Evaluation of human T-cell leukemia virus in vitro diagnostics using plasma specimens collected in Japan.

ABSTRACT:

Background

In vitro diagnostics (IVDs) for primary detection test/screening of human T-cell leukemia virus (HTLV) have recently been updated to new-generation products in Japan. In this study, the performance of these products was evaluated and discussed in terms of the usability of HTLV diagnosis in Japan.

Methods

The performance of 10 HTLV IVDs for primary detection test and confirmatory/discriminatory test was evaluated. Plasma specimens that had been declared ineligible for transfusion were provided by the Japanese Red Cross Blood Center.

Results

The diagnostic specificity of the IVDs was 100% (160/160). Six sandwich assays resulted in all HTLV-1/HTLV-positive specimens being positive (46/46). On the other hand, one sandwich assay, IVD under development 2 (UD2), r

SUBMITTER: Kusagawa S 

PROVIDER: S-EPMC10283183 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature