浙江省HIV抗体盲样质控考核结果分析及不同品牌分析灵敏度比较

目的调查医疗机构选用不同方法学检测抗HIV抗体的能力情况,比较不同品牌和方法学对抗HIV抗体和抗原的分析灵敏度。方法定制6个不同浓度的抗HIV-1抗体标准物质,对218家实验室开展盲样质控考核,统计医院满分率、项目脱靶率和方法学脱靶率。采用3种不同稀释液对定制标准物质倍比稀释,获得低浓度抗HIV-1抗体和HIV-p24抗原标准物质,对考核中的6款化学发光品牌和3款ELISA品牌进行分析灵敏度的比较以及稀释液的影响比较。结果医院满分率为95.9%(209/218),抗HIV-1抗体项目脱靶率为1.8%,均为假阴性脱靶。ELISA、化学发光法(CLIA)和胶体金法(GICA)的脱靶率分别为0、13.3%和40.0%。在抗HIV-1抗体浓度为1 NCU/m L时3款CLIA品牌不能检出,1款CLIA品牌不能检出2 NCU/m L的抗体浓度。2款GICA品牌不能检出12 NCU/m L的抗体浓度。3、4代ELISA和3代CLIA品牌对抗HIV-1抗体检测的分析灵敏度优于部分4代CLIA品牌,而4代CLIA品牌对HIV-p24抗原的分析灵敏度显著高于4代ELISA。不同稀释液对检测结果影响存在显著差异,但不影响定性结果判断。结论 GICA检测抗HIV抗体存在较高的漏检风险。4代CLIA对HIV抗原检测分析灵敏度较高,但对抗HIV抗体检测的分析灵敏度相对弱于ELISA和3代试剂。稀释液的差异不是免疫定性分析的主要影响因素。

Analysis of results of blindness examination of HIV antibody with controls in Zhejiang province and comparison of the analysis sensitivity of different brands

Objective To investigate the ability of different medical institutions to detect HIV antibodies and compare the analysis sensitivity of different brands and methodology to HIV antibodies and antigens. Methods 6 different concentrations of HIV-1 antibody standard substance were customized, and 218 laboratories were conducted blindness examination. The full credit rate and the miss rate of item as well as methodology were analyzed. In the further supplementary experiment, HIV-1 antibody standard substances and HIV-p24 standard substances, which were diluted to low concentration with 3 different diluents, were designed to compare the analysis sensitivity of 6 chemiluminescent brands and 3 ELISA brands. The influence of different diluents were also compared Results The full credit rate of hospital was 95.9% (209/218).The miss rate of HIV-1 antibody item was 2.1%, all of which were false negative miss. The miss rates of ELISA, chemiluminescence(CLIA) and gold immunochromatography assay(GICA) were 0, 13.3% and 40% respectively. 3 CLIA brands cannot detect the HIV-1 antibody of 1NCU/ml and 1 CLIA brand cannot detect the antibody of 2NCU/ml. 2 GICA brands cannot detect the antibody concentration of 12NCU/ml. In the supplementary experiment, the sensitivity of 3, 4 generation ELISA and 3 generation CLIA brands to HIV-1 antibody detection was sensitive to some 4 generation CLIA brands, while the sensitivity of 4 generation CLIA brands to HIV-p24 antigen was significantly higher than that of the 4 generation ELISA. The effect of different diluents on test results is significant, but it does not affect the qualitative results. Conclusions There is a high risk of false negative detection with GICA. The 4 generation CLIA is highly sensitive to the detection and analysis of HIV antigen, but the sensitivity to HIV antibody detection is relatively weaker than that of ELISA and 3 generation reagents. The difference of diluent is not the main influence factor of immunoassay.