Carbohydrate antigen-125 quantitative determination kit and application thereof

A quantitative detection and sugar chain antigen technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of weakening, inaccurate results, conflicting work efficiency requirements, etc., and achieve the effect of good reaction binding ability

Inactive Publication Date: 2014-03-26
上海裕隆医学检验所股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The enzyme-linked immunosorbent assay in the experimental stage generally has good sensitivity, accuracy and reproducibility for the detection of CA125 concentration. The indicators have been weakened to varying degrees. In addition, the commonly used PMT detectors are point measurements, and peak correction must be performed before work. Not only is the work efficiency contrary to the requirements of mass operations, it is more likely to lead to inaccurate results.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Kit 1 includes a microwell reaction plate coated with CA125 (sugar chain antigen 125) antibody, the concentration of monoclonal antibody coating is 1ug, and 6 bottles of calibrator, the concentrations of CA125 antigen are 5 U / ml, 15 U / ml, respectively. U / ml, 50 U / ml, 100 U / ml, 300 U / ml, 600 U / ml, 2 bottles of quality control products, the CA125 antigen concentrations are 50U / ml, 300 U / ml and 1 bottle of enzyme conjugate , the concentration of enzyme-labeled antibody is 1ug / ml, 1 bottle of concentrated washing solution, the content of Tween-20 is 0.01%, 1 bottle of luminescent substrate A and luminescent substrate B.

[0068] Application of this kit for detection and its results:

[0069] 1. Preliminary preparation

[0070] (1) Equilibrate the kit at room temperature (18-26°C) for 20 minutes.

[0071] (2) Take out the concentrated washing solution from the kit, dilute it with fresh purified water 1:20 and add it

[0072] corresponding storage location.

[0073] (3) P...

Embodiment 2

[0117] Kit 2 includes a microwell reaction plate coated with CA125 (sugar chain antigen 125) antibody, the monoclonal antibody coating concentration is 2ug, including 6 bottles of calibrator, and the CA125 antigen concentration is 5U / ml, 15U / ml respectively , 50U / ml, 100 U / ml, 300 U / ml, 600U / ml, 2 bottles of quality control products, the CA125 antigen concentration is 50KU / ml, 300 U / ml and 1 bottle of enzyme conjugate, the enzyme-labeled antibody The concentration is 0.5ug / ml, and it also includes 1 bottle of concentrated washing solution with a Tween-20 content of 0.05%, 1 bottle of luminescent substrate A and 1 bottle of luminescent substrate B, each 5ml.

[0118] The detection procedure is the same as that of kit 1, except that the amount of calibrator added to each well is 50ul, the amount of quality control substance added to each well is 50ul, the amount of sample to be tested is added to each well 50ul, and the amount of enzyme conjugate added to each well is 100ul.

[01...

Embodiment 3

[0126] The reagent components of kit 3 are the same as kit 1, the operation steps are the same as kit 1, and the amount of detection reagent added is the same as that of kit 1. The difference is that the CA125 monoclonal antibody coated on the microwell plate is replaced with the existing CA125 antibody 3ug

[0127] , the resulting recovery rate, detection range, minimum detection limit, correlation coefficient, repeatability coefficient of variation and inter-assay difference coefficient of variation results are:

[0128] Table 10 The results of kit 3 for detection

[0129] .

[0130] The stability testing steps are the same as kit 1, and the results are as follows:

[0131] Table 11 Stability of kit 3 for detection

[0132] .

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Abstract

The invention provides a carbohydrate antigen-125 quantitative determination kit and a detection method thereof. According to the scheme, a principle of a double-antibody sandwich enzyme immunoassay chemiluminescence method is adopted to prepare a carbohydrate antigen-125 quantitative determination kit. The kit comprises a CA125 (carbohydrate antigen-125) antibody-coated micro-plate / strip, six calibration material bottles, two quality control bottle, an enzyme conjugate, a washing concentrate bottle, a luminous substrate A1 bottle and a luminous substrate B1 bottle. The kit is applied to large-scale detection and manual detection one by one or group by group and has the beneficial effects of high sensitivity, high accuracy and high reproducibility.

Description

technical field [0001] The invention relates to a detection method of sugar chain antigen 125, in particular to a detection method using a sugar chain antigen 125 quantitative detection kit. Background technique [0002] Sugar chain antigen 125 (CA125) in human serum is the main marker of epithelial ovarian cancer, and its specificity can reach more than 80%. In the early stage of ovarian tumor recurrence, the concentration increases several months earlier than clinical, so its concentration is used for An important index to evaluate ovarian cancer. For patients with ovarian cancer who have been diagnosed histologically, the detection of CA125 concentration is helpful to detect the treatment effect and disease, and can be used to assist in judging the prognosis. However, it should be noted that other factors can also cause Increased serum CA125, such as 1% of healthy women, 3% of patients with benign ovarian tumors and 6% of non-ovarian-related benign disease patients. [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/535G01N35/00
CPCG01N33/57484G01N33/57449
Inventor 穆海东汪宁梅沈珏璟刘洵言佐一含高学武
Owner 上海裕隆医学检验所股份有限公司
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