| Message: | In vitro diagnostic reagents are widely used in medical research and clinical laboratory, and are important indicators of clinical diagnostic information quality. In vitro diagnostic reagents usually refer to the products and services that can help to judge the disease or body function by detecting the body including blood, body fluid and tissue samples outside the human body to obtain relevant clinical diagnostic information. In vitro diagnostic stability is an index to ensure the quality and accuracy of test results. It is an essential basic attribute of reagents and an important reference for the production, transportation, storage and use of in vitro diagnostic reagents.
In vitro diagnostic reagent stability test usually includes real-time and actual stability, accelerated stability, bottle opening or sealing stability, re dissolution stability, sample stability, transportation and stability, reagent and sample storage stability, etc. The purpose of these stability studies is to determine the transportation, storage and storage conditions of the reagent product after opening, and to determine the storage life of the product and the storage life after opening. In addition, it can also verify that the stability of the product changes when the storage conditions and shelf life change, so as to evaluate and adjust the composition, process and packaging materials of the product according to the results. |
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