Govt bans serological test kits for TB diagnosis
New Delhi: 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."
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.
The WHO serodiagnostic test policy statement clearly recommends that these commercial tests not be used for the diagnosis of pulmonary and extra-pulmonary TB.
It further noted that the "currently available commercial serodiagnostic tests (also referred to as serological tests) provide inconsistent and imprecise findings. There is no evidence that existing commercial serological assays improve patient outcomes, and high proportions of false-positive and false-negative results may have an adverse impact on the health of patients."
Government has already declared tuberculosis (TB) 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 of the air-borne disease to government.
The notification of TB cases by all healthcare providers will help patients in getting better access to quality diagnosis and treatment.
This would facilitate early diagnosis, rational treatment, prevention of complications, drug resistance and reduce deaths due to TB.