A comparative study on the performance of four commercial kits for anti-HIV confirmatory assay in detection of HIV infection
10.3760/cma.j.cn112866-20200310-00056
- VernacularTitle:四种HIV抗体确证试剂盒用于HIV感染检测性能的比较研究
- Author:
Yan XIA
1
;
Zhihong GUO
;
Mingyu LUO
;
Xiaobei DING
;
Jiafeng ZHANG
Author Information
1. 浙江省疾病预防控制中心,杭州 310051
- Keywords:
Human immunodeficiency virus;
Kits for anti-HIV confirmatory assay;
Detection performance
- From:
Chinese Journal of Experimental and Clinical Virology
2021;35(2):218-223
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the performance of four commercial kits for anti-HIV confirmatory assay and to provide a reference for clinical application.Methods:Two western blot (WB) kits and two recombinant immunoblot assay/line immune assay kits were used to detect 185 samples in parallel, McNermar test was used to analyze the consistency between the testing results and HIV infection status. Compared to the testing result of the most used MP company’s WB kit, the odds ratio ( OR) was calculated. Results:The consistency of the testing results with the status of HIV infection by the four kits was 83.24%-92.43%, and the Kappa value was 0.558-0.831.The OR value of IMT company’s WB kit obtained from 57 HIV-uninfected samples was 0.932(95% CI: 0.446-1.946, P=0.851), and the OR values of WT company’s recombinant immunoblot assay (RIBA) and MK company’s line immune assay (LIA) were 2.348(95% CI: 1.069-5.158, P=0.034) and 23.064 (95% CI: 5.125-103.789, P<0.001), respectively. The OR value of LIA obtained from 128 HIV-infected samples was 0.153 (95% CI: 0.034-0.700, P=0.016). LIA showed fewest reactions by testing 95 HIV positive screening samples, which was significantly different from any other kit ( P< 0.05). There was no significant difference among the other three kits. In the case of non-specific reactions, the numbers of bands were all ≤4, and the proportion of light-colored bands accounted for 52.1% (37/71). The main bands were gp160(81.3%), p24(71.9%), and p17(28.1%). Conclusions:There was no significant difference between the two WB kits. The RIBA/LIA detection kits could reduce the generation of indeterminate result, but the LIA kit has the risk of false negative for weakly reactive samples.