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Magnetic microparticle separating chemiluminescence immune analysis determination reagent kit for detecting related sign object and preparing method thereof

A technology of markers and magnetic particles, which is applied in the field of immunoanalysis medicine, can solve the problems of limited popularization and inability to be widely used in clinical diagnosis and scientific research, and achieve the effects of ensuring sensitivity, improving sensitivity, and facilitating operation and production

Active Publication Date: 2009-03-04
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing foreign chemiluminescence immunoassay kit is a closed automatic chemiluminescence measurement system, which requires an expensive automatic chemiluminescence measuring instrument, which limits the promotion and use, and cannot be widely used in clinical diagnosis and scientific research.

Method used

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  • Magnetic microparticle separating chemiluminescence immune analysis determination reagent kit for detecting related sign object and preparing method thereof
  • Magnetic microparticle separating chemiluminescence immune analysis determination reagent kit for detecting related sign object and preparing method thereof
  • Magnetic microparticle separating chemiluminescence immune analysis determination reagent kit for detecting related sign object and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of CA19-9 Magnetic Particle Separation Chemiluminescent Immunoassay Assay Kit of the present invention

[0034] 1. Marker preparation

[0035] 1. The horseradish peroxidase-labeled CA19-9 monoclonal antibody adopts the sodium periodate oxidation method, and the specific labeling process is as follows:

[0036] Weigh 5mg HRP and dissolve in 1ml double distilled water. Add 0.2ml freshly prepared 0.1M NaIO to the supernatant 4 The solution was stirred at room temperature in the dark for 20 minutes. Add 20μl of 0.2M pH9.5 carbonate buffer to increase the pH of the above hydroformylated HRP to 9.0-9.5, then immediately add 10mg of antibody in 1ml of 0.01M carbonate buffer, and stir gently at room temperature for 2 Hour. The above solution was put into a dialysis bag, and dialyzed against 0.15M pH7.4 PBS at 4°C overnight. Centrifuge at 10,000rpm for 30 minutes to remove the precipitate. The supernatant is the enzyme conjugate. Add an equal amount of...

Embodiment 2

[0069] Example 2 Preparation of the alpha-fetoprotein (AFP) magnetic particle separation chemiluminescent immunoassay assay kit of the present invention

[0070] Except that the enzyme and biotin-labeled antibody were replaced by AFP monoclonal antibody as the marker mixture, and the concentration of the calibrator was 0, 5, 20, 60, 200, 500 ng / ml, the AFP magnetic field was prepared using the same method as in Example 1. Microparticle Separation Chemiluminescent Immunoassay Assay Kit.

[0071] According to routine manufacturing and verification procedures in the art, the prepared kit is verified, see Table 2 below:

[0072] Table 2

[0073] Test items Inspection standards test result accuracy The average recovery rate is 90.0-110.0% 103.8％ specificity Cross-reaction rate with its analogues ≤0.01% 0.004％ Precision CV(%) ≤15％(n＝10) 6％ sensitivity ≤2ng / mL 1.2ng / mL stability Store each reagent component at 37°C for at least 6 ...

Embodiment 3

[0078] Example 3 Preparation of Follicle Stimulating Hormone (FSH) Magnetic Particle Separation Chemiluminescence Immunoassay Assay Kit of the present invention

[0079] FSH magnetic particles were prepared using the same method as in Example 1, except that the enzyme and biotin-labeled antibodies were replaced by FSH monoclonal antibodies as the label mixture, and the concentrations of the calibrator were 0, 1.0, 2.5, 10, 40, and 160 mIU / ml. Separate Chemiluminescent Immunoassay Assay Kit.

[0080] According to routine manufacturing and verification procedures in the art, the prepared kit is verified, see Table 3 below:

[0081] table 3

[0082] Test items Inspection standards test result accuracy The average recovery rate is 90.0-110.0% 101.9％ specificity Cross-reaction rate with its analogues ≤0.01% 0.005％ Precision CV(%) ≤15％(n＝10) 7％ sensitivity ≤0.5mIU / mL 0.4mIU / mL stability Store each reagent component at 37°C for at...

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Abstract

The invention relates to the immunoassay medical field, particularly provides a magnetic particle separation chemiluminescence immunoassay assay kit and a preparation method thereof used for detecting disease related markers. The kit of the invention comprises: 1) a calibrator; 2) magnetic particles which are coated with streptavidin; 3) disease related marker antibodies of enzyme markers and biotin markers; and 4) a chemiluminescence substrate. Further, the method for preparing the kit according to the invention includes the following steps: 1) pure raw materials are used to prepare the calibrator; 2) the streptavidin is used to coat the magnetic particles; 3) the mixed liquid of the enzyme and the biotin markers are prepared; 4) the calibrator, the chemiluminescence substrate as well as the mixed liquid of the enzyme and the biotin markers are packaged in a separated way; and 5) a finished product is packaged. The kit has the advantages of convenience, rapidness, sensitivity, stability, and the like.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine, in particular, the invention provides a magnetic particle separation chemiluminescence immunoassay assay kit and a preparation method thereof. Background technique [0002] In the past ten years, the research and application of marker immunoassay technology has developed rapidly, and has been widely used in various fields of biomedical basic theory research and clinical disease diagnosis. Among them, the technology is mature, advanced and practical, and easy to popularize mainly include: radioimmunoassay, enzyme immunoassay, time-resolved fluorescence immunoassay and chemiluminescence immunoassay. The basic theory of these ultra-trace detection technologies is generally the same, but the tracers used and the signals emitted are different. According to a large number of experimental results and clinical application data, from the perspective of practicability, stability, accuracy and develo...

Claims

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Application Information

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IPC IPC(8): G01N33/543G01N33/53G01N33/58G01N33/577G01N21/76
Inventor 胡国茂唐宝军应希堂
Owner CHEMCLIN DIAGNOSTICS CO LTD
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