Quantitative determination kit for carbohydrate antigen 125 (CA125), and detection method thereof

A technology of CA125 and kit, applied in the field of kits for measuring the content of carbohydrate antigen 125 in serum

Inactive Publication Date: 2012-01-18
INNER MONGOLIA KEHUI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, co-detection with other tumor markers or continuous detection can also reduce the false positive results of diagnosis

Method used

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  • Quantitative determination kit for carbohydrate antigen 125 (CA125), and detection method thereof
  • Quantitative determination kit for carbohydrate antigen 125 (CA125), and detection method thereof
  • Quantitative determination kit for carbohydrate antigen 125 (CA125), and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] 1. Operating procedures for preparing magnetic bead buffer: see Table 1 for the formula, taking the preparation of 1L as an example:

[0078] 1. Weigh 4.58g of TRIS and 6.81g of NaCl in a 1L container, weigh 0.96g of TWEEN-20 in a 20ml container, add an appropriate amount of water to dissolve it completely, and then pour it into the above container;

[0079] 2. Use a pipette to take 0.2ml of Proclin-300 and dissolve it completely in a beaker of a small amount of purified water, then pour it into the above-mentioned 1L container; then add 800ml of purified water into the 1L container, stir well to completely dissolve the reagent;

[0080] 3. Adjust the PH meter to measure the PH value; use HCl or NaOH to adjust the PH value, and measure the PH value between 7.95-8.05 to meet the requirements;

[0081] 4. Weigh 3g of BSA (bovine serum albumin) and pour it into the above container;

[0082] 5. Finally, adjust the volume to 1000ml, measure the pH value, and if the range is...

Embodiment 2

[0098] 1. Operating procedures for the preparation of enzyme reactant diluent: the formula is shown in Table 2, taking the preparation of 1L as an example:

[0099] 1. Take Tris 6.06g, NaCl 13.0g, Zncl 2 0.05g, Proclin-300 0.2ml and MgCl 2 0.05g in the flask; then add 800ml of purified water into the flask and stir thoroughly to dissolve the reagent completely;

[0100] 2. Use HCl or NaOH to adjust the pH, and measure the pH to be in the range of 7.35-7.45;

[0101] 3. Weigh 3g of BSA and pour it into the above container;

[0102] 4. Finally, adjust the volume to 1000ml, measure the pH value, and if the range is between 7.35-7.45, it meets the requirements, and filter with a 0.2um filter; after filtering, label it and store it in a cold storage at 2-8°C, with a validity period of 12 months;

[0103] Enzyme reactant diluent Table 2

[0104]

[0105] 2. Coupling of alkaline phosphatase (ALP) and anti-CA125 monoclonal antibody

[0106] 1. Add 10 mg of ALP to 5 ml of nor...

Embodiment 3

[0113] Reaction enhancer preparation operating procedures: see the formula (Table 3), taking the preparation of 1L as an example:

[0114] 1. Weigh 1.56g of TRIS (trihydroxymethylaminomethane, molecular formula: (HOCH2)3CNH2) and 4.23g of NaCl in a 1L container; use a pipette to measure 0.2ml of Proclin-300 into a beaker of a small amount of purified water After completely dissolved, pour into the above 1L container;

[0115] 2. Use a graduated cylinder to measure 800ml of purified water into a 1L container, stir well until it is completely dissolved; adjust the pH with HCL or NaOH, and measure the range between 7.35-7.45;

[0116] 3. Weigh 30.9g of Mak into the above 1L container;

[0117] 4. Finally, set the volume to 1000ml. After completely dissolving, measure the PH value. If the range is between 7.35-7.45, it meets the requirements. Filter with a 0.2um filter; after filtering, label it and store it in a cold storage at 2-8°C. month;

[0118] Preparation of reaction en...

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Abstract

The present invention discloses a quantitative determination kit for carbohydrate antigen 125 (CA125). The quantitative determination kit is characterized in that: the kit comprises a CA125 magnetic separation reagent, an enzyme reactant, a reaction reinforcing agent, a diluent, a CA125 standard sample, a CA125 quality control sample, a cleaning solution, a concentrated solution and a substrate solution. The invention further discloses a preparation method for the kit. According to the kit provided by the present invention, a chemiluminescence technology is combined with immunomagnetic nanoparticles; a reaction system approaching to the homogeneous phase is provided; compared to the prior art, the kit provided by the present invention has higher detection sensitivity and higher specificity, and reaches better performance parameters, and the product cost is substantially reduced.

Description

technical field [0001] The invention relates to a kit for measuring serum and a testing method thereof, in particular to a kit for testing carbohydrate antigen 125 (CA125) content in serum and a testing method thereof. Background technique [0002] CA125 is a glycoprotein with a relative molecular mass of 200kD, which is widely distributed on the surface of mesothelial tissue cells such as pleura, pericardium, peritoneum, endometrium, reproductive tract and amnion. When these parts undergo malignant transformation or are stimulated by inflammation, the level of CA125 in serum will increase significantly. As the main marker of ovarian cancer, CA125 is used for the curative effect and reexamination monitoring of ovarian cancer. The concentration of CA125 in most ovarian cancer patients will show a continuous increase trend, which can be used as a marker for disease progression, prognosis and chemotherapy efficacy. Serum CA 125 levels can also increase in digestive tract mali...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/76G01N33/577G01N33/531
Inventor 不公告发明人
Owner INNER MONGOLIA KEHUI BIOLOGICAL TECH
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