Explain the qualification for the 2 weeks Calibration Curve stability (“depends on customer use”). Is this instrument run frequency or use or a switch to fresh reagent packs?
These reagents are rather sensitive to light and to a lesser degree, temperature. If a user runs a kit every day, he will be increasing the amount of time the reagent is exposed to light and elevated temperature. This could result in decreased curve stability. If a user batches this test or only runs once or twice a week, there is less time the material is exposed to light and elevated temperature. Additionally, some users may improperly leave the reagents out of 2-8ºC storage (or uncapped) longer than is necessary and as such will accelerate the calibration curve instability.
