Validation of a rapid immunochromatographic assay for diagnosis of Trypanosoma cruzi infection among latin-american migrants in Geneva, Switzerland
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2010-08
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Resumo
Chagas’ disease is a global public health problem due to the recent exchange of population between Latin
America and other regions, including Europe. The recent development of rapid diagnostic tests (RDTs) for
Trypanosoma cruzi infection may improve patient access to diagnosis and care worldwide. We evaluated the
diagnostic accuracy of the Chagas Stat-Pak RDT in a cohort of undocumented Latin-American migrants living
in Geneva, Switzerland. Study participants were enrolled in a primary health care center. The Chagas Stat-Pak
test was performed independently on blood and serum samples. A combination of two commercialized enzymelinked
immunosorbent assay (ELISA)-based serological tests was used for comparison (reference standard). A
total of 999 adults (median age, 36 years) were included in the study; the majority were women (83%) and
originally from Bolivia (47%) or Brazil (25%). A total of 125 participants (12.5%) were diagnosed with T. cruzi
infection; with the exception of three individuals, all individuals diagnosed with T. cruzi were originally from
Bolivia. The sensitivity and specificity of the Chagas Stat-Pak test on blood samples were 95.2% (95%
confidence interval [95% CI], 89.2% to 97.9%) and 99.9% (95% CI, 99.3% to 100%), respectively. When the test
was performed on serum samples, the sensitivity was 96% (95% CI, 91% to 98.3%), and the specificity was 99.8%
(95% CI, 99.2% to 99.9%). The concordance of test results for blood and serum samples was 99.7%. Both
negative and positive predictive values were above 98%. The Chagas Stat-Pak is an accurate diagnostic test for
T. cruzi infection among Latin-American migrants living in Europe. The mild deficit in sensitivity should be
interpreted in light of its ease of use and capacity to provide immediate results, which allow more people at risk
to have access to diagnosis and care both in countries where Chagas’ disease is endemic and in countries where
this disease is not endemic.
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Immunochromatographic, Trypanosoma cruzi, Chagas disease
Citação
CHAPPUIS, François; MAURIS, Anne; HOLST, Marylise; ALBAJAR-VINAS, Pedro; JANNIN, Jean; LUQUETTI, Alejandro O.; JACKSON, Yves. Validation of a rapid immunochromatographic assay for diagnosis of Trypanosoma cruzi infection among latin-american migrants in Geneva, Switzerland. Journal of Clinical Microbiology, Washington, v. 48, n. 8, p. 2948-2952, Aug. 2010.