HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

Abstract

<jats:title>Abstract</jats:title> <jats:p><jats:bold>Background: </jats:bold>Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Despite many HTLV positive cases being reported in southeastern China, the detection of HTLV has not been prioritized in routine blood screening. Additionally, data on the prevalence of HTLV infection among blood donors is also limited.<jats:bold>Objective: </jats:bold>The objective of this study was to investigate the prevalence of HTLV among blood donors in three Chinese provinces through their representative blood centers, to evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening.<jats:bold>Methods: </jats:bold>From November 2018 to March 2019, blood plasma samples were collected from Hebei, Changsha, and Shenzhen blood centers and were screened for the HTLV-1/2 antibody using a CLIA and enzyme-linked immunosorbent assay (ELISA). This was followed by confirmatory tests using INNO-LIA HTLV I/II.<jats:bold>Results: </jats:bold>A total of 59,929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in the Shenzhen blood center (0.0943%, 27/28, 621) was higher than Hebei (0.0248%, 4/16,144), and Changsha (0.0198%, 3/15,164) (<jats:italic>p</jats:italic> &lt; 0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, and only one sample from the Shenzhen blood center was confirmed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100 000 (1/59 929). The HTLV-infected blood came from a 32-year-old first-time female donor with a high school degree, who belonged to the SHE ethnic minority and was born in the Fujian province.<jats:bold>Conclusion: </jats:bold>In summary, the overall prevalence of HTLV-1/2 among blood donors in the three blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies reminded us of the importance of HTLV screening among blood donors in China.</jats:p>