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Thermo LC-MS Solutions Receive ANVISA Registration in Brazil

By Labmedica International staff writers
Posted on 03 Oct 2017
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Image: The Endura MD mass spectrometer (Photo courtesy of Thermo Fisher Scientific).
Image: The Endura MD mass spectrometer (Photo courtesy of Thermo Fisher Scientific).
Thermo Fisher Scientific’s (Hampton, NH, USA) liquid chromatography mass spectrometry (LC-MS) in vitro diagnostic (IVD) systems, which enable the quantitation of analytes in complex matrices, have received registration by Brazil’s National Health Surveillance Agency (ANVISA), allowing clinical laboratories in the country to now screen and quantify drugs efficiently.

The Thermo Scientific Endura MD mass spectrometer (MS), Prelude MD high performance liquid chromatography (HPLC) system and ClinQuan MD software have been recognized by ANVISA as capable of meeting its Good Manufacturing Practice (GMP) requirements. This will allow clinical laboratories in Brazil to leverage the high sensitivity and quantitative accuracy of Thermo Fisher Scientific’s LC-MS IVD systems for developing and validating their own methods for the analysis of a large range of drug analytes.

Both Prelude MD and Endura MD combine the capabilities of HPLC with Thermo Scientific TurboFlow technology to enable automated in-line sample cleanup, thus eliminating the need for error-prone manual tasks. Both the systems are powered by the ClinQuan MD software, which is designed to safely store, retrieve and process data from laboratory-developed IVD tests. In line with the Clinical Laboratory Improvements Amendments (CLIA), the software generates time-stamped audit trails to ensure the integrity of results is preserved at all times.

“Clinicians need the flexibility to create and validate their own laboratory-developed tests in order to answer the most complex clinical questions,” said Marc Chalom, applications manager, chromatography and mass spectrometry, Thermo Fisher. “With this in mind, we are expanding our LC-MS IVD product offering to a broader geographical market, so that more labs can benefit from the performance and reliability of our technologies to optimize their workflow”.

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