Emerging Role of Mass Spectrometry on Clinical Setting: Critical Issues and Perspectives
Alessio Cortelazzo
Clinical Trial Manager | Director Diagnostic | Associate Professor in Clinical Biochemistry and Clinical Molecular Biology
Mini Review - Volume 7 Issue 1 - May 2018
Before Mass Spectrometry Finds Application in the Real Clinical Setting
Before the latter half of the 20th century, no translation into routine clinical practice of several molecules was achieved during MS-based biochemical research applications. Criticism was raised, especially regarding the reproducibility of the MS studies performed. The most widely criticized items in MS-based biomarker discovery studies were
a) The adoption of standardized operating procedures for pre-analytical and analytical items,
b) Poor study design,
c) Lack of multi-centric studies, and
d) Unreliable data evaluation and statistical analyses.
The lack of standardization, widely considered a relevant source of random and systematic errors, has been the basis for uncertainty of analytical results and poor comparability. The successful use of mass spectrometry for the discovery of clinically-relevant novel possible molecular biomarkers required a careful consideration of standardized operating procedures, for pre-analytical variables, including samples handling and storage.