Comparison of three immunoassay systems for screening of HIV infection in blood donation in China

Mei-Yu Wang, Sushil Devare, Jian-Fang Liu, Xiao-Ting Lv, Peng Yin, Nan Guo, Ping Fu, Bin-Ting Wu, Yong-Hua Yin, Ling Ke, Xue Li, Hua Shan, Yu Liu


Background: Preventing transfusion-transmitted HIV infection requires a sensitive and specific donor screening strategy. Currently, there is no public data to compare the performance of the two-different-EIAs strategy, the single-EIA and single-CLIA strategies for HIV donor screening in China. The aim of this study is to evaluate the performance of the three strategies.
Methods: HIV Ag/Ab chemiluminescence microparticle immunoassay (ARCHITECT CMIA, Abbott Diagnostics, a version of CLIA) was performed on 2,138 samples. Western blot (WB) was used to confirm all samples with one or both EIA reactive or grey zone results and all samples with reactive Abbott CMIA results. The performance of the three strategies was evaluated by comparing testing results to HIV infection status as defined by WB positive results.
Results: The positive and the negative coincidence rates of CMIA HIV Ag/Ab tests with confirmed HIV infection status were 98.41% (95% CI: 91.47–99.59%) and 99.32% (95% CI: 98.87–99.63%) respectively, equal or higher than EIAs. CMIA results yield the strongest correlation with HIV infection status.
Conclusions: This is the first study to compare the performance of recently allowed single-EIA, single-CLIA donor screening strategy to the currently used two-different-EIAs strategy for HIV donor screening in China. Our results indicate that CMIA performed better than EIAs with a strong correlation with WB confirmed infection status. Implementation of one-CMIA strategy can further reduce the risk of transfusion transmitted HIV infection while decrease unnecessary waste of blood and permanent deferral of donor caused by false positive results.