Objective To investigate the quality of current domestic HIV antibody detecting kits and to assure the credibility of experimental results.Methods The sensitivity and specificity of three kinds of domestic HIV antibody detection ELISA kits made in three different years were evaluated and compared by testing the serum panel from National AIDS Reference Laboratory.Results The sensitivity of kits produced by three domestic manufacturers in 2001 is significantly better than the kits produced in 1998 and 1999.The false negative rates were apparently decreasing.Conclusions The quality of domestic HIV antibody detecting kits has been improving steadily.The sensitivity of double antigen sandwich ELISA assay is apparently better than the indirect ELISA assay.

Objective To evaluate the quality and proficiency testing of HIV confirmatory laboratories in China.Methods Sevenyear consecutive assessments of the laboratories added up to 297 times,including function and serum technology evaluations from 1997 to 2004.Questionnaires were used for the evaluation of function,including laboratory quality management, training and quality validation of the lower level laboratories.The serum technology evaluation used the same serum panel to screen HIV antibody and perform western blot(WB) confirmatory test.The two parts of evaluation results gave 100 scores each with excellent(above 95),good(81～95),pass(71～80),weak(60～70) and failure(below 60).Results The consistency rate between ELISA and WB in all laboratories was above 85 percent from 1998 to 2004,with a rate above 95 percent from 2001 to 2004.The excellent rates were all above 55 percent during these years,among which the highest is 91.67 percent in 2003.Only one laboratory failed in 1999.Conclusion The strict quality evaluation shows the testing ability of HIV confirmatory laboratory is improving year by year.The standardized management,performed with the training,validation and technical guidance to the lower level laboratory would continuously improve the quality of HIV confirmatory laboratories.