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New expanded analytical instrument portfolio of medical devices for clinical diagnostic laboratories

Thermo Fisher Scientific

Thermo Scientific MD portfolio provides an extensive range of chromatography and mass spectrometry instruments for laboratory developed tests

6 Aug 2019
Charlie Carter
Life Sciences Editor

Industry news

Thermo Fisher Scientific has expanded its portfolio of analytical instruments for clinical diagnostic laboratories with the addition of three systems now listed as Class I medical devices with the United States Food and Drug Administration (U.S. FDA). The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory developed tests (LDTs).

Vanquish™ MD HPLC, TSQ Altis™ MD, and TSQ Quantis™ MD by Thermo Fisher Scientific

The Thermo Scientific Medical Device (MD) portfolio of liquid chromatography-mass spectrometry (LC-MS) systems now includes the single-channel Thermo Scientific Vanquish MD High Performance Liquid Chromatography (HPLC) system, the enhanced sensitivity of the Thermo Scientific TSQ Altis MD Series mass spectrometer, and the Thermo Scientific Quantis MD Series mass spectrometer for routine testing.

The new systems join the existing dual-channel Thermo Scientific Prelude MD HPLC and four-channel Thermo Scientific Prelude LX-4 MD HPLC systems to form a more complete MD portfolio of analytical solutions. These comprehensive platforms enable clinical laboratories to achieve their desired sensitivity and throughput goals, while conforming to in vitro diagnostic (IVD) regulations. The analytical solutions are designed to ensure confidence in laboratory developed tests (LDTs) through a complete suite of LDT-enabled software with a laboratory information system (LIS) option. In addition, the enhanced product portfolio is designed to increase throughput of clinical diagnostic assays for the detection of small to large molecules within complex biological matrices.

Thermo Fisher is showcasing the MD portfolio during the 71st American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2019), being held August 4–8, 2019, in Booth #2110 at the Anaheim Convention Center, Anaheim, California.

"Clinical laboratories need the ability to develop and optimize sensitive and reliable laboratory developed tests that are crucial in the diagnosis and monitoring of acute and chronic diseases," said Bradley Hart, senior director, clinical marketing, chromatography and mass spectrometry, Thermo Fisher Scientific. "With the new MD portfolio of Class I medical devices listed with the U.S. FDA, scientists in clinical diagnostic laboratories can now choose from a unique portfolio of liquid chromatography and mass spectrometry platforms to develop assays essential for clinical decision-making."

Designed to bring high-quality analytical performance for LDTs to clinical diagnostic laboratories, the TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers offer similar throughput for the analysis of human samples, but differ by sensitivity. The Vanquish MD HPLC system is the ideal chromatographic separations system for laboratories where analyte resolution is critical. The small, powerful single channel Vanquish MD HPLC instrument meets analytical needs, as well as space and resource limitations.

The MD portfolio is powered by Thermo Scientific TraceFinder LDT 1.0 Software. Included as standard, the software provides a workflow-oriented approach to high-throughput quantitation, including an administrator console for managing user-based permissions, data repositories, and auditing capabilities. In addition, an optional middleware solution is available to provide bidirectional communication between TraceFinder LDT Software and the LIS.

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TSQ Quantis™ MD Mass Spectrometer

Thermo Fisher Scientific

Achieve the sensitivity to perform routine quantitative analyses with remarkable speed and robustness. The Thermo Scientific™ TSQ Quantis™ MD Series mass spectrometer can be used by clinical diagnostic laboratories to meet their routine requirements for laboratory developed tests (LDTs). With Active Ion Management (AIM+) technology,the TSQ Quantis MD Series delivers confident quantitation for routine analyses of human specimens.

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TSQ Altis™ MD Mass Spectrometer

Thermo Fisher Scientific

Develop in vitro diagnostic tests for demanding quantitative analyses leveraging the enhanced sensitivity and remarkable speed and robustness of the Thermo Scientific™ TSQ Altis™ MD Series Mass Spectrometer. The TSQ Altis MD Series mass spectrometer, a Class I medical device, offers superb analytical performance and features the maximum usability, sensitivity and robustness required for laboratory developed tests (LDTs) from clinical diagnostic laboratories.

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Thermo Scientific™ Vanquish™ MD HPLC System

Thermo Fisher Scientific

Develop in vitro diagnostic tests with superior resolution. The Thermo Scientific™ Vanquish™ MD HPLC is the ideal chromatographic separations system for laboratories whose analyte resolution is more critical than sample throughput and batch turnaround time. The small, powerful single channel Vanquish MD HPLC meets analytical needs, as well as space and budget limitations.

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. AACCThe American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo is the largest meeting for clinical laboratory professionals in the world. This year's meeting is being held in Atlanta, USA, July 26th-30th, 2015.Clinical Mass SpectrometryMass spectrometry is emerging as a superior method of analysis over the longstanding, gold standard of immunoassay. Clinical mass spectrometry systems are increasingly accessible to medical laboratories and are capable of providing results with more speed and less expense than traditional methods. From simple mass spectrometers to IVDR class A compliant, highly sophisticated systems performing liquid chromatography tandem mass spectrometry (LC/MS/MS), find the latest product news, reviews and resources to make a purchasing decision for your laboratory. HPLCHigh-performance liquid chromatography (HPLC) is a technique for separating, identifying, and quantifying components in mixtures. It is widely used in chemical, pharmaceutical, and environmental analysis to ensure purity and identify unknown compounds. Explore the best HPLC systems in our peer-reviewed product directory; compare products, read reviews, and get pricing directly from manufacturers.

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