Quality control object for substituting patients' positive blood

A quality control product and positive technology, applied in the field of immunology, can solve problems such as difficult standardization, difficult inactivation, and unstable quality, and achieve the effects of reducing detection errors, simple production and preparation, and avoiding infectivity

Active Publication Date: 2013-11-06
GENCLONN BIOTECH HANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many disadvantages in using positive blood from patients to prepare positive quality control products: 1) It is difficult to obtain positive blood from patients with high titer and high specificity; ; 3) the cost is relatively high, 4) some pathogen infection cases are scarce, and it is difficult to obtain enough positive blood in a short period of time; At the same time, when collecting and inactivating the patient's positive blood, the operator also has the risk of potential infection
However, the above patents did not disclose the specific composition of the prepared heterologous cross-linked product, which caused the quality of the heterologous cross-linked product to be unstable between different batches, prone to detection errors, and poor substitution

Method used

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  • Quality control object for substituting patients' positive blood
  • Quality control object for substituting patients' positive blood
  • Quality control object for substituting patients' positive blood

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Use SPDP cross-linking reagent (purchased from Thermo Scientific, product number 21857) to prepare mouse anti-HSV-II McAb and healthy non-infected HSV-II human IgG heterologous cross-linked product as HSV-II in patient's positive blood Antibody surrogate, the process is as follows:

[0049] (1) Dissolve 5 mg mouse anti-HSV-II McAb in cross-linking buffer (0.1M potassium phosphate, 0.1M NaCl, pH7.5), stir and add 50 μl SPDP cross-linking agent (3.2 mg / ml, dissolved in In absolute ethanol), after reacting at room temperature for 2 hours, put it into a dialysis bag, dialyze with reducing buffer (0.1M sodium acetate, 0.1M NaCl, pH4.5), and change the solution four times;

[0050] (2) Dissolve 5mg of healthy human IgG not infected with HSV-II in the cross-linking buffer, stir and add 50μl SPDP cross-linking agent, react at room temperature for 2 hours, put it into a dialysis bag, and dialyze with the cross-linking buffer , change the liquid four times;

[0051] (3) Add 30 ...

Embodiment 2

[0057] Example 2 Experiments on substitution of mouse anti-HSV-II McAb and healthy non-HSV-II-infected human IgG heterologous cross-linked product, quality control stability and cryopreservation stability

[0058] Experiments were carried out using the mouse anti-HSV-II McAb prepared in Example 1 and the heterologous cross-linked product of healthy human IgG not infected with HSV-II as a substitute for the HSV-II antibody in the patient's positive blood.

[0059] (1) Preparation of quality control products. The heterologous cross-linked products with tetrameric heterologous cross-linked antibodies accounted for 50%, 70%, 90% and 100% of the mass ratio in the prepared heterologous cross-linked products were sequentially prepared as patient Surrogates for HSV-II antibodies in positive blood. When the heterologous cross-linked antibody in tetrameric form accounts for 50%, 70% or 90% of the mass ratio of the prepared heterologous cross-linked product, the remaining 50%, 30% or 10...

Embodiment 3

[0080] Example 3 Alternative experiment of mouse anti-HSV-1 McAb and healthy non-infected HSV-1 human IgG heterologous crosslinker

[0081] Using the SPDP cross-linker to prepare mouse anti-HSV-I McAb and healthy non-HSV-I-infected human IgG heterologous cross-linked product as a surrogate for HSV-I antibody in patient-positive blood, except for mouse anti-HSV -I McAb replaces mouse anti-HSV-II McAb, and the specific process is the same as in Example 1.

[0082] Experiments were carried out using the mouse anti-HSV-1 McAb prepared in Example 3 and the heterologous cross-linked product of healthy human IgG not infected with HSV-1 as a substitute for the HSV-1 antibody in the patient's positive blood. The heterologous cross-linked products in which the mass ratio of tetrameric heterologous cross-linked antibody in the prepared heterologous cross-linked product is 50%, 70%, 90% and 100% are sequentially prepared. When the heterologous cross-linked antibody in tetrameric form acc...

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Abstract

The invention provides a heterologous cross-linking object containing heterologous cross-linking antibody in a tetramer form, the heterologous cross-linking object is obtained from cross-linking reactions between two heterologous antibodies, the mass ratio of the heterologous cross-linking antibody in a tetramer form in the heterologous cross-linking object is preferably not less than 50%, the heterologous cross-linking object can be taken as a substituent of a pathogen antibody in the patients' positive blood, and can be applied to a immunity detection kit as a quality control object to substitute the patients' positive blood after being diluted by a diluting liquid. The heterologous cross-linking object has the advantages of simple production and preparation, low cost, and very good stability and safety. Furthermore, qualities of different batches of quality control objects are stable, so detection errors can be effectively reduced.

Description

technical field [0001] The present invention relates to a quality control product that can replace the patient's positive blood. The quality control product includes a diluent and a heterologous cross-linked antibody in the form of a tetramer obtained from two heterologous antibodies through a cross-linking reaction. The heterologous cross-linked product belongs to the technical field of immunology. [0002] Background technique [0003] Pathogens such as viruses, bacteria, fungi and parasites pose an increasing threat to humans today. Immunoassay methods based on specific and highly sensitive reactions between antigens and antibodies, such as colloidal gold immunochromatography, latex immunochromatography, radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), time-resolved Fluorescence immunoassay (TRFIA) or chemiluminescence immunoassay (CLIA) have been widely used in clinical immunoassays. These immunoassay methods are generally used to qualitatively or qu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/531
CPCY02A50/30
Inventor 潘剑用周海涛闵丹
Owner GENCLONN BIOTECH HANGZHOU
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