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.
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 have 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 USFDA, 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).