Procalcitonin collaurum immune colorimetric determination detection kit and preparation method thereof

Abstract

The invention provides a procalcitonin collaurum (PCT) immune colorimetric determination detection kit and a preparation method thereof and belongs to the field of in vitro diagnostic reagent. The kit provided by the invention is based on a collaurum immune colorimetric method and comprises R1, R2 and PCT calibration substances, wherein the reagent R1 is arranged as a buffer solution containing surface active agent and the reagent R2 is arranged as solution containing the gold nanoparticle labeled with procalcitonin antibody. The invention also provides the preparation method for the kit. The kit provided by the invention has the characteristics of high sensitivity, strong specificity, high reaction speed and high stability; the kit is fit for various biochemical analyzers; after the reaction, the reaction cup is difficult to be polluted; the biochemical analyzer can be conveniently cleaned.

Description

technical field [0001] The invention relates to the field of in vitro diagnostic reagents, in particular to a procalcitonin colloidal gold immunocolorimetric assay kit for quantitatively detecting procalcitonin PCT in human blood and a preparation method thereof. Background technique [0002] Procalcitonin (PCT) is the precursor peptide of calcitonin (CT), a glycoprotein composed of 116 amino acids, without hormone activity. PCT cannot be detected in healthy human blood (<0.1ng / ml), and the plasma PCT concentration can be significantly increased 2-6 hours after bacterial infection, and is positively correlated with the severity of inflammation, while in severe infection (such as bacterial, parasitic infection) and systemic manifestations, the PCT level is significantly increased, at this time PCT> 0.5ng / ml. Then gradually reduce to normal level with the control of inflammation and remission of the condition. PCT can selectively respond to systemic bacterial infection...

AI Technical Summary

Problems solved by technology

Among them, gel chromatography and high performance liquid chromatography are accurate in detection results, but they are time-consuming and expensive, and cannot be promoted in clinical practice; immunochemiluminescence method has high sensitivity and is suitable for clinical PCT determination, but it needs to be used with special instruments. The price is expensive; enzyme-linked immunosorbent assay is commonly used in clinical practice, but the operation is complicated, the reaction time is long, and the linear range is narrow; radioimmunoassay is more sensitive in detecting serum PCT in normal people, and it can detect free PCT and It can detect combined PCT and calcitonin gene-related peptide precursor, which improves the sensitivity compared with enzyme immunoassay and immunochemiluminescence, but it takes a long time and the labeled radioactive elements are contaminated, which limits the Clinical application of this method

Colloidal gold chromatography is simple and fast, and the whole detection process does not exceed 30 minutes. It does not rely on instruments, and is easy and fast to operate. It is suitable for bedside testing, but generally it can only be used for qualitative or semi-quantitative detection, and cannot give quantitative results.

[0005] The purpose of the present invention is to solve many deficiencies in the above-mentioned method, and provide a kind of high-efficiency, fast, good repeatability, high accuracy, high detection linearity, high analytical sensitivity method for clinical, the present invention also solves colloidal gold reagent at the same time The two major technical problems of marker self-sedimentation and cuvette contamination provide a reliable guarantee for clinical diagnosis and reduce detection costs

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