Stability is an essential attribute of in vitro diagnostic reagents
Stability is the ability of an in vitro diagnostic reagent to maintain the consistency of characteristics over time, a basic attribute that a reagent must have, an important indicator to ensure the effectiveness of a reagent during use, and the responsibility of the manufacturer.
On September 5, 2014, the State Food and Drug Administration issued the "Announcement on the Announcement of In Vitro Diagnostic Reagent Registration Application Materials Requirements and Approval Document Format (No. 44 of 2014)", Annex 3 of the announcement stipulates that "stable The stability research data includes the real-time stability research data of at least three batches of samples stored under actual storage conditions until the expiration date of the finished product, and should fully consider the unfavorable conditions of the product during storage, transportation and use, and conduct corresponding stability research. Explain in detail the basis for the determination of the stability research method and the specific test methods and processes". The above regulations are the basis for the review of the stability study part of the in-vitro diagnostic reagent product registration materials, and stipulate the requirements, batches and conditions of the stability study, but the specific research methods and contents are not specified in detail. The Technical Guidelines for Stability Research of Biological Products (Trial)" and the guidance document EP25-A issued by the Clinical and Laboratory Standards Institute (CLSI) of the United States, introduce the basic content of in vitro diagnostic reagent product stability research and Precautions.
