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Kit for testing concentration level of HER-2 ECD in human serum

A HER-2ECD and kit technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of restricting large-scale clinical application and promotion, high cost of imported reagents and instruments, and cumbersome operation, etc., to facilitate long-term promotion and use , Overcome the false positive problem and ensure the effect of the linear range

Inactive Publication Date: 2017-07-21
童坤
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Due to the closed reagent instrument system, the cost of imported reagent instruments is high, and the operation is cumbersome, which limits its large-scale clinical application and promotion.

Method used

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  • Kit for testing concentration level of HER-2 ECD in human serum
  • Kit for testing concentration level of HER-2 ECD in human serum
  • Kit for testing concentration level of HER-2 ECD in human serum

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Embodiment Construction

[0040] The present invention will be further described in detail below in conjunction with specific examples.

[0041] 1. Preparation of reagent R1 component in human serum epidermal growth factor receptor-2 extracellular domain protein detection kit

[0042] Accurately weigh 5.0 g of 2-(N-morpholine) ethanesulfonic acid, 10.0 g of PEG20000, 100.0 g of sodium chloride, and 1.0 g of sodium azide in a 1L beaker with an electronic balance, add 800 ml of purified water, and stir to make it fully Dissolve, adjust the pH to 6.0±0.2 with 1M sodium hydroxide or hydrochloric acid, adjust the volume to 1L with purified water, filter with 0.45um microporous membrane, take the subsequent filtrate and store it at 2-8°C for later use.

[0043] 2. Preparation of reagent R2 component in human serum epidermal growth factor receptor-2 extracellular domain protein detection kit

[0044] Step 1, prepare coating solution 50mmol / L PH=6.0: Accurately weigh 10.7g of 2-(N-morpholine)ethanesulfonic ac...

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Abstract

The invention relates to a kit for testing concentration level of epidermal growth factor receptor-2- extracellular region protein (hereinafter referred to as HER-2 ECD) in the human serum. The technical problem to be solved is to provide a kit for testing the concentration level of HER-2 ECD in the human serum, which is applicable to a full automatic biochemical analyzer and a specific protein apparatus; the kit consists of three associated parts which are reagent R1, reagent R2 and a calibration product Cal; after calibration on a specific instrument, above reagent combination is directly applied to test a clinic serum sample, and the acquired result is the concentration level of HER-2 ECD in the human serum. Compared with a chemiluminiscence method, the result has high consistence, the cost is lower, and the kit is more suitable for the application and popularization of clinical detection. The technical scheme can provide a kit for testing the concentration level of HER-2 ECD in the human serum, which is good in both affinity of antibody and specificity, high in method sensitivity, and good in stability.

Description

technical field [0001] The invention relates to the technical field of biological detection, in particular to a kit for measuring the concentration level of HER-2 ECD in human serum. Background technique [0002] HER-2 ECD is a soluble glycoprotein formed by cleavage of the extracellular region of HER-2 protein by protease and shedding from the cell surface into the blood. Serum HER-2 ECD detection has the advantages of good correlation with tumor tissue HE reagent R2 detection and easy real-time dynamic detection, which is an important supplement to histological detection. At present, the method for detecting serum HER-2 ECD in the market is mainly chemiluminescence method. Siemens ADVIA HER-2 / neu serological chemiluminescence detection system is currently the only serological detection product certified by the US Food and Drug Administration (FDA) in the world. , for the monitoring and management of metastatic breast cancer patients with initial serum levels greater than ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/538
CPCG01N33/577G01N33/538
Inventor 童坤芮兵
Owner 童坤
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