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LC-MS Medical Devices for in vitro Diagnostics
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LC-MS Medical Devices for In Vitro Diagnostic Use
Increase efficiency, throughput, and cost savings— performing laboratory developed tests (LDTs) and in vitro diagnostic (IVD) assays by liquid chromatography-mass spectrometry.
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GET YOUR COPY: 5 REASONS TO
IMPLEMENT LC-MS FOR LDTs ›
Vanquish MD HPLC System
Better separation, accuracy, and ease-of-use
TSQ Altis MD Series mass spectrometer
Enhanced sensitivity with remarkable speed and
robustness for laboratory developed tests
Increase efficiency, productivity, and cost savings
Our comprehensive LC-MS platform enables accurate results, facilitates cost savings, and allows clinical laboratories to achieve organizational and scientific goals while ensuring confidence in results of LDTs.
5 Reasons to Implement LC-MS for LDTs
TSQ Quantis MD Series mass spectrometer
IVD compliance with sensitivity, remarkable speed,
and robustness for routine laboratory developed tests
PORTFOLIO SUMMARY
Ease, efficiency, and flexibility for laboratory developed tests
Benefits of choosing LC-MS for LDTs
Superior specificity, selectivity, sensitivity
Compared to traditional immunoassays, LC-MS enables accurate results, thus reducing false positives or negatives.
Fast speed and high throughput capability
Enable faster turnaround time in clinical laboratories
Comprehensive and flexible
Allows spontaneous detection of multiple analytes
in the same run
in the same run
Cost savings and increased productivity
Compared with immunoassay, LC-MS methodology reduces costs associated with testing kits and consumables and sample and potential labor costs
Reasons to Choose Class I Medical Devices
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Compliance
Hardware manufactured follows ISO 13485 and FDA 21 CFR 820 standards; dedicated, integral LDT software for clinical workflow and auditing capability
Reasons to Choose Class I Medical Devices
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Regulatory Trends
Global clinical diagnostics market is trending towards LC-MS devices conforming to FDA and EU regulation to perform LDTs
Reasons to Choose Class I Medical Devices
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Connectivity
A middleware software (B-Link® Universal LIS/LIMS Connector)
for bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS)
for bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS)
Reasons to Choose Class I Medical Devices
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Risk Control
Thorough validation and verification process; Medical device-certified engineer for service; Quality tracking in place to ensure the highest instrument performance