Shimadzu MSACL Wednesday Corporate Workshop 

Implementation of a fully integrated automated sample preparation system for routine clinical LC-MS/MS analysis

Lack of availability of a fully automated LC-MS/MS system has been one of the largest barriers to meaningful adoption of mass spectrometry in the routine clinical laboratory. Our laboratory evaluated the workflow attributes and analytical performance characteristics of the Clinical Laboratory Automation Module 2000 (CLAM-2000) integrated with the Prominence LCMS-8050 platform for routine analysis of total 25-OH Vitamin D (25-OHD). This instrument configuration enabled complete integration of automated sample preparation with LCMS analysis during the validation study. The method validation included patient samples obtained from our academic medical center and was performed according to Clinical and Laboratory Standards Institute (CLSI) guidelines.  The CLAM-2000 Prominence LCMS-8050 method was linear from 2ng/mL- 150 ng/mL for 25-OH D3, 3-epi 25-OH D3 and 25-OH D2. Precision was excellent with coefficients of variation < 6%. The method agreed with our validated manual LCMS method, however the CLAM-2000 Prominence LCMS-8050 system had the additional advantage of resolving the 3-epimer of 25-OH Vitamin D3. Trueness was confirmed using NIST 972a Vitamin D reference materials. In addition, the integrated CLAM-2000 Prominence LCMS-8050 system allowed complete automation from aspiration of the sample from the primary specimen collection tube to end result. Use of the system reduced labor requirements, improved workflow efficiency and enabled significant time savings for routine LC-MS/MS testing in the clinical laboratory.

Lorin Bachmann, PhD, DABCC

Associate Professor of Pathology

Co-Director of Clinical Chemistry

Virginia Commonwealth University