Liquid chromatography-mass spectrometry (LC-MS/MS) is one of the most promising diagnostic technologies in the in-vitro diagnostics industry, but it is not yet widely adopted by mainstream laboratories. An estimated five percent of LC-MS/MS instruments reside in truly clinical diagnostic settings while the majority are deployed in research and reference laboratories.
by Dr Bori Shushan
There are three compelling reasons for clinical labs to incorporate LC-MS/MS solutions into their routine operations:
- Quality from improved specificity
- Workflow efficiency
- Meeting market demand
Direct measurement technology is more specific and can address the limitations inherent to immunoassay testing. In particular, for small-molecule analyte testing, immunoassay results can be elevated due to the presence of metabolites from other drugs with core structures that are similar to the targeted analyte.
As LC-MS/MS solutions are typically found in specialty laboratories, most clinical labs must outsource certain tests. Transporting samples adds complexity, cost, and time to the testing process. In drugs of abuse testing for example, patients are initially screened using immunoassay and then confirmed using LC-MS/MS. Having this capability within the laboratory can provide quick turnaround times for faster diagnosis and treatment for patients. LC-MS/MS methods can also test for multiple analytes simultaneously where immunoassay methods require a separate test for each analyte.
Meeting market demand
The market demand that LC-MS/MS addresses arises from trends such as the growing use of opiates and increasingly more stringent regulations. On-site LC-MS/MS testing can deliver both qualitative and quantitative accuracy and precision to help clinicians understand the actual consumption of abused and or prescription drugs.
While the reasons for adopting LC-MS/MS are compelling, there are logistical and regulatory barriers to entry rooted in the current state of LC-MS/MS automation. LC-MS/MS processes are automated to some degree, but the entire process must be improved. Workflows still require many manual steps, including sample preparation and data entry into LIMS systems. This takes labour and time and can lead to errors, all of which are unacceptable to regulatory bodies and laboratory managers. The industry recognizes that innovative solutions are required to address these analytical challenges; however, only when LC-MS/MS achieves the rigorous engineering and quality developments required for regulatory approval will more labs be allowed to adopt this gold standard technology and make a meaningful advancement in diagnostic testing.