General requirements for kit selection:
1 The specificity of the measurement method used is good, and the sensitivity, accuracy and precision are in line with the method performance recommended by the Clinical Laboratory Center of the Ministry of Health, IFCC, WHO, etc.
2 The kit should be stored for at least 1 year.
3. Water-soluble, low viscosity, non-corrosive, non-toxic, non-flammable, non-polluting environment.
4 The standards or standard reference materials used meet the standards and requirements recommended by the Clinical Laboratory Center of the Ministry of Health, IFCC, and WHO.
Precautions for purchasing kits:
1. Read the instructions of the kit carefully, have an understanding of the kit selection method, choose the reference method kit for scientific research work, choose the recommended conventional method kit for medical prevention work, or choose the public method kit for determination methods. In addition, the composition of the kit and the performance of the method are analyzed, whether it is used manually or for use in an automated analyzer. It belongs to the latter, and whether its experimental parameters are consistent with the experimental parameters of the automatic analyzer of the unit.
2 Whether there is an approval number from the Ministry of Health. All kits that have been included in the scope of approval and management of in vitro diagnostic reagents for clinical testing of the Ministry of Health should not be used if they do not have a production approval number. For those who have a production approval number, it is also necessary to check the credibility of the manufacturer.
3. Inspect and test the packaging, physical performance, and methodological performance indicators of the kit, and apply them in practice. Those who meet the requirements of the manual and the experimental requirements of the laboratory can be purchased.
4. According to the comprehensive analysis of the daily workload of the unit, the amount of analyzer reagents, and the 4 stabilization period after reconstitution of the reagent, the products with suitable packaging and recent delivery should be purchased.
5 Pay attention to the influence of the season on the quality of the reagent. Generally in the season when the temperature is low** reagent to prevent the kit from deteriorating during transportation.
6. Under the premise of kit quality, you should choose the best product.
ELISA assay kits