Immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity

A technology for immunoglobulin and detection kits, which is applied in the field of immunoglobulin G4 subtype detection kits, can solve the problems of weakened affinity and insufficient sensitivity, and achieve the effect of simple operation and low false positive rate

Active Publication Date: 2017-05-31
BYRON DIAGNOSTICS SHANGHAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The purpose of the present invention is to solve the technical problems existing in the above prior art, to provide a kind of immunoglobulin G4 subtype (IgG4) detection kit with both specificity and sensitivity, which effectively eliminates HAMA and RF interference, specifically Therefore, glycosylation modification of mouse anti-human IgG4 monoclonal antibody can effectively weaken its affinity for RF and HAMA recognition, and the use of glycosylation modified mouse monoclonal antibody to develop immunoglobulin G4 kit can achieve weakening of HAMA and RF Interference, the advantages of improving reagent specificity, and solving the technical problem of insufficient sensitivity caused by cutting FC segment to eliminate RF method

Method used

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  • Immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity
  • Immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity
  • Immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity

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Effect test

Embodiment 1

[0035] According to the concentration of each solute, NaCl: 9g / L, glucose: 70g / L, sucrose: 50g / L, sodium azide: 1g / L, use purified water to make a saccharification modification solution, and use the saccharification modification solution to prepare Saquin (product number M9170 , M9124) was diluted to 0.15 mg / mL, stirred at 60 rpm at 25°C for 24 hours; the buffer was replaced, and prepared as a mouse anti-human immunoglobulin G4 (IgG4) monoclonal antibody labeled with glycosylation modifications using conventional chemical coupling Latex microsphere solution was used as the first reagent, and Good's buffer was used as the second reagent. The Siemens IgG4 calibrator was used to draw the standard curve on the automatic biochemical analyzer, and the test was screened by Siemens reagents to obtain false positive interference samples. The results are shown in Table 1 below (Note: According to the requirements of CFDA for in vitro diagnostic kits, most items are considered qualified i...

Embodiment 2

[0041] According to the concentration of each solute NaCl: 9g / L; glucose: 50g / L; sucrose: 30g / L, sodium azide: 1g / L, use purified water to make a saccharification modification solution, and use the saccharification modification solution to prepare Saquin (product number M9170 , M9124) was diluted to 0.40mg / mL, stirred at 30°C and 100rmp for 24 hours; the buffer was replaced, and the mouse anti-human immunoglobulin G4 (IgG4) monoclonal antibody labeled with glycosylation modification was prepared using conventional chemical coupling Latex microsphere solution was used as the first reagent, and phosphate buffer was used as the second reagent. The Siemens IgG4 calibrator was used to draw the standard curve on the automatic biochemical analyzer, and the test was screened by Siemens reagents to obtain false positive interference samples. The results are shown in Table 2 below (Note: According to the requirements of CFDA for in vitro diagnostic kits, most items are qualified if the l...

Embodiment 3

[0046] According to the concentration of each solute NaCl: 9g / L; glucose: 70g / L; sucrose: 50g / L, sodium azide: 1g / L, use purified water to make a saccharification modification solution, and use the saccharification modification solution to prepare Southernbiotech (product number 9190 -01, 9200-01) diluted to 0.15mg / mL, stirred at 100rmp at 25°C for 24 hours; replaced with buffer, prepared as mouse anti-human immunoglobulin G4 (IgG4) labeled with glycosylation modification using conventional chemical coupling The latex microsphere solution of monoclonal antibody was used as the first reagent, glycine buffer was used as the second reagent, and the Siemens IgG4 calibrator was used to draw the standard curve on the automatic biochemical analyzer, and the test was screened by Siemens reagents to obtain false positive interference samples. The results are shown in Table 3 (Note: According to the requirements of CFDA for in vitro diagnostic kits, most items are qualified if the linear...

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Abstract

The invention belongs to the technical field of biological detection and particularly relates to an immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity. In order to solve technical problems of poor specificity and low sensitivity in the prior art, the invention provides the immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity. The immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity comprises a first reagent; and the first reagent is a latex microsphere solution labeled with glycosylated mouse anti-human immune globulin G4 monoclonal antibody. As the detection kit adopts the glycosylated mouse anti-human immune globulin G4 monoclonal antibody, the immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity, provided by the invention, is simple and convenient to operate, can treat antibodies on a mass scale and is beneficial for industrialization; a problem that no commercial HBR is available is solved; therefore, compared with Siemens reagent, the reagent has the advantage that the false positive rate of the reagent is greatly reduced during detecting HAMA and RF disturbance samples; a problem of low sensitivity caused by a method for cutting off an FC segment to eliminate RF is solved; and the linear range of the immune globulin G4 subtype IgG4 detection kit with consideration to both specificity and sensitivity can reach 0.040-4.000 g/L.

Description

technical field [0001] The invention belongs to the technical field of biological detection, and in particular relates to an immunoglobulin G4 subtype (IgG4) detection kit taking into account both specificity and sensitivity. Background technique [0002] IgG in normal people includes four subtypes, of which IgG1 accounts for 60-70%, IgG2 accounts for 15-20%, IgG3 accounts for 5-10%, and IgG4 accounts for 1-7%. IgG4-related disease is a chronic, systemic disease that is closely related to IgG4 lymphocytes. This type of disease is characterized by elevated serum IgG4 levels and IgG4-positive cells infiltrating various organs and tissues. Commonly affected organs include the lacrimal gland, pancreas, and The retroperitoneal space, etc., the involved organs or tissues can cause diffuse swelling due to chronic inflammation and fibrosis. The disease responds well to corticosteroid therapy. [0003] IgG4 is the subtype of immunoglobulin G with the lowest content in the human bod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6854
Inventor 王钊王金凤蒋欣
Owner BYRON DIAGNOSTICS SHANGHAI
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