CAJ | 학술논문

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.
목적 평고3충HBV DNA형광정량PCR검측시제적림상응용성능.방법 통과평행검측1001례림상혈청양본급제도희석적양성양본,종정량선성범위、준학성、령민도、특이성등방면,비교분석A시제(자주분리법)、B시제(면핵산제취적"일보법")여목전국내림상엄범응용적우질시제C적상관성화차이,병여면역학결과진행비교.결과 767례균유수치적표본중,삼충시제균치차이무통계학의의.단재저병독재량조중,결과상차교대,A시제령민도최고,B시제차지,C시제배후.결론 채용료"일보법"면핵산제취적B시제,핵산득솔고,구유교관적검측범위화정량준학성,조작겁기간단,불실위일충상가적선택.
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.