CAJ | 학술논문

目的评价基于磁珠法处理样本的新型乙型肝炎病毒YMDD突变核酸检测试剂(简称"磁珠法试剂")的临床应用性能.方法用新开发的磁珠法试剂与已获证上市的基于煮沸法的乙型肝炎病毒YMDD突变核酸检测试剂(简称"煮沸法试剂")平行检测324例临床HBV阳性血清样本,比较两种试剂的准确性、特异性和灵敏性.结果磁珠法试剂与煮沸法试剂检测YMDD突变阳性一致性为100％ (95％ CI:98.0％～100％),阴性一致性为97.12％ (95％ CI:92.8％～99.2％),总一致性为98.76％ (95％ CI:96.9％～99.7％).对4例不符样本进行测序复核,复核后磁珠法试剂检测结果与测序复核结果一致(Kappa值=0.975).结论磁珠法乙型肝炎病毒YMDD突变核酸检测试剂与已上市的煮沸法试剂检测结果具有较好的一致性,且具有内标监控假阴性,有更高的灵敏度,符合临床检测要求,具有良好的临床应用价值.
목적 평개기우자주법처리양본적신형을형간염병독YMDD돌변핵산검측시제(간칭"자주법시제")적림상응용성능.방법 용신개발적자주법시제여이획증상시적기우자비법적을형간염병독YMDD돌변핵산검측시제(간칭"자비법시제")평행검측324례림상HBV양성혈청양본,비교량충시제적준학성、특이성화령민성.결과 자주법시제여자비법시제검측YMDD돌변양성일치성위100％ (95％ CI:98.0％～100％),음성일치성위97.12％ (95％ CI:92.8％～99.2％),총일치성위98.76％ (95％ CI:96.9％～99.7％).대4례불부양본진행측서복핵,복핵후자주법시제검측결과여측서복핵결과일치(Kappa치=0.975).결론 자주법을형간염병독YMDD돌변핵산검측시제여이상시적자비법시제검측결과구유교호적일치성,차구유내표감공가음성,유경고적령민도,부합림상검측요구,구유량호적림상응용개치.
Objective To evaluate the clinical application of a novel hepatitis B virus YMDD mutation DNA diagnostic kit (magnetic beads method kit).Methods A total of 324 HBV clinical serum samples was tested with the magnetic beads method kit and another kind of fluorescence diagnostic kit (boiling method).Accuracy, specificity, and sensitivity were compared.Results The consistency of positive detection rate of two kits was 100％ (95％ CI : 98.0％～ 100％), negative consistency was 97.12％ (95％ CI : 92.8％～99.2％) and the total consistency was 98.76％ (95％ CI : 96.9％～99.7％).Four cases of discrepant samples were confirmed by sequencing, and statistical analysis performed by Kappa test (Kappa =0.975) shows good consistency between the two methods.Conclusions The magnetic beads method kit has good consistency compared to the regular boiling method kit, and the polymerase chain reaction (PCR) detection system contains an internal positive control (internal control) to avoid a false negative resuit, which is more suitable for clinical diagnosis.