The Clinical and Laboratory Standards Institute (CLSI) has updated guidance on mass spectrometry in the clinical laboratory.
The US-based international organisation’s publication of Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance. Approved Guideline (C50-A) aims to provide accurate, state-of-the-art information and guidance for appropriate use of MS in the clinical laboratory.
The CLSI says development of more user-friendly, affordable and versatile mass spectrometers, as well as the availability of stable isotopes that serve as internal standards to facilitate more accurate quantification, has allowed a large increase in the use of mass spectrometry (MS) for clinical applications.
The document includes guidance, references and quality assurance markers aimed at assisting with implementation and correct operation of an MS system for its many applications.
The document covers:
- Information on maintaining optimum performance.
- Approaches to ensuring accurate and precise mass measurement.
- Verification of methods.
- Quality control of assays within and between instruments.
- Instrument troubleshooting.
- Sample preparation.
- Interpretation of results.
- Limitations of the technology.
The stated goal of this guideline is to provide basic understanding of the technology and how it should be used in the clinical laboratory with an emphasis on:
- Advantages and disadvantages.
- Precautions required in its use.
- Quality-control awareness.
- Assay verification/validation.
- Approaches to reporting results.
- Communication of the data.
The document is intended to be a basic resource for clinical chemists, health practitioners, instrument manufacturers, regulatory agencies and those responsible for developing standards, implementing policy and teaching.
The new, approved guideline was developed by CLSI in partnership with the International Federation of Clinical Chemistry and Laboratory Medicine.
CLSI, formerly NCCLS, is a global, nonprofit, membership-based organisation dedicated to developing standards and guidelines for the healthcare and medical testing community.