ABSTRACT Background: The screening of Trypanosoma cruzi-infected blood donors using two serological techniques frequently leads to conflicting results. This fact prompted us to evaluate the diagnostic performance of four “in-house” immunodiagnostic tests and two commercially available enzyme-linked immunosorbent assays (ELISAs). Material and Methods: One hundred and seventy-nine blood donors, whose screening for Chagas disease was doubtful, underwent three in-house ELISAs, one in-house immunoblotting test (TESA-blot), and two commercial ELISAs (bioMérieux and Wiener) in an attempt to define the presence or absence of infection. Simultaneously, 29 donors with previous positive results from three conventional serological tests and 30 donors with constant negative results were evaluated. Results: The ELISA-Wiener showed the highest rate in sensitivity (98.92%) and the ELISA-bioMérieux, the highest specificity (99.45%), followed by the TESA-blot, which showed superior performance, with lower false-negative (2.18%) and false-positive (1.12%) rates. In series, the combination composed of the TESA-blot and ELISA-bioMérieux showed slightly superior performance, with trifunctional protein deficiency (TFP) = 0.01%. Conclusion: Our study confirms the high sensitivity and specificity of commercial kits. To confirm the presence or absence of T. cruzi infection, the combination of TESA-blot and ELISA-bioMérieux may be suggested as the best alternative. Individually, the TESA-blot performed the closest to the gold standard; however, it is not commercially available.

Epidemiological screening combined with serological tests has become an important tool at blood banks for the characterization of donors with or without Trypanosoma cruzi infection. Thus, the objective of the present study was to describe the sociodemographic and epidemiological characteristics of blood donors with non-negative serology for T. cruzito determine possible risk factors associated with serological ineligibility. Sociodemographic and epidemiological data were collected by analysis of patient histories and interviews. The data were analyzed descriptively using absolute and relative frequencies and odds ratio (OR) evaluation. The frequency of serological ineligibility was 0.28%, with a predominance of inconclusive reactions (52%) and seropositivity among first-time donors (OR = 607), donors older than 30 years (OR = 3.7), females (OR = 1.9), donors from risk areas (OR = 4) and subjects living in rural areas (OR = 1.7). The risk of seropositivity was higher among donors who had contact with the triatomine vector (OR = 11.7) and those with a family history of Chagas disease (OR = 4.8). The results demonstrate the value of detailed clinical-epidemiological screening as an auxiliary tool for serological definition that, together with more specific and more sensitive laboratory methods, will guarantee a higher efficacy in the selection of donors at blood centres.

Atualmente, um dos maiores problemas na triagem sorológica de doadores de sangue para doença de Chagas é a alta freqüência de reações indeterminadas, o que faz com que muitos indivíduos sadios sejam rotulados como portadores de uma doença grave. O presente trabalho tem o objetivo de analisar o comportamento sorológico para doença de Chagas dos doadores do Hemocentro Regional de Uberaba, MG e propor mecanismos para reduzir o índice de inaptidão sorológica para essa doença. Através de estudo retrospectivo, foi analisado o resultado sorológico de 79.729 amostras obtidas de doações de sangue realizadas neste Serviço entre janeiro de 2000 e dezembro de 2004. Os resultados foram analisados quanto às variáveis: tipo de doador (novo e de retorno), gênero e idade (inferior ou igual a 30 anos e superior a 30 anos). Para a análise estatística foram realizados os testes do Qui-Quadrado e de comparação de proporções (Z). A ocorrência de doações com sorologia não negativa para doença de Chagas entre doadores novos foi significativamente superior aos de retorno, com p< 0,0001. Quanto à idade, a proporção de positivos no grupo maior de 30 anos foi significativamente superior à do grupo com idade igual ou inferior a 30 anos (p< 0,0001). O elevado número de reações indeterminadas nesse Serviço está de acordo com estudos recentes, reforçando a necessidade da implementação de testes sorológicos 100% específicos ou de exames confirmatórios práticos e rápidos, passíveis de serem introduzidos nas rotinas dos serviços de hemoterapia, reduzindo o descarte desnecessário de bolsas de sangue.

Currently one of the major problems in the serological selection of blood donors in respect to Chagas' disease is the high incidence of indeterminate reactions, making a large number of healthy individuals incorrectly diagnosed as seriously ill. This paper aims at evaluating the serological pattern of Chagas' disease of donors of the Uberaba Blood Center and also to propose mechanisms to reduce the rate of serological ineligibility due to suspicion of this disease. A retrospective study of the serological results of 79,729 samples of blood was carried out between January 2000 and December 2004. The results were analyzed according to the following variables: type of donor (first-time and multiple), gender and age (less than or equal to 30 or more than 30 years old). The statistical analysis was made using the chi-square test and a comparison of proportions (Z). Indeterminate results in respect to Chagas' disease among first-time donors were significantly higher than those of multiple donations with p < 0.0001. As for age, the proportion of positivity in the over 30-year-old group was significantly higher to that of the under or equal to 30-year-old group (p < 0.0001). The high number of indeterminate reactions at this center is in accordance with recent studies, highlighting the need of implementing serological tests with 100% specificity or the use of practical and fast confirmation tests to be routinely introduced in hemotherapy services, reducing the unnecessary rejection of blood bags.