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1.
J Clin Microbiol ; 38(2): 851-4, 2000 Feb.
Article in English | MEDLINE | ID: mdl-10655396

ABSTRACT

Although screening for Trypanosoma cruzi antibodies is mandatory in most South American countries, current tests are insensitive and have poor specificity. A recently optimized line immunoassay (the INNO-LIA Chagas assay) for the serological confirmation of Chagas' disease was evaluated at a large blood bank in São Paulo, Brazil. Sera from blood donors who reacted in at least one of three serological screening assays (n = 1,604) and who returned for a follow-up were retested, and the donors were interviewed to assess their epidemiological risk. The results obtained by the confirmatory assay evaluated in this study were compared to those obtained by the three different screening assays. Upon consideration of the consensus results obtained by the three different screening assays as a "gold standard," the INNO-LIA Chagas assay showed a sensitivity of 99.4% (95% confidence interval [CI], 98.3 to 99.9) and a specificity of 98.1% (95% CI, 96.6 to 99.0) for positive (n = 503) and negative (n = 577) sera. The INNO-LIA Chagas assay confirmed the results for significantly larger numbers of positive samples of at-risk individuals independent of the number of positive screening tests (P = 0.017, Mantel-Haenszel test). In conclusion, the INNO-LIA Chagas assay reliably confirmed the presence of antibodies to T. cruzi and can be implemented as a confirmatory assay for Chagas' disease serology.


Subject(s)
Antibodies, Protozoan/blood , Antigens, Protozoan/immunology , Chagas Disease/diagnosis , Immunoassay/methods , Trypanosoma cruzi/immunology , Animals , Antigens, Protozoan/genetics , Brazil/epidemiology , Chagas Disease/epidemiology , Humans , Peptides/immunology , Recombinant Proteins/immunology , Retrospective Studies
2.
Transfusion ; 39(7): 711-7, 1999 Jul.
Article in English | MEDLINE | ID: mdl-10413278

ABSTRACT

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.


Subject(s)
Chagas Disease/diagnosis , Peptides/immunology , Animals , Antigens, Protozoan/blood , Brazil/epidemiology , Chagas Disease/blood , Chagas Disease/epidemiology , Enzyme-Linked Immunosorbent Assay , Evaluation Studies as Topic , Humans , Immunoassay/methods , Recombinant Proteins/blood
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