一项前瞻性研究，评估在 HBV 流行地区使用 cobas® 6800 系统筛查献血样本中 HIV RNA、HCV RNA 和 HBV DNA 的 cobas® MPX 检测试剂盒的临床特异性

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus Pub Date : 2024-11-07 DOI:10.1016/j.jcvp.2024.100197

Lei Zhou , Lin Wang , Xiaofang Gong , Xiaochun Liu , Yaxuan Zou , Yingying Wang , Jinfeng Zeng , Liang Zang

{"title":"一项前瞻性研究，评估在 HBV 流行地区使用 cobas® 6800 系统筛查献血样本中 HIV RNA、HCV RNA 和 HBV DNA 的 cobas® MPX 检测试剂盒的临床特异性","authors":"Lei Zhou , Lin Wang , Xiaofang Gong , Xiaochun Liu , Yaxuan Zou , Yingying Wang , Jinfeng Zeng , Liang Zang","doi":"10.1016/j.jcvp.2024.100197","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Nucleic acid testing (NAT) is widely used for screening blood donors for infectious diseases to enhance transfusion safety. Roche's advanced cobas® MPX assay detects human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) using the cobas® 6800/5800 Systems, based on real-time PCR technology, providing improved sensitivity. This study aims to evaluate the clinical sensitivity and specificity of the cobas® MPX assay and its effectiveness in identifying infected donors in HBV endemic areas, particularly those with occult HBV infection (OBI).</div></div><div><h3>Materials and methods</h3><div>A total of 12,067 donor samples from the Dalian Blood Center (DLBC, northern China) were tested for HIV, HCV, and HBV using both the cobas® MPX assay on the cobas® 6800 system and the previous generation cobas® TaqScreen MPX test v2.0 on the cobas s 201 system as the reference method. Testing was conducted using individual-donation testing (IDT) and primary pool of six donations (PP6), following the manufacturer's instructions and the operational procedures of the instruments. Samples with inconsistent results underwent repeated confirmation tests.</div></div><div><h3>Results</h3><div>Cobas® MPX demonstrated 100.00 % overall percent agreement (95 % CI, 99.22 %-100.00 %) for IDT and 99.89 % (95 % CI, 99.82 %-99.95 %) for PP6. Kappa coefficients were 1.0 for IDT and 0.76 for PP6. Cobas® MPX specificity was 100.00 % (95 % CI, 99.22 %-100.00 %) for IDT and 99.99 % (95 % CI, 99.94 %-100.00 %) for PP6. Sensitivity was 100.00 % (95 % CI, 2.50 %-100.00 %) for IDT and 86.67 % (95 % CI, 68.36 %-95.64 %) for PP6. A total of 12 HBV NAT-yield cases were detected by cobas® MPX.</div></div><div><h3>Conclusion</h3><div>Cobas® MPX demonstrated outstanding sensitivity and specificity in screening HIV, HCV, and HBV in routine blood donations, particularly enhancing occult HBV detection in endemic regions.</div></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"5 1","pages":"Article 100197"},"PeriodicalIF":1.6000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A prospective study to evaluate the clinical specificity of the cobas® MPX test kit for screening for HIV RNA, HCV RNA, and HBV DNA in blood donation samples using the cobas® 6800 system in HBV endemic areas\",\"authors\":\"Lei Zhou , Lin Wang , Xiaofang Gong , Xiaochun Liu , Yaxuan Zou , Yingying Wang , Jinfeng Zeng , Liang Zang\",\"doi\":\"10.1016/j.jcvp.2024.100197\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Nucleic acid testing (NAT) is widely used for screening blood donors for infectious diseases to enhance transfusion safety. Roche's advanced cobas® MPX assay detects human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) using the cobas® 6800/5800 Systems, based on real-time PCR technology, providing improved sensitivity. This study aims to evaluate the clinical sensitivity and specificity of the cobas® MPX assay and its effectiveness in identifying infected donors in HBV endemic areas, particularly those with occult HBV infection (OBI).</div></div><div><h3>Materials and methods</h3><div>A total of 12,067 donor samples from the Dalian Blood Center (DLBC, northern China) were tested for HIV, HCV, and HBV using both the cobas® MPX assay on the cobas® 6800 system and the previous generation cobas® TaqScreen MPX test v2.0 on the cobas s 201 system as the reference method. Testing was conducted using individual-donation testing (IDT) and primary pool of six donations (PP6), following the manufacturer's instructions and the operational procedures of the instruments. Samples with inconsistent results underwent repeated confirmation tests.</div></div><div><h3>Results</h3><div>Cobas® MPX demonstrated 100.00 % overall percent agreement (95 % CI, 99.22 %-100.00 %) for IDT and 99.89 % (95 % CI, 99.82 %-99.95 %) for PP6. Kappa coefficients were 1.0 for IDT and 0.76 for PP6. Cobas® MPX specificity was 100.00 % (95 % CI, 99.22 %-100.00 %) for IDT and 99.99 % (95 % CI, 99.94 %-100.00 %) for PP6. Sensitivity was 100.00 % (95 % CI, 2.50 %-100.00 %) for IDT and 86.67 % (95 % CI, 68.36 %-95.64 %) for PP6. A total of 12 HBV NAT-yield cases were detected by cobas® MPX.</div></div><div><h3>Conclusion</h3><div>Cobas® MPX demonstrated outstanding sensitivity and specificity in screening HIV, HCV, and HBV in routine blood donations, particularly enhancing occult HBV detection in endemic regions.</div></div>\",\"PeriodicalId\":73673,\"journal\":{\"name\":\"Journal of clinical virology plus\",\"volume\":\"5 1\",\"pages\":\"Article 100197\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2024-11-07\",\"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/S266703802400022X\",\"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/S266703802400022X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

