Japanese...
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| Veröffentlicht in: | Journal of virological methods 2003-09, Vol.112 (1), p.145-151 |
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| creator | Mine, Hideko Emura, Hiroyuki Miyamoto, Masaki Tomono, Tsugikazu Minegishi, Kiyoshi Murokawa, Hiroyuki Yamanaka, Retsuji Yoshikawa, Akira Nishioka, Kusuya |
| description | Nationwide nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) of blood donated voluntarily after serological screening was implemented on July 1st 1999 for transfusion and plasma fractionation by the Japanese Red Cross blood transfusion services. From February 1st 2000, HBV, HCV and HIV-1 NAT screening of pools of 50 negative serologically screened donated blood was started and the results were reported within 1 day after blood donation. Systems were established for rapid shipment, electronic communication, automated specimen preparation, pooling and automated amplification and detection. At present, NAT screening is carried out within 1 day after donation. This report describes the blood screening system by NAT and the results obtained from over 16 million blood samples using simultaneous screening for HBV, HCV and HIV-1 with multiplex reagent. Between February 1, 2000 and December 31, 2002, 16 012 175 serologically negative units were tested by NAT. 308 units with Hepatitis B virus DNA (HBV DNA) were detected. The sensitivity of 50 pool NAT screening with input volume of 0.2 ml is significantly higher than that of highly sensitive HBsAg testing. 46 cases with HCV RNA and six cases with HIV-1 RNA were detected. These cases were not detected by HCV antibody and HIV-1 antibody screening. The false positive rate was 0.18%. The NAT system was developed from serological screening test negative non-remunerated voluntary donations. We supply blood products to medical organizations after screening by NAT for HBV, HCV and HIV-1 for transfusion and source plasma for fractionation. This is the first automated integrated system for prevention of transfusion transmitted HBV, HCV and HIV-1 infections, by NAT screening. |
| doi_str_mv | 10.1016/S0166-0934(03)00215-5 |
| format | Article |
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From February 1st 2000, HBV, HCV and HIV-1 NAT screening of pools of 50 negative serologically screened donated blood was started and the results were reported within 1 day after blood donation. Systems were established for rapid shipment, electronic communication, automated specimen preparation, pooling and automated amplification and detection. At present, NAT screening is carried out within 1 day after donation. This report describes the blood screening system by NAT and the results obtained from over 16 million blood samples using simultaneous screening for HBV, HCV and HIV-1 with multiplex reagent. Between February 1, 2000 and December 31, 2002, 16 012 175 serologically negative units were tested by NAT. 308 units with Hepatitis B virus DNA (HBV DNA) were detected. The sensitivity of 50 pool NAT screening with input volume of 0.2 ml is significantly higher than that of highly sensitive HBsAg testing. 46 cases with HCV RNA and six cases with HIV-1 RNA were detected. These cases were not detected by HCV antibody and HIV-1 antibody screening. The false positive rate was 0.18%. The NAT system was developed from serological screening test negative non-remunerated voluntary donations. We supply blood products to medical organizations after screening by NAT for HBV, HCV and HIV-1 for transfusion and source plasma for fractionation. This is the first automated integrated system for prevention of transfusion transmitted HBV, HCV and HIV-1 infections, by NAT screening.