New Biomarker Validation - Usability & Precision Testing Partner
Project Description
USA / Worldwide CLIA laboratory needed for a usability study and a precision study as part of analytical validation for a new biomarker. The test platform consists of a sample preparation kit and then uses mass spectrometry to generate data for algorithmic analysis.
The usability study aims to verify the clarity of our instructions for use, involving up to 15 operators (to be distributed across labs as needed) who will be asked to, during a half day, follow the instructions using mock-up materials and provide feedback.
The precision study will follow CLSI guideline EP05. About one or two operators will be asked to run one full assay cycle per day for 5 consecutive days. Training will be provided before the study. All materials needed will be provided.
Both studies require the use of a Waters® MassTrak ACQUITY UPLC I-Class PLUS/Xevo TQ-S micro IVD System.
Project Information
Number:25-00470
Industry:Medical Research
