Despite significant improvements in immunoassay designs which has reduced interferences, mass spectrometry is very useful in clinical laboratories. Specifically, mass spectrometry benefits can be noted in academic medical centers and large reference laboratories for two major reasons:
- Immunoassays for cyclosporine, tacrolimus, sirolimus and mycophenolic acid are subjected to significant interferences from drug metabolites.
2. Immunoassays are not available for some clinically significant analytes, for example, certain steroids, less frequently monitored therapeutic drugs, and confirmation of positive drug screens.
Currently, all tests using mass spectrometry are lab developed tests and face challenges from recently implemented FDA regulations as well as difficulties in standardization. Moreover, errors are introduced during preparation of lab made standards and controls. These problems can be circumvented by implementing automated mass spectrometry in clinical laboratories. There is no such system at present. Semi-automated mass spectrometry systems are available for immunosuppressants. In these cases, companies provide reagents, calibrators, controls, etc. for analysis thus reducing sources of error. However, totally automated systems are expected to hit the clinical laboratory market in 2026. Because of lack of knowledge in mass spectrometry among many practicing medical laboratory scientists, there is a perception that only specially trained laboratory professionals can operate mass spectrometry instrumentation. However, with semi-automated and future development of fully automated mass spectrometry, any trained professional can operate such analyzers. This will be a paradigm shift in clinical laboratories. In this session, we will educate participants about principles of mass spectrometry, the methodology nuances of mass spectrometry analysis, and how the available semi-automated systems work. We will also provide publicly available information about future-forward, automated mass spectrometry to the audience. Further, this session will review operational and budget considerations related to integration of automated mass spectrometry solutions within the laboratory.
Faculty/Authors
Amitava Dasgupta, PhD
MelodyBoudreaux Nelson, DCLS, CC(NRCC), MS, MLS(ASCP)cm
Physician Competencies: Medical knowledge, patient care, practice-based learning
CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Educational Activity
Accreditation Statement: The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME).
Credit Designation Statement: The American Society for Clinical Pathology (ASCP) designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Instructions
To claim CME/CMLE credit for the exercise, do the following:
- Review the Technical Considerations.
- Review the Faculty Disclosures.
- Click Go to Course to view an overview of the modules in this course.
- Click Access to begin the course.
- Submit the course Evaluation.
- Enter the maximum number of credits offered and click Claim CME to register credit.
Faculty Disclosure
Technical Considerations
Release Date: 09/06/2024
Review Date:
Expiration Date: 03/06/2025