As a provider of CE-IVD compliant products, we take a lot of effort to fulfill ever-increasing regulatory requirements. Before products are introduced to the market they are comprehensively validated to ensure that they meet the highest standards in clinical diagnostics. The quality of our products is also extensively and continuously monitored. On a regular basis we are also audited by a range of regulatory bodies that confirm our compliance in accordance with a number of industry standards including DIN EN ISO 9001, DIN EN 13485 and ISO 13485 CMDR.
The non-targeted metabolomics in GAC is an Ultra High Performance Liquid Chromatography/Mass Spectrometry (UPLC-MS/MS 2 ) based analytical platform. The platform is licensed by Metabolon, Inc, a prominent metabolomics company located in Research Triangle Park, North Carolina, USA. The metabolic analysis is performed using identical instruments to Metabolon, Inc, . Acquity UPLC (Waters) coupled to Q Exactive Orbitrap MS (Thermo Scientific). The measurement is incorporated in two separate UPLC/MS/MS 2 injections, one injection is optimized for acidic compounds and the other is optimized for basic compounds. This approach currently permits the detection of ~700 small molecules with a total instrument analysis time of 24 min (two injections at 12 min each). The resulting MS/MS 2 data are matched to Metabolon’s database library that include retention time, molecular weight ( m/z ), preferred adducts, and in-source fragments as well as their associated MS/MS spectra for all molecules in the library. The library allows a rapid and high-confidence identification of the experimentally detected molecules based on a multi parameter matching without the need for additional analyses. This platform enables the high-throughput collection and relative quantitative analysis of analytical data and identifies a large number and broad spectrum of molecules with a high degree of confidence.