NEW DELHI (NNN-Bernama): The Indian government has banned the use of serodiagnostic test kits for diagnosis of tuberculosis in the country following inaccurate results that could pose a health risk, Press Trust of India reported.
"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," said a notification issued by India's Ministry of Health and Family Welfare.
The Ministry said "it is necessary and expedient to prohibit the manufacture, sale, distribution and use of the said test kits in public interest."
Over an estimated two million people contract TB in the country each year. The government estimates that about 1.5 million TB suspects are subjected to serological tests every year in India at an estimated cost of US$15 million (over Rs 75 crore).
The test kits have been banned with immediate effect and follows a policy statement issued by 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 statement clearly recommends that commercial tests not be used for the diagnosis of pulmonary and extra-pulmonary TB.
The government had also sent a warning to various states for not using the serodiagnostic or serological tests.
The government has declared tuberculosis a notifiable disease since May 7 this year, making it mandatory on all private doctors, healthcare providers and clinical establishments treating such patients to report each case to the government. -NNN-BERNAMA
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