{"title":"[HCV筛选试验技术评价]。","authors":"Yoko Kobayashi, Masami Tomoda, Hitomi Miura, Asako Satho","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Advances in treatment have resulted in a high rate of sustained virological response in patients with hepati- tis C, whereas many asymptomatic carriers of hepatitis C virus (HCV) remain untreated. Therefore, HCV antibody screening holds great significance. However, the measurement principles or types of antigen used in screening vary according to the manufacturer, leading to discrepancies in the results obtained using differ- ent screening reagents. In this study, the performances of five HCV antibody screening assays - ARCHITECT HCV, ECLusys Anti-HCV II assay, HISCL HCV Ab assay, LUMIPULSE II Ortho HCV, and LUMIPULSE Presto Ortho HCV- were compared using 2,042 serum samples. The positive rates for the various assays ranged from 3.6% to 4.5%, and 1,937 and 70 samples were determined as negative and positive, respectively. Discordant results were obtained for 35 samples (1.7%). Additional confirmatory testing was performed on 105 samples that tested positive with at least one reagent. Thus, of the 35 samples with discordant results, 24 single-positive samples were highly likely to be false-positive and 5 single-negative sam- ples were likely to be truly positive. Considering that HCV antibody would not be missed by any assay, those showing no or minimal non-specific or crossover reactions would be ideal for HCV antibody screening. Indeed, further improvement of screening reagents is also needed.</p>","PeriodicalId":21457,"journal":{"name":"Rinsho byori. The Japanese journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2017-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[The Technical Evaluation of HCV Screening Assay].\",\"authors\":\"Yoko Kobayashi, Masami Tomoda, Hitomi Miura, Asako Satho\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Advances in treatment have resulted in a high rate of sustained virological response in patients with hepati- tis C, whereas many asymptomatic carriers of hepatitis C virus (HCV) remain untreated. Therefore, HCV antibody screening holds great significance. However, the measurement principles or types of antigen used in screening vary according to the manufacturer, leading to discrepancies in the results obtained using differ- ent screening reagents. In this study, the performances of five HCV antibody screening assays - ARCHITECT HCV, ECLusys Anti-HCV II assay, HISCL HCV Ab assay, LUMIPULSE II Ortho HCV, and LUMIPULSE Presto Ortho HCV- were compared using 2,042 serum samples. The positive rates for the various assays ranged from 3.6% to 4.5%, and 1,937 and 70 samples were determined as negative and positive, respectively. Discordant results were obtained for 35 samples (1.7%). Additional confirmatory testing was performed on 105 samples that tested positive with at least one reagent. Thus, of the 35 samples with discordant results, 24 single-positive samples were highly likely to be false-positive and 5 single-negative sam- ples were likely to be truly positive. Considering that HCV antibody would not be missed by any assay, those showing no or minimal non-specific or crossover reactions would be ideal for HCV antibody screening. Indeed, further improvement of screening reagents is also needed.</p>\",\"PeriodicalId\":21457,\"journal\":{\"name\":\"Rinsho byori. The Japanese journal of clinical pathology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Rinsho byori. The Japanese journal of clinical pathology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rinsho byori. The Japanese journal of clinical pathology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
治疗的进步导致丙型肝炎患者持续病毒学应答率很高,而许多无症状的丙型肝炎病毒(HCV)携带者仍未得到治疗。因此,HCV抗体筛选具有重要意义。然而,在筛选中使用的抗原的测量原理或类型因制造商而异,导致使用不同的筛选试剂获得的结果存在差异。在这项研究中,比较了5种HCV抗体筛选方法(ARCHITECT HCV, ECLusys Anti-HCV II assay, HISCL HCV Ab assay, LUMIPULSE II Ortho HCV和LUMIPULSE Presto Ortho HCV)的性能,使用2042份血清样本。各种检测方法的阳性率在3.6% ~ 4.5%之间,分别有1937份和70份样品被确定为阴性和阳性。35个样本(1.7%)的结果不一致。对至少一种试剂检测呈阳性的105个样本进行了进一步的确认检测。因此,在35个结果不一致的样本中,24个单阳性样本极有可能是假阳性,5个单阴性样本极有可能是真阳性。考虑到HCV抗体不会被任何检测遗漏,那些没有或只有很少的非特异性或交叉反应的抗体将是HCV抗体筛选的理想选择。确实,筛选试剂也需要进一步改进。
[The Technical Evaluation of HCV Screening Assay].
Advances in treatment have resulted in a high rate of sustained virological response in patients with hepati- tis C, whereas many asymptomatic carriers of hepatitis C virus (HCV) remain untreated. Therefore, HCV antibody screening holds great significance. However, the measurement principles or types of antigen used in screening vary according to the manufacturer, leading to discrepancies in the results obtained using differ- ent screening reagents. In this study, the performances of five HCV antibody screening assays - ARCHITECT HCV, ECLusys Anti-HCV II assay, HISCL HCV Ab assay, LUMIPULSE II Ortho HCV, and LUMIPULSE Presto Ortho HCV- were compared using 2,042 serum samples. The positive rates for the various assays ranged from 3.6% to 4.5%, and 1,937 and 70 samples were determined as negative and positive, respectively. Discordant results were obtained for 35 samples (1.7%). Additional confirmatory testing was performed on 105 samples that tested positive with at least one reagent. Thus, of the 35 samples with discordant results, 24 single-positive samples were highly likely to be false-positive and 5 single-negative sam- ples were likely to be truly positive. Considering that HCV antibody would not be missed by any assay, those showing no or minimal non-specific or crossover reactions would be ideal for HCV antibody screening. Indeed, further improvement of screening reagents is also needed.