Assessment of Five Different HIV ELISA Kits

Objective The aim of this study was to evaluate the reliability of five different ELISA kits for the testing of HIV in blood samples. Methods ELISA kits obtained from local (Kit-A, B, and E) and oversea (Kit-C and D) manufactures were used in this study. Bloods, either obtained from the volunteers or provided by the Health Ministry, were used for the testing of HIV. The following parameters were compared: the compliance rate, positive identification rate,false positive identification rate, stability,detection limit and pro-zone phenomena.Results All 5 ELISA kits achieved national standard with a compliance rate of 100%. For the standard samples, the positive identification rate was 100%.The positive identification rate of the 21 658 blood donor samples was 0.01%.ELISA kit-C had a lower false positive identification rate than the ELISA Kit-D, A, B and E (P0.05). The accuracy (5.98%) and stability (5.93%) of the ELISA Kit-C were lower than the ELISA Kit-A,B,D,and E (P0.05). Although the detection limit of the ELISA Kit-A, B and E is 0.125NCU, the false positive identification rate for this ELISA kit is high. Pro-zone effect was not observed in the ELISA Kit-C. Conclusion All the ELISA kits used in this study meet the national standard. The false positive identification rate of the three locally made ELISA kits was higher than the two imported ELISA kits,the minimum detectable limit of these locally made ELISA kits was lower than the other two kits. The ELISA Kit-C should be used for the screening of HIV.