title: [Preliminary evaluation of the commercial kit Chagas ( Trypanosoma cruzi ) IgG-ELISA ® in Colombian individuals].
abstract: BACKGROUND
  The diagnosis of Chagas' disease is essential to provide early treatment and improve patients' prognosis . The discriminatory efficiency of the serological tests varies according to the disease prevalence and the test- antigen used .
  
  
  OBJECTIVE
  To evaluate the discriminatory efficiency of the commercial kit Chagas ( Trypanosoma cruzi ) IgG-ELISA ® (Nova Tec Immunodiagnostica GmbBH) in a group of Colombian individuals, using indirect immunofluorescence antibody testing (IFAT) and enzyme immunoassay (ELISA) tests as references.
  
  
  METHODS
  Seventy-eight samples from chronic chagasic patients (36 asymptomatic and 42 symptomatic) and 21 healthy controls were included. Seventeen samples from non-infected people with Chagas' disease epidemiological risk, seven with leishmaniasis and nine with non-chagasic cardiomyopathy were also analyzed. Real time PCR was performed on four individuals whose results differed among tests.
  
  
  RESULTS
  Significant differences at 450 nm optical absorbance were found (p<0.0001) when the median absorbance values of healthy controls (0.143), asymptomatic (2.401) and symptomatic (2.776) chagasic patients were compared, as well as when asymptomatic and symptomatic patients (p=0.0408) and seronegative people with epidemiological risk (0.232), cardiomyopathy (0.367) or leishmaniasis (0.337) were compared with chagasic patients (p<0.0001). Finally, there were differences among healthy controls and non-infected people with epidemiological risk (p=0.0264), patients with non-chagasic cardiomyopathy (p=0.0015) and patients with leishmaniasis (p=0.002). Real-time PCR was positive in three out of four analyzed cases.
  
  
  CONCLUSIONS
  The commercial ELISA test allowed us to discriminate the chagasic patients from the controls. A phase II study of diagnostic tests for determining field reliability of this test is required.
authors: Laboratorio de Parasitología Molecular, Departamento de Microbiología, Facultad de Ciencias, Pontificia Universidad Javeriana.
authors: Mónica
authors: M
authors: Llano
authors: Laboratorio de Parasitología Molecular, Departamento de Microbiología, Facultad de Ciencias, Pontificia Universidad Javeriana.
authors: Paula
authors: P
authors: Pavía
authors: Grupo de Parasitología, Instituto Nacional de Salud.
authors: Astrid Carolina
authors: AC
authors: Flórez
authors: Grupo de Inmunobiología y Biología Celular, Facultad de Ciencias, Pontificia Universidad Javeriana.
authors: Adriana
authors: A
authors: Cuéllar
authors: Grupo de Ciencias Básicas Médicas, Facultad de Medicina, Universidad de los Andes.
authors: John M
authors: JM
authors: González
authors: Laboratorio de Parasitología Molecular, Departamento de Microbiología, Facultad de Ciencias, Pontificia Universidad Javeriana.
authors: Concepción
authors: C
authors: Puerta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000913:Antibodies, Protozoan / Q000097:blood*; D058070:Asymptomatic Diseases; D014355:Chagas Disease / Q000175:diagnosis* / Q000453:epidemiology; D003105:Colombia / Q000453:epidemiology; D016054:DNA, Protozoan / Q000097:blood; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D019084:Fluorescent Antibody Technique, Indirect; D006331:Heart Diseases / Q000097:blood; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D007896:Leishmaniasis / Q000097:blood; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000175:diagnosis; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D014349:Trypanosoma cruzi / Q000276:immunology*; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D016054:DNA, Protozoan; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic