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}
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.
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