A multi-Chinese blood center study testing serologic-negative donor samples for hepatitis C virus and human immunodeficiency virus with nucleic acid testing.
BACKGROUND
A multi-blood center study was conducted to evaluate a human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) multiplex nucleic acid testing (NAT) donor screening test and to determine the residual risk for HIV-1 and HCV infection.


METHODS
A commercially available HIV-1 and HCV assay (Procleix, Chiron Corp.) was used for simultaneous detection of HIV-1 RNA and HCV RNA on 89,647 unlinked donor samples. NAT was performed with pools of 16 samples that had passed all routine screening tests. Single-donor NAT was performed for samples that had been disqualified by any reactive screening test result(s). Anti-HCV (Ortho third-generation HCV enzyme immunoassay [EIA]), alanine aminotransferase, and HCV NAT (Roche COBAS Amplicor HCV test) confirmatory tests were used for HCV EIA-nonreactive, HCV NAT-reactive samples.


RESULTS
Three HCV NAT yield cases and no HIV-1 yield cases were detected. The yield rate for HCV NAT was 3.4 per 10(5) (95 percent confidence interval [CI], 0.7-9.8). The estimated incidence rate for HCV is 24.2 per 100,000 person-years (95% CI, 3.4-88.0). If minipool NAT is added to routine donor screening, the residual risk for HCV is estimated to be reduced to 1 in 20.4x10(4) (95% CI, 1 in 5.2x10(4)-1 in 165.5x10(4)).


CONCLUSIONS
The residual risk for transfusion-transmitted HCV infection is still relatively high in China. Incorporating NAT technology into blood donor screening would be estimated to reduce the residual risk of HCV infections eightfold over current EIA screening.
Shan
Hua
H
Division of Blood Transfusion, HIV Specialty Testing Laboratory, Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland 21287, USA. hshan@jhmi.edu
Ren
Fu-rong
FR
Zhao
Hai-yan
HY
Zhang
Yuan-zhi
YZ
Wen
Guo-xing
GX
Yao
Fu-zhu
FZ
Gao
Guo-jing
GJ
Yan
Li-xing
LX
Jiang
Chao-fu
CF
Bai
Xu-hua
XH
Tiemuer
Mei-hei-li
MH
Tu
Yuan-quan
YQ
Zhu
Fa-ming
FM
Zheng
You-rong
YR
Cui
Li
L
Liu
Chang-li
CL
Gong
Xiao-yan
XY
Lv
Qiu-shuang
QS
Zheng
Peng
P
Ziermann
Rainer
R
Ness
Paul
P
Wang
Jing-xing
JX
D001782:Blood Donors; D002681:China; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000175:diagnosis* / Q000517:prevention & control / Q000635:transmission; D016174:Hepacivirus / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis* / Q000517:prevention & control / Q000635:transmission; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D012306:Risk; D065227:Transfusion Reaction