The use of
liquid chromatography-
tandem mass spectrometry (
LC-MS/MS) in
clinical laboratories is increasing and is likely to expand into even more clinical venues in the
future.
Mass spectrometry is the standard
method for analyte identification in the
clinical chemistry field; however, differences in
mass spectrometry protocols and handling
affect the accuracy and reliability of these tests and prevent direct comparisons of results between
laboratories. For example, the results of
laboratories using
LC-MS/MS
methods are less likely to be reproducible than those of
laboratories using conventional, automated
methods. This is due to inadequate handling of the
equipment and/or poor
quality control after the implementation of the
method, which may result in unnecessary medical
expenditures or even adverse outcomes for the
patients. Unfortunately, guidelines to monitor the accuracy of
LC-MS/MS-based clinical tests are still lacking. In general, the
quality control methods used in conventional clinical tests could also be applied to
LC-MS/MS. However, additional
quality control methods specific to
LC-MS/MS
techniques must be continuously employed to maintain the same quality level achieved during
method development and verification. This
report is intended to help
clinical laboratories that operate
LC-MS/MS improve the accuracy and reliability of their testing by providing guidance for
quality assurance and improvement, based on a collection of existing guidelines and
expert opinions from the
literature.