</description><identifier>ISSN: 0166-0934</identifier><identifier>EISSN: 1879-0984</identifier><identifier>DOI: 10.1016/S0166-0934(03)00215-5</identifier><identifier>PMID: 12951223</identifier><identifier>CODEN: JVMEDH</identifier><language>eng</language><publisher>London: Elsevier B.V</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Antibodies, Viral - blood ; Automated NAT ; Biological and medical sciences ; Blood Donors ; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis ; HBV ; HCV ; Hepatitis B - diagnosis ; Hepatitis B virus - classification ; Hepatitis B virus - genetics ; Hepatitis B virus - isolation & purification ; Hepatitis C - diagnosis ; Hepatitis Viruses - genetics ; Hepatitis Viruses - isolation & purification ; HIV Infections - diagnosis ; HIV-1 ; HIV-1 - genetics ; HIV-1 - isolation & purification ; Humans ; Japan ; Mass Screening ; Medical sciences ; Nucleic Acid Amplification Techniques ; Nucleic Acids - analysis ; Sensitivity and Specificity ; Transfusions. Complications. Transfusion reactions. Cell and gene therapy ; Viremia</subject><ispartof>Journal of virological methods, 2003-09, Vol.112 (1), p.145-151</ispartof><rights>2003</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-fc4b9b15b2601a2b8055131ec3a05129cc5b789d841a53142e329d6aee42bf6a3</citedby><cites>FETCH-LOGICAL-c422t-fc4b9b15b2601a2b8055131ec3a05129cc5b789d841a53142e329d6aee42bf6a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0166-0934(03)00215-5$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15114535$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12951223$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mine, Hideko</creatorcontrib><creatorcontrib>Emura, Hiroyuki</creatorcontrib><creatorcontrib>Miyamoto, Masaki</creatorcontrib><creatorcontrib>Tomono, Tsugikazu</creatorcontrib><creatorcontrib>Minegishi, Kiyoshi</creatorcontrib><creatorcontrib>Murokawa, Hiroyuki</creatorcontrib><creatorcontrib>Yamanaka, Retsuji</creatorcontrib><creatorcontrib>Yoshikawa, Akira</creatorcontrib><creatorcontrib>Nishioka, Kusuya</creatorcontrib><creatorcontrib>Japanese Red Cross NAT Research Group</creatorcontrib><title>High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan</title><title>Journal of virological methods</title><addtitle>J Virol Methods</addtitle><description>Nationwide nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) of blood donated voluntarily after serological screening was implemented on July 1st 1999 for transfusion and plasma fractionation by the Japanese Red Cross blood transfusion services. From February 1st 2000, HBV, HCV and HIV-1 NAT screening of pools of 50 negative serologically screened donated blood was started and the results were reported within 1 day after blood donation. Systems were established for rapid shipment, electronic communication, automated specimen preparation, pooling and automated amplification and detection. At present, NAT screening is carried out within 1 day after donation. This report describes the blood screening system by NAT and the results obtained from over 16 million blood samples using simultaneous screening for HBV, HCV and HIV-1 with multiplex reagent. Between February 1, 2000 and December 31, 2002, 16 012 175 serologically negative units were tested by NAT. 308 units with Hepatitis B virus DNA (HBV DNA) were detected. The sensitivity of 50 pool NAT screening with input volume of 0.2 ml is significantly higher than that of highly sensitive HBsAg testing. 46 cases with HCV RNA and six cases with HIV-1 RNA were detected. These cases were not detected by HCV antibody and HIV-1 antibody screening. The false positive rate was 0.18%. The NAT system was developed from serological screening test negative non-remunerated voluntary donations. We supply blood products to medical organizations after screening by NAT for HBV, HCV and HIV-1 for transfusion and source plasma for fractionation. This is the first automated integrated system for prevention of transfusion transmitted HBV, HCV and HIV-1 infections, by NAT screening.