Five reasons to implement LC-MS platforms for your laboratory developed tests

Importance of the Topic

Liquid chromatography–mass spectrometry (LC-MS) has evolved into a cornerstone technology for laboratory-developed tests (LDTs) in clinical diagnostics, offering unmatched specificity, sensitivity and multi-analyte capability. As clinical needs expand across endocrinology, toxicology, pharmacology and therapeutic drug monitoring, robust LC-MS workflows are essential for delivering fast, accurate and reliable results.

Objectives and Article Overview

This article outlines five key reasons to implement Class I IVD-compliant LC-MS platforms for LDTs. It reviews enhancements in analytical performance, throughput, platform flexibility, data connectivity and cost efficiency, demonstrating how modern LC-MS solutions address the main challenges faced by diagnostic laboratories.

Methodology and Instrumentation

The approach centers on combining ultra-high-performance liquid chromatography (UHPLC) with triple quadrupole mass spectrometry in selected reaction monitoring (SRM) mode. Method development and routine operation are streamlined by integrated software that automates method creation, sample loading, data acquisition, review and reporting. Middleware options enable seamless bidirectional communication with laboratory information systems (LIS/LIMS), ensuring traceability and data integrity in a regulated environment.

Used Instrumentation

• Thermo Scientific™ Vanquish™ UHPLC system for high-resolution separations
• Thermo Scientific™ TSQ Altis™ MD Series triple quadrupole MS for ultra-sensitive analyses
• Thermo Scientific™ TSQ Quantis™ MD Series triple quadrupole MS for high-throughput assays
• Thermo Scientific™ TraceFinder™ LDT software for end-to-end quantitation workflows
• B-Link® LIS/LIMS Connector for bidirectional data exchange

Main Findings and Discussion

1. Enhanced specificity and selectivity over immunoassays enable confident quantitation in complex matrices.
2. Throughput is maximized with up to 30,000 SRMs definable and acquisition speeds of 600 SRMs/sec.
3. A comprehensive instrument portfolio allows laboratories to match sensitivity and productivity to specific assay requirements.
4. Integrated software and middleware ensure efficient method development, data review and regulatory compliance.
5. Fixed costs per test decrease as sample volumes increase, improving overall laboratory productivity.

Benefits and Practical Applications

Implementation of these LC-MS platforms supports a wide range of clinical assays— from newborn screening to therapeutic drug monitoring— delivering rapid turnaround, high data quality and scalable workflows. The reduction in per-test costs and increased automation align with both scientific and business objectives.

Future Trends and Opportunities

• Integration of artificial intelligence and machine learning for automated method optimization and anomaly detection
• Further miniaturization and microflow LC to reduce solvent consumption and enhance sensitivity
• Expanded cloud-based LIMS connectivity for real-time data sharing and remote monitoring
• Development of multiplexed assays covering broader analyte panels in a single run

Conclusion

Adopting IVD-compliant LC-MS systems for laboratory-developed tests demands initial investment and validation effort, but yields significant gains in analytical performance, workflow efficiency and cost control. Modern platforms and software solutions simplify implementation and pave the way for advanced diagnostic capabilities.

References

• Listed with U.S. FDA