Stability is the basic attribute that in vitro diagnostic reagents must have
Stability is the ability of in vitro diagnostic reagents to maintain the consistency of characteristics over time. It is a basic attribute that the reagent must have. It is an important indicator to ensure the effectiveness of the reagent during use, and it is also the responsibility of the manufacturer.
On September 5, 2014, the State Food and Drug Administration issued the "Announcement on the Publication of In Vitro Diagnostic Reagents Registration Application Requirements and Approval Document Format (2014 No. 44)". Annex 3 of the announcement stipulates that "Stable The sexual research data includes the real-time stability research data of at least three batches of samples stored under actual storage conditions until the expiry date of the finished product, and the adverse conditions of the product during storage, transportation and use should be fully considered, and corresponding stability studies should be carried out. Explain in detail the basis for the determination of the stability research method and the specific test methods and processes". The above-mentioned regulations are the review basis for the stability research part of the in-vitro diagnostic reagent product registration materials, which stipulate the requirements, batches and conditions of the stability research, but the specific research methods and contents have not been specified in detail. Now refer to the " Technical Guidelines for Stability Research of Biological Products (for Trial Implementation)" and the guidance document EP25-A issued by the Clinical and Laboratory Standards Institute (CLSI), which introduces the basic content of the stability research of in vitro diagnostic reagent products and Precautions
