Evaluation of the Roche cobas s 201 system and cobas TaqScreen multiplex test for blood screening: a European multicenter study.
BACKGROUND
The Roche cobas TaqScreen test, an automated, multiplex nucleic acid test for blood screening for hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA, human immunodeficiency virus type 1 (HIV-1) groups M and O, and HIV-2 RNA, on the cobas s 201 platform, was evaluated by six European blood screening laboratories.


METHODS
The 95 percent limit of detection (LOD) of the cobas TaqScreen test for HBV, HCV, and HIV-1, using dilutions of the WHO International Standards, were evaluated. The clinical performance was determined by testing between 2000 to 6000 routine donor samples. Some laboratories evaluated the robustness, cross-contamination, and workflow.


RESULTS
The mean 95 percent LOD (95% lower and upper confidence intervals) for HBV, HCV, and HIV-1 across all the laboratories were 3.8 (range, 3.0-5.2), 10.8 (range, 8.4-14.4), and 56.7 (range, 43.0-79.2) IU/mL, respectively. A total of 23,716 donors were tested in pools of 6. Fourteen initially reactive pools were detected, of which 6 contained a reactive donation, giving a positive predictive value of the pool results of 43 percent. One of the reactive donations was a HBV yield case (hepatitis B surface antigen-negative/anti-HBc-positive). Evaluation of the workflow for the system showed that an optimized batch loading in which a pipettor (Hamilton Microlab Star IVD) was utilized to half capacity was better than a full batch loading.


CONCLUSIONS
The 95 percent LOD for the three viruses were comparable to those obtained by Roche. The test and platform were shown to be sensitive, specific, flexible, and robust.
Scottish National Blood Transfusion Centre, Edinburgh, UK.
Lisa
L
Jarvis
Janine
J
Becker
Alzira
A
Tender
Alexander
A
Cleland
Lucinda
L
Queiros
Ana
A
Aquiar
Joana
J
Azevedo
Giuseppe
G
Aprili
Fausto
F
Bressan
Pilar
P
Torres
Serafin
S
Nieto
Antonella
A
Ursitti
Jose
J
Montoro
Enrique
E
Vila
Concha
C
Ramada
John
J
Saldanha
D001782:Blood Donors; D004279:DNA, Viral / Q000235:genetics; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006509:Hepatitis B / Q000175:diagnosis / Q000821:virology; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis / Q000821:virology; D006801:Humans; D008403:Mass Screening / Q000295:instrumentation / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D004279:DNA, Viral