ISO/PWI 26861

Biotechnology — Analytical methods — Development of reference spectra for microbial species identification by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS)

Apstrakt

This document describes general requirement and considerations for the use of Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) technology in laboratories for the development of reference spectra for the identification of microbial species. The document covers general principles of positive and negative ion mass spectrometry and their application to the identification of microorganisms.
It specifies methods for establishing new reference spectra including choice of specimen, culture media, protein extraction, replicates and quality attributes of spectra. It also covers a quality management approach for MALDI-TOF MS instrument use, covering verification and validation of method, calibration, internal quality control, change control and external quality assessment. The intended users are research and industrial laboratories using MALDI-TOF MS and developing reference spectra, including those in pharmaceutical, environmental monitoring, biobanking, and hospital research settings.
The analysis methods in food microbiology and in human and veterinary diagnostics are not in the scope of this standard.