Dried blood spot sampling: Gain confidence in your diagnostic screening

In recent years, clinicians and researchers have become very enthusiastic about the potential applications of dried blood spot quantification by mass spectrometry. With the application already being used for a wide range of medical applications such as drug toxicology and anti-doping, there is a significant drive for its incorporation into clinical diagnostic screening workflows.

However, such a move is not without its challenges. Scientists and technical analysts alike have faced difficulties with ensuring the sensitivity, reproducibility, and overall accuracy of their workflows, and in a clinical setting these all form essential pillars for ensuring a result, and ultimately a diagnosis, is delivered with confidence.

Realizing these hurdles, Waters Corporation has developed the RenataDX™ Screening System, a fully integrated flow-injection tandem mass spectrometry (FIA-MS/MS) IVD system for high-throughput dried blood spot analysis that promises to deliver a robust and streamlined workflow. In this article, we explore the key elements of this screening system and how they come together to form an effective and dependable offering for a diagnostics lab.

Delivering results with confidence

Screening samples extends far beyond the walls of a diagnostics lab. When a scientist processes a sample and delivers a result, they are influencing the care of a patient. Waters developed the RenataDX™ Screening System with this principle in mind, designing the platform as a fully integrated bench-top system that is compatible with laboratory-developed tests (LDTs) and third-party reagent kits. The incorporated MassLynx™ (IVD) Software promises fully integrated data acquisition, processing and reporting through laboratory information management systems (LIMS), and even third-party middleware applications, such as Integrated Software Solutions' OMNI-Lab software.

Coupled with the data collection software, Waters also includes the IonLynx™ Application Manager, which is designed to ensure results are processed on time and has notable features such as user-definable rules that, if breached, trigger an automatically generated report on out-of-specification samples, and the ability to export data electronically to compatible LIMS systems.

Ensuring minimal downtime

Unscheduled downtime can be disastrous, not only does it prevent scientists from accomplishing their work, in a clinical setting it can create a domino effect of delay, extending waiting times and leaving patients without answers. Waters has created a service program with the RenataDX™ System to minimize disruptions in the lab. It guarantees that members of the Clinical Service Program* will receive a prioritized service including a two-hour response time to support calls and an on-site response within 48 hours.

System flexibility in an adaptable lab

The RenataDX™ Screening System has been built to offer the flexibility a clinical lab might require. Whether a lab is using a laboratory-developed test or a commercial reagent kit, the platform can be adapted to either, so it is not locked to a prescriptive workflow. The system can handle samples in microtiter, deep-well plates or vials and perhaps most importantly, users can tailor parameters such as sample injection volumes, wash settings and even add a further three trays to the traditional 12-plate configuration. Flexibility like this is key in clinical diagnostics to meet the volume of incoming samples during busy periods.

Additional resources

• For an example of the analytical performance of the RenataDX™ Screening System for the analysis of amino acids, free carnitines, and acylcarnitines in dried blood spot analysis, download this case study.

• Plus, in this video, you can watch a full technical overview of the fully integrated flow-injection tandem mass spectrometry (FIA-MS/MS) IVD system.

*When and where available on specific products. Response time is based on Waters’ standard five-day business week. Contact a local Waters office for availability.

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