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

Junpeng Zhao,Ran Li,Wei Han,Jinfeng Zeng,Lilin Wang,Lunan Wang,Xuezhen Zeng,Xiujuan Cui,Linfeng Wu,Feixue Zhao,Xiaoxuan Xu,Yunlong Chen,Dandan Du,Tong Li

doi:10.1186/s12879-020-05282-2

Abstract

BackgroundHuman 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. 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.MethodsFrom 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.ResultsA 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) (p < 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.ConclusionsIn 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.

Highlights

Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies
This study investigated the prevalence of HTLV-1/2 among blood donors in three blood centers (South region: Shenzhen blood center; Central region: Changsha blood center; North region: Hebei blood center), using chemiluminescence immunoassay (CLIA) and enzyme-linked immunosorbent assay (ELISA) at the same time
115 were initially detected as reactive in ELISA and/or CLIA, of which one sample was only reactive in ELISA but non-reactive in CLIA; 109 donations were reactive in CLIA and non-reactive in ELISA, and 5 samples were detected as reactive in ELISA and CLIA (Fig. 2)

Summary

Introduction

Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Data on the prevalence of HTLV infection among blood donors is limited. HTLV-1/2 infection is a high-risk factor for lymphoproliferative and inflammatory conditions and can cause adult T-cell leukemia/lymphoma and HTLV-1associated myelopathy/tropical spastic paraparesis [3,4,5]. Both HTLV-3 and HTLV-4 have not been linked to diseases [2]. The latest data describe that the prevalence of HTLV-1/2 was 2.51 per 100,000 in the major areas of China between January 2016 and December 2017 [10], which is lower than the US, Japan, and European countries [11,12,13,14]

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