The new protocol states that the verification must be carried out in at least two different locations and the type of sample used for the verification must also be mentioned.
Nowadays, it is common to test patients with serious infections for antibiotic sensitivity. This helps doctors find out how sensitive bacteria and fungi are to different antibiotics. And they are able to decide which medicine to give them. Although there are many test kits available in the market. But there are no uniform guidelines for assessing their capabilities.
The Indian Council of Medical Research (ICMR), the country’s apex agency for health research, has issued protocols on testing and validation methods to be adopted by companies before launching such test kits on the market. walk.
The new protocol requires verification to be carried out at at least two different sites. Which represent the geographical diversity of the country. The type of sample used for verification must also be mentioned.
The ICMR said in a paper that samples isolated from sterile places such as blood or cerebrospinal fluid are more clinically significant than samples isolated from non-sterile places such as urine or sputum, which which may indicate colonization.
This validation protocol provides a comprehensive framework for systematically evaluating and confirming the diagnostic performance of a given test. This ensures its reliability and usefulness for clinical decision-making.
Published on: January 20, 2025 6:45 PM (IST)