CLSI Publishes new Approved Guideline for use of Mass Spectrometry in the Clinical Laboratory

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