Immunoturbidimetric assay apolipoprotein E detection kit

Abstract

The invention relates to an immunoturbidimetric assay apolipoprotein E detection kit, and relates to the technical field of kit. The kit is composed of three parts which are an R1 reagent, an R2 reagent, and a calibrator. The R1 reagent is composed of 40-50mmol / L of a buffer solution with a pH value of 7, 70-150mmol / L of a surfactant, 15-30mmol / L of disodium ethylenediamine tetraacetate, and 0.1-1% of a preservative. The R2 reagent is prepared by adding anti-human-apolipoprotein-E antiserum with a volume ratio of 30-50% into a certain amount of the R1 reagent. The calibrator is 80-200g / L ApoE antigen, and also comprises 0.2-15% of a preservative, 1-4% of a stabilizing agent, and 1-10% of a surfactant, wherein the percentages are human serum matrix volume amount percentages. The kit has the advantages of simple operation, high sensitivity, good specificity, fast determination, and accurate and reliable result.

Description

technical field [0001] The invention relates to the technical field of kits, in particular to an immunoturbidimetric method apolipoprotein E detection kit. Background technique [0002] Apolipoprotein E (ApoE) is a glycoprotein of 299 amino acids bound to phospholipids. Its molecular weight is 34kD. ApoE can be synthesized in various tissues, but the liver is the main one. First, a propeptide containing 317 amino acids is synthesized. Mature ApoE is formed by ylation and asialolation of extracellular fluid; ApoE is secreted into the blood and transferred to lipoproteins. ApoE is a structural protein necessary for lipoproteins. It can participate in lipoprotein metabolism, regulate cholesterol levels, activate lecithin sterol lipid transferase (LCAT) by binding to the receptors of various tissue cells, and has a certain immune function. Regulatory effect. Determination of ApoE provides an important theoretical basis for the diagnosis and treatment of hyperlipidemia, athe...

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Problems solved by technology

[0003] Known methods for measuring ApoE include chromatography, electrophoresis, and immunoassay. Among them, chromatography and electrophoresis are cumbersome to operate, and they cannot perform batch sample analysis and directly go to full-automatic biochemical analyzers. Immunodiffusion, radioimmunoassay, fluorescence-labeled immunoassay, enzyme-labeled immunoassay, and chemiluminescence immunoassay also have many deficiencies; if special equipment is required, the sample needs to be processed, and it cannot be used on a fully automatic biochemical analyzer Perform batch monitoring and analysis, etc.

The immunoturbidimetric method commonly used in clinical practice is popular because of its small amount of sample, which can be directly analyzed in batches on a fully automatic biochemical analyzer, and is easy to operate; however, the currently established methods and reagents have some shortcomings and deficiencies, mainly in : First, the antibody titer is not high, and the specificity, affinity, and affinity are not good; second, the calibration serum is based on human serum, although the human serum with negative hepatitis B surface antigen, negative HIV test, and normal alanine aminotransferase However, it is also difficult to rule out the possibility that there are no other infectious diseases, which brings little danger to the operator; and the calibration serum is a freeze-dried product, and the value of each batch is different. It needs to be reconstituted with water before use. It is extremely inconvenient; in addition, after reconstitution, it must be frozen and stored, especially it cannot be thawed repeatedly, which not only causes waste of reagents, but also cannot guarantee the quality, the measurement results vary greatly, and its stability is not good; the third is for high-fat, The anti-interference ability of jaundice and hemolysis samples is poor; the fourth is that the single-point calibration solution is used for calibration, which does not conform to the calculation of the curve regression equation, resulting in the phenomenon of low high values ​​and high low values, and the measured results are inaccurate; fifth, antiserum Precipitation occurs in a short period of time, making it difficult to operate on the machine and affecting the detection effect

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