What is the significance of the stability study of in vitro diagnostic reagents

What is the significance of the stability study of in vitro diagnostic reagents

In vitro diagnostic reagents are widely used in medical research and clinical testing, and are an important indicator of the quality of clinical diagnostic information. In-vitro diagnostic reagents generally refer to products and services that are outside the human body, and obtain relevant clinical diagnostic information by testing the body, including blood, body fluids, and tissue samples, which can help judge diseases or body functions. The stability of in vitro diagnostics is an indicator that guarantees its quality and accuracy of test results. It is an essential attribute of reagents and an important reference for the production, transportation, storage and use of in vitro diagnostic reagents.

In vitro diagnostic reagent stability tests usually include real-time and actual stability, accelerated stability, bottle opening or unsealing stability, reconstitution stability, sample stability, transportation and stability, and reagent and sample storage stability. The purpose of these stability studies is to determine the transportation, storage and storage conditions of reagent products after opening, and to determine the shelf life of the product and the shelf life after opening. In addition, it can also verify that the stability of the product changes when the storage conditions and shelf life are changed, so as to evaluate and adjust the product's composition, process, and packaging materials based on the results.

Take the index of actual and sample storage stability as an example. This index is one of the important factors that affect the effect of in vitro diagnostic reagents. The storage of reagents should be placed and stored in strict accordance with the instructions. For example, for freeze-dried powder reagents containing peptides, the water content and oxygen content in the storage environment have a great influence on the stability of the reagents. Therefore, unopened freeze-dried powders should be stored in a refrigerator in a refrigerator as much as possible.

Samples to be tested, such as samples processed by medical institutions after collection, should be stored as required according to their performance and risk factors. During routine blood tests, the blood and anticoagulant should be shaken and the samples should be placed at room temperature (about 20°C). ) After 30 minutes, 3h, and 6h, the machine will be tested. Some special samples, such as nasopharyngeal swab samples collected during the nucleic acid test of the new coronavirus, need to use a virus sampling tube containing a virus preservation solution, and the specimens used for virus isolation and nucleic acid testing should be tested as soon as possible, within 24 hours The tested specimens can be stored at 4°C; the specimens that cannot be tested within 24 hours should be stored at -70°C or below (if there is no storage condition of -70°C, they should be temporarily stored in the refrigerator at -20°C).

Hubei New Desheng Materials specializes in the production and development of in vitro diagnostic reagents, chemiluminescence reagents, luminescent substrates, biological buffers, blood collection tube additives and enzyme preparations. Desheng has been established for decades and has its own R&D team. It has been researching and developing in vitro diagnostic reagents for many years. It has many kinds of chemical reagent products under its umbrella. At present, the products produced by Desheng have been sold to many countries around the world, and they have been repurchased with praise, and have reached long-term cooperation with many companies. If you are interested in understanding, you can call for consultation. Desheng welcomes your calls.