NEW DELHI: These days, it’s common practice to test a patient suffering from a serious infection for antibiotic susceptibility. This helps doctors know how sensitive bacteria and fungi are to different antibiotics, and thus, decide on the medicines to administer. And, though there are many test kits available in the market, there is no uniform guideline to assess their capabilities.
Indian Council for Medical Research (ICMR), the country’s apex agency for health research, has, therefore, released protocols on testing and validation methods to be followed by companies before launching such test kits in the market. The new protocols mandate that validation should be carried out at a minimum of two different sites, representing the country’s geographic variations. The type of specimen used for validation must also be mentioned. “Isolates from sterile sites like blood or cerebro-spinal fluid are more clinically significant than those from non-sterile sites like urine or sputum, which may indicate colonisation,” the ICMR said in a document.
“This validation protocol lays out a comprehensive framework to systematically evaluate and confirm the diagnostic performance of a given test, ensuring its reliability and its utility for clinical decision-making,” the agency said.
According to the agency, the policy document prepared in consultation with the Central Drugs Standard Control Organisation (CDSCO) will also help innovators and developers understand the kind of evidence required to be generated before approaching the validating laboratory and prepare for the validation process.
Antimicrobial resistance or AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat.
