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Human alpha1-microglobulin (MG) determination kit with high sensitivity and wide detection range

A microglobulin and kit technology, applied in the field of immunodiagnosis, can solve the problems of not being able to detect serum, plasma and urine samples at the same time, the reagent sensitivity is not enough, and the sensitivity and linear range cannot be well considered.

Inactive Publication Date: 2019-04-16
BEIJING BEIER BIOENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the kits for the detection of α1-MG in clinical practice are mainly immunoturbidimetry kits. Due to the insufficient sensitivity of the reagents, most of the test samples are serum, and some serum and urine are tested together; the kits use α1-MG alone. MG polyclonal antibody or paired monoclonal antibody
The disadvantage is that the reagents can not take into account the sensitivity and linear range well, and due to the problem of the calibration system, the same reagent cannot detect serum, plasma and urine samples at the same time

Method used

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  • Human alpha1-microglobulin (MG) determination kit with high sensitivity and wide detection range
  • Human alpha1-microglobulin (MG) determination kit with high sensitivity and wide detection range
  • Human alpha1-microglobulin (MG) determination kit with high sensitivity and wide detection range

Examples

Experimental program
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Effect test

Embodiment 1

[0063] A human α1-microglobulin assay kit, comprising reagent 1, reagent 2 and human α1-MG calibrator with different gradient concentrations; wherein,

[0064] Reagent 1 included the following final concentrations of components: 50 mM PBS buffer (pH 7.4), 1.5% (w / v) BSA, 3% (w / v) PEG6000, 1.5% (w / v) Mw Be the dextran of 40000, the NaCl of 150mM, the Tween-20 of 0.05% (w / v), the Krovin300 of 0.1% (w / v), the EDTA of 2mM;

[0065] Reagent 2 includes the components of the following final concentrations: carboxyl latex microspheres (average particle diameter is 223nm, microsphere final concentration is 0.015% (w / v)), 0.003% (w / v) labeled human α1-MG monoclonal antibody, carboxylated latex microspheres (average particle diameter is 123nm, microsphere final concentration is 0.2% (w / v)), 0.045 % (w / v) labeled human α1-MG polyclonal antibody, 50mM PBS buffer (pH7.2), 100mM ammonium chloride, 1% (w / v) BSA, 5% (w / v) sucrose, 0.05% (w / v) Tween-20, 0.1% (w / v) ProClin300.

[0066] Calib...

Embodiment 2

[0072] A human α1-microglobulin assay kit, comprising reagent 1, reagent 2 and human α1-MG calibrator with different gradient concentrations; wherein,

[0073] Reagent 1 included the following final concentrations of components: 20 mM MOPS buffer (pH 7.4), 0.5% (w / v) BSA, 2% (w / v) PEG8000, 150 mM NH 4 Cl, the Mw of 3% (w / v) is the polylysine of 5000, the Tween-20 of 0.05% (w / v), the Krovin500 of 0.1% (w / v), the EDTA of 5mM;

[0074] Reagent 2 includes the components of the following final concentrations: carboxyl latex microspheres (average particle diameter is 186nm, final concentration of microspheres is 0.02% (w / v)), 0.005% (w / v) of human α1-MG monoclonal antibody / v) labeled human α1-MG monoclonal antibody, carboxylated latex microspheres (average particle diameter is 88nm, microsphere final concentration is 0.2% (w / v)), 0.04 % (w / v) labeled human α1-MG polyclonal antibody, 50mM HEPES buffer (pH 7.4), 150mM potassium chloride, 0.1% (w / v) gelatin, 4% (w / v) sucrose, 0.5 % ...

Embodiment 3

[0081] A human α1-microglobulin assay kit, comprising reagent 1, reagent 2 and human α1-MG calibrator with different gradient concentrations; wherein,

[0082] Reagent 1 includes the following final concentrations of components: 100 mM Tris-Cl buffer (pH 8.0), 0.25% (w / v) of BSA, 1% (w / v) of PEG20000, 0.5% (w / v) The Mw is 500000 dextran, the KCl of 50mM, the Tween-80 of 0.05% (w / v), the ProClin300 of 0.1% (w / v), the EDTA of 5mM;

[0083] Reagent 2 includes the following final concentration components: carboxyl latex microspheres (average particle diameter is 196nm, microsphere final concentration is 0.015% (w / v)), 0.007% (w / v) labeled human α1-MG monoclonal antibody, carboxyl latex microspheres (average particle diameter is 70nm, microsphere final concentration is 0.25% (w / v)), 0.06 % (w / v) labeled human α1-MG polyclonal antibody, 50mM MOPS (pH 7.2), 50mM magnesium chloride, 0.2% (w / v) gelatin, 0.2% (w / v) BSA, 3% (w / v) Sucrose, 1% (w / v) Glucose, 0.05% (w / v) Tween-20, 0.1% ...

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Abstract

The embodiment of the invention relates to the field of immunodiagnosis, in particular to a human alpha1-microglobulin (MG) determination kit with high sensitivity and a wide detection range. The human alpha1-MG determination kit provided by the embodiment of the invention comprises a reagent 1, a reagent 2 and human alpha1-MG calibration products of different gradient concentrations, wherein thereagent 2 comprises carboxylated latex microspheres labeled with a human alpha1-MG monoclonal antibody only and carboxylated latex microspheres labeled with a human alpha1-MG polyclonal antibody only;and the average particle size of the carboxylated latex microspheres labeled with the human alpha 1-MG monoclonal antibody only is larger than that of the carboxylated latex microspheres labeled withthe human alpha 1-MG polyclonal antibody. The human alpha1-MG determination kit provided by the invention can complete the detection of a single sample within 10 minutes with excellent precision, accuracy and anti-interference performance, can well reflect the renal tubular reabsorption function and glomerular filtration function, is very suitable for clinical biochemical analyzers, and greatly facilitates clinical examination.

Description

technical field [0001] The invention relates to the field of immunodiagnosis, in particular to a human α1-microglobulin assay kit with high sensitivity and wide detection range. Background technique [0002] In 1975, Ekstron et al isolated α1-microglobulin (ie α1-MG) from the urine of patients with chronic cadmium poisoning. α1-MG is a glycoprotein with a molecular weight of about 33KDa, mainly synthesized by liver cells and lymphocytes, and widely distributed in body fluids and on the surface of lymphocyte membranes. [0003] In plasma, α1-MG exists in free form or bound form (combined with IgA). The bound form of α1-MG is not easily filtered by the glomerulus, while the free form of α1-MG can freely pass through the glomerulus, but is almost completely absorbed by the proximal convoluted tubule. Epithelial cells reabsorb and metabolize in the form of pinocytosis, and only trace amounts of free α1-MG can be excreted in urine. There are gender and age differences in the co...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/543G01N33/532
CPCG01N33/532G01N33/5432G01N33/68
Inventor 不公告发明人
Owner BEIJING BEIER BIOENG
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