title: Serodiagnosis of tuberculosis based on the analysis of the 65 kD heat shock protein of Mycobacterium tuberculosis.
abstract: OBJECTIVE
  To evaluate the 65 kD heat shock protein (hsp) antigen in serum samples of tuberculosis (TB) patients by enzyme-linked immunosorbent assay (ELISA) using monoclonal antibodies (mAbs) specific to the 65 kD hsp antigen for the diagnosis of TB.
  
  
  METHODS
  Serum samples were obtained from 188 different groups of patients (confirmed TB [n = 24], clinically suspected TB [n = 48], non-TB disease controls [n = 74] and healthy individuals [n = 42]) and analysed by ELISA using mAbs to the 65 kD hsp antigen. The Kruskal Wallis test (non-parametric analysis of variance) with the Dunnett post test was used for statistical analysis.
  
  
  RESULTS
  The method yielded 82% sensitivity and 89% specificity for the diagnosis of TB. The mean (+ or -SD) absorbance value of the 65 kD hsp antigen in TB patients (1.73 + or - 0.27) was significantly higher than in the non-TB disease control group (1.12 + or - 0.42, P < 0.001) and was also higher than among healthy individuals (1.06 + or - 0.42, P < 0.001).
  
  
  CONCLUSIONS
  The detection of the 65 kD hsp antigen in serum samples from confirmed and suspected TB patients by ELISA using mAb against purified 65 kD antigen gives a reliable diagnosis and could be considered as a diagnostic marker for TB. The absence of the 65 kD hsp antigen in healthy control BCG-vaccinated subjects indicates the diagnostic value of this assay in regions of endemicity.
authors.affiliation: Biochemistry Research Laboratory, Central India Institute of Medical Sciences, Nagpur, India.
authors.forename: A N
authors.initials: AN
authors.lastname: Rajan
authors.forename: R S
authors.initials: RS
authors.lastname: Kashyap
authors.forename: H J
authors.initials: HJ
authors.lastname: Purohit
authors.forename: G M
authors.initials: GM
authors.lastname: Taori
authors.forename: H F
authors.initials: HF
authors.lastname: Daginawala
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000276:immunology; D001426:Bacterial Proteins / Q000276:immunology*; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D018834:Chaperonin 60; D018833:Chaperonins / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D012494:Sampling Studies; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D014376:Tuberculosis / Q000097:blood* / Q000175:diagnosis* / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D001426:Bacterial Proteins; D015415:Biomarkers; D018834:Chaperonin 60; C074119:heat-shock protein 65, Mycobacterium; D018833:Chaperonins