Editorial Article: Clinical diagnostics: Empowering laboratory testing with ‘less intimidating’ mass spectrometry

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Dr. Yan Victoria Zhang, Associate Professor at the University of Rochester Medical Centre

In this SelectScience^® interview, we speak with Dr. Victoria Zhang, Associate Professor at the University of Rochester Medical Centre, as she shares her vision of enhancing clinical diagnostics and reveals how mass spectrometry is helping to achieve her goals. Zhang also discusses how her collaboration with Thermo Fisher Scientific supported her expert team to evaluate new devices to potentially overcome common mass spec challenges, including their experience with the installation and evaluation of the Thermo Scientific^TM Cascadion^TM SM Clinical Analyzer. Looking ahead, Zhang outlines her hopes for the future of therapeutic drug monitoring (TDM) management — the clinical practice of measuring drugs to optimize individual dosage regimens to ensure effectiveness and safety — and explains how her research could impact patient wellbeing. 

SS: Please tell us a bit about your role

VZ: I am an associate professor at the University of Rochester Medical Centre, and I'm the director of the clinical chemistry division. The division currently covers clinical chemistry services, clinical mass spectrometry and toxicology lab, and point of care services. About four years ago, I was asked to take on a vice-chair position in the department for the clinical enterprise strategy to build laboratory services for our entire six-hospital medical system. 

SS: What are the big-picture goals of your current research?

VZ: Overall, my research goal is to enhance clinical diagnostics through advanced technologies and translational science. Another academic passion is to improve laboratory quality globally and particularly for developing countries. I have been the chair for AACC Global Lab Quality Initiative Asian Pacific region and developed workshops to help laboratories in this region improve the quality of their laboratory services. I have also been actively involved in serology studies during this pandemic. I was the chair of the AACC Task Force for SARS-CoV-2 serology testing. We have a paper published for practical recommendations for implementing and interpreting SARS CoV-2 serology testing in clinical laboratories, which was available online in March and will be in print in September in Clinical Chemistry.
I have spent most of my research efforts exploring mass spectrometry and its applications in clinical diagnostics. I have devoted a significant amount of academic time to look into these challenges and tried to develop a community for solutions to these challenges.

SS: What challenges are you currently facing?

VZ: For mass spec, there are certainly a lot of challenges. The first challenge is well-trained people. How do we get people qualified and competent at using mass spec? In my lab, we are experiencing severe staff shortages for the whole department, and I think there is a national shortage of medical technologists. Secondly, if we can hire somebody, how do we train them? Mass spec is unique, manual and labor-intensive and requires a high level of competency to run the instrument and troubleshoot. Medical technologist training programs rarely teach mass spec beyond a lecture or two. 
In addition, a clinical mass spectrometry lab requires people at different competency levels including bench level, troubleshooting experts and assay development level. Each level requires additional training and experience which are not readily available. The laboratory-developed tests also added another layer of challenges to implement the assays in-house and this challenge is related to the shortage of high-level staff for assay development. 

SS: How do you think the Cascadion SM Clinical Analyzer might help overcome these challenges?

VZ: The Cascadion SM Clinical Analyzer is a very exciting new platform that I was recently introduced to. We’re currently evaluating the Cascadion SM Clinical Analyzer’s performance. Given our experience so far, the installation is very straightforward, and it appears less intimidating to the staff and even people with very limited experience. We are gathering more information as we speak. I am hopeful that the Cascadion SM Clinical Analyzer, and automated mass spec in general, will help us overcome the staffing challenge and the requirements for training. 

SS: What improvements could you envisage in TDM management?

VZ: Therapeutic drug monitoring can be measured or monitored in two ways, generally speaking. One way is using an immunoassay which is typically implemented on automated analyzers, and the other way is on mass spec, such as a liquid chromatography-tandem mass spec. Tandem mass spec is the only tool that is available to analyze certain drugs. Mass spectrometry plays a significant role in supporting TDM management in the clinical setting. 
As I mentioned, one of the challenges for mass spectrometry is its manual and labor-intensive process, so people are becoming interested in automation. I and a colleague who has now retired worked together on a paper in 2015 to discuss some potential models for automated clinical mass spectrometry. At that time, we proposed two models: one was a standalone model, and the other was an integrated model. It is interesting to see that the Cascadion SM Clinical Analyzer from Thermo Fisher Scientific is essentially a standalone automated mass spec, as outlined in that paper. 
I think the automation of mass spectrometry platforms will improve TDM services. However, we are still at the stage of exploring its full utility and efficiency, with limited laboratories adopting this technology. As we have more experience with the technology, we will learn more about its advantages and limitations in clinical laboratories. What we learned will not only impact TDM, but also other services in clinical mass spectrometry in general.  

SS: If you had to summarize, what are the key standout features of the Cascadion SM Clinical Analyzer?

VZ: One of the standout features is that it is less intimidating. It really looks like an automated analyzer. I think this helps people get over a very big psychological hurdle when they first use a mass spec. Another feature is its ease of use. We have people with limited to no mass spectrometry experience to get trained on the instrument. People feel like they can get comfortable with the first round of training and are confident to use the instrument by the end of their training. 

SS: What impact do you hope your research/work will have in the future?

VZ: I hope my work in clinical mass spec can make a difference in the rapidly growing and changing world of clinical diagnostics, to help us improve technology and practices to help address patients’ needs in the most effective and efficient way. I hope my efforts in the Global Lab Quality Initiative help improve laboratory quality in developing countries. I also hope my involvements in the current SARS-CoV-2 serology studies help our community get through this pandemic.

Thermo Fisher Scientific products are distributed globally so uses, applications, and availability of product in each country depend on local regulatory marketing authorization status.