Technological advancements in Liquid Chromatography (LC) coupled to Mass Spectrometry (MS) technology, especially in the last decade, have opened several options to leverage this technology in the clinical diagnostic laboratory arena. Hence, from the analysis of acylcarnitines and amino acids in neonatal blood spots during the early 90s, LC-MS technology is now being used for other applications, such as endocrinology, toxicology, pharmacology, and therapeutic drug monitoring. However, it is still far from being considered as the “first choice” when it comes to deciding the technology for laboratory developed tests (LDTs).
The good part…or is it the good part?
LC-MS offers several benefits over traditionally used technologies. However, most clinical diagnostic laboratories that are using LC-MS in today's world face some daunting challenges from development, optimization, and implementation of methods to meet the daily requirements of their routine assays to achieving their scientific and business goals. Clinical diagnostic laboratories have very few options when it comes to instruments that are in vitro diagnostic (IVD) compliant and can be used for development and optimization of LDTs.
If an LC offered enough separation capability, it might lack the desired speed or throughput. Similarly, if a certain MS offered enough robustness, it might not deliver the desired sensitivity for every analyte.
In addition, the lack of comprehensive software for method development to report generation, and lack of connectivity to the preferred laboratory information management system (LIMS) can create some additional challenges. The new portfolio of Class I medical devices1 from Thermo Fisher Scientific aims to bridge these gaps and enable every clinical diagnostic laboratory to achieve their desired success with their LDTs. A lot can be said about this portfolio, however, its critical features and their benefits are summarized below in five concise points.


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