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J Lab Physicians. 2013 Jan;5(1):11-6. doi: 10.4103/0974-2727.115902.

Diagnostic performance of commercially available enzyme-linked immunosorbent assay kit in the diagnosis of extrapulmonary tuberculosis.

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Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India.



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.


In this study we assessed this commercially available kit in detecting extrapulmonary TB (EPTB).


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.


The serological tests either singly or in combination failed or performed poorly to diagnose EPTB.


Diagnosis; extrapulmonary tuberculosis; serology

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