Evaluation of four domestic and three imported fourth-generation HIV diagnostic reagents
10.3760/cma.i.issn.0254-5101.2011.09.023
- VernacularTitle:4种国产和3种进口第4代HIV抗原抗体检测试剂的质量评价
- Author:
Xiuhua LI
;
Sihong XU
;
Aijing SONG
;
Jianhui NIE
;
Youchun. WANG
- Publication Type:Journal Article
- Keywords:
Fourth-generation HIV diagnostic reagents;
HIV bank of negative samples;
HIV bank of samples positive for nucleic acid;
BBI seroconversion panel;
Evaluation of quanlity
- From:
Chinese Journal of Microbiology and Immunology
2011;31(9):847-850
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of four domestic and three imported fourth-generation HIV diagnostic reagents.Methods The specificity and sensitivity of these assays were analyzed when testing HIV negative samples and HIV-1 RNA positive samples.The relative seroconversion sensitivity index was analyzed when testing BBI seroconversion panels.Results The sensitivity of seven 4th-generation assays were 100％ (95％ CI:99.86％-100％ ),and one sample at the window period of HIV-1 infection were detected as positive.Of the seven assays,one imported assay exhibited the relative largeδ + value (1.0892),and the small δ+ value were found on the remaining six assays (0.0836-0.3003 ).For the samples negative for HIV antibody,varying degrees of false positives were observed on the seven assays ( specificity:97.80％ -99.60％,δ- value:-1.3803 to -0.4778).When testing the BBI seroconversion panels,the relative seroconversion sensitivity index of domestic assays were -0.500-0,however,which of imported assays were -0.600 and -0.700.Conclusion The seven reagents exhibited high sensitivity and specificity.The 4th generation HIV assays can be used as blood screening reagents to find the samples at window period of HIV-1 infection,thus indicating the certain meaning in reducing the transmission risk of HIV-1 for fourth-generation HIV diagnostic reagents.However,the better efficiency to detect HIV-1 early infection was observed on the imported assays than on the domestic assays.
