Compounded latex particle-enveloped cystatin C detection kit

A detection kit and composite latex technology, applied in the field of medical immunology in vitro diagnosis, to achieve high sensitivity, accurate and reliable measurement results, and good specificity

Inactive Publication Date: 2012-08-15
AILEX TECH GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, latex particle-enhanced turbidimetry is the most common method, but the highest detection limit of latex particle-enhanced turbidimetry can only reach 0.1 mg / l, and the linearity can only reach 8 mg / l, which has limitations in clinical application

Method used

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  • Compounded latex particle-enveloped cystatin C detection kit
  • Compounded latex particle-enveloped cystatin C detection kit
  • Compounded latex particle-enveloped cystatin C detection kit

Examples

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Embodiment 1

[0022] The diluent of the present invention is configured from the following materials.

[0023] Reagent R1 was prepared as follows:

[0024] PH7.4 phosphate buffer 45mmol / l;

[0025] Polyethylene glycol 6000 85mmol / l;

[0026] Disodium EDTA 8.5mmol / l;

[0027] NaN3 accounted for 0.9% of the total reagent R1.

[0028] Components can be added sequentially at room temperature, added simultaneously, or individually packaged and prepared just before assay.

[0029] Reagent R2 was prepared as follows:

[0030] The polystyrene latex particles with a diameter of 186 nm and the polystyrene latex particles with a diameter of 45 nm were mixed in a ratio of 1:4. The goat anti-human cystatin C polyclonal antibody and the mixed polystyrene latex particles were mixed at a mass ratio of 30:100. After the two were mixed evenly, they were adsorbed at 37°C for 8 hours, and then dialyzed to remove the unlinked antibody. Blocking solution consisting of 0.1% skimmed milk powder and 0.2mm gly...

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Abstract

The invention relates to the field of medical immunity in-vitro diagnosis, and in particular relates to a determination kit for detecting cystatin C in blood serum. The kit comprises a reagent R1, a reagent R2 and a calibrator, wherein the reagent R1 is a phosphate buffer system which comprises 30-60mmol/l phosphate buffer solution with PH value of 7.2-7.6, 60-95mmol/l polyethylene glycol 6000-8000 and 6-13mmol/l ethylene diamine tetraacetic acid. The reagent R2 comprises two kinds of polystyrene latex particle sensitization particles with different sizes and enveloped by goat anti-human cystatin C polyclonal antibody; and the reagent R2 also comprises latex diluent and confining liquid. The calibrator is 0-10mg/l bovine serum matrix and also comprises 0.2-2.2% preservative and 1-10% stabilizer. Compared with the prior art, the kit provided by the invention has the characteristics of high sensitivity, good specificity, high speed and accurate and reliable determination result.

Description

[technical field] [0001] The invention relates to the field of in vitro diagnosis of medical immunity, in particular to a kit for measuring cystatin C in serum. [Background technique] [0002] Kidney disease is a common clinical disease, and renal dysfunction caused by various reasons is a risk factor for the progression to end-stage renal disease and cardiovascular disease. The only way to stop kidney disease from getting worse is to diagnose it early and treat it early to reverse damaged kidney function. The concentration of cystatin C is hardly affected by prerenal factors, and can be freely filtered through the glomeruli without reabsorption and excretion by renal tubules, and there is no extrarenal excretion pathway. Many studies have found that cystatin C is a sensitive indicator reflecting renal function damage. [0003] The latex particle-enhanced turbidimetric immunoassay (PETIA) is a relatively stable and accurate method for homogeneous immune turbidimetric detec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
Inventor 李子樵房君江
Owner AILEX TECH GRP CO LTD
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