摘要

背景核酸检测（NAT）被广泛用于对献血者进行传染病筛查，以提高输血安全性。罗氏公司先进的cobas® MPX检测法基于实时PCR技术，使用cobas® 6800/5800系统检测人类免疫缺陷病毒（HIV）、丙型肝炎病毒（HCV）和乙型肝炎病毒（HBV），提高了灵敏度。本研究旨在评估 cobas® MPX 检测法的临床灵敏度和特异性，以及它在识别 HBV 流行地区受感染供体（尤其是隐性 HBV 感染（OBI）供体）方面的有效性。材料与方法采用cobas® 6800系统上的cobas® MPX检测法和cobas s 201系统上的上一代cobas® TaqScreen MPX检测法v2.0作为参考方法，对大连血液中心（DLBC，中国北方）的12,067份献血者样本进行了HIV、HCV和HBV检测。检测采用个体捐献检测（IDT）和六次捐献初选库（PP6），按照生产商的说明和仪器的操作程序进行。结果Cobas® MPX在IDT和PP6中的总体一致性分别为100.00%（95% CI，99.22%-100.00%）和99.89%（95% CI，99.82%-99.95%）。IDT 的卡帕系数为 1.0，PP6 为 0.76。IDT 和 PP6 的 Cobas® MPX 特异性分别为 100.00 %（95 % CI，99.22 %-100.00 %）和 99.99 %（95 % CI，99.94 %-100.00 %）。IDT 的灵敏度为 100.00 %（95 % CI，2.50 %-100.00 %），PP6 的灵敏度为 86.67 %（95 % CI，68.36 %-95.64 %）。结论cobas® MPX在常规献血中筛查HIV、HCV和HBV方面表现出了出色的灵敏度和特异性，尤其是在流行地区提高了隐性HBV的检测能力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

A prospective study to evaluate the clinical specificity of the cobas® MPX test kit for screening for HIV RNA, HCV RNA, and HBV DNA in blood donation samples using the cobas® 6800 system in HBV endemic areas

Background

Nucleic acid testing (NAT) is widely used for screening blood donors for infectious diseases to enhance transfusion safety. Roche's advanced cobas® MPX assay detects human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) using the cobas® 6800/5800 Systems, based on real-time PCR technology, providing improved sensitivity. This study aims to evaluate the clinical sensitivity and specificity of the cobas® MPX assay and its effectiveness in identifying infected donors in HBV endemic areas, particularly those with occult HBV infection (OBI).

Materials and methods

A total of 12,067 donor samples from the Dalian Blood Center (DLBC, northern China) were tested for HIV, HCV, and HBV using both the cobas® MPX assay on the cobas® 6800 system and the previous generation cobas® TaqScreen MPX test v2.0 on the cobas s 201 system as the reference method. Testing was conducted using individual-donation testing (IDT) and primary pool of six donations (PP6), following the manufacturer's instructions and the operational procedures of the instruments. Samples with inconsistent results underwent repeated confirmation tests.

Results

Cobas® MPX demonstrated 100.00 % overall percent agreement (95 % CI, 99.22 %-100.00 %) for IDT and 99.89 % (95 % CI, 99.82 %-99.95 %) for PP6. Kappa coefficients were 1.0 for IDT and 0.76 for PP6. Cobas® MPX specificity was 100.00 % (95 % CI, 99.22 %-100.00 %) for IDT and 99.99 % (95 % CI, 99.94 %-100.00 %) for PP6. Sensitivity was 100.00 % (95 % CI, 2.50 %-100.00 %) for IDT and 86.67 % (95 % CI, 68.36 %-95.64 %) for PP6. A total of 12 HBV NAT-yield cases were detected by cobas® MPX.

Conclusion

Cobas® MPX demonstrated outstanding sensitivity and specificity in screening HIV, HCV, and HBV in routine blood donations, particularly enhancing occult HBV detection in endemic regions.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of clinical virology plus Infectious Diseases

CiteScore

2.20

自引率

0.00%

发文量

审稿时长

66 days