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Full-range C-reactive protein detection kit

A detection kit and reactive protein technology, applied in the field of medical immunology, can solve problems such as narrow measurement range, low sensitivity, inability to diagnose infectious diseases or observe curative effect, and achieve high sensitivity and accuracy, high accuracy , the effect of long-term stability

Active Publication Date: 2013-09-18
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The routine clinical method for measuring CRP is the immunoturbidimetric method, and the measuring range is generally 3-200 mg / L, but the sensitivity is relatively low, and it is impossible to accurately measure the CRP content below 3 mg / L. Risk indicators for predicting the risk of cardiovascular and cerebrovascular diseases in the future
The detection range of clinical high-sensitivity CRP is 0.1-100mg / L, and the measurement range is relatively narrow, so it is impossible to accurately measure the content of CRP at high concentrations. Therefore, it cannot be used for the diagnosis of infectious diseases or observation of curative effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of embodiment 1 full range CRP reaction kit

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

[0025] 1. Rabbit anti-human CRP antibody (20.5 mg / mL): The titer measured by indirect ELISA method is above 1:500000.

[0026] 2. latex: two kinds of styrene latexes that the present invention adopts are styrene latexes with carboxyl groups, and the average particle diameters of styrene latex particles are 60nm and 240nm respectively. Among them, 60nm was purchased from Bangs Company, and 240nm was self-made. The preparation method was: 4.2595g styrene (St), 0.6000g methacrylic acid (MAA), and water were added to a three-necked flask and stirred for 10-30min; , N into the mixed system for 30min 2 , then add 50ml of aqueous solution containing potassium persulfate and sodium chloride (which contains potassium persulfate 0.1065g, sodium chloride 0.0032g), and then continue to feed 20min of N 2 Then heat up to ...

Embodiment 2

[0033] The mensuration of embodiment 2C reactive protein

[0034] Detection tool: Hitachi 7060 automatic analyzer.

[0035] Analysis method: 2-point endpoint method; main wavelength: 570nm, secondary wavelength: 700nm; sample volume: 4.0μl (microliter); R1: 140μl; R2: 140μl; calibration method: spline function Spline; reaction direction: rising; determination Temperature: 37°C; after mixing the sample with R1, read the absorbance A at 10 seconds 1 ; Add R2 at 3-5 minutes, read absorbance A at 5 minutes 2 . The absorbance of the reaction was calculated as A 2 with A 1 calibration difference.

[0036] Calculation method: multi-point calibration, using spline function as the calculation mode, and making a dose / response curve 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.

[0037] Reference range: serum C-reactive protein1mg / L when healthy people have no infection, ...

Embodiment 3

[0038] Example 3 Test of various performance indicators of the full-scale CRP detection kit

[0039] 1. Sensitivity test

[0040] Measure the samples of 6 kinds of different CRP contents, each sample is measured 10 times, by calculating mean value and SD value, as can be seen from Table 1, the sensitivity of detection kit of the present invention is 0.3mg / L.

[0041] Table 1

[0042] CRP (mg / L)

Measurement times

average

2.6SD

M+2.6SD

M-2.6SD

0

10

0.0000

0.031

0.05

-0.02

0.1

10

0.0904

0.044

0.10

0.01

0.2

10

0.1878

0.056

0.16

0.04

0.3

10

0.2915

0.058

0.21

0.08

0.4

10

0.3977

0.044

0.23

0.12

0.5

10

0.4912

0.032

0.25

0.15

[0043] 2. High value linear determination

[0044] Measure 10 kinds of samples with differen...

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Abstract

The invention discloses a full-range C-reactive protein detection kit, which comprises a reagent R1 and a reagent R2. The reagent R1 is a proper buffer solution; the reagent R2 is formed by the following steps: sensitizing two or more styrene latex with different average grain diameters by using an anti-human C-reactive protein antibody; placing the sensitized styrene latex with the different average grain diameters into the proper buffer solution respectively to form reagents; and finally mixing the reagents in different proportions, wherein the reagent R2 contains 0.8 to 3.5 mg / mL of the styrene latex combined with the anti-human C-reactive protein antibody. The full-range C-reactive protein detection kit not only can measure lower CRP content but also can measure high CRP content, and has the advantages of high sensitivity and stability and accurate measurement.

Description

technical field [0001] The invention belongs to the field of medical immunology, and relates to an immunodetection reagent, and further, the invention relates to a full-range C-reactive protein detection kit. Background technique [0002] C-reactive protein (CRP) is a kind of capsular C polysaccharide that can bind to Streptococcus pneumoniae. It is an acute phase protein synthesized by liver cells when the body is stimulated by microbial invasion or tissue damage. It exists in trace amounts in the serum of healthy people ( about 580ng / ml). When an inflammatory disease occurs or tissue ulceration or necrosis occurs, it will rise rapidly in the blood, but its content will return to normal with the recovery of tissue structure and function. Therefore, the determination of high-concentration CRP has extensive clinical significance in diagnosing the severity, progress, prognosis and therapeutic effect of bacterial infection, cancer and other diseases. [0003] On the other han...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68G01N33/531G01N33/559G01N21/31
Inventor 邹炳德
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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