Liquid double-reagent kit for measuring free light chains in serum or urine by double-latex method

A free light chain and double latex technology, applied in the field of medical immunology, can solve the problems of low sensitivity, large sample size, and distorted results, and achieve the effects of wide linear range, strong specificity, and high sensitivity

Active Publication Date: 2011-09-07
BEIJING STRONG BIOTECH INC
View PDF9 Cites 33 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Theoretically, the level of free light chains can reflect the patient's condition and treatment effect in real time; 2. A single measurement of free light chains in urine cannot accurately judge the condition because: under normal circumstances, the increase of FLC in urine It can be detected synchronously in serum and fluid. If the patient with B cell malignant proliferation disease is accompanied by renal failure, the change of light chain in urine cannot be detected, which will lead to misdiagnosis, while the determination of FLC in serum will not be disturbed, which is more diagnostically accurate. precise
Moreover, when using urine as a sample, the patient's 24-hour urine needs to be collected, and the sample size is large and the stability is poor.
[0007] Although studies have shown that the clinical significance of monitoring free light chains in blood is high, the development of determination of free light chains in serum is relatively slow due to the following aspects
One, traditional methods have low sensitivity and cannot be accurately quantified, such as: electrophoresis, immunofixation electrophoresis, etc., the double latex method used in the present invention has a sufficiently high sensitivity; two, specific antibody prepa

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Liquid double-reagent kit for measuring free light chains in serum or urine by double-latex method
  • Liquid double-reagent kit for measuring free light chains in serum or urine by double-latex method
  • Liquid double-reagent kit for measuring free light chains in serum or urine by double-latex method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Kit for the determination of free kappa light chains in serum or urine by double latex method

[0037] The main components and proportions of the kit are as follows:

[0038] Reagent R1:

[0039] Tris Buffer 20mmol / L

[0040] Sodium azide (preservative) 0.1%

[0041] Sodium chloride (electrolyte) 154mmol / L

[0042] PEG-6000 (polymer accelerator) 3%

[0043] Tween-20 (surfactant) 0.2%

[0044] Bovine serum albumin (stabilizer) 0.5%

[0045] Reagent R2:

[0046] Tris Buffer 20mmol / L

[0047] Sodium azide (preservative) 0.1%

[0048] Sodium chloride (electrolyte) 154mmol / L

[0049] Tween-20 (surfactant) 0.2%

[0050] Bovine serum albumin (stabilizer) 0.5%

[0051] Goat anti-human kappa light chain polyclonal antibody 5-8%

[0052] 1.0%-5.0% of latex particles of 40-80nm, 3.0%-8.0% of latex particles of 100-200nm. When the antibody is coated, the two types of latex are separately coated to ensure that the antibody is evenly coated.

[0053] Kappa light chain c...

Embodiment 2

[0062] Kit for Determination of Free Lambda Light Chain in Serum or Urine by Double Latex Method

[0063] The main components and proportions of the kit are as follows:

[0064] Reagent R1:

[0065] Tris Buffer 20mmol / L

[0066] Sodium azide (preservative) 0.1%

[0067] Sodium chloride (electrolyte) 154mmol / L

[0068] PEG-6000 (polymer accelerator) 4%

[0069] Tween-20 (surfactant) 0.2%

[0070] Bovine serum albumin (stabilizer) 0.5%

[0071] Reagent R2:

[0072] Tris Buffer 20mmol / L

[0073] Sodium azide (preservative) 0.1%

[0074] Sodium chloride (electrolyte) 154mmol / L

[0075] Tween-20 (surfactant) 0.2%

[0076] Bovine serum albumin (stabilizer) 0.5%

[0077] Goat anti-human Lambda light chain polyclonal antibody 5-8%

[0078] 1.0%-5.0% of latex particles of 40-80nm, 3.0%-8.0% of latex particles of 100-200nm. When the antibody is coated, the two types of latex are separately coated to ensure that the antibody is evenly coated.

[0079] Lambda light chain cal...

Embodiment 3

[0088] Correlation, sensitivity and linear range of the kappa free light chain kit of the present invention

[0089] In order to better compare the superiority of the reagent of the present invention, the selected clinical samples are patient serum collected in a hospital, because the determination of urine samples is relatively easier than serum.

[0090]As a control reagent, "Free Kappa / Lambda Light Chain Assay Kit" was used (see "Wu Jianguo, Wang Yusan. Issues that should be considered in the determination of serum free light chains [J], Journal of Clinical Laboratory, 2004, (22) 3: 165-167 .”). The principle of the contrast reagent is as follows: the monoclonal antibody is coated with uniform latex particles, the reaction absorbance is measured at a wavelength of 570nm, and the corresponding substance content in the sample is calculated according to the calibration curve. Its R1 is a colorless transparent buffer solution; R2 is a milky white latex solution sensitive to mo...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
Diameteraaaaaaaaaa
Sensitivityaaaaaaaaaa
Sensitivityaaaaaaaaaa
Login to view more

Abstract

The invention relates to a liquid double-reagent kit for measuring free light chains in serum or urine by a double-latex method. The kit provided by the invention comprises a reagent R1, a reagent R2 and a light chain antigen calibrator with known concentration, wherein the reagent R1 comprises a macromolecular accelerant, a preservative, a surface active agent, a reaction promoter, a stabilizer, an electrolyte and a buffer solution; R2 comprises two types of latex particles with different diameters, wherein the diameters of the latex particles are respectively in ranges from 40nm to 80nm and from 100nm to 200nm; the two types of latex particles are both cross linked with kappa-type or lambda-type anti-FLC (full-load current) polyclonal antibody, and the latex particles comprise the preservative, the surface active agent, the reaction promoter, the electrolyte, the stabilizer and the buffer solution; the light chain antigen calibrator with known concentration comprises the preservative, the electrolyte, the stabilizer, kappa-type or lambda-type FLC antigen and the buffer solution. The kit in the invention has the advantages that the specificity is strong, the sensitivity is high, the linear range is wide, the operation is simple, and the kit is suitable for various full automatic biochemical analyzers.

Description

technical field [0001] The present invention relates to the field of medical immunology, and relates to an immunodetection reagent. Furthermore, the present invention relates to a reagent for measuring free light chains of immunoglobulins in serum or urine. Background technique [0002] Immunoglobulin (Ig for short) is a general term for globulins with antibody activity or chemical structure similar to antibodies. It exists in large amounts in normal human serum and in trace amounts in urine. The Ig molecular structure is a "Y" globulin composed of two heavy chains (Heavy chain, H chain) and two light chains (Light chain, L chain) and disulfide bonds. Human immunoglobulins are divided into IgM, IgG, IgA, IgD, and IgE according to their heavy chains, and the corresponding heavy chains are μ, γ, α, δ, ε; light chains are divided into κ (kappa) and λ (lambda) 2 types, any immunoglobulin contains two light chains of the same type, namely κ type or λ type, and the ratio of the t...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): G01N33/68G01N33/536
Inventor 徐丽刘希高爱民
Owner BEIJING STRONG BIOTECH INC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap