Waters Corporation has announced that the Chinese Food and Drug Administration (CFDA) approved its Acquity UPLC I- Class IVD/Xevo TQ-S IVD System for in vitro diagnostic (IVD) use in China.
The system was approved for clinical analysis of a variety of compounds that include diagnostic indicators and compounds for treatment monitoring.
"The practice of medicine is changing from a reactive approach to treating disease, to one that is more proactive and preventive," said Jeff Mazzeo, senior director, health sciences for Waters Division.
"To facilitate this transition, better diagnostic and predictive tools are needed so that disease can be detected earlier or even prevented. That is where Waters technologies like the Acquity TQD System and Acquity UPLC I-Class IVD/Xevo TQ-S IVD systems, approved for IVD use by the CFDA in 2014 and 2015, respectively, can make a significant impact,” he added.
Using LC-MS technology, clinical laboratories perform qualitative and quantitative analyses of patients' samples to aid clinicians in many ways. These tests may be used to confirm a clinical suspicion; assist in the selection, optimization and monitoring of treatment; provide a prognosis; screen for disease in the absence of clinical signs or symptoms; and establish and monitor the severity of physiological disturbance. Liquid chromatography separates analytes and interferents within a given sample, while mass spectrometry technology is used for detection and confirmation of those analytes.
The recently CFDA approved Acquity UPLC I-Class IVD/Xevo TQ-S IVD System features Waters' UltraPerformance LC technology coupled with a tandem quadrupole mass spectrometer designed for the most demanding UPLC-MS/MS quantitative analysis. This system uses StepWave, a breakthrough off-axis ion source technology, and RADAR, an information rich acquisition method, enabling the system with sensitivity and robustness.