HIV-1, HCV and HBV seronegative window reduction by the new Roche cobas TaqScreen MPX test in seroconverting donors.
BACKGROUND
By shortening the pre-seroconversion 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.


OBJECTIVE
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.


METHODS
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. Pre-seroconversion sensitivity exceeded that of COBAS AmpliScreen testing in pools of 24.


CONCLUSIONS
The cobas TaqScreen MPX test shortens the pre-seroconversion 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.
Wiedmann
Michael
M
Roche Diagnostics GmbH, Roche Molecular Diagnostics, Werk Penzberg, Nonnenwald 2, 82377 Penzberg, Germany. michael.wiedmann@roche.com
Kluwick
Sabine
S
Walter
Martina
M
Fauchald
Gabriele
G
Howe
Joerg
J
Bronold
Martina
M
Zauke
Michael
M
D001782:Blood Donors; D015483:HIV Antibodies / Q000097:blood; D015497:HIV-1 / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006510:Hepatitis B Antibodies / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007118:Immunoassay; D008403:Mass Screening; D021141:Nucleic Acid Amplification Techniques; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D019914:Taq Polymerase
D015483:HIV Antibodies; D006510:Hepatitis B Antibodies; D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D019914:Taq Polymerase