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.
Jarvis
Lisa
L
Scottish National Blood Transfusion Centre, Edinburgh, UK.
Becker
Janine
J
Tender
Alzira
A
Cleland
Alexander
A
Queiros
Lucinda
L
Aquiar
Ana
A
Azevedo
Joana
J
Aprili
Giuseppe
G
Bressan
Fausto
F
Torres
Pilar
P
Nieto
Serafin
S
Ursitti
Antonella
A
Montoro
Jose
J
Vila
Enrique
E
Ramada
Concha
C
Saldanha
John
J
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