CAJ | 학술논문

目的：评价基于NP968核酸提取仪(磁珠法)的实时荧光定量PCR系统检测乙型肝炎病毒DNA(HBVDNA)的性能。方法采用NP968自动核酸提取仪(磁珠法)提取血浆HBVDNA，经实时荧光定量PCR系统检测，分析其精密度、线性、回收率、最低检出限、参考区间，并将检测结果与传统煮沸法进行相关性分析，从而评价该法对HBVDNA检测的性能。结果基于NP968自动核酸提取仪(磁珠法)的实时荧光定量PCR系统检测HBVDNA，其低、高水平批内精密度均<3/5TEa (TEa=0.4/靶值×100%)，批间精密度均<4/5TEa；在4.16E2~4.16E8 IU/ml范围内具良好线性关系(Y=1.010X+0.271,R2=0.989)；回收率为104%；最低检出限1.00E2 IU/ml；参考区间为<1.00E3 IU/ml；检测结果与煮沸法之间具良好相关(Y=0.995X+0.526,R2=0.951)。结论基于NP968自动核酸提取仪(磁珠法)的实时荧光定量PCR系统实现了快速、自动化提取HBVDNA，对检测HBVDNA具良好检测性能，适合临床推广使用。
목적：평개기우NP968핵산제취의(자주법)적실시형광정량PCR계통검측을형간염병독DNA(HBVDNA)적성능。방법채용NP968자동핵산제취의(자주법)제취혈장HBVDNA，경실시형광정량PCR계통검측，분석기정밀도、선성、회수솔、최저검출한、삼고구간，병장검측결과여전통자비법진행상관성분석，종이평개해법대HBVDNA검측적성능。결과기우NP968자동핵산제취의(자주법)적실시형광정량PCR계통검측HBVDNA，기저、고수평비내정밀도균<3/5TEa (TEa=0.4/파치×100%)，비간정밀도균<4/5TEa；재4.16E2~4.16E8 IU/ml범위내구량호선성관계(Y=1.010X+0.271,R2=0.989)；회수솔위104%；최저검출한1.00E2 IU/ml；삼고구간위<1.00E3 IU/ml；검측결과여자비법지간구량호상관(Y=0.995X+0.526,R2=0.951)。결론기우NP968자동핵산제취의(자주법)적실시형광정량PCR계통실현료쾌속、자동화제취HBVDNA，대검측HBVDNA구량호검측성능，괄합림상추엄사용。
Objective To evaluate the performance of NP968 nucleic acid extraction (MACS)-based real-time fluorescence quantitative PCR detection system for hepatitis B virus DNA (HBV DNA). Methods Using the NP968 automated nucleic acid ex-traction system (MACS) to extract HBV DNA from the serum , and the DNA was detected by real-time fluorescence quantitative PCR system. In order to evaluate the performance of the detection system for HBV DNA, the precision, linearity, recovery rate, the lowest detection limit and reference interval of the testing system have been analyzed, and the correlation analysis with traditional boiling method was carried out. Results In the NP968 nucleic acid extraction (MACS)-based real-time fluorescence quantitative PCR detection system for HBV DNA, the within-run precision of the low and high level are all<3/5TEa (target TEa=0.4/value x 100%) and the between-run precision are all <4/5TEa; In the range of 4.16E2-4.16E8 IU/ml ,there has good linear relationship (Y=1.010X+0.271, R2=0.989); the recovery rate is 104%. The minimum detection limit is 1.00E2 IU/ml; reference interval is <1.00E3 IU/ml, and the detection results between boiling method and MACS-based real-time fluorescence quantitative PCR has a good correlation (X+Y=0.995 0.995, R2=0.951). Conclusion The NP968 nucleic acid extraction (MACS)-based real-time fluores-cence quantitative PCR detection system can extract the HBV DNA quickly and automatically and has good detection performance, so the detection system is suitable for clinical application.