Revista Panamericana de Salud Pública
On-line version ISSN 1680-5348
Print version ISSN 1020-4989
SAEZ-ALQUEZAR, Amadeo; MURTA, Márcia; MARQUES, Waldelania Pereira and SILVA, Guilherme Rodrigues da. The results of an external quality control program for serological screening for antibodies against Trypanosoma cruzi in blood donors in Brazil. Rev Panam Salud Publica [online]. 2003, vol.13, n.2-3, pp.129-137. ISSN 1680-5348. http://dx.doi.org/10.1590/S1020-49892003000200014.
OBJECTIVES: In 1995 a series of external quality control programs (EQCPs) was launched for serology laboratories in Brazil, open to both public and private blood-bank laboratories. These "programs" have been held several times per year since 1995. The objective of this paper is to present the results achieved during eight programs conducted between April 1999 and August 2001, in terms of serological screening for Chagas' disease. METHODS: The participants in these eight EQCPs were serology laboratories from public and private institutions. The number of participants in each respective program that sent in its results was 94, 90, 85, 94, 100, 103, 102, and 116. At the beginning of each EQCP a blinded panel of sera was sent to each participating institution. Each panel consisted of 24 serum samples with different reactivities for the markers for which the serological screening of blood donors is obligatory in Brazil; among the 24 samples were some negative ones. The participants had 60 days to complete their testing and send in their results for evaluation. Later, each participant received an answer key for the sera panel, to use in self-evaluation. RESULTS: The three tests that the participants used most frequently were enzyme-linked immunosorbent assay (ELISA), indirect hemagglutination (IHA), and indirect immunofluorescence (IIF). Of these three, the ELISA was used most often, ranging from 92% to 98% of the laboratories for the eight programs. The screening strategy that was most often used was a combination of an ELISA test and an IHA test (ranging from 58% to 83% of the laboratories for the eight programs). In the various programs, the large majority of participating laboratories (range, 83.6%-98.1%) obtained accurate results without any false negative results. Of the 5 406 tests carried out during the eight programs using positive anti-T. cruzi sera samples, 85 (1.6%) were reported as negative in 58 laboratories. However, only 14 of those laboratories were unable to identify one or more positive samples after using all their screening tests. There were no significant differences found between the blood banks in the eight programs (P = 0.5936). No association was found between false negative results and any particular sample or any specific diagnostic kit. IHA testing had the highest proportion of false negatives, ranging from 0.7% to 7.9% for the eight programs. Of 32 855 tests performed during the eight programs using negative anti-T. cruzi sera, 106 (0.32%) were reported as false positives. The percentage of participating laboratories that had one false positive result per program varied from 1% to 16%, and between 0% and 4% of the labs per program had more than one false positive result. In comparison to testing done in Brazil in 1994-1995, the proportion of false negative results has declined. CONCLUSIONS: The results of this study point to a decrease over time in the proportion of false negative results. In the 1999-2001 programs, the highest percentage of false negative results was found with IHA testing. Therefore, it is recommended to give preference to ELISA testing for screening blood donors.
Keywords : Tamizaje serológico; bancos de sangre; control de calidad; serología; programas de evaluación; anticuerpos anti-Trypanosoma cruzi; enfermedad de Chagas.