Key Factors for the Stability of In Vitro Diagnostic Reagents: 3 Major Problems and Solutions
In vitro diagnostic reagent stability refers to the ability of an in vitro diagnostic medical device to maintain its performance characteristics within the limits specified by the manufacturer, reflecting the product's ability to grow with In the process of storage, transportation and use of in vitro diagnostic reagents, various influencing factors such as temperature, humidity, light, repeated freezing and thawing, bottle opening, vibration, etc. may affect the stability of the product. The stability study period is generally long (6 to 24 months), and the characteristics of the product itself are fully considered at the beginning of the research design, and the optimal design of the research conditions can avoid time waste and reduce the R&D cost of the enterprise. Frequently asked questions in in vitro diagnostics and stability studies are as follows: 1. Storage conditions do not include worst conditions. Some companies set a wide range of temperature conditi...