The sensitivity of a diagnostic reagent has two different meanings: first, the sensitivity represents that the reagent has the ability to detect the minimum amount of substances to be tested; Secondly, sensitivity also indicates the positive detection ability of the reagent in the population or a large number of samples, that is, the degree of false negative. Sensitivity is the primary quality standard of diagnostic reagents. If the sensitivity of the reagent does not meet the standard, then the reagent is worthless.
It refers to the ability of the reagent to correctly detect the non-existent substance to be tested (i.e., no false negative). In general, the more specific the diagnostic reagent is, the better its quality is. The specificity of conventional immunodiagnostic reagents depends on the purity and specificity of antigens on the one hand, and on the specificity of antibodies on the other hand.
It refers to the close degree between each measurement result and the average value when the same sample is measured repeatedly, that is, the conformity degree between the repeated measurement values. Whether used for qualitative or quantitative diagnosis, the precision of the reagent is also very important. Generally, the intra-batch C.V. (coefficient of variation) of the reagent should be less than 15%.
It usually refers to the time that the reagent can be stored under specified conditions. The better the stability of the reagents, the longer their validity period. Before the expiration date, their sensitivity and specificity should not be changed.
Any advanced test reagent should be easy to operate. Under the condition that the sensitivity and specificity of the reagent can not be reduced, the less the experiment and determination steps, the better, and the result calculation should also be simple; In qualitative determination, the judgment of Yin and Yang results should also be simple and clear.
The diagnostic reagent is used to diagnose whether the patient or the tested person contains certain infectious factors or whether certain functions of the body are normal, so the reagent itself needs to be safe and non-infectious. In order to protect the staff from the infection of positive substances, all materials containing infectious factors must be inactivated before use. In order to protect the staff from damage during operation, the containers of each component of the kit should avoid using glass materials, try to use plastic products, and avoid using metal aluminum caps, and use plastic materials instead. Avoid using strong acid and alkali reagents in chemical reagent components.
The purpose of developing diagnostic reagents is to be used for clinical auxiliary diagnosis. The production cost should not be too high, and the market price should also be reasonable.
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