Testing for microbial pathogens in healthcare is an essential tool in the fight against diseases, used for everything from diagnosis of diseases to drug resistance, virulence and more.
One of the most common types of test for identifying and understanding microbial pathogens in healthcare is the nucleic acid amplification test (NAAT). Accuracy and reliability of such tests is, in some cases, a matter of life and death for both patients and laboratory professionals. It is a highly regulated area and, while the types of tests abound, laboratories often need to develop their own methods to meet their own specific needs.
ISO 17822, In vitro diagnostic test systems – Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens – Laboratory quality practice guide, details quality practices for the design, validation and verification of methods needed for testing microbial pathogens in human samples.
David Sterry, Manager of the committee that developed the standard, said quality procedures for quality testing is paramount.
“What’s more, studies have shown that the use of regulatory body-approved tests or test systems that were developed and manufactured in accordance with quality standards and the current European IVD Directive often help reduce the variability in test results,” he said.
“This standard provides guidance and recommended best practices to laboratories that not only help them demonstrate conformity to the many regulatory requirements, but also ensure better results for improved patient outcomes.”
ISO 17822 was developed by ISO technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, whose secretariat is held by ANSI, ISO’s member for the USA. It can be purchased from your national ISO member or the ISO Store.