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Cystatin-C latex enhanced turbidimetric immunoassay kit for inhibiting interference of rheumatoid factors

A rheumatoid factor and latex enhancement technology, applied in biological testing, material inspection products, measuring devices, etc., can solve the problems of complex reagent preparation process, loss of antibody antibody activity, and increased reagent cost, so as to achieve accurate and reliable measurement results and increase speed and sensitivity, the effect of eliminating interference

Active Publication Date: 2018-01-19
SICHUAN MACCURA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, part of the antibody will be lost in the enzyme digestion and purification process of IgG, which will also affect the activity of the antibody to a certain extent, increasing the cost of the reagent, and more importantly, the preparation process of the reagent is further complicated, which sets an insurmountable obstacle for controlling the difference between batches of reagents. , thus limiting the clinical promotion of such reagents

Method used

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  • Cystatin-C latex enhanced turbidimetric immunoassay kit for inhibiting interference of rheumatoid factors
  • Cystatin-C latex enhanced turbidimetric immunoassay kit for inhibiting interference of rheumatoid factors
  • Cystatin-C latex enhanced turbidimetric immunoassay kit for inhibiting interference of rheumatoid factors

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment one: test in the cystatin C assay kit containing different NHS amounts

[0031] 1. Cystatin C assay reagents containing different amounts of NHS 1

[0032] Cystatin C assay reagent 1-A: 200mmol / L phosphate buffer, 120g / L sodium chloride, 200mg / L goat anti-human IgM antibody, 0g / L NHS, biological preservative Proclin300 5g / L, surfactant TX100 2g / L;

[0033] The components in Cystatin C Determination Reagent 1-B, C, D, E, F, G, H and I are the same as those in Reagent 1-A, except that the concentration of NHS is different, they are 1g / L NHS, 5g / L respectively NHS, 10g / L NHS, 20g / L NHS, 30g / L NHS, 40g / L NHS, 45g / L NHS and 50g / L NHS.

[0034] 2. Cystatin C assay kit assay reagent 2: 200mmol / L glycine buffer, 5.0g / L latex particles sensitized by anti-human cystatin C polyclonal antibody, 5g / L biological preservative Proclin300, 2g / L Surfactant TX100, 5g / L bovine serum albumin, 200g / L trehalose.

[0035] 3. Preparation of cystatin C samples containing different...

Embodiment 2

[0040] Embodiment two: contain the cystatin C assay kit of different concentrations PEG4000

[0041] 1. Cystatin C assay reagents containing different concentrations of PEG4000

[0042] Cystatin C assay reagent 1-1: 200mmol / L phosphate buffer, 120g / L sodium chloride, 200mg / L goat anti-human IgM antibody, biological preservative Proclin300 5g / L, surfactant TX100 2g / L , 0mmol / LPEG4000

[0043] The components of cystatin C assay reagents 1-2, 3, 4, 5, 6, 7 and 8 are the same as reagent 1-1, except that the concentration of PEG4000 is different, they are 0.5mmol / LPEG4000, 1mmol / LPEG4000, 2mmol respectively / LPEG4000, 3mmol / LPEG4000, 4mmol / LPEG4000, 5mmol / LPEG4000 and 6mmol / LPEG4000.

[0044] 2. Cystatin C assay kit assay reagent 2: 200mmol / L glycine buffer, 5.0g / L latex particles sensitized by anti-human cystatin C polyclonal antibody, 5g / L biological preservative Proclin300, 2g / L Surfactant TX100, 5g / L bovine serum albumin, 200g / L trehalose.

[0045] 3. Preparation of cystati...

Embodiment 3

[0050] Embodiment three: contain the cystatin C assay kit of different concentration NHS and PEG4000

[0051] 1. Cystatin C assay reagents containing different concentrations of NHS and PEG4000

[0052] Cystatin C assay reagent 1-A1: 200mmol / L phosphate buffer, 120g / L sodium chloride, 200mg / L goat anti-human IgM antibody, 0g / L NHS, biological preservative Proclin300 5g / L, surfactant TX100 2g / L, 0mmol / LPEG4000

[0053] The components in Cystatin C Determination Reagent 2-B2, C3, D4, E5, F6, G7 and H8 are the same as those in Reagent 1-A1, except that the concentrations of NHS and PEG4000 are different (1g / L NHS, 0.5mmol / LPEG4000), (5g / L NHS, 1mmol / LPEG4000), (10g / L NHS, 2mmol / LPEG4000), (20g / L NHS, 3mmol / LPEG4000), (30g / L NHS, 4mmol / LPEG4000), (40g / L NHS, 5mmol / LPEG4000) and (45g / L NHS, 6mmol / LPEG4000).

[0054] 2. Cystatin C assay kit assay reagent 2: 200mmol / L glycine buffer, 5.0g / L latex particles sensitized by anti-human cystatin C polyclonal antibody, 5g / L biological ...

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Abstract

The invention provides a cystatin-C latex enhanced turbidimetric immunoassay kit for inhibiting interference of rheumatoid factors. The kit comprises a reagent 1 and a reagent 2. The reagent 1 is a solution for promoting a reaction between antigen and antibody. The reagent 2 is an antibody-coated sensitized latex particle dispersion. The reagent 1 contains 1-40 g / L of N-hydroxysuccinimide, and thereagent 2 also can contain 0.5-4 mmol / L of PEG. The kit of the invention can effectively eliminate the interference of rheumatoid factors contained in a latex enhanced turbidimetric immunoassay sample with immunodetection results, and has characteristics of high sensitivity, good specificity, fast measurement and accurate and reliable measurement result.

Description

technical field [0001] The invention relates to the field of in vitro diagnostic reagents, in particular to a cystatin C latex-enhanced immune turbidimetric kit for inhibiting rheumatoid factor interference. Background technique [0002] Cystatin C (Cystatin, Cys C) is a cysteine ​​protease inhibitor. In nucleated cells and body fluids, it is a low molecular weight, basic non-glycosylated protein with a molecular weight of 13.3KD and composed of 122 amino acid residues. It can be produced by all nucleated cells in the body with a constant production rate. Circulating cystatin C is cleared only by glomerular filtration, is an endogenous marker of changes in glomerular filtration rate, and is reabsorbed in the proximal convoluted tubule, but is completely eliminated after reabsorption It is metabolized and decomposed and does not return to the blood. Therefore, its blood concentration is determined by glomerular filtration, independent of any external factors, such as gender,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/544G01N33/68
CPCG01N33/54313G01N33/54393G01N33/544G01N33/68G01N33/721
Inventor 耿英利罗湘宇甘萍萍黎明马春霞
Owner SICHUAN MACCURA BIOTECH CO LTD