Immunoturbidimetric kit for detecting procalcitonin

Abstract

The present invention relates to the field of medical immunology, particularly to an immunoturbidimetric kit for detecting procalcitonin. The kit comprises a reagent R1 and a reagent R2, wherein the reagent R1 comprises a buffer liquid, a stabilizer, a protection agent, a coagulant, a hemolytic agent and a preservative, the reagent R2 comprises a buffer liquid, a stabilizer, a protection agent, a preservative and a polystyrene latex microsphere-procalcitonin antibody complex, and the polystyrene latex microspheres comprise two types of microspheres such as microspheres having a particle size of 80-150 nm and microspheres having a particle size of 150-400 nm. According to the present invention, the test results show that the kit has advantages of good stability and long storage period, can directly detect the PCT in whole blood, and further has advantages of high detection result accuracy, high sensitivity and wide linear detection range.

Description

technical field [0001] The invention relates to the field of medical immunity, in particular to an immunoturbidimetric detection kit for detecting procalcitonin. Background technique [0002] Procalcitonin (PCT) is a glycoprotein consisting of 116 amino acids with a molecular weight of about 13Kd. Its structure is stable and not affected by hormone activity in the body. Its half-life in the human body is 25-30h, stable Good is better. PCT is mainly produced by the liver, and the neuroendocrine cells of the spleen, kidney and lung are also important places for its production. [0003] PCT is a clinical marker and an important parameter in the diagnosis and monitoring of infections in bacterial inflammatory diseases. Widely used in hematology oncology, anesthesiology, internal medicine, transplant surgery, neonatology and pediatrics and other diagnostic and treatment departments. Under normal circumstances, PCT exists in human serum in a free form, and its level is very low...

AI Technical Summary

Problems solved by technology

Radioimmunoassay can detect serum PCT in normal people, but it cannot distinguish between free PCT, bound PCT and calcitonin gene-related peptide precursor, and it takes too long (19-22h). There are certain limitations; high-performance liquid chromatography is time-consuming and difficult to automate; enzyme-linked immunosorbent assay is complicated to operate and takes a long time; it is generally qualitative or semi-quantitative, and the results have large deviations; chemiluminescence has high sensitivity It can meet the clinical PCT detection requirements, but it needs to be matched with special equipment, which is expensive; colloidal gold colorimetry is a qualitative detection, fast and easy, and can obtain the PCT concentration range, but cannot obtain accurate values

Transmission immunoturbidimetry is a relatively stable PCT detection method. The determination method is simple, fast, and can be automated. However, due to the limitations of the method, the existing published turbidimetric kits using this detection principle have a detection limit. The problem of low sensitivity and narrow linear range, and the need to use serum or plasma as the sample to be tested. Before the test, the blood needs to be separated and processed to extract serum or plasma. The operation is cumbersome and time-consuming.

Moreover, a large amount of venous blood is required to obtain serum or plasma, which undoubtedly increases the suffering of the subjects and is not suitable for some special patients who have difficulty in blood collection, such as children, especially infants, and people with extensive burns and scalds

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