HIV-1, HCV and HBV seronegative window reduction by the new Roche cobas® TaqScreen MPX test in seroconverting donors

• Published in: Journal of clinical virology 2007-08, Vol.39 (4), p.282-287
• Main Authors: Wiedmann, Michael, Kluwick, Sabine, Walter, Martina, Fauchald, Gabriele, Howe, Joerg, Bronold, Martina, Zauke, Michael
• Format: Article
• Language: English
• Subjects: Allergy and Immunology; Blood Donors; HBV; HCV; Hepacivirus - genetics; Hepacivirus - immunology; Hepacivirus - isolation & purification; Hepatitis B Antibodies - blood; Hepatitis B virus - genetics; Hepatitis B virus - immunology; Hepatitis B virus - isolation & purification; Hepatitis C Antibodies - blood; HIV Antibodies - blood; HIV-1; HIV-1 - genetics; HIV-1 - immunology; HIV-1 - isolation & purification; Humans; Immunoassay; Infectious Disease; Mass Screening; NAT; Nucleic Acid Amplification Techniques; Polymerase Chain Reaction - methods; Real-time PCR; RNA, Viral - blood; Sensitivity and Specificity; Seroconversion window; Taq Polymerase
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2007.05.001

Abstract Background By shortening the preseroconversion window in the viral screening of donated blood, nucleic acid amplification testing greatly improves safety and efficiency, particularly when combined with multiple target detection and maximal automation. Objectives Evaluation of seronegative window reduction during HIV-1, HCV and HBV infection by the novel cobas® TaqScreen MPX test for simultaneous nucleic acid detection of HIV-1 (groups M and O), HIV-2, HCV and HBV using the cobas s 201 system. Study design Testing of HIV-1, HCV, and HBV seroconversion panels (20 each) using the cobas® TaqScreen MPX test versus reference immuno- and nucleic acid technology assays. Results The cobas® TaqScreen MPX test detected HIV-1 and HCV infection earlier than immunoassays in 20/20 and 19/20 panels, and HBV DNA earlier than or on the same day as HBsAg in 19/20 and 18/20 panels, and later in 1 and 2 panels on neat samples and 1:6 dilutions. Preseroconversion sensitivity exceeded that of COBAS® AmpliScreen testing in pools of 24. Conclusion The cobas® TaqScreen MPX test shortens the preseroconversion window in minipools of six, evidencing high sensitivity, and significantly enhances blood-screening efficiency by the simultaneous automated detection of multiple viruses in a single test.