What century-old technique is revolutionizing clinical laboratories worldwide? Yes, we’re talking about mass spectrometry. In the last two decades alone, mass spectrometry (MS) has grown from being a large, expensive, and highly complex platform that is restricted to academics, to an indispensable tool for routine clinical chemistry testing.

This rapid advancement is largely due to the advent of electrospray ionization (ESI) and matrix-assisted laser desorption ionization (MALDI), for which a joint Nobel Prize was awarded in 2002. This allowed coupling of mass spectrometry to liquid chromatography. These improvements have expanded the limited scope of application for this technology from drugs of abuse confirmation and newborn screening to microbiology, anatomic pathology, pharmacogenetics, immunology, endocrinology, metabolomics, proteomics, and more.

With significantly broadened applications and reduced instrument size and cost, MS has become a very attractive testing platform for clinical laboratories. However, it remains a high-complexity test that requires many considerations before implementation.

In Monday morning’s session “Building New or Adding On: Fundamentals for Overcoming Challenges in Operationalizing Clinical Mass Spectrometry,” Deborah French, PhD, discussed the fundamental principles and major applications of clinical liquid chromatography and mass spectrometry. It is important to recognize that there are many different types of liquid chromatography techniques and mass spectrometers that may be used for a variety of applications, French noted. French discussed the most commonly used combination of these to provide optimum sensitivity and specificity for the desired analysis. Measurement of total testosterone was used as an example to describe the development and validation process. Fortunately, help is available to new users through published methods, CLSI documents, and of course colleagues. “You can call us, we will be nice to you,” French said.

Shannon Haymond, PhD, described ways to facilitate operational quality and sustainability. She discussed staff skill requirements and offered guidance on the development of training and competency plans. Often, the most difficult aspect of the implementation process is finding or training qualified staff, Haymond noted. Successful implementation of any clinical MS program relies on successful training and retention of testing personnel.

Haymond shared experiences from her own clinical laboratory. She has developed CLSI GP21-A3 compliant extensive training checklists for LC-MS/MS, published by Clinical Laboratory News and available from www.aacc.org. There are also a number of training resources available through national conferences and mass spec vendors, Haymond said. But thanks to her efforts, directors and managers of mass spec labs now have access to CLSI-compliant training checklists to make their lives easier. “I know it’s overwhelming to think about transitioning everything over to the new CLSI format, but I urge you to start somewhere and use these templates to move forward,” Haymond said.

Both speakers highlighted the enormous potential of this technology and how they rely on it everyday for generating high-quality patient results. This was further supported by the overflowing number of attendees to this session, of which 79% reported (using an automated polling system) that they currently use this technology. Fortunately, an overflow room was setup nearby to accommodate all attendees, with moderator Yan Victoria Zhang, PhD, taking questions from that room via text messages. Mass spec is going strong: Is your lab ready to embrace it?