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 S...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-02-01
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| Series: | Journal of Clinical Virology Plus |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S266703802400022X |
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| author | Lei Zhou Lin Wang Xiaofang Gong Xiaochun Liu Yaxuan Zou Yingying Wang Jinfeng Zeng Liang Zang |
| author_facet | Lei Zhou Lin Wang Xiaofang Gong Xiaochun Liu Yaxuan Zou Yingying Wang Jinfeng Zeng Liang Zang |
| author_sort | Lei Zhou |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9ec334621bd9449688c54aae62602268 |
| institution | Kabale University |
| issn | 2667-0380 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical Virology Plus |
| spelling | doaj-art-9ec334621bd9449688c54aae626022682025-02-08T05:01:31ZengElsevierJournal of Clinical Virology Plus2667-03802025-02-0151100197A 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 areasLei Zhou0Lin Wang1Xiaofang Gong2Xiaochun Liu3Yaxuan Zou4Yingying Wang5Jinfeng Zeng6Liang Zang7Dalian Blood Center, Dalian, Liaoning, 116001, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR ChinaShenzhen Blood Center, Shenzhen 518025, PR ChinaDalian Blood Center, Dalian, Liaoning, 116001, PR China; Corresponding author: Dalian Blood Center, Yanan Road, Dalian, Liaoning, 116001, PR China.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.http://www.sciencedirect.com/science/article/pii/S266703802400022XBlood donationNucleic acid testingHepatitis B virusOccult infection |
| spellingShingle | Lei Zhou Lin Wang Xiaofang Gong Xiaochun Liu Yaxuan Zou Yingying Wang Jinfeng Zeng Liang Zang 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 Journal of Clinical Virology Plus Blood donation Nucleic acid testing Hepatitis B virus Occult infection |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | prospective study to evaluate the clinical specificity of the cobas r mpx test kit for screening for hiv rna hcv rna and hbv dna in blood donation samples using the cobas r 6800 system in hbv endemic areas |
| topic | Blood donation Nucleic acid testing Hepatitis B virus Occult infection |
| url | http://www.sciencedirect.com/science/article/pii/S266703802400022X |
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