India: Govt bans serological test kits for TB diagnosis
Government has banned the use of serodiagnostic test kits for diagnosis of Tuberculosis in the country, following inaccurate results which could pose a health risk.
"The central government is satisfied that the use of serodiagnostic test kits for diagnosis of tuberculosis are giving inconsistent and improper results leading to wrong diagnosis and their use is likely to involve risk to human beings and whereas safer alternatives are available," said a notification issued by the Ministry of Health and Family Welfare.
The Ministry held that "it is necessary and expedient to prohibit the manufacture, sale, distribution and use of the said test kits in public interest."
An estimated over two million people contract TB in the country each year. Government estimates that about 1.5 million TB suspects are subjected to serological tests every year in India at an estimated cost of USD 15 million (over Rs 75 crore).
The test kits have been banned with immediate effect following exercise of powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940.
The ban follows a negative policy statement issued by the WHO over commercial serodiagnostic tests for tuberculosis stating that "commercial serological tests provide inconsistent and imprecise findings resulting in highly variable values for sensitivity and specificity."
The government had also sent a warning to various states for not using the serodiagnostic tests due to their inaccurate results.
"There is no evidence that existing commercial serological assays improve patient-important outcomes, and high proportions of false-positive and false-negative results adversely impact patient safety. Overall data quality was graded as very low and it is strongly recommended that these tests not be used for the diagnosis of pulmonary and extra- pulmonary TB," the WHO policy statement concluded.
Government of India notification banning TB serological (blood) tests June 2012
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