Integrating mass spectrometry testing into routine laboratory practice: Reflections from Keio University Hospital

• Mass spectrometry is gaining broader adoption in clinical laboratories despite requiring specialized expertise and resources
• Keio University Hospital is pioneering the use of mass spectrometry testing, changing how physicians approach evidence collection for clinical practice
• Barriers to the wider adoption of mass spectrometry in Japan are not without difficulty, but the long-term benefits outweigh initial hurdles

A highly precise and accurate analytical technique, mass spectrometry (MS) is widely recognized as an indispensable tool in laboratory testing. For a long time, however, MS was confined to a niche role, primarily available in specialized, tertiary, or research settings. Consequently, the advantages of mass spectrometry were not readily accessible to a broader range of clinical environments.

The field is now seeing an accelerated drive to integrate this sophisticated technology into routine clinical laboratory operations. Although this shift holds significant promise, it necessitates substantial investment in specialized knowledge and equipment. To understand how one facility is successfully navigating these requirements, we reached out to Dr. Terumichi Nakagawa, the Clinical Chemistry Lead at Keio University Hospital’s Clinical Laboratory.

Keio University Hospital’s Department of Clinical Laboratory Science is considered a tertiary laboratory with a daily sample load of 1,500 to 1,700 per day in an institution that has been serving the greater Tokyo metropolitan area for decades. The laboratory takes care of testing for several departments within the hospital with a wide testing menu.

Dr. Nakagawa spearheads the mass spectrometry testing program at Keio University Hospital, which was established in 2013. His initial interest in the technology was sparked by a lecture at Kyorin University, which focused on its vast potential, particularly in drug and toxicology screening. “I was impressed by the ability of mass spectrometry to look specifically at molecules to see a wide variety of substances,” he explained. This first exposure prompted his further research and the technology's wider implementation in clinical environments.

At Keio University Hospital, mass spectrometry has been leveraged to measure urinary steroid metabolites – a capability that reflects the precision and specificity of the technology. This particular diagnostic testing method was developed by the  Hospital’s very own Dr Keiko Honma, turning the hospital’s mass spectrometry capabilities into a national resource, with samples arriving from across Japan. Regrettably, this highly valuable diagnostic service has since been put on hold due to financial constraints.

Even so, the growing interest in mass spectrometry among physicians continues to drive conversations about the technology. “Doctors [..] have made many enquiries about mass spectrometry measurements,” noted Dr Nakagawa. Physicians are keen not only to understand how to better interpret results, but also to explore mass spectrometry’s potential in research collaborations with clinical labs.

Globally, the growing number of research papers demonstrating mass spectrometry’s value in clinical decision-making has amplified interest. “The increasing availability of mass spectrometry instruments,” Dr Nakagawa observed, “is also helping to lower the hurdles for their use in medical environments.” Dr Nakagawa expects that mass spectrometry will soon change how physicians approach evidence collection for their clinical practice.

Despite the clear potential of mass spectrometry (MS) in clinical settings and laboratories, its wider adoption is restricted by several significant challenges. Dr. Nakagawa identifies financial demands, specialized environmental needs, and the specifics of Japan's insurance system as the most critical barriers.

One of the foremost challenges is cost. Mass spectrometry equipment represents a significant investment due to its cutting-edge technology. This high upfront cost, combined with the inefficiency of processing large sample volumes, creates economic hurdles. “It takes a long time to recover the cost of the equipment, making it less appealing to laboratories with tight financial constraints,” Dr Nakagawa remarked.

Infrastructure is another key obstacle. Mass spectrometers operate with organic solvents, which require laboratories to have robust exhaust ventilation systems. Implementing the technology becomes logistically complex, especially for labs in older buildings that may not possess these capabilities.

Moreover, the lack of compatibility with Japan’s insurance reimbursement system adds another layer of difficulty. The insurance point system, designed to allocate testing costs, fails to accommodate many of the advanced functions where mass spectrometry excels, making cost recovery even harder. While initial costs are high, institutions should take into account the significant value these instruments can provide in the long term. It is important to view this investment not only in a financial sense, but also as a strategic involvement to support the future of diagnostic testing and overall healthcare for communities.

Recognizing these challenges, Dr Nakagawa believes the key to broader adoption of mass spectrometry lies in demystifying the technology and making it more user-friendly. “Mass spectrometry needs to shed its image as something that is only for experts,” he emphasized. Currently, many diagnostic technologies thrive because they are easy to operate and integrate smoothly into clinical workflows. Simplifying the interface and operation of mass spectrometry instruments will make the technology more approachable for non-specialists, similar to other emerging technologies in the market.

To convey the value of this diagnostic method to physicians, Dr Nakagawa sees it as being driven by three key factors: 

1. Its ability to rapidly adapt to a diversifying range of analytes
2. Its capacity to provide high-evidence-level test results through more specific measurements
3. Its capability to handle disease markers that are becoming more minute and difficult to measure

Mass spectrometry is thriving globally, and Dr Nakagawa believes Japan is on a similar path. The rising demand for higher precision and broader analytical range will make mass spectrometry an essential tool. “It is important to propose the use of mass spectrometry in appropriate situations and to recognise its unique value,” he advises. He envisions a future where healthcare professionals appreciate the distinctive capabilities of mass spectrometry testing and can confidently propose its use in appropriate clinical applications.

The journey to incorporating mass spectrometry testing into clinical laboratories is not without difficulty, but the rewards are undeniable. More than a tool for measurement, mass spectrometry is a gateway to higher precision, better evidence, and a transformative approach to medical diagnostics and better patient outcomes.

Keio University Hospital’s clinical laboratory is boldly taking steps towards this future, integrating mass spectrometry testing into routine clinical laboratory practices.

Revised and republished with permission from Lab Insights. Read the original article.