ICMR has issued new protocols for testing antibiotics, know what is the guideline?

The new protocol states that verification should be done at at least two different locations and the type of sample used for verification should also be mentioned.

These days, it is common to test the antibiotic sensitivity of patients suffering from serious infections. 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 to assess 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 testing kits in the market.

The new protocol mandates that verification should be done at at least two different sites. Which represent the geographical diversity of the country. The type of sample used for verification should also be mentioned.

ICMR said in a document that samples isolated from sterile locations such as blood or cerebrospinal fluid are more clinically significant than samples isolated from non-sterile locations such as urine or sputum which may indicate colonization.

This validation protocol forms a comprehensive framework to systematically evaluate and confirm the diagnostic performance of a given test. Thereby ensuring its reliability and usefulness for clinical decision making.