HTLV screening using chemiluminescence immunoassay among blood donors in three blood centers in China

Background Human T-cell lymphotropic virus (HTLV) remains a concern for blood safety. The detection of HTLV has not yet been applied for routine blood screening in China, even though lots of HTLV positive cases have been reported in southeastern China. However, data on the prevalence of HTLV infection among blood donors is limited. Objective The objective was to investigate the prevalence of HTLV among blood donors in three representative blood centers in China and evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening. Methods From November 2018 to March 2019, blood plasma samples collected from Hebei, Changsha and Shenzhen blood centers were screening for HTLV-1/2 antibody using Lumipulse G HTLV-I/II Immunoreaction Cartridges set (CLIA) and enzyme-linked immunosorbent assay (ELISA), followed with confirmatory test using INNO-LIA HTLV I/II. Results A total of 59929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in Shenzhen blood center (0.0943%, 27/28621) was higher than Hebei (0.0248%, 4/16144) and Changsha (0.0198%, 3/15164) ( P <0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, only 1 sample from Shenzhen blood center was confirmed and typed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100,000 (1/59929). The HTLV-infected blood donor was a first female donor at age 32 with high school degree, born in Fujian province, and SHE minority. Conclusion In summary, the overall prevalence of HTLV-1/2 among blood donors in the tree blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies found in the study reminded us the importance of HTLV screening among blood donors in China. In the view of HTLV prevalence and cost, all the first-blood donors should undergo HTLV screening as a systematic strategy to reduce the risk of transmission of HTLV through blood transfusion.