The prospects of clinical mass spectrometry: A case study from Singapore General Hospital

Traditionally used by scientists for research purposes, mass spectrometry is gaining popularity within healthcare organizations looking to incorporate this advanced technology into the clinical laboratory. Mass spectrometry has evolved from its first utilization for newborn screening to therapeutic drug monitoring, toxicology, clinical endocrinology, biochemical screening for genetic disorders, and analysis of proteins and peptides. Reports show that the global clinical mass spectrometry market is expected to grow to an estimated market size of US$ 1.2 billion by 2027, up from US$ 697.2 million in 2019.¹

At Roche Experience Days (RED) 2023, Ms. Jayme Wong, Senior Principal Medical Laboratory Scientist, Singapore General Hospital (SGH), provided an overview of the opportunities and barriers of implementing clinical mass spectrometry. She discussed how SGH initiated and integrated clinical mass spectrometry services into their existing infrastructure and offered insights into the future trends and advances in the sector.

While there are several mass spectrometry techniques that the clinical laboratory can leverage, liquid chromatography with tandem mass spectrometry (LC-MS/MS) is a commonly used approach. This analytical tool combines chromatographic separation of a sample’s components with the detection by mass spectrometry, which then creates, separates, and detects charged ions based on mass/charge ratio.²

Within clinical services, Ms. Wong discussed the tremendous opportunities for LC-MS/MS and the advantages over traditional methods, such as immunoassays. The analytical benefits include:

• Analytical specificity: identifying and quantifying compounds with reduced risk of interference from similar compounds

• Analytical sensitivity: detecting compounds at picogram or nanogram levels per milliliter and at low abundance in complex samples

“Although LC-MS/MS offers exceptional technical performance compared to traditional assays. Its adoption and success require very careful consideration of some factors for everyday use,” said Ms. Wong.

In 2022, the Clinical Biochemistry Laboratory at SGH analyzed 12.3 million tests, equivalent to 2.4 million specimens, according to Ms. Wong. The wide repertoire of tests offered at SGH includes routine tests for renal, liver, cardiac, bone, and respiratory functions and specialized tests for endocrine hormones, tumor markers, special proteins, biogenic amines, trace metals, therapeutic drugs, vitamins, and calculi. Automated chemistry and immunoassay platforms are among the available analytical instrumentation used in the laboratory, as are other specialized platforms, including LC-MS/MS.

In 2007, SGH achieved a significant milestone by installing its inaugural clinical LC-MS/MS system, with an additional two systems being introduced in 2013. Over a span of 16 years, SGH Clinical Biochemistry laboratory has continually maintained and expanded its clinical mass spectrometry services, introducing new assays to its repertoire.

Implementing clinical mass spectrometry can be daunting and often comes with many unseen challenges. Ms. Wong offered an overview of essential considerations that lab leaders should ponder before embarking on the journey. Considerations include:

• Initial investment costs for equipment and infrastructure setup

• Ongoing costs for training, reagents and consumables, maintenance and technical support

• Availability of good local vendor support 

• Available space and infrastructural support

• Health and environmental considerations

• Workflow optimization catering to clinical and operational needs

• Necessity of ongoing regular maintenance

• Assay requirements (assay development vs ready IVD assay kits)

• Expertise and training

• Compliance with accreditation and regulatory requirements 

   

To navigate through these challenges, lab leaders can leverage several strategies:

• Utilizing validated IVD kits and agency guidance documents for regulatory compliance

• Simplifying workflows and continual training of staff

• Employing dedicated technologists and protocols for troubleshooting

• Maintaining backup instruments to address unexpected malfunctions

• Conducting preventative maintenance on weekends to maximize operational uptime and enhance test turnaround times.

   

Along with the above strategies, Ms. Wong also shared other areas of improvements pursued by the laboratory, including technology upgrades, method and result reporting enhancements, automation of specimen preparation, education initiatives, and enhanced service contracts with the mass spectrometry vendor. Ms. Wong highlighted that gaining support from senior management staff and clinical stakeholders is crucial for the successful implementation of clinical mass spectrometry.

Upcoming trends and necessities that could facilitate the integration of mass spectrometry into routine clinical practice were discussed in the presentation.

To advance LC-MS/MS in clinical laboratories, improvements in hardware, development of robust IVD assays or test applications, and the introduction of IVD grade LC-MS/MS systems are essential, along with necessary enhancements in IT and greater acknowledgment and support from mass spectrometry vendors for clinical diagnostics.

To close, Ms. Wong highlighted advancing trends and transformations which include advancements in miniaturization and microfluidic technologies, possible future integration of LC-MS/MS systems with automation platforms or tracks, adaptation of LC-MS/MS for multiplexing and use of mass spectrometry at the point of care setting for tissue diagnostics in the operating room.

Ms. Wong concludes by noting, “The future of mass spectrometry and lab medicine depends on the collective and collaborative efforts of the scientific and clinical community and the industry partners to advocate its importance in patient-centered diagnosis.” 

If you want to hear more from Ms. Wong on the successful integration of clinical mass spectrometry, click here to watch her full presentation at RED 2023.