一种国产HIV-1核酸定量检测试剂的性能和临床应用初步评价

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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。

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关键词 ：人类免疫缺陷病毒1型, 定量, 最低检测限, 分析特异性, 一致性

Abstract：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.

Key words： HIV-1 RNA quantitative limit of detection specificity consistency

收稿日期: 2024-01-09

中图分类号:

R446

基金资助: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）

通讯作者: 邓中平,E-mail：dzp2007kc@163.com;田向荣,E-mail：jsutianxr@jsu.edu.cn

引用本文:

谭杰, 邓中平, 郑芳, 丁峰, 刘让蛟, 田向荣. 一种国产HIV-1核酸定量检测试剂的性能和临床应用初步评价[J]. 湖南师范大学学报(医学版), 2024, 21(2): 133-138. TAN Jie, DENG Zhongping, ZHENG Fang, DING Feng, LIU Rangjiao, TIAN Xiangrong. Preliminary evaluation of the performance and clinical application of a domestic quantitative RT-PCR assay for Detection of HIV-1 nucleic acid. HuNan ShiFan DaXue XueBao(YiXueBan), 2024, 21(2): 133-138.

链接本文:

http://yxb.hunnu.edu.cn/CN/ 或 http://yxb.hunnu.edu.cn/CN/Y2024/V21/I2/133

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