CAJ | 학술논문

目的：比较3种丙型肝炎病毒（HCV）RNA荧光定量PCR检测试剂的临床应用性能。方法采用国产 A 试剂（磁珠分离法）、国产 B 试剂（荧光探针法）和目前国际临床广泛应用的 C试剂（内标法）同时检测110例丙型肝炎患者临床血液样本及梯度稀释的强阳性标本，从试剂间的相关性、检测灵敏度、特异度等对结果进行对比分析。结果A 和 B、A 和 C、B 和 C 试剂间的相关系数分别为0．845、0．917、0．860（P 均＜0．01）。在3种方法均有数值的58例标本中，3种试剂所检出的 HCV RNA 水平比较差异无统计学意义（P ＞0．05）。但在低病毒载量（＜103 IU ／ml）组中，3种试剂灵敏度比较差异有统计学意义（P ＜0．01），C 试剂灵敏度最高，A 试剂次之，B 试剂最低。当病毒载量在2．00×103～2．00×106 IU ／ml 时，3种试剂的定量结果与理论值均有很好的相关性与重复性，其检测浓度的平均值与理论浓度的双对数线性相关系数分别为0．9983、0．9823、0．9999（P 均＜0．01）；当病毒载量为2．00×102 IU ／ml 时，C 试剂的检测结果最接近，A 试剂次之，B 试剂未能检出。结论C 试剂作为国际上广泛应用于临床 HCV RNA 定量检测的试剂，优势明显；国产 A 试剂总体性能优于 B 试剂，且费用较国外试剂低廉，性价比较高。
목적：비교3충병형간염병독（HCV）RNA형광정량PCR검측시제적림상응용성능。방법채용국산 A 시제（자주분리법）、국산 B 시제（형광탐침법）화목전국제림상엄범응용적 C시제（내표법）동시검측110례병형간염환자림상혈액양본급제도희석적강양성표본，종시제간적상관성、검측령민도、특이도등대결과진행대비분석。결과A 화 B、A 화 C、B 화 C 시제간적상관계수분별위0．845、0．917、0．860（P 균＜0．01）。재3충방법균유수치적58례표본중，3충시제소검출적 HCV RNA 수평비교차이무통계학의의（P ＞0．05）。단재저병독재량（＜103 IU ／ml）조중，3충시제령민도비교차이유통계학의의（P ＜0．01），C 시제령민도최고，A 시제차지，B 시제최저。당병독재량재2．00×103～2．00×106 IU ／ml 시，3충시제적정량결과여이론치균유흔호적상관성여중복성，기검측농도적평균치여이론농도적쌍대수선성상관계수분별위0．9983、0．9823、0．9999（P 균＜0．01）；당병독재량위2．00×102 IU ／ml 시，C 시제적검측결과최접근，A 시제차지，B 시제미능검출。결론C 시제작위국제상엄범응용우림상 HCV RNA 정량검측적시제，우세명현；국산 A 시제총체성능우우 B 시제，차비용교국외시제저렴，성개비교고。
Objective To compare the clinical application performance of three types of hepatitis C virus (HCV)-RNA fluorescent quantitative PCR detection reagents.Methods Domestic A reagent (magnet-ic bead separation method),domestic B reagent (fluorescence probe method)and C reagent currently widely used internationally (internal standard method)were adopted to detect 1 1 0 clinical blood in patients with Hep-atitis and strong-positive samples with gradient dilution.The correlation,sensitivity and specificity were statisti-cally compared among the results of three detection reagents.Results The correlation coefficient of three types of reagents was 0.845,0.91 7 and 0.860 (all P <0.01 ).In 58 samples detectable by three methods,no sig-nificant difference was found in HCV RNA level among three kinds of reagents (P >0.05).However,in the low viral load group (<1 .00 ×1 03 IU /ml),the sensitivity significantly differed among three types of reagents with highest sensitivity in C reagent,followed by A and B reagents.In the viral load group (2.00 ×1 03 ~2.00 ×1 06 IU /ml),high levels of correlation and repeatability between the quantitative results and theoretical val-ues were observed in all reagents.The double logarithmic linear correlation coefficient of the mean and theoreti-cal concentration was 0.9983,0.9823 and 0.9999 (all P <0.01 ).When the viral load was 2.00 ×1 02 IU /ml,the detected concentration was the most similar to the theoretical concentration in C reagent,followed by A reagent and undetected in B reagent.Conclusions C reagent was superior to A and B reagents in the HCV-RNA fluorescent quantitative PCR detection.Compared with B reagent,A reagent exhibited better perform-ance.A reagent was cheaper compared with C reagent.Thus,A reagent could be used as a cost-effective HCV-RNA fluorescent quantitative PCR detection.