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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

Year: 2024

Type: article

Abstract: ABSTRACT Background: Nucleic acid testing (NAT) is globally employed in donor infectious disease screening to enhance transfusion safety. Roche's advanced cobas® MPX assay detects human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) on the cobas® 6800/8800 Systems, offering improved sensitivity and automation. This study assesses cobas® MPX's sensitivity and specificity in HIV, HCV, and HBV detection in routine blood donor samples before licensure in China. Materials and Methods: Specificity and sensitivity of cobas® MPX were evaluated using samples from Dalian Blood Center (DLBC, northern China) donors. 12,067 donor samples were tested using both cobas® MPX and s 201 MPX2 for HIV, HCV, and HBV. Discrepant samples underwent confirmation tests. Sequential samples from six donors were NAT tested. Results: Cobas® MPX showed 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. cobas® MPX detected 12 HBV NAT-yield cases. 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.

Source: Journal of Clinical Virology Plus

DOI: 10.1016/j.jcvp.2024.100197