â—Ž The Ministry of Health stipulates that hepatitis B reagents, hepatitis C reagents, AIDS reagents, syphilis reagents and blood group reagents must use products that have passed the certification of the Ministry of Health Biological Products Inspection and have anti-counterfeit labels. , Simplicity, safety and economy make a comprehensive evaluation.
â—Ž Sensitivity: It has two meanings, 1) the ability of the reagent to detect the minimum amount of the tested substance; 2) the ability of the reagent to detect positives in the crowd or a large number of samples (the fewer false negatives, the better), depending on the package The comprehensiveness of the object.
â—Ž Specificity: refers to the ability of the reagent to correctly detect the non-existent test substance (no false positive), depending on the purity and specificity of the coating antigen (body) and the labeled antigen (body).
â—Ž Precision: ELISA reagent generally refers to the CV within the batch, and its value should be less than 15%; quantitative reagent should also examine the linear range
Kit selection:
◎ Stability: The time that the reagent can be stored under the specified conditions. Generally, a destructive test is used to store the reagent at 37 ℃, and its sensitivity, specificity and precision are regularly measured until its quality index begins to decline. It is generally considered Each stable day at 37 ℃ is equivalent to one and a half months at 4-10 ℃.
â—Ž Convenience: Refers to the previous question that does not affect the first three indicators of the reagents. The fewer the experiment and the measurement steps, the better. The judgment of the results in the qualitative test is simple and clear.) The calculation of the quantitative test results should also be simple.
â—Ž Safety: It means that the reagent is safe and harmless to the operator and the environment.
â—Ž Economy: Under the same quality conditions, reagents reduce costs through large-scale production or technological progress, and the market price is relatively reasonable.
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