ABSTRACT
Objective To compare the sensitivity, specificity and consistency of five kits for quantitative detection of hepatitis B virus (HBV) DNA. Methods Four domestic fluorescence kits, A, B, C, and D, and Roche Cobas Ampliprep/Cobas TaqMan HBV test for quantitation of HBV DNA in serum, were applied to detect the National Standards, an additional plasma for sensitivity (7 times dilution), 15 plasma samples from healthy blood donor and 45 plasma samples from chronic hepatitis B patients. Results All five kits showed the correct results for the 9 positive specimens and 8 negative specimens from the National Standards. The quantitative results of specimens for sensitivity met requirements of the National Standards. The lowest concentration of HBV DNA by these three kits was 15.6 IU/mL. The lowest detection level of HBV DNA for domestic kit B was ≤500 IU/mL. There was linear correlation between the results by Roche kit and domestic kit C (r> 0.98). Kit D showed 2 false-negatives results in the 15 healthy blood donor samples. The coincidence rates between 4 domestic kits and the Roche kit ranged from 50% to 96% (A: 61%, B: 50%, C: 96%, D: 83 %). The consistency rate of kit C with the Roche kit was significantly higher than those of kit D, A and B (X2=5.62, P<0.05, X2=28. 93, P<0.01, X2=44.31,P<0.01, respectively). The consistency rates among these 5 kits were highest when testing samples with HBV DNA levels between 1×104-1×107 IU/mL. Conclusions The qualities of domestic kits vary remarkably and kit C has the greatest consistency rate with the Roche kit. Therefore, the qualities of domestic kits need to be further improved.