Waters Corporation, the world's leading specialty measurement company, announced that Brazil's National Health Surveillance Agency (ANVISA) has approved the Waters Acquity UPLC, Acquity UPLC I-Class System, and three mass spectrometers, the Xevo TQD, Xevo TQ-S micro, and Xevo TQ-S1, for in-vitro diagnostic (IVD) use.
This provides Brazil’s clinical laboratories access to leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the analysis of a variety of compounds that include diagnostic indicators in laboratory-developed tests.
"Waters was a pioneer in the use of LC-MS as medical devices over a decade ago," said Jose Castro-Perez, director, Health Sciences Marketing at Waters. "We are committed to expanding the number of Waters LC-MS systems listed and registered as IVD medical devices around the world that can support the changing practice of medicine and the laboratory tests that are used to proactively and preventatively diagnose and treat diseases. We are pleased to make our IVD instruments available to scientists in Brazil.”
Using LC-MS technology, clinical laboratories perform qualitative and quantitative analyses of patients' samples to aid clinicians in many ways. Over recent years, the scope of use for IVD LC-MS instrument systems in the clinical environment has widened and the number of tests that can be developed and validated by diagnostic laboratory service providers has grown rapidly. Liquid chromatography separates analytes and interferences within a given sample, while mass spectrometry technology is used for detection and quantification of those analytes. LC-MS technology is also commonly used in forensic toxicology testing.
Waters’ IVD medical devices are designed to optimize clinical laboratory workflows. The systems now available in Brazil include:
Acquity UPLC I-Class/Xevo TQD IVD System, which is a rugged, robust, and reliable LC-MS clinical analyzer for routine quantitative analysis;
Acquity UPLC I-Class/Xevo TQ-S micro IVD System, which offers high LC-MS performance from a compact instrument design with rapid, reliable, and reproducible quantitative data;
Acquity UPLC I-Class/Xevo TQ-S IVD System, which enables accurate quantitative sensitivity for LC-MS analysis of samples with complex matrices or low concentrations that are commonly encountered in clinical laboratories.
Waters’ LC-MS IVD instrument systems have previously been listed with U.S. FDA, CE marked in Europe under the European Directive 98/79/EC (IVDD), and registered in China (registration of the Acquity UPLC I-Class/TQ-S micro IVD system is in process).