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FIELD EVALUATION OF A RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR DETECTION OF TRYPANOSOMA CRUZI INFECTION BY USE OF WHOLE BLOOD
Ensaio imunocromatográfico rápido
Infecção
Uso de sangue total
Avaliação
Rapid Immunochromatographic Assay
Infection
Use of Whole Blood
Evaluation
Author
Affilliation
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Universidad Mayor de San Simon. Facultad de Medicina. Centro Universitario de Medicina Tropical. Cochabamba, Bolivia.
Médecins Sans Frontiéres-Spain. Barcelona, Spain / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Doenças Parasitárias. Rio de Janeiro, RJ, Brasil.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Médecins Sans Frontiéres-Spain. Barcelona, Spain.
Universidad Mayor de San Simon. Facultad de Medicina. Centro Universitario de Medicina Tropical. Cochabamba, Bolivia.
Médecins Sans Frontiéres-Spain. Barcelona, Spain / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Doenças Parasitárias. Rio de Janeiro, RJ, Brasil.
Abstract
Laboratory and clinical diagnostic classification of seropositive individuals, followed by treatment and supportive therapy, is an established component of Chagas' disease control in areas where this disease is endemic. However, most Chagas' disease patients live in remote areas where neither equipped laboratories nor skilled human resources are widely available. Employing a rapid diagnostic test (RDT), when using whole blood samples, is the best option for Chagas' disease control. A high sensitivity and specificity for the Chagas Stat-Pak RDT (Chembio Diagnostic Systems, Inc., Medford, NY) has been reported for assays using serum and plasma, but its validity for the detection of antibodies to Trypanosoma cruzi infection in whole blood is unknown. This cross-sectional study measured the sensitivity and specificity of the Chagas Stat-Pak with whole blood, using conventional serological assays for comparison. The interobserver reliability in the interpretation of the Chagas Stat-Pak results and "ease-of-use" criterion needed to perform the Chagas Stat-Pak and conventional assays were also measured. The Chagas Stat-Pak yielded a high specificity (99.0%, 95% confidence interval [CI] = 98.4 to 99.4%) but a relatively low sensitivity (93.4%, 95% CI = 87.4 to 97.1%). The interobserver reliability was excellent (kappa [n = 1,913] = 0.999, P < 0.0001), and the quantified ease-of-use criterion suggested that the RDT is simple to perform. Despite the attributes of the Chagas Stat-Pak, it is not an ideal diagnostic test for the population investigated in the present study due to its relatively low sensitivity and high cost. The RDT manufacturer is called upon to improve the test if the international community hopes to make progress in controlling Chagas infections in areas where this disease is endemic.
Keywords in Portuguese
Trypanosoma cruziEnsaio imunocromatográfico rápido
Infecção
Uso de sangue total
Avaliação
Keywords
Trypanosoma cruziRapid Immunochromatographic Assay
Infection
Use of Whole Blood
Evaluation
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