What are the storage conditions and validity period of trace elements clinical diagnostic reagent assay kit

As an indispensable tool in clinical testing, the storage conditions and validity period of the Trace Elements Clinical Diagnostic Reagent Assay Kit are directly related to the accuracy and stability of the test results. Reasonable storage management not only ensures the activity of the reagent, but also extends its service life and improves the reliability of the test.

Importance of storage environment
Trace element diagnostic kits contain a variety of chemical components that are sensitive to temperature, humidity and light. The ideal storage environment should be kept dry, cool and away from direct sunlight. Excessive humidity can cause the reagent to become damp and agglomerated, affecting its reaction performance; strong light exposure may cause degradation or denaturation of sensitive components in the reagent, thereby affecting the accuracy of the measurement. It is recommended that the relative humidity of the storage environment be controlled between 30% and 60% to avoid moisture in the reagent.
In addition, the storage place should avoid corrosive gases and strong vibrations. Corrosive gases such as hydrogen sulfide and chlorine can easily corrode the reagent bottle cap and packaging materials, resulting in reduced sealing. Vibration and impact may cause the reagent bottle to break or mix, affecting the stability of the reagent.

Temperature control requirements
Temperature is one of the important factors affecting the stability of trace element reagents. Most trace element test kits are recommended to be stored in a low temperature environment of 2°C to 8°C, similar to the refrigeration conditions of a refrigerator. Low temperature can effectively slow down chemical reactions and biodegradation processes, and extend the shelf life of the reagents.
Some special ingredients are more sensitive to temperature, such as enzymatic reaction systems, and freeze-thaw cycles must be strictly avoided. Repeated freezing and thawing can easily destroy the molecular structure, resulting in inactivation or reduced activity of the reagents. If freeze-thaw occurs, it should be determined whether it can continue to be used according to the specific reagent instructions. It is generally not recommended to use it again.
If refrigeration conditions cannot be guaranteed, the stability and shelf life of the test kit stored at room temperature will be significantly shortened. It is generally recommended that the room temperature storage should not exceed the time marked on the reagent manual, which usually ranges from several weeks to several months.

Protective packaging and sealing
The packaging design of the test kit directly affects its storage performance. Well-sealed packaging can effectively block the entry of air, water vapor and pollutants, and prevent the reagents from oxidation and moisture. Aluminum foil bags, sealed plastic bottles and vacuum packaging are often used to protect the stability of reagents.
After opening, the reagent kit should be used up as soon as possible to avoid long-term exposure to the air. During use, care should be taken to avoid cross contamination and keep the utensils and operating environment clean. Some reagents are designed to be disposable to avoid repeated opening and further ensure quality.

Determination and management of expiration date
The expiration date of the reagent kit refers to the maximum period of use during which the reagent can ensure the detection performance and accuracy under the specified storage conditions. The expiration date is generally determined by the manufacturer based on the stability test data and quality control standards, and is commonly 12 to 24 months.
Stability tests include accelerated aging tests and long-term storage tests, which evaluate the stability of reagents by simulating the performance changes of reagents under different environments. Reagent performance parameters such as sensitivity, specificity, linear range, background signal, etc. are all used as assessment indicators.
Clinical laboratories should strictly abide by the expiration date of reagents during use. Expired reagents may cause increased deviation in measurement results and affect clinical diagnosis and judgment. A sound inventory management system should be established, and products that are about to expire should be used first to avoid waste.

Precautions for storage after opening
The reagent kit should be stored according to the instructions after opening. Most reagent kits require storage at 2°C to 8°C away from light. Some reagents may need to be stored frozen and cannot be frozen and thawed multiple times. It is recommended that they be quickly sealed and placed back in the specified temperature storage environment after each use.
The effective shelf life after opening is generally shorter than that of unopened state, usually ranging from several days to several weeks. Clinical laboratories should arrange the dosage reasonably according to the test volume to avoid long-term exposure of reagents and deterioration.

Special requirements for the storage of special element reagents
Certain trace elements such as lead, cadmium, mercury and other detection reagents have more stringent storage requirements. Some reagents for heavy metal ion detection contain organic solvents or volatile chemicals, which need to be kept away from fire and avoid high temperatures.
Some reagents contain enzymes or antibody components and need to be refrigerated or frozen to maintain their activity. Avoid violent shaking during storage to reduce physical damage.