比较两种国产不同核酸提取方法定量检测乙型肝炎病毒（HBV）核酸试剂的检测效能。方法选择经抗病毒治疗且HBV DNA 载量在﹤1x104 IU/ml的乙型肝炎患者血清标本36份，采用两种国产HBV核酸定量检测试剂盒平行检测HBV DNA，对阳性血清进行梯度稀释后再检测，从定量线性范围、准确性、灵敏度、特异性等方面比较两种试剂的差异。结果在36例临床血清中，14份经科华试剂检测的结果为﹤500 IU/ml，而圣湘试剂检测的结果仍﹥1.00×103 IU/ml；对其中获得检测数据的31份标本进行两种试剂检测结果的相关性分析，发现一致性较好（r=0.817，P﹤0.05）；两种方法检测乙型肝炎患者血清HBV DNA的阳性率分别为55.6％和94.4％，差异具有统计学意义(x2=12.07，P=0.000)；对强阳性血清进行梯度稀释后定量检测显示，两种试剂检测水平的平均值与理论水平的线性相关性较好（湖南圣湘r=0.999，上海科华r=0.992），但圣湘所有检测的相对偏差均在±0.3logIU/ml之内，而科华有两次检测的相对偏差超出了±0.3logIU/ml范围，提示圣湘试剂检测结果更稳定，使用纳米磁珠核酸提取法的检测结果较煮沸法更加准确。结论以纳米磁珠为提取核酸方法不仅具有更广的线性范围，同时可显著提高国产HBV DNA检测试剂的灵敏度和准确性。%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.
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