摘要
目的:初步评估一种国产新近注册上市的人类免疫缺陷病毒1型核酸测定试剂(PCR荧光探针法)(以下简称Sansure HIV-1)的检测性能及临床适用性。方法:以WHO HIV-1血清盘、HIV-1 RNA国家标准品和临床收集的经血源性传染相关病原体阳性样本,考察Sansure HIV-1试剂盒的基因型检测能力、最低检测限、分析特异性和定量准确度。收集临床经罗氏Cobas TaqMan HIV-1 Version 2.0(简称Cobas HIV-1)检验后剩余的374例样本评价Sansure HIV-1的临床检测性能,并采用相关性分析和Bland-Altman等统计方法分析对比二者的性能。结果:(1)Sansure HIV-1检测10例WHO各基因亚型血清盘均为阳性。(2)各样本定量检测结果浓度对数值与理论对数值的绝对偏差均不超过±0.4个对数数量级。(3)将HIV-1 RNA国家参考品稀释至浓度为50 IU/mL及25 IU/mL,检测阳性率均为100%,稀释至12.5 IU/mL的检测阳性率为75%,临床相似病原体阳性样本均检测为阴性,无非特异性交叉反应。(4)两种试剂检测374例临床样本的阳性率一致,均为66.84%(250/374)。(5)以Cobas HIV-1检测结果为参照,Sansure HIV-1检测的阳性一致性达到99.20%(95%CI:96.82%~99.86%),阴性一致性为98.38%(95%CI:93.71%~99.72%),总一致性为98.93%(95%CI:94.04%~99.75%)。(6)两种试剂检测结果均判定为阳性的248例样本的线性回归方程为y=0.8357x+0.7379,相关系数r=0.8901(P<0.0001)。(7)比较两种试剂检测结果的Bland-Altman分析标准差为SD=0.5606(Log10 IU/mL),也证明了两种试剂检测的PCR定量结果具有较高一致性。结论:所评价的Sansure HIV-1测定试剂具有很好的定量准确性,同时对HIV M组、O组、N组及其基因亚型具有全面的检测覆盖性,最低检测限达到25 IU/mL,与临床常见的经血传播病原体无交叉反应;在临床样本检测方面,与进口的Cobas HIV-1试剂相比,阳性检出率和定量结果均具有较高的一致性,国产Sansure HIV-1核酸测定试剂盒具有较好的临床适用性,可适用于大部分临床检测需求。
Objective To preliminarily evaluate the detection performance and clinical applicability of a newly developed Real-Time Quantitative PCR Kit for HIV-1 RNA detection(referred to as Sansure HIV-1)Methods The genotype detection ability,limit of detection,specificity and quantitative detection accuracy of the Sansure HIV-1 were investigated by using WHO HIV-1 serum,National Standards of HIV-1 RNA and clinical samples positive for blood-borne infection pathogens collected by SANWAY Clinical Laboratories INC as samples.The remaining 374 of clinical samples tested by Roche Cobas TaqMan HIV-1 Version 2.0(referred to as Cobas HIV-1)were collected to evaluate the clinical diagnosis performance of Sansure HIV-1.Statistical methods such as correlation and Bland-Altman analysis were used to compare the performance of the two assays.Results(1)The 10 cases of WHO Subtype Blood inventory detected by Sansure HIV-1 were all positive.(2)The absolute deviation between the logarithmic value of each sample concentration and the theoretical logarithmic value did not exceed±0.4 log orders of magnitude.(3)The positive rates were 100%when the HIV-1 RNA National Standards were diluted to 50 IU/mL and 25 IU/mL,and the positive rate was 75%when diluted to 12.5 IU/mL.All clinically similar pathogen were tested negative using Sansure HIV-1,and no cross-reaction occurred.(4)The positive rates of Cobas HIV-1 and Sansure HIV-1 in testing 374 clinical samples were both 66.84%(250/374).(5)Taking the Cobas HIV-1 test results as a reference,the positive consistency of the Sansure HIV-1 reached 99.20%(95%CI:96.82%-99.86%),and the negative consistency was 98.38%(95%CI:93.71%-99.72%),and the total consistency was 98.93%(95%CI:94.04%-99.75%).(6)The linear regression equation of 248 samples tested positive by both assays was y=0.8357x+0.7379,and the r was 0.8901(P<0.0001).(7)Further,Bland-Altman analysis showed the SD was 0.5606(Log10 IU/mL),confirmed that the RT-PCR quantitative results detected by the two reagents were highly consistent.Conclusion The evaluated Sansure HIV-1 assay has good quantitative accuracy and good subtype detection coverage for HIV group M,Group O and group N with a detection sensitivity of 25 IU/mL.There is no cross-reaction with common clinical blood-borne pathogens.Sansure HIV-1 showed great consistency in terms of positive detection rate and quantitative results compared with Roche Cobas HIV-1 in testing clinical plasma samples,Considering cost-effectiveness and accessibility,the Sansure HIV-1 assay kit has good clinical applicability and can suitable for the requirements of most clinical applications.
作者
谭杰
邓中平
郑芳
丁峰
刘让蛟
田向荣
TAN Jie;DENG Zhongping;ZHENG Fang;DING Feng;LIU Rangjiao;TIAN Xiangrong(School of Biology and Environmental Science,Jishou University,Jishou 416000,China;Academy for Advanced Interdisciplinary Studies,Peking University,Beijing 100871,China;Hunan Provincial Key Laboratory of Genetic Diagnosis Technology,Changsha 410205,China;Hunan Normal University,Changsha 410081,China;The First Hospital of Changsha,Changsha 410005,China;SANWAY Clinical Laboratories INC,Changsha 410205,China)
出处
《湖南师范大学学报（医学版）》
2024年第2期133-138,148,共7页
Journal of Hunan Normal University(Medical Sciences)
基金
国家科技重大专项“艾滋病和病毒性肝炎等重大传染病防治”(2018ZX10732401)
