[Evaluation of multiplex nucleic acid testing assays for screening of hepatitis B virus DNA in blood donation process].
OBJECTIVE
To evaluate the multiplex nucleic acid testing (NAT) assays for HBV, HCV and HIV in detecting HBV DNA in plasma samples.


METHODS
534 plasma samples collected form several areas were detected with Abbott Architect i2000 HBsAg, ani-HBs, HBeAg, anti-HBe, anti-HBc and anti-HBc IgM diagnostic kits. HBV DNA levels of those samples were detected with Roche COBAS AmpliPrep/COBAS TaqMan HBV Test. Two kinds of multiplex NAT assays for HBV, HCV and HIV were used to test HBV DNA of those 534 samples. Results of serology-markers and quantitative HBV DNA levels with results of NAT were compared.


RESULTS
HBV DNA was positive in all 81 HBsAg, HBeAg and anti-HBc positive samples, detected by both of NAT assays. HBV DNA was positive in 11 and 19 of 200 HBsAg negative samples when detected with the two kinds of NAT assays separately. Compared with the quantitative results detected by Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, the HBV DNA positive rates were 96.9% and 94.3% in 193 samples of HBV DNA levels over 500 IU/ml while 40.2% and 45.3% in 117 samples of HBV DNA levels below 500 IU/ml while 99.3% and 96.0% in 151 samples of DNA negative HBV.


CONCLUSIONS
There are some occult low level HBV DNA carriers with HBsAg negative results in China. NAT assays for HBV, HCV and HIV may be useful to improve the transfusion safety.
Zhou
Cheng
C
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Wu
Xing
X
Huang
Wei-jin
WJ
Lan
Hai-yun
HY
Gu
Wen-jie
WJ
Qi
Zi-bai
ZB
Liang
Zheng-lun
ZL
Li
He-min
HM
D001782:Blood Donors; D004279:DNA, Viral / Q000097:blood* / Q000235:genetics; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D012698:Serologic Tests / Q000379:methods
D004279:DNA, Viral