In 2015, the new Guidelines for Blood Banks Operation Procedures issued by the National Health and Family Planning Commission of the People’s Republic of China permitted the use of one EIA (single-EIA strategy) or one CLIA (single-CLIA strategy) for HIV antibody/antigen testing in parallel with nucleic acid testing (NAT). If either of the two EIAs demonstrated reactive result, the blood donation will be discard and the blood donor will be deferred permanently. Serological screening for HIV antibody/antigen was performed routinely using two EIAs in parallel in China for decades as required by government policy ( 4). In China, HIV prevalence in the first-time blood donors was estimated to be 66/100,000 (95% CI: 59–74) and HIV incidence among repeat donors was estimated to be 9/100,000 (95% CI: 7–12) person-years ( 3). Chinese Center for Disease Control and Prevention reported approximately 64 thousand people living with HIV infection as of May 2016, and a rapid increase of sexual transmission of HIV which signals a potential risk of the virus spreading to the general population ( 2). WHO reported there were approximately 36.7 million people suffering from HIV at the end of 2016, among which, 1.8 million were newly infected ( 1). HIV continues to be one of the major threats to public health worldwide as well as one of the major transfusion-transmitted infections. Received: 29 April 2019 Accepted: Published: 03 July 2019. Keywords: Blood screening China CMIA strategies 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. Our results indicate that CMIA performed better than EIAs with a strong correlation with WB confirmed infection status. CMIA results yield the strongest correlation with HIV infection status.Ĭonclusions: 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. 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. The performance of the three strategies was evaluated by comparing testing results to HIV infection status as defined by WB positive results. 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. Methods: HIV Ag/Ab chemiluminescence microparticle immunoassay (ARCHITECT CMIA, Abbott Diagnostics, a version of CLIA) was performed on 2,138 samples. The aim of this study is to evaluate the performance of the three strategies. 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. Mei-Yu Wang 1,2, Sushil Devare 3, Jian-Fang Liu 4, Xiao-Ting Lv 4, Peng Yin 4, Nan Guo 5, Ping Fu 1,2, Bin-Ting Wu 1,2, Yong-Hua Yin 1,2, Ling Ke 1,2, Xue Li 1, Hua Shan 5, Yu Liu 1,2ġ Institute of Blood Transfusion, Chinese Academy of Medical Sciences & Peking Union Medical College, Chengdu 610052, China Ģ Sichuan Blood Safety and Blood Substitute International Science and Technology Cooperation Base, Chengdu 610052, China Ĥ Abbott Diagnostics, Shanghai R&D Center, Shanghai 200003, China ĥ Transfusion Medicine Service, Stanford University Medical Center, California, USAĬontributions: (I) Conception and design: H Shan, S Devare, Y Liu, P Yin (II) Administrative support: JF Liu, XT Lv, P Yin, H Shan (III) Provision of study materials or patients: Y Liu (IV) Collection and assembly of data: MY Wang, Y Liu (V) Data analysis and interpretation: MY Wang, Y Liu (VI) Manuscript writing: All authors (VII) Final approval of manuscript: All authors.īackground: Preventing transfusion-transmitted HIV infection requires a sensitive and specific donor screening strategy. Policy of Dealing with Allegations of Research Misconduct.Policy of Screening for Plagiarism Process.
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