Trace albumin kit based on latex immunonephelometry process and preparation method thereof

Abstract

The invention discloses a trace albumin kit based on a latex immunonephelometry process. The trace albumin kit comprises a reagent A and a reagent B, wherein the reagent A is a glycine buffer system with the pH value of 8.5-9.4 and contains 0.1-0.5g / L macromolecular polymerization accelerator, 1-10g / L surfactant and 0.5-10g / L electrolyte; and the reagent B is an MES buffer system with the pH value of 7.0-7.5 and contains 2.5-3g / L goat anti human trace albumin multicolonal antibody, 5-10mL / L goat anti human trace albumin multicolonal antibody coated latex, 1-10g / L surfactant and 0.5-10g / L electrolyte. The invention also discloses a method for preparing the reagent B. The kit can effectively avoid non-specific reaction, relatively high detection sensitivity and relatively low detection limit and can be applied to clinical trace albumin determination.

Description

technical field [0001] The invention belongs to the technical field of immunodetection, and in particular relates to a microalbumin kit based on latex immunoturbidimetry and a preparation method thereof. Background technique [0002] Microalbumin refers to the tiny amount of albumin that occurs in human urine. Albumin is a normal protein in the blood, but only very small amounts are present in the urine under physiological conditions. Under normal circumstances, the concentration of microalbumin in the urine does not exceed 20 mg / L. When the concentration of microalbumin in the urine reaches 20-200 mg / L, it is microalbuminuria, which reflects the abnormal leakage of protein in the human kidney. The detection of microalbumin is the most sensitive and reliable diagnostic index for early detection of nephropathy. The diagnosis of the disease can be made more accurately through the test results of microalbumin in urine, combined with the onset, symptoms and medical history sta...

AI Technical Summary

Problems solved by technology

[0004] However, in the latex immunoturbidimetric method, although the added polymer accelerator can make the antibody more likely to bind to the antigen, it will also make the antibody bind to other substances, resulting in non-specific enhancement; and the activation of latex also makes the reactivity of the antibody itself Significant increase, increasing the excess polymer accelerator will cause more latex to aggregate and further promote non-specific reactions. As a result, the particle size of the aggregated latex particles is likely to be uneven, the reaction reproducibility is low, and the characteristic wavelength of the detection not fixed

In the process of clinical use, the parameters are fixed, and the change of the characteristic wavelength makes this technology have certain limitations in actual clinical application.

In addition, the latex used in the existing latex immunoturbidimetric method needs to separate excess EDC, NHS and other activating reagents during the preparation process, and needs to be sealed, which is cumbersome in operation.

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