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目的比较罗氏公司与我国圣湘生物公司的Ⅰ型人类免疫缺陷病毒(HIV-1)病毒载量定量检测试剂的性能。方法首先,对国产新开发的HIV-1试剂定量线性范围和灵敏度做了初步评估,然后,收集227例疑似HIV感染者样本血浆,分别用两个公司的试剂进行检测,采用Kappa检验分析两种试剂检测的一致性;并对于线性检测范围内的阳性样本,采用Bland-Altman和Pearson法分析比较两种试剂病毒载量检测的一致性和相关性。结果圣湘生物研发的HIV-1检测试剂可测定的线性定量范围为50IU/ml-1.00E+08IU/ml,灵敏度达到50IU/ml;两种试剂检测227例样本,阳性一致性为100.00%,阴性一致性为98.15%,总一致性为99.56%,其Kappa值为0.988,P=0.012,表明两种试剂在定性检测上具有很好的一致性;两种试剂对病毒载量定量检测的线性相关性系数R=0.775、P=0.022,仅2.31%的点(4个样本)在95%的一致性界限外。结论国产新型HIV-1定量检测试剂具有很好的检测线性范围和灵敏度,与Roche Cobas TaqMan RT-PCR HIV-1V2.0试剂对227份临床样本的定量检测结果对比,两者具有很好的线性相关性和一致性。
Objective To compare the performance of Roche’s HIV-1 viral load quantitative detection reagents with our company. Methods Firstly, the quantitative linear range and sensitivity of domestic newly developed HIV-1 reagents were evaluated. Then, 227 samples of HIV-infected persons were collected and tested with two companies’ reagents. Kappa test was used to analyze the two Reagent detection consistency; And for the linear detection range of positive samples, Bland-Altman and Pearson analysis was used to compare the consistency of the two reagents and viral load detection and correlation. Results The linearity range of HIV-1 detection reagent developed by Shengxiang Biological was 50IU / ml-1.00E + 08IU / ml with a sensitivity of 50IU / ml. The positive detection rate of the two reagents was 100.00% The negative consistency was 98.15%, the total consistency was 99.56%, the Kappa value was 0.988, P = 0.012, which showed that the two reagents had good consistency in qualitative detection. The linearity of the two reagents in quantitative detection of viral load The correlation coefficient R = 0.775, P = 0.022, only 2.31% of the points (4 samples) outside the 95% agreement margin. Conclusion The new domestic HIV-1 quantitative detection reagent has a good linear range and sensitivity. Compared with the quantitative detection results of 227 clinical samples of Roche Cobas TaqMan RT-PCR HIV-1V2.0 reagent, both of them have good linearity Relevance and consistency.