Each experimental design is unique. A critical component to the success of any stable isotope analysis and tracer experiment is the production of a customized kit that provides everything necessary to administer a test. The details of this kit will be agreed upon during the Protocol Design phase. Metabolic Solutions will execute the kit production using standard operating procedure (SOPs).
Approval and Initiation
Once a project has been initiated, the Study Director will identify the following for production:
- Regulatory requirements (GLP vs. non-GLP)
- Kit type (Gastric Emptying, Doubly Labeled Water etc.)
- Isotope identification
- Dose information (chemical form, labeling and dose size)
- Number of kits to be produced
- Label requirements
- Date required
Following a step-wise SOP with quality assurance oversight, each kit is assembled according to the protocol design. Often, the means and method to ship the collected specimens back to Metabolic Solutions are part of the kit assembly. For example, a pre-addressed FedEx label or UPS shipping documents may be included. Finally the finished kits are assigned a unique lot number and expiration date for identification purposes.
Storage and Shipment
The completed kits can be shipped directly to your study sites or held in our finished goods inventory until needed. Our temperature controlled, secure facility can be used to facilitate the logistics of your project.