title: Chagas' disease diagnosis: a multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi.
abstract: A rapid serologic test for diagnosis of T. cruzi infection (Chagas Stat Pak) was developed using recombinant proteins in an immunochromatographic assay. This cassette format test was evaluated first in blind with a panel of 393 coded serum samples. The Chagas Stat-Pak identified 197 infected (98.5% sensitivity) and 183 non-infected individuals (94.8% specificity). A second evaluation was performed with 352 sera from four Latin America countries tested independently in each country, showing a sensitivity of 100% and specificity of 98.6%. A third set of tests comparing sera with plasma and eluates from filter paper as well as serum preserved in 50% glycerol did show identical results as those obtained with serum. This rapid test (15 min) uses one device per sample, does not require refrigeration nor a laboratory structure or specialized skills to be performed, accepts different types of samples and may be stored for long periods of time for result checking and documentation. These attributes together with the high sensitivity and specificity demonstrated herein, make this test a suitable tool for field studies, small laboratories and emergencies at blood banks in the countryside of endemic areas.
authors.affiliation: Instituto de Patologia e Saúde Pública, Faculdade de Medicina, Universidade Federal de Goiás, Goiania, Brazil.
authors.forename: Alejandro O
authors.initials: AO
authors.lastname: Luquetti
authors.forename: Carlos
authors.initials: C
authors.lastname: Ponce
authors.forename: Elisa
authors.initials: E
authors.lastname: Ponce
authors.forename: Javan
authors.initials: J
authors.lastname: Esfandiari
authors.forename: Alejandro
authors.initials: A
authors.lastname: Schijman
authors.forename: Susana
authors.initials: S
authors.lastname: Revollo
authors.forename: Nestor
authors.initials: N
authors.lastname: Añez
authors.forename: Bianca
authors.initials: B
authors.lastname: Zingales
authors.forename: Rafael
authors.initials: R
authors.lastname: Ramgel-Aldao
authors.forename: Antonio
authors.initials: A
authors.lastname: Gonzalez
authors.forename: Mariano J
authors.initials: MJ
authors.lastname: Levin
authors.forename: Eufrosina S
authors.initials: ES
authors.lastname: Umezawa
authors.forename: José
authors.initials: J
authors.lastname: Franco da Silveira
mesh_terms: D000818:Animals; D000913:Antibodies, Protozoan / Q000032:analysis*; D001118:Argentina / Q000453:epidemiology; D001938:Brazil / Q000453:epidemiology; D014355:Chagas Disease / Q000175:diagnosis* / Q000453:epidemiology; D019353:Endemic Diseases; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D013030:Spain / Q000453:epidemiology; D013048:Specimen Handling; D014349:Trypanosoma cruzi / Q000276:immunology* / Q000302:isolation & purification; D014687:Venezuela / Q000453:epidemiology
chemical_list: D000913:Antibodies, Protozoan; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins