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Alpha 1-microglobulin detection kit

A detection kit and microglobulin technology, which is applied in the field of medical immunity, can solve the problems of reagent quality decline, poor reagent stability, and easy coalescence, etc., and achieve the effect of simple detection, low production cost and high sensitivity

Inactive Publication Date: 2016-06-22
宁波天康生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the connection between antibody and latex is usually carried out by chemical coupling method. As an R2 reagent, it is very easy to coalesce, which makes the quality of the reagent decrease with the prolongation of storage time.
Poor reagent stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of α1-microglobulin detection kit

[0024] The kit of the present invention relates to the main raw materials of reagents as follows:

[0025] 1. α1-microglobulin antibody: polyclonal antibody (commercially available).

[0026] 2. Latex: The present invention only exemplarily uses polystyrene latex particles (commercially available) with a diameter of 80-200 nm and carboxyl groups to carry out experiments.

[0027] The preparation of the main reagent of this embodiment is as follows:

[0028] Reagent R1: phosphate buffer solution containing 2.5% PEG6000 (polyethylene glycol 6000), 95mmol / L NaCl, this reagent is a colorless transparent solution.

[0029] Reagent R2: polystyrene latex particles with a particle diameter of 120 nm were sensitized with an anti-human α1-microglobulin antibody. The reagent is a milky white solution. Specific steps are as follows:

[0030] 1. Take 1ml (100mg / ml) latex, wash 3 times with 0.02M (mol / L), pH 5.0 MES solu...

Embodiment 2

[0037] Example 2: Determination of α1-microglobulin

[0038] Detection tool: Hitachi 7060 automatic analyzer.

[0039] Analysis method: two-point endpoint method; main wavelength: 600nm, secondary wavelength: -: sample volume: 2ul (microliter); R1: 200ul; R2: 50ul; reaction direction: rising; measurement temperature: 37 ° C; sample mixed with R1 After mixing, read the absorbance A1 at 10 seconds; add R2 at 3-5 minutes, and read the absorbance A2 after 5 minutes. The reaction absorbance was calculated as the difference between A2 and A1.

[0040] Calculation method: multi-point calibration, the dose / response curve is made according to the absorbance and reference serum value, and the sample content can be calculated on the dose / response curve according to its absorbance value.

Embodiment 3

[0041] Example 3 α1-microglobulin detection kit performance evaluation

[0042] 1. Analytical Sensitivity Assessment

[0043] Use 5% bovine serum albumin solution as a blank sample, and the blank sample should not contain the analyte. 20 consecutive detections were performed on the biochemical analyzer, and the mean and standard deviation SD of the 20 results were calculated. The detection limit of the reporting method is the mean value of the blank plus two standard deviations (+2SD). As can be seen from Table 1, the sensitivity is 1.03mg / L.

[0044] Table 1

[0045]

[0046] 2. High value linear evaluation

[0047] 1 part of low-value serum (5mg / L) and 1 part of high-value serum (120mg / L) were divided into 9:1, 4:1, 2:1, 1:2, 1:3, 1:9 (sample order No. 1 to No. 6), prepared 6 samples with different concentrations, each sample was repeatedly measured twice, as can be seen from Table 2, the highest detection range of the detection kit of the present invention can reach...

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Abstract

The invention discloses an alpha 1-microglobulin detection kit. The alpha 1-microglobulin detection kit comprises a reagent R1 and a reagent R2, wherein the reagent R1 is a buffer solution; the reagent R2 is a mixture of an alpha 1-microglobulin antibody-sensitization polystyrene latex particles and the buffer solution. The alpha 1-microglobulin detection kit disclosed by the invention has the advantages that 1, the detection is simple and quick, the sensitivity is high, the accuracy is good, the anti-jamming capacity is strong, and the production cost is low; 2, an alpha 1-microglobulin detection method adopted by the invention is a latex-enhanced turbidimetric immunoassay method, so that the alpha 1-microglobulin detection method enables the detection of alpha 1-microglobulin to be more economic, more convenient and quicker, is suitable for an automatic biochemical analyzer in most hospitals, and quick quantitative detection on emergency treatment can be specially realized.

Description

technical field [0001] The invention belongs to the field of medical immunity and relates to an immunological detection reagent, furthermore, the invention relates to an α1-microglobulin detection kit. Background technique [0002] The invention is suitable for the assay kit of α1-microglobulin, and the product is used for in vitro quantitative determination of the content of α1-microglobulin in human serum or urine for auxiliary diagnosis. α1-microglobulin (α1-MG or AMG) is an indicator for evaluating renal function. Increased urine concentration is mainly seen in renal tubular damage, such as chronic renal failure; increased serum levels indicate renal insufficiency caused by various kidney diseases , such as early glomerular injury, primary glomerulonephritis, interstitial nephritis, diabetic nephropathy, etc., the decrease in blood level indicates severe liver damage, which is seen in patients with liver disease. [0003] Diagnostic methods: RIA method, ELISA method, CL...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/68
Inventor 陆雪龙宋高峰李清华周裕国
Owner 宁波天康生物科技有限公司
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