Objective The goal of this clinic study is to evaluate the application performance for 2 new HBV DNA Quantitative Fluorescence Diagnostic Kits, which are recently emerged in the market.Methods Serial diluted HBV serum samples and 1001 clinical serum samples with random virus load were tested quantitatively with the 3 diagnostic kits A, B and C. By studying their linear range, specificity,precision and sensitivity, the two new reagents (A and B ) were used to test these samples and also to compare them with the quantitative results from the boiling method kit (C) which is of better quality and reliability than similar diagnostic kits in current market. Furthermore, the immunoassy results of these samples were evalued and compared with their quantitative results. Results The quantitative results of 767 samples showed that their average values of the 3 kits have no significant difference. However, in the low viral load group, the results of kit A showed the best sensitivity(1.00E + 01 IU/ml)and had much better sensitivity than kit B (1.00E + 02 IU/ml), while kit C kit ( 5.00E + 02 IU/ml ) failed to test positive for most of the low concentration samples. Conclusion The nucleic acid extraction-free method ( kit B) showed much better accuracy and much larger linear range than the conventional method. In this method, the nucleic acid templates extracted by lysis buffer all went into the PCR reaction, resulting in high extraction efficiency and minimum nucleic acid loss. With a simple procedure, great accuracy and good sensitivity, this new test kit is suitable for routine clinical lab usage.%目的 评估3种HBV DNA荧光定量PCR检测试剂的临床应用性能.方法 通过平行检测1001例临床血清样本及梯度稀释的阳性样本,从定量线性范围、准确性、灵敏度、特异性等方面,比较分析A试剂(磁珠分离法)、B试剂(免核酸提取的"一步法")与目前国内临床广泛应用的优质试剂C的相关性和差异,并与免疫学结果进行比较.结果 767例均有数值的标本中,三种试剂均值差异无统计学意义.但在低病毒载量组中,结果相差较大,A试剂灵敏度最高,B试剂次之,C试剂排后.结论 采用了"一步法"免核酸提取的B试剂,核酸得率高,具有较宽的检测范围和定量准确性,操作极其简单,不失为一种上佳的选择.
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