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Antibodies, Viral - blood</subject><subject>Automated NAT</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>HBV</subject><subject>HCV</subject><subject>Hepatitis B - diagnosis</subject><subject>Hepatitis B virus - classification</subject><subject>Hepatitis B virus - genetics</subject><subject>Hepatitis B virus - isolation & purification</subject><subject>Hepatitis C - diagnosis</subject><subject>Hepatitis Viruses - genetics</subject><subject>Hepatitis Viruses - isolation & purification</subject><subject>HIV Infections - diagnosis</subject><subject>HIV-1</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - isolation & purification</subject><subject>Humans</subject><subject>Japan</subject><subject>Mass Screening</subject><subject>Medical sciences</subject><subject>Nucleic Acid Amplification Techniques</subject><subject>Nucleic Acids - analysis</subject><subject>Sensitivity and Specificity</subject><subject>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</subject><subject>Viremia</subject><issn>0166-0934</issn><issn>1879-0984</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFksuO1TAMhisEYg4DjwDKBgQShVyaXlYIjoABjcQCWFdp6rZGaVKS9MB5dHbkXMSwm00i2Z_tX_afZY8ZfcUoK19_TU-Z00YUz6l4QSlnMpd3sg2rqyaF6-JutvmHXGQPQvhBKZWVEPezC8YbyTgXm-zPFY4TiZN36zgtayRBewCLdiRuIKwkMxqDzpIA3hk3olbG7ImFUUXcAemMcz3pnXU-kMF5MsGSMhEDeUd26Nfw8r_Q9hQiyvZkWmdlCc7zal0PA2oEq_dnIO4XyBnp0qRVG0BNlMaeqHkxmNDULkmKEOJB6C-MEwkL6EPq2DuADXjUN68m4mLgN_GgRrCRoCWf1aLsw-zeoEyAR-f_Mvv-4f237VV-_eXjp-3b61wXnMd80EXXdEx2vKRM8a6mUjLBQAtF0w4brWVX1U1fF0xJwQoOgjd9qQAK3g2lEpfZs1Pfxbufa5Lczhg0GKMsuDW0lSh5WTXFrSCr60oWFU-gPIHauxA8DO3icVZ-3zLaHszRHs3RHi7fUtEezdHKVPfkPGDtZuhvqs5uSMDTM6BCuvPgldUYbjjJWCHFodGbEwdpbzsE34bj9aBHDzq2vcNbpPwFQn3crw</recordid><startdate>20030901</startdate><enddate>20030901</enddate><creator>Mine, Hideko</creator><creator>Emura, Hiroyuki</creator><creator>Miyamoto, Masaki</creator><creator>Tomono, Tsugikazu</creator><creator>Minegishi, Kiyoshi</creator><creator>Murokawa, Hiroyuki</creator><creator>Yamanaka, Retsuji</creator><creator>Yoshikawa, Akira</creator><creator>Nishioka, Kusuya</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>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20030901</creationdate><title>High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan</title><author>Mine, Hideko ; Emura, Hiroyuki ; Miyamoto, Masaki ; Tomono, Tsugikazu ; Minegishi, Kiyoshi ; Murokawa, Hiroyuki ; Yamanaka, Retsuji ; Yoshikawa, Akira ; Nishioka, Kusuya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-fc4b9b15b2601a2b8055131ec3a05129cc5b789d841a53142e329d6aee42bf6a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Antibodies, Viral - blood</topic><topic>Automated NAT</topic><topic>Biological and medical sciences</topic><topic>Blood Donors</topic><topic>Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis</topic><topic>HBV</topic><topic>HCV</topic><topic>Hepatitis B - diagnosis</topic><topic>Hepatitis B virus - classification</topic><topic>Hepatitis B virus - genetics</topic><topic>Hepatitis B virus - isolation & purification</topic><topic>Hepatitis C - diagnosis</topic><topic>Hepatitis Viruses - genetics</topic><topic>Hepatitis Viruses - isolation & purification</topic><topic>HIV Infections - diagnosis</topic><topic>HIV-1</topic><topic>HIV-1 - genetics</topic><topic>HIV-1 - isolation & purification</topic><topic>Humans</topic><topic>Japan</topic><topic>Mass Screening</topic><topic>Medical sciences</topic><topic>Nucleic Acid Amplification Techniques</topic><topic>Nucleic Acids - analysis</topic><topic>Sensitivity and Specificity</topic><topic>Transfusions. Complications. Transfusion reactions. Cell and gene therapy</topic><topic>Viremia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mine, Hideko</creatorcontrib><creatorcontrib>Emura, Hiroyuki</creatorcontrib><creatorcontrib>Miyamoto, Masaki</creatorcontrib><creatorcontrib>Tomono, Tsugikazu</creatorcontrib><creatorcontrib>Minegishi, Kiyoshi</creatorcontrib><creatorcontrib>Murokawa, Hiroyuki</creatorcontrib><creatorcontrib>Yamanaka, Retsuji</creatorcontrib><creatorcontrib>Yoshikawa, Akira</creatorcontrib><creatorcontrib>Nishioka, Kusuya</creatorcontrib><creatorcontrib>Japanese