How do the System Suitability Kits work on the Lipidyzer Platform?
The system suitability test allows you to confirm the platform performance is reproducible and robust, that the assay is performing to specification, and that the limit of detection is being met. The System Suitability kits (containing unlabeled molecular species) have been designed to allow the user to measure all of these attributes.
The user can run one of two tests; a "Quick" test or a "Comprehensive" test:
- The Quick System Suitability test is to be run weekly for a lab operating the Lipidyzer Platform daily and takes less than 20 minutes to complete. An ampoule from the kit is opened and diluted to the appropriate concentration as instructed in the embedded protocol downloadable from the software for “Quick Test.” One injection of a blank sample and an injection of the “LOD” sample are made (with the DMS ON method only), and the software reports a simple PASS or FAIL based on meeting a threshold cutoff in counts per second (cps) for 18/20 scans collected.
- The Comprehensive System Suitability test is more extensive and runs for 3.5 hours. This is directed at users running the Lipidyzer Platform in between other LC-MS/MS assays or after a period of inactivity (i.e. more than 10 days). An ampoule from the kit is opened and diluted to the appropriate concentration as instructed in the embedded protocol for “Comprehensive Test.” Two injections of a blank sample, two injections of the “LOD” sample and three injections of the “RSD” sample are made with both methods (DMS On and Off). The software reports a simple PASS or FAIL based on meeting a threshold cutoff in counts per second (cps) for 18/20 scans collected for the LOD sample and a coefficient of variation (%CV) value for the RSD sample (see figure, both tables reported). A sample must have a CV of 15% or less to pass the comprehensive test.