Evaluation of the accuracy of domestic commercial HBV DNA real-time polymerase chain reaction kits using COBAS TaqMan HBV Test as reference / 中华实验和临床病毒学杂志

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate of the accuracy of domestic commercial HBV DNA real-time polymerase chain reaction kits.</p><p><b>METHODS</b>Using COBAS TaqMan HBV Test as reference, we evaluate the accuracy of a domestic commercial HBV DNA real-time polymerase chain reaction kit (PG).</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>