How to judge the technical functions of in vitro diagnostic reagents

The functions of in-vitro diagnostic reagents are mainly manifested in three aspects:

1. Analytical function: mainly includes precision, accuracy, sensitivity, specificity, linear scale or determination scale, etc. Some technical indicators in the product instructions may not be completely common.

2. Diagnostic function: the sensitivity and specificity of the substance being detected.

3. Stability: production date, expiration date, effective date, and calibration requirements of the product.

The raw materials and processes used in the reagents should have clear quality requirements and be validated, and the functions of the final product should meet the requirements of clinical use.

The main factors affecting product function include raw materials, processes and the establishment of reaction systems, functional evaluation methods, the establishment of internal reference products by enterprises, and clinical evaluation.

The storage of in-vitro diagnostic reagents is special and requires certain conditions. According to the type and function of the in-vitro diagnostic reagents, product zoning and classification storage management should be implemented. The product storage warehouse should meet the requirements of temperature and humidity, dust prevention, ventilation, light avoidance, storage period, etc. It should be equipped with temperature and humidity monitoring and control facilities or equipment, and maintain monitoring records. Most in-vitro diagnostic reagents need to be stored at low temperature (2-8℃), a few types need to be frozen, and some types can be stored at room temperature. Specific requirements are clearly indicated in the product instructions.

Are there any special requirements for the transportation of in-vitro diagnostic reagents? During the transportation of in-vitro diagnostic reagents, the transportation conditions and packaging requirements of the products should be met. Products with low temperature and refrigeration requirements indicated in the instructions and labels should be transported and stored using low temperature and refrigeration facilities and equipment in accordance with relevant regulations.