What are the main aspects of the unpacking stability of in vitro diagnostic reagents?

Release time:

2020-08-25


In vitro diagnostic reagents are used to diagnose whether a patient or subject contains a certain infectious agent or whether a certain function of the body is normal, so the reagent itself needs to be safe and non-infectious. In vitro diagnostic reagents are biological reagents. Some active groups have different chemical instability trends, and are prone to reactions such as hydrolysis, enzymolysis, and oxidation, which affect the quality and stability of the reagents. Today, I will mainly talk about the stability of in vitro diagnostic reagents.

Opening stability, namely opening stability, is to investigate the influence of external factors on the performance of the reagent under normal use conditions. Since reagents, test strips, etc. will come into contact with air to produce oxidation and degradation reactions after opening, the external conditions of some reagents after opening the bottle and the original storage conditions are very different, and some reagents may also be used by users twice. Therefore, various environmental factors should be fully taken into consideration when formulating the research method of opening stability.

If the reagent contains alkaline substances, it will be placed in the biochemical analyzer for a long time after opening the bottle, the carbon dioxide in the air will react with the alkaline components in the reagent, which will affect the accuracy of the test results. Therefore, for the above reagents, the cap should be tightly closed after each use to avoid contact with air.

The temperature range of the reagent tray of the biochemical analyzer is generally 5~15˚C. Therefore, when the reagent contains temperature-sensitive components, the reagent should be put back into the 2~8˚C refrigerator for storage immediately after use, and used as soon as possible . Usually the reagents should be recalibrated 7 days after opening the bottle before testing to improve the accuracy of the test results.

The method for testing the stability of a certain reagent is as follows: open the three batches of the kit and store it in a refrigerator at 2~8˚C for 30 days, and take samples at 0, 15, 30, and 45 days from the date of storage. Tighten the bottle cap after each sampling and put it back at 2~8˚C for storage. Refer to the linearity, accuracy, precision, minimum detection limit and other testing methods in the product technical requirements to test the product, and all indicators should comply with the proposed technology The performance index requirements in the requirements.

Unpacking stability is a particularly important parameter of in vitro diagnostic reagents. It is an important indicator to ensure the effectiveness of the reagents during use. It has important guiding significance for the production, storage and use of products. Desheng is a professional in vitro diagnostic reagent Manufacturers pay special attention to the stability of reagents. Customers who need to purchase can directly consult customer service on the official website.