Key Factors for the Stability of In Vitro Diagnostic Reagents: 3 Major Problems and Solutions

 In vitro diagnostic reagent stability refers to the ability of an in vitro diagnostic medical device to maintain its performance characteristics within the limits specified by the manufacturer, reflecting the product's ability to grow with  

In the process of storage, transportation and use of in vitro diagnostic reagents, various influencing factors such as temperature, humidity, light, repeated freezing and thawing, bottle opening, vibration, etc. may affect the stability of the product. The stability study period is generally long (6 to 24 months), and the characteristics of the product itself are fully considered at the beginning of the research design, and the optimal design of the research conditions can avoid time waste and reduce the R&D cost of the enterprise.

Frequently asked questions in in vitro diagnostics and stability studies are as follows:

　　1. Storage conditions do not include worst conditions. Some companies set a wide range of temperature conditions, but did not verify the worst conditions. If the manufacturer should clearly state the specific range of temperature such as 10-30°C, the research process should include long-term studies at 30°C.

　　2. Insufficient research time. For cost saving considerations or design issues, some companies have problems such as not conducting research at T0 (the starting point), too few intermediate time points, and not covering the time points after the claimed validity period. It should be noted that the start time should be as close as possible to the production time of the product, and the basic data should be retained to facilitate the comparison with the results of subsequent studies. Increasing the setting of intermediate time points and collecting more data points is conducive to early identification of data drift. Cover a reasonable amount of time after the expected statement to allow room for uncertainty.

　　3. The results of the study are unclear. The ambiguity of the results stems from the ambiguity of the acceptance criteria, such as the CV requirement for precision references and the acceptable level of data bias for quality controls. Based on the original test values and clear acceptance standards, the manufacturer should clarify the data processing process, display the quality change trend of the product in the form of tables and graphs, and determine the validity claim based on the analysis of the results.

The results of the study should demonstrate that the declared product is able to meet the stability requirements under the claimed storage conditions and for the duration of time. The specific range of storage conditions should be clarified in the research data and stability claims, such as "stored at 2~8°C", and it is not recommended to use uncertain words such as "refrigerated", "frozen", "room temperature" to describe the storage temperature.

The reagents produced by the Poclight Biotech supply Immunoassay Products, Platforms and Services. And the test kits are stable in use and transportation. The biggest advantage is that there is no need for a cold chain, which greatly reduces the cost of the customer and extends the clia Kit Validation and Quality Testing. Individually packaged for a single serving, it is easy to use and avoids waste.

The lyophilized beads reagent dissolves instantaneously after adding the sample to achieve a homogeneous reaction, and the first sample only takes 3 minutes, Accurate and Rapid Immunoassay Rapid Test. It has the advantages of high precision, good repeatability test kits, low cost, fast speed and easy storage.

The testing items cover inflammation, metabolism, thyroid hormone, cytokines, CD factors, myocardium and other fields, and can be widely used in laboratory departments, emergency departments, ambulance centers, clinical departments, ICUs, primary hospitals, third-party laboratories, physical examination centers, etc.