Field evaluation of a rapid immunochromatographic assay for detection of Trypanosoma cruzi infection by use of whole blood. 1. Médecins Sans Frontières – Spain 2. Universitario de Medicina Tropical - Universidad Mayor de San Simon, Bolivia
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1. Médecins Sans Frontières – Spain
2. Universitario de Medicina Tropical - Universidad Mayor de San Simon, Bolivia
3. Instituto Oswaldo Cruz - Fiocruz, Rio de Janeiro, Brazil
April – June 2007
(pop. = 46,000)
Quality control applied at health clinic and laboratory levels.
1,913 study participants
M:F ratio = 0.95
Mean age = 9.3 years (SD= 4.4)
Median age = 9.0 years (interquartile range = 6-13)
Positive Negative Total
1913Results – sensitivity & specificity
93.4% sensitivity (95% CI: 87.4% - 97.1%)
99.0% specificity (95% CI: 98.4% - 99.4%)
Trained, non-laboratory health workers concurred on 1,911 of 1,913 test results yielding:
99.9% overall agreement
kappa = .999 (p<.0001)
Questionnaire items scored according to a scheme outlined in the Methods section of the article.
Total of 51 possible points:
Chagas Stat-Pak = 39.25 points (77%)
IHA assay = 34 points (67%)
ELISA conventional = 30 points (59%)
ELISA recombinant = 30 points (59%)
Cross-reactivity may occur between sera of patients infected with T. cruzi and sera of patients infected with Leishmania spp. when using conventional assays for the diagnosis of Chagasic infections.
8 / 121 = 6.6%