The 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.
Clinical and Laboratory Standards Institute (CLSI) has recently published Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline (C50-A) to provide accurate information and guidance for the appropriate use of MS in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of an MS system for its many applications.
The document includes:
• 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 goal of this guideline is to provide a 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.
This 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 as part of a partnership effort with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).