Reagent for determining procalcitonin and preparation method of reagent

Abstract

The invention relates to a reagent for determining procalcitonin and a preparation method of the reagent, in order to provide the reagent which has the characteristic of high accuracy degree, and the provided preparation method has the characteristic of convenience in preparation. The technical scheme is that the reagent for determining procalcitonin comprises the following components: a. a procalcitonin reagent 1, b. a procalcitonin reagent 2, and c. a liquid-type procalcitonin reference calibration item. The preparation method of the reagent for determining procalcitonin comprises the following steps of: (1) uniformly mixing the procalcitonin reagent 1; (2) removing the procalcitonin reagent 2, the removing process specifically comprises the following steps of: a. taking a suspension, b. carrying out reaction on a mixture, c. acquiring a carboxylic latex microsphere suspension, d. regulating the concentration, e. taking the suspension in step (3), and adding into the step (4), f. reacting, g. adding cholamine, and h. carrying out centrifugal treatment; and (3) treating the liquid-type procalcitonin reference calibration product: mixing according to the amount of a formula, and ranking according to the content of the procalcitonin or adding a procalcitonin pure product in the mixed liquid.

Description

technical field [0001] The invention relates to a reagent for measuring procalcitonin and a preparation method of the reagent, in particular to a reagent for detecting procalcitonin in serum or plasma by latex-enhanced immune turbidimetry and a preparation method, which can be widely used in medicine and biochemical technology. Background technique [0002] Serum procalcitonin (Procalcitionin, PCT) is composed of 116 amino acids, a glycoprotein with a molecular weight of 13KD. Its half-life is 25-30 hours. The plasma PCT content of healthy people is extremely low, lower than 0.5ng / ml in normal human blood. Its level in plasma increases when severe bacterial, fungal, and parasitic infections, as well as sepsis and multiple organ failure; autoimmunity, allergies, and local infections, viral infections, chronic non-specific inflammation, cancer fever PCT levels will not increase in diseases such as graft host rejection and so on; this determines the high specificity of PCT, ...

AI Technical Summary

Problems solved by technology

At present, there are two kinds of kits in the market, tube type and plate type, but this method has the disadvantages of low luminescence efficiency and unstable labeling of acridinium ester, luminol, and isoluminol directly labeled antibodies; and this direct labeling method Belongs to the instant light-emitting type, it is difficult to guarantee the stability and repeatability of the test results, and special testing instruments are required

Not convenient for routine laboratory development

However, the electrochemiluminescence immunoassay kit for detecting PCT using the biotin-avidin system needs to be equipped with an expensive automatic electrochemiluminescence detector, which cannot be carried out in conventional laboratories, and it will bring unnecessary costs to patients and increase the burden on patients.

ELISA uses artificially synthesized PCT monoclonal antibody for detection. Although the method is specific, the detection limit is 10 μg / L, which cannot detect the PCT concentration in normal human serum.

Chinese patent (Application No.: 201110210250.4) also discloses a kit for detecting procalcitonin, which uses magnetic particle-coupled antibody as a fixed separation phase, biotin-streptavidin multistage amplification system, and horseradish Oxidase is a catalytic enzyme that catalyzes the luminescent substrate. Although the detection sensitivity is improved, the entire reaction takes a long time (at least 40 minutes), and the sample needs magnetic separation pretreatment

This method needs to wash the reaction tube. If it is washed manually, it will cause human error. If it is washed with an instrument, it is necessary to prepare another washing instrument, which will increase the cost of the laboratory.

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