Wai-Chiu Tsoi , Catriona Simpson , Lisa Jarvis , Alan Smith , Ninette Robbins , Ramune Sepetiene , Sonu Bhatnagar
{"title":"Alinity新的抗HCV II检测法用于丙型肝炎病毒血液常规筛查的多中心评价","authors":"Wai-Chiu Tsoi , Catriona Simpson , Lisa Jarvis , Alan Smith , Ninette Robbins , Ramune Sepetiene , Sonu Bhatnagar","doi":"10.1016/j.jcvp.2023.100136","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Anti-HCV immunoassays remain the primary serologic test for HCV screening among blood donors. Since 1990s, Anti-HCV assays have evolved and those currently available detect infection earlier and have improved sensitivity and specificity compared with older generation assays. The new Alinity s Anti-HCV II assay, with its innovative design, has improved sensitivity, which shall further enhance safety of blood.</p></div><div><h3>Methods</h3><p>Alinity s Anti-HCV II assay was evaluated at 2 blood services (HKRCBTS & SNBTS). The overall sensitivity was evaluated using known positive samples (<em>n</em> = 5 at HKRCBTS; 50 at SNBTS) and 3 seroconversion panels (panel members =14 at each site). A total of 7,532 blood donor samples were tested to determine the clinical specificity.</p></div><div><h3>Results</h3><p>The clinical sensitivity of the new assay was found to be 100% at both sites. HCV seroconversion panel detection rates were 57.1% (8/14) and 14.3% (2/14) for the Alinity s Anti-HCV II and Anti-HCV assays respectively, resulting in an improvement in seroconversion sensitivity of 42.8% for the Anti-HCV II assay over the Anti-HCV assay. The specificity of the Anti-HCV II assay was 100% at HKRCBTS, and 99.95% at SNBTS.</p></div><div><h3>Conclusions</h3><p>The Anti-HCV II assay detected all known positive specimens and was able to detect samples in seroconversion panels earlier compared to the Anti-HCV assay. The assay showed excellent clinical specificity and generated fewer false-reactive results and was found to be suitable for routine blood donor screening.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 1","pages":"Article 100136"},"PeriodicalIF":1.6000,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Multicenter evaluation of the new Alinity s anti-HCV II assay for routine hepatitis C virus blood screening\",\"authors\":\"Wai-Chiu Tsoi , Catriona Simpson , Lisa Jarvis , Alan Smith , Ninette Robbins , Ramune Sepetiene , Sonu Bhatnagar\",\"doi\":\"10.1016/j.jcvp.2023.100136\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Anti-HCV immunoassays remain the primary serologic test for HCV screening among blood donors. Since 1990s, Anti-HCV assays have evolved and those currently available detect infection earlier and have improved sensitivity and specificity compared with older generation assays. The new Alinity s Anti-HCV II assay, with its innovative design, has improved sensitivity, which shall further enhance safety of blood.</p></div><div><h3>Methods</h3><p>Alinity s Anti-HCV II assay was evaluated at 2 blood services (HKRCBTS & SNBTS). The overall sensitivity was evaluated using known positive samples (<em>n</em> = 5 at HKRCBTS; 50 at SNBTS) and 3 seroconversion panels (panel members =14 at each site). A total of 7,532 blood donor samples were tested to determine the clinical specificity.</p></div><div><h3>Results</h3><p>The clinical sensitivity of the new assay was found to be 100% at both sites. HCV seroconversion panel detection rates were 57.1% (8/14) and 14.3% (2/14) for the Alinity s Anti-HCV II and Anti-HCV assays respectively, resulting in an improvement in seroconversion sensitivity of 42.8% for the Anti-HCV II assay over the Anti-HCV assay. The specificity of the Anti-HCV II assay was 100% at HKRCBTS, and 99.95% at SNBTS.</p></div><div><h3>Conclusions</h3><p>The Anti-HCV II assay detected all known positive specimens and was able to detect samples in seroconversion panels earlier compared to the Anti-HCV assay. The assay showed excellent clinical specificity and generated fewer false-reactive results and was found to be suitable for routine blood donor screening.</p></div>\",\"PeriodicalId\":73673,\"journal\":{\"name\":\"Journal of clinical virology plus\",\"volume\":\"3 1\",\"pages\":\"Article 100136\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2023-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of clinical virology plus\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2667038023000030\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical virology plus","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667038023000030","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Multicenter evaluation of the new Alinity s anti-HCV II assay for routine hepatitis C virus blood screening
Background
Anti-HCV immunoassays remain the primary serologic test for HCV screening among blood donors. Since 1990s, Anti-HCV assays have evolved and those currently available detect infection earlier and have improved sensitivity and specificity compared with older generation assays. The new Alinity s Anti-HCV II assay, with its innovative design, has improved sensitivity, which shall further enhance safety of blood.
Methods
Alinity s Anti-HCV II assay was evaluated at 2 blood services (HKRCBTS & SNBTS). The overall sensitivity was evaluated using known positive samples (n = 5 at HKRCBTS; 50 at SNBTS) and 3 seroconversion panels (panel members =14 at each site). A total of 7,532 blood donor samples were tested to determine the clinical specificity.
Results
The clinical sensitivity of the new assay was found to be 100% at both sites. HCV seroconversion panel detection rates were 57.1% (8/14) and 14.3% (2/14) for the Alinity s Anti-HCV II and Anti-HCV assays respectively, resulting in an improvement in seroconversion sensitivity of 42.8% for the Anti-HCV II assay over the Anti-HCV assay. The specificity of the Anti-HCV II assay was 100% at HKRCBTS, and 99.95% at SNBTS.
Conclusions
The Anti-HCV II assay detected all known positive specimens and was able to detect samples in seroconversion panels earlier compared to the Anti-HCV assay. The assay showed excellent clinical specificity and generated fewer false-reactive results and was found to be suitable for routine blood donor screening.
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