Kit for testing lipoprotein a(Lp(a))

A technology for detecting kits and lipoproteins, which is applied in the field of medical immunity, can solve the problems of decreased reagent quality, prone to coalescence, poor reagent stability, etc., and achieves the effects of simple detection, high sensitivity and low production cost.

Inactive Publication Date: 2016-06-15
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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  • Kit for testing lipoprotein a(Lp(a))
  • Kit for testing lipoprotein a(Lp(a))

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: Preparation of Lp(a) detection kit

[0025] The kit of the present invention relates to the main raw materials of reagents as follows:

[0026] 1. Lp(a) antibody: monoclonal antibody (commercially available).

[0027] 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.

[0028] The preparation of the main reagent of this embodiment is as follows:

[0029] Reagent R1: phosphate buffer solution containing 1.5% PEG6000 (polyethylene glycol 6000), 95mmol / L NaCl, this reagent is a colorless transparent solution.

[0030] Reagent R2: polystyrene latex particles with a particle diameter of 80 nm were sensitized with an anti-human Lp(a) antibody. The reagent is a milky white solution. Specific steps are as follows:

[0031] 1. Take 1ml (100mg / ml) latex, wash 3 times with 0.02M (mol / L), pH 5.0 MES solution (2-morpholineethanesul...

Embodiment 2

[0038] Embodiment 2: Determination of Lp(a)

[0039] Detection tool: Hitachi 7060 automatic analyzer.

[0040] Analysis method: two-point endpoint method; main wavelength: 570nm, secondary wavelength: 700nm; 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.

[0041] 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

[0042] Embodiment 3: Lp (a) detection kit performance evaluation

[0043] 1. Analytical Sensitivity Assessment

[0044] Use 5% bovine serum albumin solution as a blank sample, and the blank sample should not contain the analytes. 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 6.42mg / L.

[0045] Table 1

[0046]

[0047] 2. High value linear evaluation

[0048] Mix 1 part of low-value serum (10mg / L) and 1 part of high-value serum (1000mg / L) at 9:1, 4:1, 2:1, 1:1, 1:2, 1:3, 1:4 , 1:9 (the sample sequence number is No. 1~6), prepared 6 samples with different concentrations, each sample was measured twice, as can be seen from Table 2,

[0049] The highest detection range of the detection kit of the present invention can...

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Abstract

The invention discloses a kit for testing lipoprotein a(Lp(a)). The kit comprises a reagent R1 and a reagent R2, wherein the reagent R1 is a buffer solution, and the reagent R2 is a mixture of lipoprotein a(Lp(a)) antibody sensitized polystyrene latex particles and the buffer solution. The kit has the advantages of simplicity and rapidness in detection, high sensitivity, good accuracy, high anti-interference capacity and low production cost; a method for detecting the lipoprotein a(Lp(a)) is latex enhanced immunoturbidimetry, with the adoption of the method, lipoprotein a(Lp(a)) can be detected more economically, more conveniently and more quickly, and the kit is suitable for automatic biochemical analyzers in most hospitals, and in particular, quick and quantitative detection can be realized during emergency treatment.

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 a lipoprotein a (Lp (a)) assay kit and a detection kit. Background technique [0002] Lipoprotein a assay kit, this product is used for in vitro quantitative determination of lipoprotein (a) (Lp(a)) content in human serum, for auxiliary diagnosis. Lipoprotein (a) is a unique lipoprotein, its lipid composition structure is very similar to LDL, and it is named after it contains a special apolipoprotein (a). In 1987, it was discovered that the primary structure of lipoprotein (a) has significant homology with plasminogen, and its increase has a tendency to lead to thrombosis. The level of Lp(a) in the body is not related to blood lipids and apolipoproteins, and is an important independent risk factor for atherosclerotic heart and brain diseases. It has great diagnostic value for the onset, course and outcome of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/92
CPCG01N33/92G01N2333/47
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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