In this study, we evaluated three Class I medical devices to address these challenges: Prelude MD (two channel HPLC), Endura MD (tandem MS) and ClinQuan MD (data processing software). The HPLC instrument consists of two separate channels, both of which include an online sample cleanup Thermo Scientific™ TurboFlow™ column for removing sample matrix, and an analytical column for chromatographic separation. This HPLC is capable of cross-channel sequencing by only introducing the portion of the chromatogram of target compounds into the mass spectrometer therefore doubling the sample throughput. The mass spectrometer is a triple-stage quadrupole tandem MS, providing up to 500 SRM transitions per second for compound identification and quantitation. The data processing software includes three levels of user permissions for technicians, supervisors, and lab directors. This software has built-in flexibility in assigning roles and responsibilities, and an audit trail function is provided for streamlining record keeping.
United States
