关键词: 乙型肝炎病毒, 核酸, 国产检测试剂盒, 效能

Abstract: Objective To evaluate the efficacy of two domestic kits using different nucleic acid extraction methods for quantitative detection of serum hepatitis B virus（HBV） nucleic acids. Methods Thirty-six serum samples from hepatitis B patients with HBV DNA levels <1x10⁴ IU/ml after antiviral treatment were collected and HBV DNA was detected by kits from two pharmaceutical Co..The quantitative linear range,accuracy,sensitivity and specificity of each kits were evaluated and compared. Results Out of 36 serum samples,the HBV DNA levels in 14 were <500 IU/ml by KELONG reagent,while they were>1.00× 10³ IU/ml by San Xiang reagent;There was a good correlation in 31 samples by the two reagents（r=0.817,P<0.05 ）;The positive rates of serum HBV DNA were 55.6% and 94.4%,respectively,by the two kit detection（x²=12.07,P=0.000）;We detected serum HBV DNA in some strong positive samples after serial dilution and the results showed a good linear correlation （San Xiang: r=0.999,KELONG:r=0.992）;The relative deviations by San Xiang kit repetition was within ±0.3logIU/ml,while it was beyond ±0.3logIU/ml in two detections by KELONG. Conclusions The findings in this study suggests that the San Xiang reagent is more stable as it use nanometer magnetic extraction, which might be superior to boiling method for DNA extraction because the magnetic nanoparticle has wider liner ranger and significantly improves the sensitivity and accuracy of HBV DNA detection.

Key words: Hepatitis B virus, Nucleic acids, Domestic kits, Efficacy