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Colloidal gold test strip for fast detecting rheumatoid factors

A technology of rheumatoid factor and colloidal gold test paper, which is applied in measurement devices, instruments, scientific instruments and other directions to achieve the effects of cost reduction, simple operation and convenient use

Inactive Publication Date: 2012-10-03
蓝十字生物药业(北京)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] At present, there are few reports on products for the rapid detection of rheumatoid factor that can guarantee the sensitivity and specificity of detection at the same time, and are easy to use, simple to operate, and save resources.

Method used

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  • Colloidal gold test strip for fast detecting rheumatoid factors
  • Colloidal gold test strip for fast detecting rheumatoid factors
  • Colloidal gold test strip for fast detecting rheumatoid factors

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] According to the principle of colloidal gold detection, the mucus end of the colloidal gold test strip of the present invention is immersed in the liquid to be tested, or the sample fiber layer at the mucus end is dripped with the liquid to be tested, and the substance in the liquid to be tested is in the capillary of the fiber layer material Under the action, it moves along the test strip from the sample end to the hand-held end. When the target substance in the test solution passes through the gold label fiber layer, it adheres to the colloidal gold-labeled protein and moves towards the absorbent paper pad. When the target substance passes through the detection line, the colloidal gold aggregates on the detection line due to the specific combination of the target substance and the substance coated on the detection line, which makes the detection line develop color. The remaining colloidal gold-labeled proteins continue to migrate to the control line, because the colloi...

Embodiment 2

[0057] Embodiment 2. Preparation performance verification of test strips

[0058] Biologically active raw materials: anti-μ chain IgM, human denatured IgG, and anti-human IgG are purchased from ArtronBioResearch Inc., Canada

[0059] Reagents: bovine serum albumin (BSA) and casein were purchased from Sigma.

[0060] Nitrocellulose membrane: Sartorius, Germany

[0061] The test strip preparation procedure is as follows

[0062] Step 1. Mix anti-μ chain IgM with human denatured IgG as follows:

[0063] Prepare a mixture of anti-μ chain IgM and human denatured IgG, dilute the anti-μ chain IgM and human denatured IgG with 20mM PBS, and prepare a specific concentration so that the coating concentration is shown in Table 1.

[0064] Step 2. Preparation of colloidal gold-labeled human denatured IgG

[0065] Take a 40nm colloidal gold solution, add 0.2M K at a final concentration of 16 μl / ml 2 CO 3 , add human denatured IgG to prepare a specific concentration so that the coating...

Embodiment 3

[0090] Embodiment 3. Determination experiment of the minimum detection limit of the product of the present invention.

[0091] RF is the only serological diagnostic standard for rheumatoid arthritis. At present, there is no unified statement on the definition of the reference value, which is generally set at <20-30IU / ml.

[0092] 1. Clinical reference value or critical value of similar reagents

[0093](1) The normal reference value of immune turbidimetry in "Practical Medical Test Reference Values ​​and Analysis of Abnormal Results" published by People's Medical Publishing House: <30KU / L;

[0094] (2) Chinese Journal of Modern Medicine, 2004, 14 (14), "The Clinical Significance of Detecting Rheumatoid Factors IgM-RF, IgG-RF and IgA-RF in Rheumatoid Arthritis" and Beckman's instructions The critical value of Beckman immunoturbidimetric assay reagent is 20IU / mL;

[0095] (3) Jiangxi Medical Laboratory Journal, 2002, 20 (5), "A Comparative Study of Latex Agglutination Test and...

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Abstract

The invention discloses a colloidal gold test strip for fast detecting rheumatoid factors, belonging to medical test consumables. The colloidal gold test strip is characterized in that human denatured IgG with a colloidal gold label is enveloped on a gold label fiber pad; anti-mu chain IgM and human denatured IgG are enveloped on a T line, and the ratio of unit area envelop quantity of the human denatured IgG on the colloidal gold label, the anti-mu chain IgM and human denatured IgG on the T line on the gold label fiber pad is 0.133-0.889 to 5 to 1. The test strip uses an antibody capture method and a double antigen sandwich method principle during detection, has sensitivity and specificity, can fast detect the rheumatoid factors in human serum, plasma or whole blood by combining with an immune colloidal gold technique and has the advantages of simplicity, sensitivity and accuracy.

Description

[0001] technology field, [0002] The invention belongs to the field of biological detection and relates to a medical detection consumable, in particular to a colloidal gold test strip for rapid detection of rheumatoid factor. Background technique [0003] Rheumatoid arthritis (RA) is an autoimmune disease with chronic, symmetrical and progressive polyarthritis as the main manifestation, and its etiology is still unclear. 0.32% to 0.36% (Tang Fulin. Diagnosis and treatment of rheumatoid arthritis should be standardized, Chinese Medical Journal, 2004, 84 (12), 971-973). It is generally believed that it is related to infection, heredity, endocrine metabolism, and nutrition. Cold and humidity are the main causes of its disease. RF was first discovered in the serum of patients with rheumatoid arthritis and is an autoantibody against denatured IgG. The positive rate of patients with rheumatoid arthritis (RA) is 70%-80%, the positive rate of systemic lupus erythematosus (SLE) is ...

Claims

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Application Information

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IPC IPC(8): G01N33/558
Inventor 聂丽芳孙茜
Owner 蓝十字生物药业(北京)有限公司
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