IGF-1 detection kit as well as preparation method and detection method thereof

A technology of IGF-1 and detection kit, which is applied in the fields of in vitro diagnosis, medicine and immunity, can solve the problems of reducing sensitivity, etc., and achieve the effect of simple and convenient operation, good stability and wide detection range

Pending Publication Date: 2022-05-27
NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, even if the two-step cleaning of the sandwich method is used, there is still a risk of HOOK effect, which reduces the sensitivity of detection.

Method used

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  • IGF-1 detection kit as well as preparation method and detection method thereof
  • IGF-1 detection kit as well as preparation method and detection method thereof
  • IGF-1 detection kit as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1I

[0061] Example 1IGF-1 detection kit

[0062] IGF-1 assay kits include release agents, displacers, solid phase reagents, luminescent reagents, calibrators, and controls.

[0063]In the present embodiment, the releaser is glycolic acid; the replacement agent is sodium citrate; the solid phase reagent is an IGF-1 antibody-coated magnetic particle suspension, the magnetic particle concentration is 0.1mg / ml, the coated antibody is a monoclonal antibody; the luminescent reagent is acrididinate labeled IGF-1 antibody liquid, the antibody concentration is 0.1μg / ml, the labeled antibody is a monoclonal antibody, composed of two different antigenic sites for IGF-1; the calibrator is prepared by IGF-1 antigen at a concentration of 0~ 2000ng / Liquid calibrators with 6 different concentration points in the ml range; the quality control is a liquid control product formulated by IGF-1 antigen with a concentration of 2 different concentration points in the range of 0 to 300 ng / ml.

[0064] So...

Embodiment 2

[0079] Example 2 preparation method of the kit

[0080] The preparation method of the IGF-1 detection kit, including the following steps:

[0081] Preparation of solid phase reagent dilution: buffer, inorganic salt, protein protector, surfactant, chemical stability, preservative, blocker sequentially dissolved into purified water, adjusted pH to 6.0 ~ 8.0 range, according to the amount of preparation for volume, filtered by 0.22μm filter and prepared.

[0082] Preparation of luminescent reagent diluent: buffer, inorganic salt, protein protector, surfactant, chemical stability, preservative, blocker sequentially dissolved into purified water, adjust the pH to 5.0 ~ 7.0 range, according to the amount of preparation for volume, filtered by 0.22 μm membrane after backup.

[0083]Preparation of calibrator dilution: buffer, inorganic salt, protein protector, surfactant, chemical stability, preservatives in turn dissolved into purified water, adjust the pH to 5.0 ~ 8.0 range, according t...

Embodiment 3I

[0104] Example 3 IGF-1 detection method

[0105] Measuring instrument: MS-i3080 fully automated chemiluminescence analyzer;

[0106] Analytical method: two-step double antibody sandwich method;

[0107] Analytical parameters: releasant 20 μl, displacer 60 μl, solid phase reagent 40ul, luminescence reagent 60ul, sample: 30ul; total incubation time: 30 min;

[0108] Assay steps: first add release agent and sample incubation in the reaction tube for 10 min, then add displacer and solid phase reagent for incubation for 5 min, the instrument automatically cleans, out of the reaction tube liquid supernatant, and then add luminescent reagent, 37 °C incubation for 15 min, after cleaning to measure the luminescence value RLU;

[0109] Calibration curve production: take the concentration of the calibration product as the abscissa, and the corresponding luminous value RLU of each concentration of the calibrator as the vertical coordinate, and make the logit-log(4p) function curve;

[0110] S...

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Abstract

The invention discloses an IGF-1 detection kit and a preparation method and a detection method thereof, the IGF-1 detection kit comprises a releasing agent, a displacing agent, a solid-phase reagent, a light-emitting reagent, a calibrator and a quality control product, the solid-phase reagent is a magnetic particle suspension coated with an IGF-1 antibody, the concentration of magnetic particles is 0.1-0.8 mg / ml, and the coated antibody is a monoclonal antibody or a polyclonal antibody. The kit for clinical detection of IGF-1 is high in sensitivity, high in detection efficiency and convenient to use, can be used for auxiliary diagnosis of deficiency and excess of growth hormone (GH), and is easy and convenient to operate, high in sensitivity, high in specificity and wide in detection range.

Description

Technical field [0001] The present invention relates to the field of medicine, immunology, in vitro diagnostic techniques, in particular to the IGF-1 detection kit and the preparation method and detection method thereof. Background [0002] Insulin-like growth factor-1 (IGF-1) is a single-stranded polypeptide with a molecular weight of approximately 7.5 kDa, which consists of 70 amino acid residues, is commonly expressed in tissues, but is mainly synthesized and secreted by the liver and regulated by growth hormone. Circulating in the blood is mainly present in the form of a ternary complex formed in combination with insulin growth factor-binding protein-3 (IGFBP-3) and acidic unstable subunits (ALS). Clinically, IGF-1 is a marker that can be used to screen for growth hormone deficiency (GHD). In the body, growth hormone (GH) stimulates the synthesis of IGF-1, but because the half-life of growth hormone (GH) is short and the concentration level is easily affected by some external...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/74G01N33/543G01N33/532G01N21/76
CPCG01N33/74G01N33/54346G01N33/54326G01N33/532G01N21/76G01N2333/65G01N2800/04
Inventor 邹继华张华杰贾江花李富勇王芬李倩靓张明宇潘碧莹
Owner NINGBO MEDICAL SYSTEM BIOTECHNOLOGY CO LTD
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