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Wednesday, 20 June 2012

TB: Centre bans ‘inaccurate’ serology tests



  • ·         According to Section 26(A) of the Drugs and Cosmetic Act, 1940, the Centre has prohibited the manufacture, sale and distribution of the serodiagnostic test kits for diagnosis of tuberculosis.
  • ·         Few studies were conducted for evaluating the diagnostic accuracy of commercial serological tests for pulmonary and extra-pulmonary TB (where the infection affects parts of the body other than the lungs) with focus on their relevance in developing nations. The accuracy of serodiagnostic tests was found to be very low for both forms of TB.
  • ·         India is the first and only country to have banned these tests, following the WHO policy.
How TB can be diagnosed?
 
  • ·          Tuberculosis can be diagnosed through chest X-rays, analysis of sputum, skin tests. Chest X-rays can reveal evidence of active tuberculosis pneumonia. X-rays can also show scarring (fibrosis) or hardening (calcification) in the lungs, suggesting that the TB is contained.
  • ·          Examination of the sputum on a slide (smear) under the microscope can show the presence of TB-like bacteria. A sample of sputum is usually taken and cultured in special incubators so that the TB bacteria can be identified.

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