A recombinant peptide antigen line immunoassay optimized for the confirmation of Chagas' disease.

Background: The transfusion of contaminated blood has become the major route of transmission for Chagas' disease in Brazil. Current screening tests are insensitive and yield conflicting results, while confirmatory assays do not exist. A line immunoassay (INNO-LIA Chagas Ab [INNO-LIA]) combining rele...

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Publicado en:Transfusion Vol. 39; no. 7; pp. 711 - 718
Autores principales: Oelemann WMR, Vanderborght BOM, Verissimo Da Costa GC, Teixeira MGM, Borges-Pereira J, De Castro JAF, Coura JR, Stoops E, Hulstaert F, Zrein M, Peralta JM, Oelemann, W M, Vanderborght, B O, Verissimo Da Costa, G C, Teixeira, M G, Borges-Pereira, J, De Castro, J A, Coura, J R, Stoops, E, Hulstaert, F
Formato: algorithm research tables/charts Journal Article
Publicado: Wiley-Blackwell Jul99
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jul99
      vid: 39
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        atl: A recombinant peptide antigen line immunoassay optimized for the confirmation of Chagas' disease.
      aug:
        au:
          Oelemann WMR
          Vanderborght BOM
          Verissimo Da Costa GC
          Teixeira MGM
          Borges-Pereira J
          De Castro JAF
          Coura JR
          Stoops E
          Hulstaert F
          Zrein M
          Peralta JM
          Oelemann, W M
          Vanderborght, B O
          Verissimo Da Costa, G C
          Teixeira, M G
          Borges-Pereira, J
          De Castro, J A
          Coura, J R
          Stoops, E
          Hulstaert, F
        affil: Institute of Microbiology and the Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Brazil
      sug:
        subj:
          Trypanosomiasis Diagnosis
          Immunoassay
          Blood Donors
          Retrospective Design
          Technology, Medical
          Sensitivity and Specificity
          Human
      ab: Background: The transfusion of contaminated blood has become the major route of transmission for Chagas' disease in Brazil. Current screening tests are insensitive and yield conflicting results, while confirmatory assays do not exist. A line immunoassay (INNO-LIA Chagas Ab [INNO-LIA]) combining relevant, immunodominant recombinant and synthetic antigens on a single nylon membrane strip was evaluated for the serologic confirmation of Chagas' disease.Study Design and Methods: Sera from 1062 patients and healthy residents of four Brazilian regions endemic for Chagas' disease were used for test optimization. The established confirmation algorithm was evaluated with an independent set of positive (n = 75) and negative (n = 148) samples.Results: In the optimization phase, without an established comparative gold standard, the results with the INNO-LIA were compared with those obtained in four other screening assays. In the validation phase, the INNO-LIA showed a sensitivity of 100 percent (95% CI, 95.21-100) and a specificity of 99.32 percent (95% CI, 96.29-99.98) for well-characterized sera. Moreover, its specificity reached 100 percent with a set of 40 sera obtained from patients with documented leishmaniasis. The interpretation criteria defined in this study indicated that the INNO-LIA accurately detected the presence of antibodies to various specific antigens of Trypanosoma cruzi.Conclusion: The INNO-LIA Chagas Ab assay may become the first commercial assay to reliably confirm the presence of antibodies to T. cruzi.
      pubtype: Academic Journal
      doctype:
        algorithm
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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