Govt sets accuracy norms for TB, dengue diagnostic kits

The government has for the first time introduced India-specific performance standards for diagnostic laboratories in order to improve the accuracy, consistency and reliability of test results and bolster patient confidence in the healthcare system, according to officials familiar with the matter and documents reviewed by Mint.

- Priyanka Sharma

Developed jointly by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO), the uniform standards apply to in-vitro diagnostic (IVD) kits used to test 39 critical diseases such as dengue, tuberculosis, malaria, chikungunya, Zika virus, Nipah virus, and several respiratory infections.

“These protocols will bring uniformity to the IVD sector in India, ensuring that the test kits used are of the highest quality and safety. The new guidelines will also provide a transparent process for manu-