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Immunoassay methods, systems and kits for characterizing immunoassays

一种免疫测定、读数的技术，应用在免疫测定,鉴定免疫测定的系统,试剂盒领域，能够解决信号不能持续升高、限制检测范围等问题，达到拓宽检测范围、降低假阴性率、提高准确性的效果

Active Publication Date: 2021-06-29
BEYOND DIAGNOSTICS (SHANGHAI) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] On the other hand, because of the high dose-hook effect, when the sample concentration increases to a certain value, the signal cannot continue to increase, which limits the detection range

Method used

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  • Immunoassay methods, systems and kits for characterizing immunoassays
  • Immunoassay methods, systems and kits for characterizing immunoassays
  • Immunoassay methods, systems and kits for characterizing immunoassays

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Embodiment 1: Conventional method and method of the present invention detect insulin (INS) sample respectively

[0109] The insulin (INS) detection kit (chemiluminescence method) produced by Boyang Biotechnology (Shanghai) Co., Ltd. was used to detect the content of insulin (purchased from Fitzgerald, Catalog No: 30R-2704) in the sample.

[0110] The high-concentration insulin antigen is serially diluted, and conventional detection methods and the detection method of the present invention are used to measure the signal values ​​of samples containing different concentrations of insulin.

[0111] Conventional detection method: analyte samples of known concentration, reagent 1 (luminescent antibody, that is, luminescent particles coated with mouse monoclonal antibody) and reagent 2 (biotin-labeled antibody, that is, biotin-labeled mouse monoclonal antibody Cloning antibody) was added to the cuvette, incubated at 37°C for 15min, then added LiCA universal solution (streptavi...

Embodiment 2

[0119] Embodiment 2: Conventional method and the inventive method detect hepatitis B virus surface antibody (HBsAb) sample respectively

[0120] The hepatitis B virus surface antibody detection kit (photo-induced chemiluminescence method) produced by Boyang Biotechnology (Shanghai) Co., Ltd. was used to detect the hepatitis B virus surface antibody in the sample (purchased from Beijing Zhongke Jingda Biotechnology Co., Ltd. , Clone No: M2201) concentration.

[0121] The high-concentration HBsAb is serially diluted, and the signal values ​​of samples containing different concentrations of HBsAb are measured by conventional detection methods and the detection method of the present invention, respectively.

[0122] Routine detection method: Add the diluted HBsAb sample, reagent 1 (HBsAg-coated luminescent particles) and reagent 2 (biotin-labeled HBsAg) into the cuvette, incubate at 37°C for 15 minutes, add LiCA universal solution (streptavidin Primer-labeled photosensitive parti...

Embodiment 3

[0130] Embodiment 3: Conventional method and method of the present invention detect fetal alpha globulin (AFP) sample respectively

[0131] The content of AFP (purchased from Fitzgerald, Catalog No: 30-1370) in the sample was detected by using the fetal alpha globulin detection kit (photo-induced chemiluminescence method) produced by Boyang Biotechnology (Shanghai) Co., Ltd.

[0132] The high-concentration AFP antigen is serially diluted, and the signal values ​​of samples containing different concentrations of AFP are measured by conventional detection methods and the detection method of the present invention. The conventional detection method and the method of the present invention refer to Example 1. The test results are as follows:

[0133] table 3:

[0134]

[0135]

[0136] From Table 3 and Figure 5 It can be seen that the signal value increases with the increase of concentration from 5ng / ml to 10000ng / ml, and the concentration continues to increase, and the si...

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Abstract

The invention provides an immunoassay method, which is characterized in that the method comprises the following steps: (1) performing a chemiluminescent immune reaction on a test sample containing a target antigen (or antibody) to be tested, exciting and recording the first chemiluminescence First and second readings, and the difference between the second and first readings is recorded as A, (2) according to the known series of standard substances containing the target antigen (or antibody) to be tested The first reading and the increase A of the two readings are respectively used as a standard curve; (3) the first reading and the increase A of the two readings of the sample to be tested containing the target antigen (or antibody) to be tested are compared with the standard curve , to determine the concentration of the sample. The invention also relates to a system and a kit for identification immunoassays.

Description

technical field [0001] The invention relates to the technical field of light-activated chemiluminescence, in particular to an immunoassay method, a system for identifying immunoassays and a kit. Background technique [0002] Immunological detection is based on the principle of antigen-antibody specific reaction. Because it can use isotopes, enzymes, chemiluminescent substances, etc. to display or amplify the signal of the measured substance, it is often used to detect trace organisms such as proteins and hormones. active substance. [0003] Chemiluminescent immunoassay is a non-radioactive immunoassay technology that has developed rapidly in recent years. Its principle is to use chemiluminescent substances to amplify the signal, and use its luminous intensity to directly measure the immune binding process. This method has become an immunological method. One of the important directions of detection. [0004] Light-induced chemiluminescence is one of the commonly used method...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/53G01N33/543G01N21/63
CPCG01N21/636G01N21/76G01N33/53G01N33/54313G01N33/5761G01N33/58G01N33/6854G01N33/6893G01N33/78G01N2021/637G01N2333/72
Inventor 杨阳赵卫国张向辉
Owner BEYOND DIAGNOSTICS (SHANGHAI) CO LTD
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