Abstract
Serological tests have been widely used for detecting human T-cell lymphotropic virus type 1/2 (HTLV-1/2) antibodies in the endemic areas, but their performance in low-risk populations is rarely reported. The aim of this study was to evaluate the performance of four HTLV-1/2 screening assays and to discuss a strategy for diagnosis of HTLV-1/2 infection in a non-endemic area. At the present study, 1546 specimens repeatedly reactive (RR) by one screening ELISA were collected from blood centers/banks from January 2016 to April 2019. Avioq-ELISA, Murex-ELISA, Roche-ECLIA and Fujirebio-CLIA were independently performed on each plasma sample and compared to WB and LIA confirmatory tests. Positive or indeterminate specimens with blood available were quantified by qPCR. The results showed that 48 samples were finally confirmed as HTLV-1 positive, 13 were HTLV positive, 151 were indeterminate, and 387 were negative. All the WB-positive samples were also LIA-positive. Roche-ECLIA showed the highest sensitivity that was able to detect 91.8% positives and combined with the Murex-ELISA would significantly increase the positive detection rate (98.4%). In addition, LIA yield more indeterminate and HTLV-untyped results than WB (152 vs. 27), but was able to resolve infection status of some individuals with an indeterminate WB. Besides, 3 WB indeterminate and 1 LIA-untyped samples were confirmed as HTLV-1 positive by qPCR. Based on these findings, we put forward a proper test strategy for HTLV-1/2 diagnosis in low-prevalence areas. If possible, the Roche-ECLIA with the highest sensitivity is suggested as a second screening assay in primary labs. If not, all RR specimens are recommended to be firstly retested by Roche-ECLIA and Murex-ELISA in the reference lab. Secondly, samples reactive to any one of the two tests were quantified by qPCR, and then the NAT-negatives were furtherly submitted to LIA for confirmation. Thereby, the cost can be reduced and the diagnostic accuracy would be improved.
Highlights
Human T-lymphotropic virus (HTLV) was the first RNA retrovirus to be associated with cancer (Poiesz et al, 1980)
41 blood samples were tested by quantitative PCR (qPCR), which showed that 6 HTLV-1 positive samples and 1 HTLV-untyped samples were NAT-positive and 30 indeterminate samples were NAT-negative
We found that the combination of Roche-electrochemiluminescence immunoassay (ECLIA) and Murex-enzyme-linked immunosorbent assay (ELISA) detected 98.4% positives, which was higher than other combinations
Summary
Human T-lymphotropic virus (HTLV) was the first RNA retrovirus to be associated with cancer (Poiesz et al, 1980). HTLV is mainly spread via mother-to-child transmission, sexual contact, and through contaminated needles shared by drug users. It can be transmitted through the transfusion of infected blood components and tainted liver, kidney, or lung transplants. To mitigate these risks, mandatory screening of blood supplies for HTLV-1/2 was implemented in the mid-1980s in most developed and several developing countries (Williams et al, 1988; Maeda, 1989). Because most regions of China have long been considered non-endemic for HTLV, limited screening has been implemented
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