Red Cross NAT Research Group</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>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of virological methods</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mine, Hideko</au><au>Emura, Hiroyuki</au><au>Miyamoto, Masaki</au><au>Tomono, Tsugikazu</au><au>Minegishi, Kiyoshi</au><au>Murokawa, Hiroyuki</au><au>Yamanaka, Retsuji</au><au>Yoshikawa, Akira</au><au>Nishioka, Kusuya</au><aucorp>Japanese Red Cross NAT Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan</atitle><jtitle>Journal of virological methods</jtitle><addtitle>J Virol Methods</addtitle><date>2003-09-01</date><risdate>2003</risdate><volume>112</volume><issue>1</issue><spage>145</spage><epage>151</epage><pages>145-151</pages><issn>0166-0934</issn><eissn>1879-0984</eissn><coden>JVMEDH</coden><abstract>Nationwide nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) of blood donated voluntarily after serological screening was implemented on July 1st 1999 for transfusion and plasma fractionation by the Japanese Red Cross blood transfusion services. From February 1st 2000, HBV, HCV and HIV-1 NAT screening of pools of 50 negative serologically screened donated blood was started and the results were reported within 1 day after blood donation. Systems were established for rapid shipment, electronic communication, automated specimen preparation, pooling and automated amplification and detection. At present, NAT screening is carried out within 1 day after donation. This report describes the blood screening system by NAT and the results obtained from over 16 million blood samples using simultaneous screening for HBV, HCV and HIV-1 with multiplex reagent. Between February 1, 2000 and December 31, 2002, 16 012 175 serologically negative units were tested by NAT. 308 units with Hepatitis B virus DNA (HBV DNA) were detected. The sensitivity of 50 pool NAT screening with input volume of 0.2 ml is significantly higher than that of highly sensitive HBsAg testing. 46 cases with HCV RNA and six cases with HIV-1 RNA were detected. These cases were not detected by HCV antibody and HIV-1 antibody screening. The false positive rate was 0.18%. The NAT system was developed from serological screening test negative non-remunerated voluntary donations. We supply blood products to medical organizations after screening by NAT for HBV, HCV and HIV-1 for transfusion and source plasma for fractionation. This is the first automated integrated system for prevention of transfusion transmitted HBV, HCV and HIV-1 infections, by NAT screening.</abstract><cop>London</cop><cop>Amsterdam</cop><cop>New York, NY</cop><pub>Elsevier B.V</pub><pmid>12951223</pmid><doi>10.1016/S0166-0934(03)00215-5</doi><tpages>7</tpages></addata></record> |
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| ispartof | Journal of virological methods, 2003-09, Vol.112 (1), p.145-151 |
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| subjects | Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Antibodies, Viral - blood Automated NAT Biological and medical sciences Blood Donors Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis HBV HCV Hepatitis B - diagnosis Hepatitis B virus - classification Hepatitis B virus - genetics Hepatitis B virus - isolation & purification Hepatitis C - diagnosis Hepatitis Viruses - genetics Hepatitis Viruses - isolation & purification HIV Infections - diagnosis HIV-1 HIV-1 - genetics HIV-1 - isolation & purification Humans Japan Mass Screening Medical sciences Nucleic Acid Amplification Techniques Nucleic Acids - analysis Sensitivity and Specificity Transfusions. Complications. Transfusion reactions. Cell and gene therapy Viremia |
| title | High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan |
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