基于全自动核酸检测平台高敏HCV RNA定量检测性能评价

An Evaluation of the Performance of a Highly Sensitive HCV RNA Diagnostic Kit Based on Automatic Nucleic Acid Detection Platform

目的评价全自动核酸检测平台在高敏HCV RNA定量检测的性能及检测临床样本的能力。方法采用WHO国际标准品、HCV RNA假病毒样本、基因型血浆盘及临床样本,评价Pre-NAT II全自动核酸检测体系的正确度、精密度、线性范围、最低检出限/最低定量限、抗干扰能力等指标。结果Pre-NAT II全自动核酸检测体系的精密度<5%,最低检出限为15 IU/mL,线性范围为30~1.0×109 IU/mL。检测WHO国际标准品的实测对数值和理论对数值偏差小于±0.20(-0.04~0.19),对临床常见的内源性干扰物、抗病毒药物和自身免疫疾病样本具有良好的抗干扰能力,且检测临床样本结果与临床常用试剂检测结果一致性(符合率为100%)和相关性(r>0.98)强。结论Pre-NAT II全自动核酸检测体系准确性高、精密性好、定量范围宽、重复性好、抗干扰能力强,能够满足临床应用需求。

Objective To evaluate the performance of a highly sensitive hepatitis C virus RNA diagnostic kit(Real-Time RNA)on an automatic nucleic acid detection platform.Methods The precision,accuracy,linear range,limit of detection/limit of quantification and anti-interference ability of the automatic Pre-NAT II nucleic acid detection system were determined using WHO international standard,with HCV RNA pseudovirus samples,genotype plasma disk and clinical samples.Results For accuracy,the intra-lab precision was less than 5%.The assay showed LOD of 15 IU/mL,LOQ of 30 IU/mL and linear range of 30 IU/mLL-109 IU/mL.Quantitative results of the WHO International Standard for hepatitis C virus using this system was in line with the theoretical concentrations provided by the organization,with small deviation between-0.04 log and 0.19 log.This assay demonstrated a good tolerance to interfering substances commonly encountered in clinical practices,such as human endogenous interfering substances,anti-viral drugs and autoantibodies.By testing clinical sample in parallel with imported reagents,results generated from the HCV RNA quantitative assay were consistent with the common clinical reagent reagents and highly correlated to each other(r>0.98).Conclusion The automatic Pre-NAT II nucleic acid detection system shows a high accuracy,good precision,wide quantitative range,good repeatability and strong anti-interference ability,which could meet the needs of clinical practices.