Stop TB Partnership

Stop TB Partnership welcomes India’s ruling on serological tests


19 June 2012 - Geneva - In a welcome development, the central government of India has prohibited the manufacture for sale, distribution and use of serodiagnostic test kits for diagnosis of tuberculosis (TB).

In its official notification, the Ministry of Health and Family Welfare declares that these tests "are giving inconsistent and imprecise results, leading to wrong diagnosis."

"This is a significant victory for the TB world and for those of us who have been fighting so hard for it. It now needs strict implementation across the country to check this practice among doctors who prescribe and labs which conduct this test. At the same time it is equally important to increase access to accurate culture DST for DR-TB in the public sector.” said Blessina Kumar, Vice Chair of the Stop TB Partnership Coordinating Board and a TB/HIV activist based in India.

India’s decision is consistent with recent conclusions by the World Health Organization (WHO), which in 2011 issued a policy statement that notes: "Commercial serological tests provide inconsistent and imprecise findings resulting in highly variable values for sensitivity and specificity. 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."