September 3, 2008
New CLSI Guideline Addresses Quality Control for Commercial Microbial Identification Systems
Microbial identification systems (MISs) are test systems that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, molds, or yeast-like algae grown from culture. MISs have become increasingly complex, which has resulted in the need for a greater number of quality control (QC) organisms to check positive and negative reactivity for all components. In 2005, the American Society for Microbiology (ASM), at the suggestion of the Clinical Laboratory Improvement Advisory Committee (CLIAC), conducted a microbiology laboratory survey to determine the QC failure rates of commercial MISs in a random selection of laboratories that perform bacterial and fungal identification from culture. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed.
As a result, Clinical and Laboratory Standards Institute (CLSI) used its consensus process to develop Quality Control for Commercial Microbial Identification Systems; Approved Guideline (M50-A). This includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of 1988 regulations.
The document specifies the QC responsibilities of the manufacturer, distributor, and user, and identifies conditions under which an MIS with proven reliability can qualify for streamlined QC testing.
For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100.
CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.