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The importance of confirmatory assays in testing blood donors for human T-cell lymphotropic virus.
Martins, Marina Lobato; Barbosa-Stancioli, Edel Figueiredo; da Silva-Malta, Maria Clara Fernandes; Nunes, Sônia Mara.
Afiliação
  • Martins ML; Serviço de Pesquisa, Fundação HEMOMINAS, Belo Horizonte, Brazil.
  • Barbosa-Stancioli EF; Laboratório de Virologia Básica e Aplicada, Departamento de Microbiologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
  • da Silva-Malta MCF; Serviço de Pesquisa, Fundação HEMOMINAS, Belo Horizonte, Brazil.
  • Nunes SM; Laboratório de Sorologia, Fundação HEMOMINAS, Belo Horizonte, Brazil.
Vox Sang ; 119(3): 257-264, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38223953
ABSTRACT
BACKGROUND AND

OBJECTIVES:

Serological HTLV-1/2 screening is mandatory for blood donor candidates in Brazil. Our objective was to analyse HTLV test results in blood donors submitted for screening and confirmatory assays in a Brazilian blood bank. MATERIALS AND

METHODS:

Retrospective analysis (2017-2022) results of chemiluminescence immunoassays and confirmatory tests for HTLV-1/2 in reactive donors were performed. During the analysed period, three sets of assays were used (1) Architect rHTLV-I/II + HTLV Blot 2.4 (Western blot [WB]); (2) Alinity s HTLV I/II Reagent Kit + INNO-line immunoassay (LIA) HTLV I/II Score (LIA); (3) Alinity + WB.

RESULTS:

The analysed period comprised a total of 1,557,333 donations. The mean percentage of HTLV reactive donors using the Architect assay was 0.14%. With the change to the Alinity assay, that percentage dropped 2.3-fold (0.06%). The reactivity rate in the confirmatory tests (1064 samples) ranged from 13.5% to 30.2%, whereas 58.3%-85.9% of samples were non-reactive. The highest rates of positive (30.2%) and indeterminate (11.5%) results were seen using LIA. Considering all analysed samples, those with signal/cut-off ratio (S/CO) >50 were positive in confirmatory tests (positive predictive value, PPV = 100%), whereas samples with S/CO ≤6 are very unlikely to be truly positive (PPV = 0).

CONCLUSION:

The use of the Alinity assay reduced the frequency of false-positive results. Confirmatory tests are important to identify true HTLV infection in blood donors, because more than 58% of initially reactive individuals are confirmed as seronegative. Categorizing S/CO values is useful for assessing the likelihood of true HTLV-1/2 infection.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vírus Linfotrópico T Tipo 1 Humano / Infecções por HTLV-I Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Revista: Vox Sang Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vírus Linfotrópico T Tipo 1 Humano / Infecções por HTLV-I Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Revista: Vox Sang Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido