title: Diagnostic performance of commercially available enzyme-linked immunosorbent assay kit in the diagnosis of extrapulmonary tuberculosis.
abstract: OBJECTIVE
  Antibody based serodiagnosis tests for tuberculosis (TB) was used widely in developed and developing countries. Pathozyme Myco(®) immunoglobulin (Ig) M, IgA, and IgG were evaluated in pulmonary TB in many studies.
  
  
  METHODS
  In this study we assessed this commercially available kit in detecting extrapulmonary TB (EPTB).
  
  
  RESULTS
  A total of 354 subjects were recruited for the study, of which 217 (61.2%) were EPTB patients and 137 (38.7%) were subjects with no suggestive TB. The mean age was 29.7 ± 13.7 and 31.2 ± 15.2 years, respectively for two groups. Serum samples were tested for IgM, IgA, and IgG using Pathozyme Myco(®) IgM, IgA, and IgG kit. The individual specificity rates of IgM, IgA, and IgG were 70.8% (95% confidence interval (CI): 62.7-77.7), 77.3% (95% CI: 68.6-83.5), and 68.6%. (95% CI: 60.4-75.7); while their sensitivity was 29% (95% CI: 23.4-35.4), 24.4% (95% CI: 19.1-30.5), and 34.5% (95% CI: 28.5-41.1); respectively.
  
  
  CONCLUSIONS
  The serological tests either singly or in combination failed or performed poorly to diagnose EPTB.
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Manimuthu Mani
authors.initials: MM
authors.lastname: Sankar
authors.forename: Veena
authors.initials: V
authors.lastname: Balooni
authors.forename: Jitendra
authors.initials: J
authors.lastname: Singh
authors.forename: Sarman
authors.initials: S
authors.lastname: Singh
keywords: Diagnosis; extrapulmonary tuberculosis; serology