[Evaluation of the accuracy of domestic commercial HBV DNA real-time polymerase chain reaction kits using COBAS TaqMan HBV Test as reference].
OBJECTIVE
To evaluate of the accuracy of domestic commercial HBV DNA real-time polymerase chain reaction kits.


METHODS
Using COBAS TaqMan HBV Test as reference, we evaluate the accuracy of a domestic commercial HBV DNA real-time polymerase chain reaction kit (PG).


RESULTS
Among the samples with viral load at the range of 10(1), 10(2), 10(3), 10(4), 10(5), 10(6), 10(7) (IU/mL), the Coefficient of Correlation(r) between the result determined by domestic kit (PG) and those of Roche COBAS TaqMan HBV Test were: -0.08011, -0.05056, 0.105642, 0.312181, 0.908046, 0.866175, -0.23295, respectively; the percentage of false negative results were 60%, 30%, 33.3%, 8.3%, 0, 0, 0, respectively. Among the samples with viral load over than 10(7) (IU/ml), the result determined by PG is significantly lower.


CONCLUSIONS
The accuracy of PG is not satisfied, especially in those samples with viral load less than 10(4) (IU/ml). A implication from these observation is that samples from patients received antiviral treatment should be tested by Roche COBAS TaqMan HBV Test.
Wang
Zhao-qin
ZQ
Shenzhen Institute of Hepatology, Shenzhen Third Hospital, Shenzhen 518020, China.
Zhou
Bo-ping
BP
Chen
Xin-chun
XC
Li
Mei-zhong
MZ
Wang
Min
M
Li
Wei
W
D002681:China; D004279:DNA, Viral / Q000235:genetics; D005069:Evaluation Studies as Topic; D006509:Hepatitis B / Q000175:diagnosis / Q000821:virology*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards; D012680:Sensitivity and Specificity
D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic