CLSI Publishes New Molecular Methods Document on Interpretive Criteria for Identification of Bacteria and Fungi

Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute announces the publication of MM18—Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing. MM18 includes information on sequencing DNA targets of cultured isolates, provides a quantitative metric for perceiving microbial diversity, and can serve as the basis to identify microorganisms. By establishing interpretive criteria for microorganism identification by targeted DNA sequencing, this guideline provides structure to laboratories that identify microorganisms for medical use.

Cathy A. Petti, MD, Chairholder of MM18 said "Accurate identification of microorganisms has never been more important as we enter the era of precision medicine. Sequence-based identification informs the clinician about infections in terms of the what, gives clues about the where, and suggests the how. Additionally, sequence data are portable, enabling further insights about the pathogen in a wider global epidemiological context. The MM18 document is a critical tool for laboratorians using sequence-based methods and provides a comprehensive framework for accurate result reporting, thereby advancing the provision of care in infectious diseases."

MM18 provides information on:

• Selecting DNA targets and sizes for amplification and sequencing
• Establishing QC parameters for amplification and sequencing
• Measuring sequence quality
• Assessing reference sequences and databases
• Comparing sequences for identification
• Establishing interpretive criteria for identity scores generated by targeted DNA sequencing
• Developing clinically relevant reporting strategies for specific microorganism groups
• Identifying the limitations of targeted DNA sequencing for microbial identification

For more information about MM18, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.

For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.