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A three-point case for clinical labs to adopt LC-MS/MS technology

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:

  1. Quality from improved specificity
  2. Workflow efficiency
  3. Meeting market demand

Testing quality
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.

Workflow efficiency
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.

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Workflow transformed : the DxN VERIS fully automated system for molecular diagnostics in the EU

Delegates at EuroMedLab 2015, held in Paris 21st-25th June, attended the Beckman Coulter Molecular symposium ‘Workflow Transformed’.  Chairman Jacques Izopet (Toulouse) introduced the importance of molecular diagnostics in providing faster, reliable results, enabling improved patient management while saving laboratory time allowing redistribution of staff and resources for research and innovation.

Andrew Williams, (Nexus Global Solutions) explained how the company conducted a multi-site time/motion workflow analysis study comparing Beckman Coulter’s DxN VERIS Molecular Diagnostics System to existing batch and semi-automatic molecular diagnostic platforms.  During two 4-day studies conducted in Sheffield (UK) and Barcelona (Spain) in May 2015, the systems were run in tandem, and the study focused on key areas including time to result, hands on time, and maintenance requirements.  

Jordi Vila, (Barcelona) identified how his laboratory needed workflow improvements to reduce waste, increase efficiency, maximize use of personnel and equipment, and to reduce the potential for errors.   “Currently molecular diagnostics are undertaken on three platforms, with specific assays only run on certain days of the week,” Vila commented.  “DxN VERIS would take up less space in our cramped laboratory and allow up to 20 assays to be run at any time.   Batching would not be required as samples can be added as they arrive, and results are available as samples are running. This is a great advantage; using existing systems we have to wait until the end of the run.” 
“The VERIS simplified workflow, reduced the number of steps required from sample preparation to result from 29 to just 11,” Vila continued, “we also made savings in maintenance time and reagent/consumables. Assay reagents are stored on board for up to 14 days, and, as shown in figure 1, only four consumables are required, comparable systems need up to 20 or more.”  
 
“We reduced hands-on time for HIV-1 testing; DxN VERIS took approximately half the time to result against other systems.   We experienced workflow advantages via continuous loading; use of universal tube racks; true single sample random access; the ability to add urgent samples, and test multiple target viruses at any time.  We could save space with the need for only one instrument, together with more economical use of laboratory staff because no pipetting is required,” confirmed Vila.
 
Duncan Whittaker, (Sheffield, UK) explained that the study undertaken at his site involved comparison of DxN VERIS with three other systems. “Workloads within our department have increased by 57% in the last 3 years”, Whittaker reported. “Faced with this challenge, together with competition from other private and public laboratories and the loss of experienced staff, workflow improvements and efficient utilization of both staff and resources are key”.  

“Currently we use three systems, housed in different rooms, so a lot of staff time is spent moving from one instrument to another.  Complexity of use was studied and with these systems we found that 29 or 30 steps were required, but only 11 steps are needed with VERIS”, Whittaker continued (figure 2).

“When you combine this with the ease of use – it only took 20 minutes to train staff to use the equipment – and rapid time to result and the ability to run multiple targets on one system, we could offer significant benefits to clinicians, allowing them to deliver better patient management. Just to cite HBV as an example, we would normally do 3-4 extractions over a couple of days before batching on to the next system, so results would take several days. With VERIS we can offer same day results.”

“Feedback from renal transplant and renal dialysis departments has shown that the true single sample random access mode and rapid time to result would greatly benefit the way patients are seen and treated in clinics.  For example, with current systems, dialysis patients returning from abroad need to attend two hospital visits to confirm negative status, but with VERIS we could reduce this to one visit – an immediate benefit for the patient who may have had to travel many miles to get to us,” Whittaker concluded.

For further information about these studies, DxN VERIS Molecular Diagnostics System and the DxN VERIS assays currently available, please contact: Tiffany Page, Senior Pan European Marketing Manager Molecular Diagnostics,
Email: info@beckmanmolecular.com
or visit: www.beckmancoulter.com/moleculardiagnostics

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