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.
Taking the index of actual and sample storage stability as an example, this index is one of the important factors affecting the effect of in vitro diagnostic reagents, and the reagents should be placed and stored in strict accordance with the instructions. For example, the water content and oxygen content in the storage environment of lyophilized powder reagents containing polypeptides have a great impact on the stability of reagents. Therefore, unopened lyophilized powder should be stored in the refrigerator as close as possible.
For example, the samples collected and processed by medical institutions should be stored according to their performance and risk coefficient. For routine blood examination, the samples should be placed at room temperature (about 20 ℃) for 30 minutes, 3 hours and 6 hours after shaking the blood and anticoagulants. Some special samples, such as nasopharyngeal swab samples collected during nucleic acid detection of new coronavirus, need to use the virus sampling tube containing virus preservation solution, while the samples used for virus isolation and nucleic acid detection should be detected as soon as possible. The samples that can be detected within 24 hours can be stored at 4 ℃; the samples that cannot be detected within 24 hours should be stored at - 70 ℃ or below (if there is no - 70 ℃) The storage condition was - 20 ℃.
Hubei xindesheng Materials Co., Ltd. specializes in the production and development of in vitro diagnostic reagents, chemiluminescent reagents, luminescent substrates, biological buffers, blood collection additives and enzyme preparations. Desheng has been established for decades, has its own R & D team, and has researched and developed in vitro diagnostic reagents for many years. It has many kinds of chemical reagent products. At present, the products produced by Desheng have been sold to many countries all over the world, all of which have received high praise and re purchase, and have reached long-term cooperation with many enterprises. Interested in understanding can call consultation, Desheng welcome your call.
