Calibration product stabilizer, detection kit for determining C peptide and detection method

Abstract

The invention belongs to the technical field of biomedical examination, and particularly relates to a calibration product stabilizer, a C peptide determination detection kit and a detection method. The kit comprises a calibration product, a reagent 1, a reagent 2, a reagent R3 and a reagent R4. According to the kit, an acridinium ester-labeled anti-C peptide antibody, an antigen and a horse radishperoxidase-labeled anti-C peptide antibody are utilized to form an antibody-antigen-antibody compound. A triggering agent is added into the compound without a washing process, the compound is continuously detected for a period of time, the peak area is calculated every 0.02-0.05 S, and a dosage-reaction curve is made by using C peptide with known concentration and the calculated peak area; and the content of the C peptide in the sample to be detected is calculated according to the curve. The kit for detecting the C peptide by adopting the spatial proximity chemiluminiscence method provided bythe invention has the advantages of strong calibration product stability, strong reagent anti-interference capability, high accuracy, good specificity and wide linear range, and is suitable for beingused by medical and research institutions at all levels in combination with instrument measurement.

Description

technical field [0001] The invention belongs to the technical field of biomedical testing, in particular to a calibrator stabilizer, a C-peptide detection kit and a detection method. Background technique [0002] C-peptide is a secretory product of pancreatic β-cells, and it has a common precursor with insulin—proinsulin. A molecule of proinsulin is cleaved into a molecule of insulin and a molecule of C-peptide under special action. Therefore, in theory, C-peptide and insulin are equally secreted. The physiological function of free C-peptide in the blood is not very clear. However, C-peptide is not destroyed by the liver, and its half-life is significantly longer than that of insulin. Therefore, the determination of C-peptide level can better reflect the function of β-cell synthesis and release of insulin. [0003] For patients who have been treated with insulin, the insulin antibodies produced in the body can interfere with the determination of insulin; at the same time, t...

AI Technical Summary

Problems solved by technology

Disadvantage 1: Photoactivated chemiluminescence requires an antibody coating process. Although it is in a homogeneous system during the reaction, it is not completely homogeneous, and the emission intensity depends on various environmental factors. In different environmental systems, the emission intensity and There is a big difference in the time curve, so various external factors must be strictly controlled. For example, if there is no luminous bead within 200nm near the photosensitive bead, the singlet oxygen will decay to the ground state oxygen and enter the next energy cycle. No light signal is generated; the second disadvantage is that the strength of the light signal of photochemiluminescence depends on the size of the sample to a certain extent, there are many interfering substances in the blood, and the sample size for photochemiluminescence is generally very high , so it is easily interfered by interfering substances

The general antigen preservation solution will slowly precipitate at room temperature, resulting in the destruction of the antigen structure and the decrease of the concentration

Especially in the environment above 10°C or the environment of the solution is not good, it will lead to a sharp drop in the antigen concentration, which is irreversible, which makes the calibration test invalid, and the general calibrator stabilizer can only ensure that the calibrator Store at 4°C or even -20°C before opening the bottle for one year or even a shorter shelf life, and it is extremely unstable for repeated freezing and thawing and placing it at room temperature after opening the bottle

In addition, it is impossible to completely guarantee that the calibrator is carried out in an environment of 4°C during use and actual transportation.

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