Chemiluminescence immunoassay kit and preparation method thereof

Abstract

The invention provides a human proinsulin chemiluminescence immunoassay kit and a preparation method thereof. The kit provided by the invention comprises an anti-proinsulin reagent 1, an anti-proinsulin reagent 2, a magnetic separation reagent, a proinsulin calibrator, a chemiluminescence substrate, and a washing liquid. The invention also provides a preparation method of the kit. The preparation method comprises the following steps: coupling antibody and biotin, preparing the anti-proinsulin reagent 1, coupling enzyme and antibody, preparing the anti-proinsulin reagent 2, preparing the magnetic separation reagent, preparing the proinsulin correction sample, and preparing the chemiluminescence substrate. Compared to the proinsulin kit existing in the present market, the kit provided by the invention has the characteristics of high detection sensitivity, good repeatability, and low cost.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine, in particular, the invention provides a human proinsulin chemiluminescence immunoassay assay kit and a preparation method thereof. Background technique [0002] Proinsulin (PI) is the immature insulin initially secreted by β cells, which is a long peptide chain composed of 86 amino acids, referred to as proinsulin. It is the precursor substance of insulin, which is composed of insulin and C-peptide. It has dual immune activity, which can be combined with insulin antibody and C-peptide antibody. Proinsulin is synthesized and secreted by pancreatic β cells and mainly catabolized by the kidneys. Under physiological conditions, only a very small amount of proinsulin is released into the blood. Under pathological conditions, the release of proinsulin from pancreatic β cells increases, and the level of proinsulin in the blood increases. The biological effect of proinsulin is basically the same ...

AI Technical Summary

Problems solved by technology

Although this proinsulin chemiluminescence immunoassay kit uses chemiluminescence immunoassay, its published sensitivity and other indicators have no obvious advantages compared with ELISA. At the same time, the detection fluctuation is large and the repeatability is poor. The main disadvantages of its design are as follows : 1. The luminescence efficiency of direct labeling antibodies with isoluminol is low, and the markers are unstable. This direct labeling method belongs to the instantaneous luminescence type (that is, the entire luminescence process is completed in less than 1 second), and it is not easy to guarantee the repetition of results. 2. Using FITC and goat anti-FITC system, goat anti-FITC as polyclonal antibody, taken from goat serum, complex components in serum such as protein will interfere with the detection; at the same time, different batches of goat anti-FITC The affinity and reaction speed of anti-FITC to FITC are different, which will affect the detection effect of each batch, and cannot realize the stable hierarchical amplification of the biotin-avidin system, has no beneficial effect on the sensitivity, and there will be intra-batch and inter-batch duplication Disadvantages of poor sex

At the same time, the details of the preparation method of the proinsulin magnetic particle chemiluminescence immunoassay kit are also protected by the manufacturer as a technical secret, and no relevant information on the preparation method of the proinsulin chemiluminescence immunoassay kit has been found at home and abroad.

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