aspectos da padronização de testes sorológicos para a doença de chagas: um teste imunoenzimático para a triagem de doadores de sangue standardization of serological tests in chagas' disease: immunoenzimatic test for screening of blood bank donnors
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ID: 145398
1991
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Abstract
No diagnóstico sorológico da doença de Chagas podem ser encontradas acentuadas divergências mesmo entre laboratórios de grande experiência. Para a padronização de um teste imunoenzimático destinado primariamente à seleção de doadores de sangue foram cuidadosamente escolhidos painéis de soros que se buscaram como representativos das populações de chagásicos e de não chagásicos. Produzido para máxima sensibilidade e estabilidade, o novo reagente (bioELISA - cruzi*) foi testado em 1648 soros, com diagnóstico clínico de doença de Chagas em 219 e de outras afecções em 104. O teste foi comparado com testes já bem padronizados, de imunofluorescência (IF) e de hemaglutinação (HA), em 1325 soros. O limiar de reatividade (cut off), estabelecido como ideal, foi indicado nos testes pela absorbância de um soro de reatividade mínima. A sensibilidade do teste imunoenzimático foi de 0,9954 e a especificidade, como conegatividade, de 0,9969. Não foram vistos resultados falso-positivos em casos de sífilis, toxoplasmose, mononucleose e de soros com altos títulos de anti-estreptolisina 0, mas foram encontrados em 5 de 15 casos de leishmaniose tegumentar, 10 de 24 casos de calazar, 1 de 15 casos de artrite reumatóide e 1 de 12 casos de lupus eritematoso sistêmico. Os altos índices de sensibilidade em chagásicos e de especificidade na população geral, traduzem a elevada confiabilidade do teste para triagem de doadores de sangue e para a confirmação de suspeita clínica de doença de Chagas.
In the serological diagnosis of Chagas disease large divergences may be found even between laboratories with experience, as a consequence of different criteria for the standardization of the tests. To standardize a immunoenzimatic test developed primarily for screening blood donors, serum panels were carefully chosen so as to best represent chagasic and non-chagasic populations. Produced for the highest sensibility and stability, the new reagent (bioELISA cruzi, Biolab Diagnóstica S/A, Brasil), was tested in serum from 1648 patients 219 with Chagas disease and 104 with other diseases, plus a comparison with well standardized immunofluorescence and hemagglutination tests in 1325 sera. In the immunoenzimatic assays, the cut off was indicated by the absorbance value of a chagasic serum showing a minimal reactivity. ELISA sensibility was 0,9954 and specificity 0,9969, as conegativity. False positive results were absent with sera from sifilis, toxoplasmosis, mononucleosis and high titered sera for antistreptolysin 0 antibodies. However they were seen in 5 to 15 cases of tegu-mentar leishmaniosis, 1 of 12 Kala-azar 1 of 15 reumatoid arthritis and 1 of 12 sistemic lupus erythematosus. The high sensibility in chagasics and high specificity in the general population indicate the confiability of the imunoenzimatic assay for screening blood donors and even to confirm a clinical diagnosis of Chagas' disease.
In the serological diagnosis of Chagas disease large divergences may be found even between laboratories with experience, as a consequence of different criteria for the standardization of the tests. To standardize a immunoenzimatic test developed primarily for screening blood donors, serum panels were carefully chosen so as to best represent chagasic and non-chagasic populations. Produced for the highest sensibility and stability, the new reagent (bioELISA cruzi, Biolab Diagnóstica S/A, Brasil), was tested in serum from 1648 patients 219 with Chagas disease and 104 with other diseases, plus a comparison with well standardized immunofluorescence and hemagglutination tests in 1325 sera. In the immunoenzimatic assays, the cut off was indicated by the absorbance value of a chagasic serum showing a minimal reactivity. ELISA sensibility was 0,9954 and specificity 0,9969, as conegativity. False positive results were absent with sera from sifilis, toxoplasmosis, mononucleosis and high titered sera for antistreptolysin 0 antibodies. However they were seen in 5 to 15 cases of tegu-mentar leishmaniosis, 1 of 12 Kala-azar 1 of 15 reumatoid arthritis and 1 of 12 sistemic lupus erythematosus. The high sensibility in chagasics and high specificity in the general population indicate the confiability of the imunoenzimatic assay for screening blood donors and even to confirm a clinical diagnosis of Chagas' disease.
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ferreira1991revistaaspectos
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| Authors | ;A. Walter Ferreira;Zila R. Belem;M. Emilia G. Moura;M. E. Camargo |
| Journal | 2017 12th international conference for internet technology and secured transactions, icitst 2017 |
| Year | 1991 |
| DOI |
10.1590/S0036-46651991000200006
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