shutterstock_68827690_2It is already known to most that LC-MS, as a technology, offers several benefits for analysis (identification to confirmation to quantitation) of different analyte classes in complex biological matrices. These benefits include enhanced selectivity and specificity while adhering to the sensitivity, reproducibility, and reliability demands that are typically expected in an analytical laboratory. However, the question that looms large – is it true for everyone? Every laboratory? Every user?

Well, while some of you might be nodding your head in appreciation, others might highlight that most clinical diagnostic laboratories using LC-MS face some daunting challenges when it comes to development, optimization, and implementation of methods that are needed to meet the daily requirements of their laboratory-developed tests, which in turn enables them to better achieve their scientific and business goals.

Now, before you ask, I can already sense your question…(Did I say that I get about of clairvoyance every Friday afternoon?) WHY CAN’T THEY?

Clinical diagnostic laboratories have few options when it comes to LC-MS instruments that are in vitro diagnostic (IVD) compliant and can be used for the development and optimization of their existing and new LDTs. Not just in the variety of instruments, but the instruments that are available also lack specific performance capabilities, which in turn, impedes the process of getting quality data, over and over again. One might have an LC with sufficient separation efficiency, but it might lack speed or throughput capabilities that are needed for a clinical diagnostic lab. Similarly, a triple quadrupole MS might show sufficient sensitivity for a certain analyte in a particular matrix, however, does it perform in the same way, every time? Now assume you did manage to get an LC and an MS that does everything for you. Does that mean you can now sleep well at night? Nope…not happening…now you need a software that can control both instruments and ensure that you can acquire, monitor, review, analyze and report the data with equal confidence, every day.

Now…the clairvoyant me senses it again…those sarcastic looks….and the question that you may or may not ask…Aren’t you asking for a bit too much?

The new portfolio of Class I Medical Devices from Thermo Fisher Scientific aims to bridge these gaps and enable every clinical diagnostic laboratory to achieve their desired success with their LDTs. And, with these instruments, let’s discuss the bottom line of this particular blog post! The five reasons… every clinical lab can now be sure of the data they generate.

 

  1. Performance of the Triple Quadrupole Mass Spectrometer

The growing complexities of analytes and matrices demand mass spectrometers to demonstrate higher speed (for increased throughput), sufficient sensitivity for everyday routine assays, and enhanced sensitivity for more demanding tests. The new portfolio of Class I medical devices offers a choice of triple quadrupole MS with the Thermo ScientificTM TSQ AltisTM MD Series and the Thermo ScientificTM TSQ QuantisTM MD Series. While the TSQ Altis MD Series MS addresses critical sensitivity for challenging analytes, the TSQ Quantis MD Series MS enables achievement of sensitivity necessary for everyday routine clinical assays.

 

  1. Speed, Throughput and Efficiency

For most clinical diagnostic laboratories using LC-MS, LC separation time is longer than the MS detection time. Thus, having parallel LC channels, where you can run multiple tests simultaneously, maximizes the throughput potential of the MS and increases the productivity of the clinical diagnostic laboratory. The portfolio of Class I medical devices also offers the unique option of increasing throughput by leveraging a choice of: One LC channel (Thermo ScientificTM VanquishTM MD HPLC); Two LC channels (Thermo ScientificTM Prelude MDTM HPLC); or, Four LC channels (Thermo ScientificTM Prelude LX-4 MDTM HPLC). In addition to enhancing throughput capability, the Prelude MD HPLC saves hundreds of liters of solvent  – by design –  when compared to traditional HPLC.

 

  1. Comprehensive and Flexible Platform Options

Laboratories can now choose their optimal LC and MS combinations from an array of platforms that are supported by a complete software suite enabling confident results and data integrity. It would be so nice if we could see the ions flying through in real life. However, that is not the situation, and hence, software acts as the conduit ensuring communication between the user and LC-MS. Very often, we find ourselves in a situation where we are compelled to use and toggle between multiple software programs! Such situations not only add to the complexity of the process but also become time-consuming.  Thermo ScientificTM TraceFinderTM LDT software is an integral component of the mass spectrometer that provides a seamless approach to robust, reliable, high-throughput quantitation by automating and accelerating the processes of creating methods, loading samples, generating data, manually reviewing and editing results, and finalizing the data review and reporting process for our LC-MS medical device portfolio.

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  1. Connectivity

A middleware software solution that can facilitate bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS) is considered to be a must in today’s clinical laboratories. The B-Link® LIS/LIMS Connector allows us to have bi-directional communication between TraceFinder LDT software and the LIS or other middleware. But, does this mean that we need to have two different workstations for TraceFinder LDT and B-Link? No, both B-Link and TraceFinder LDT can reside on the same computer.

 

  1. Eliminating Costs/Increasing Productivity

The cost of the antibodies and associated reagents can make performing LDTs by immunoassay expensive. And the more tests performed, the greater the sum of the variable costs. In contrast, the more tests run on an LC-MS system, the lower the fixed cost/test. The question becomes how many tests can be run on an LC-MS system in a given time. The Class I IVD-compliant LC-MS instruments from Thermo Fisher Scientific offer the unique ability to not only conduct high throughput LC separation of samples, but also optimize the extent of high throughput MS analysis. The two-channel LCs in the Prelude MD HPLC or the four-channel LCs in the Prelude LX-4 MD HPLC offer the unique ability to significantly increase throughput capability by performing simultaneous experiments. So, for most LC-MS experiments, while the MS sits idle most of the time (while the LC is trying to do its job), multichannel LCs ensure maximization of MS potential.

 

Conclusion

Analytical results and their quality have an extremely high impact—from understanding the nature and type of disease to deciding the course of treatment. Hence, implementation of a completely new analytical approach to LDTs may not be easy for clinical diagnostic laboratories. Implementing LC-MS or transitioning to a new generation LC-MS system requires sufficient justification and commitment of resources, but can have a very positive impact on clinical and business goals. It is time to Be Sure of your LC-MS platforms for your LDTs— “With so much riding on something so small, why would you choose anything else?

 

Reference

  1. Listed with U.S. FDA

Find out more at thermofisher.com/BeSure.

In Vitro Diagnostic Medical Device.

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