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Overview
Experience versatility and accuracy from our LC-MS systems for in vitro diagnostic (IVD) tests and Laboratory Developed Tests (LDTs), which offers clinical diagnostic laboratories a unique choice to address sensitivity needs. Discover mass spectrometry solutions, comprehensive data management, connectivity, and support to help you address any molecule type or matrix complexity with absolute confidence. Our family of LC-MS/MS instruments for in vitro diagnostics deliver greater speed, specificity, and analyte range, along with lower cost per sample.
Benefits
Benefits of LC-MS for in vitro diagnostic use
Superior specificity, selectivity, sensitivity
Compared to traditional immunoassays, LC-MS enables accurate results, reducing false positives and negatives.
Speed and high throughput capability
Meet analytical needs and budget limitations with the throughput, speed, and sample capacity to boost workflow productivity for laboratory developed tests where analyte resolution is critical.
Comprehensive and flexible
Simultaneous detection of multiple analytes in the same run. Flexible options to meet sensitivity and throughput needs.
Cost Savings and increased productivity
Because the fixed cost of tests decreases when more tests are run, ultra-fast selected reaction monitoring enables detection and quantitation of increased number of analytes, without increasing run times.
Why Choose IVD systems?
Maintain compliance
Hardware manufactured following ISO 13485 and FDA 21 CFR 820; dedicated LDT software for clinical workflow and auditing capability.
Stay up-to-date on regulatory trends
Global clinical diagnostics market trending towards LC-MS devices conforming to FDA and EU regulations to perform LDTs and IVDs.
Control risk
Intensive validation and verification process, MD certified engineer for service, quality tracking in place to ensure the highest performance of instrument.
Benefit from bidirectional connectivity
A middleware software (B-Link) for bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS).
Systems & Software
LC-MS IVD systems
Our LC-MS platform solutions offer flexibility, facilitate cost savings, and enable you to achieve productivity goals, while ensuring confident IVD results.
Vanquish MD HPLC
A powerful, robust single channel system. The Thermo Scientific Vanquish MD HPLC system has a smaller footprint and excellent reproducibility to meet analytical needs, and space and budget limitations.
TSQ Quantis MD Series MS
Speed, robustness and an extended mass range. Choose Thermo Scientific TSQ Altis MD triple-stage quadrupole mass spectrometers for routine quantitative analyses.
TSQ Altis MD Series MS
Ultimate sensitivity for demanding quantitative analyses. Thermo Scientific TSQ Altis MD triple-stage quadrupole mass spectrometers deliver speed, robustness and the ability to improve selectivity with H-SRM.
Software for IVD LC-MS systems
Software is at the heart of the use and accessibility of our mass spectrometry systems. Thermo Scientific TraceFinder software is included with the purchase of our IVD systems for data acquisition and report generation, while optional B-Link bi-directional software creates a direct link between TraceFinder software and the LIS, eliminating time consuming manual errors.
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TraceFinder LDT Software
Automate and accelerate the processes of creating methods, loading samples, generating data, manually reviewing and editing results, and finalizing the data review and reporting process for a quick start-up.
B-Link Bi-Directional LIS Connection
Turnkey middleware solution that facilitates data-sharing between TraceFinder software and the Laboratory Information System (LIS), without requiring additional hardware.
| HPLC System Vanquish MD | Mass Spectrometers TSQ Altis MD Series, TSQ Quantis MD Series | |
|---|---|---|
| Intended Use | Intended to separate drugs or compounds in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. | Intended to identify and quantify inorganic and organic compound in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. |
| Indications for Use | Clinical diagnostic laboratories can use as a component of a laboratory developed test (LDT) method or workflow. | Clinical diagnostic laboratories can use as a component of a laboratory developed test (LDT) method or workflow. |
| Contraindications of Use | For in vitro diagnostic applications only. The Vanquish MD HPLC is to be operated only with hardware or software approved for in vitro diagnostic application. | For in vitro diagnostic applications only. The TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers are to be operated only with hardware or software labeled for in vitro diagnostic use. |
| Limitations of Use | Thermo Scientific instruments: TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers | Thermo Scientific instruments: Vanquish MD HPLC |
Services & Support
Instrument service and support
Maximize your instrument uptime with superior services and support.
There’s no time for downtime in your lab. Customers worldwide who depend on maximum availability of lab instruments for critical operations choose the Unity Lab Services Premier service plan to minimize disruption and stay focused on production.
Features of the Premier service plan include:
- Two-business-day, on-site response time for corrective maintenance to minimize downtime
- Unlimited enhanced technical support with immediate response, featuring remote resolution of more than 35% of issues with our remote repair services
- Proactive annual preventive instrument maintenance that increases uptime
- Semiannual service consultations delivered by highly experienced and certified service managers
Resources
LC-MS medical devices
Achieve your goals with comprehensive LC-MS systems and software. Ensure more accurate results, faster turn-around times, and cost savings.
LC-MS in clinical research
For detection, analysis, and quantitation; LC-MS utilizes an ideal separation platform and an efficient selective and sensitive platform.
LC-MS for LTDs
LC-MS enables fast, accurate analyses for laboratory developed tests. Discover the benefits and see why it is time to implement.
Detection of infectious diseases
See how IP and SRM methods successfully monitor four types of respiratory infectious diseases simultaneously.
Peptide enrichment of SARS-CoV-2
Utilize a peptide enrichment method to enhance the detection of peptides from digested SARS-CoV-2-spiked nasal fluid samples.
Detecting SARS-CoV-2 with MS
Learn about the robust, 4-minute, reliable targeted peptide absolute quantification assay developed to detect SARS-CoV-2.
Newborn screening with RECIPE kit
Screening newborns for metabolic disorders by quantitating 12 amino acids and 13 acylcarnitine in dried blood spots.
Newborn screening with Labsystem kit
Quantitation of amino acids, acylcarnitines, succinylacetone, and argininosuccinic acid for screening for metabolic disorders in newborns.
Additional resources
In Vitro Diagnostic Medical Device
| For in-vitro diagnostic use. Specifications subject to change. Availability of product in each country depends on local regulatory marketing authorization status. Not all products are available in all countries. Please consult your local sales representative for details. |
This information is presented as an example of the capabilities of Thermo Fisher Scientific products. It is not intended to encourage use of these products in any manner that might infringe the intellectual property rights of others. Specifications, terms and pricing are subject to change.
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