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Composite prostate specific antigen kit and use method thereof

A prostate-specific and kit-based technology, which is applied in measurement devices, instruments, scientific instruments, etc., to improve specificity, reduce missed detection and misdiagnosis, and reduce biopsy tests

Pending Publication Date: 2020-05-19
JIANGSU ZECEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the aforementioned technical problems in the prior art, the present invention provides a composite prostate-specific antigen kit and its use method

Method used

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  • Composite prostate specific antigen kit and use method thereof
  • Composite prostate specific antigen kit and use method thereof
  • Composite prostate specific antigen kit and use method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0037]The c-PSA calibrator is fully mixed with the c-PSA antigen and the first buffer solution, and the A-F concentration points are 0, 1.5, 3, 10, 30, 100ng / ml, and the label is stored at 2°C, and the validity period is 15 months;

[0038] Wherein, the first buffer solution is prepared by the operation comprising the following steps: accurately weigh the following components by weight: 0.3 parts of potassium dihydrogen phosphate, 1.5 parts of dipotassium hydrogen phosphate, 0.5 parts of potassium chloride, 0.5 parts of hydrogen sulfate Mycin and 190 parts of glycerin were added to 630 parts by weight of newborn bovine serum respectively, stirred at room temperature for 50 minutes, adjusted to pH 7.45, and then pure water was added until the weight of the solution was 1000 parts by weight;

[0039] The configuration method of the c-PSA quality control substance is the same as that of the c-PSA calibrator, with two concentrations of 3.5 and 30ng / ml;

[0040] The c-PSA pretreatm...

Embodiment 2

[0050] The c-PSA calibrator is fully mixed with the c-PSA antigen and the first buffer solution, and the A-F concentration point is 0, 1.5, 3, 10, 30, 100ng / ml, and the label is stored at 4°C, and the validity period is 15 months;

[0051] Wherein, the first buffer solution is prepared by the operation comprising the following steps: accurately weigh the following components by weight: 0.35 parts of potassium dihydrogen phosphate, 2 parts of dipotassium hydrogen phosphate, 1 part of potassium chloride, 1 part of hydrogen sulfate Mycin and 200 parts of glycerin were added to 640 parts by weight of neonatal bovine serum respectively, stirred at room temperature for 60 minutes, adjusted to pH 7.5, and then pure water was added until the weight of the solution was 1000 parts by weight;

[0052] The configuration method of the c-PSA quality control substance is the same as that of the c-PSA calibrator, with two concentrations of 3.5 and 30ng / ml;

[0053] The c-PSA pretreatment solu...

Embodiment 3

[0063] The c-PSA calibrator is fully mixed with the c-PSA antigen and the first buffer solution, and the A-F concentration point is 0, 1.5, 3, 10, 30, 100ng / ml, and the label is stored at 8°C, and the validity period is 15 months;

[0064] Wherein, the first buffer solution is prepared by the operation comprising the following steps: accurately weigh the following components by weight: 0.4 parts of potassium dihydrogen phosphate, 2.5 parts of dipotassium hydrogen phosphate, 1.5 parts of potassium chloride, 1.5 parts of hydrogen sulfate Mymycin and 210 parts of glycerin were respectively added in 650 parts by weight of neonatal bovine serum, stirred at room temperature for 70 minutes, adjusted to pH 7.55, and then pure water was added until the weight of the solution was 1000 parts by weight;

[0065] The configuration method of the c-PSA quality control substance is the same as that of the c-PSA calibrator, with two concentrations of 3.5 and 30ng / ml;

[0066] The c-PSA pretrea...

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Abstract

The invention discloses a composite prostate specific antigen kit and a use method thereof in the technical field related to medical detection reagents. The kit comprises a c-PSA calibrator, a c-PSA quality control product, a c-PSA pretreatment solution, a c-PSA anti-reagent, a magnetic particle reagent, a chemiluminescent substrate solution and a cleaning solution, and the c-PSA calibrator is prepared by fully mixing a c-PSA antigen and a first buffer solution; the c-PSA pretreatment solution is prepared by fully mixing a free prostate specific antigen-antibody with a second buffer solution;the c-PSA anti-reagent is prepared by adding an alkaline phosphatase labeled PSA monoclonal antibody and a fluorescein isothiocyanate labeled PSA monoclonal antibody into a second buffer solution andfully mixing; the magnetic particle reagent is prepared by diluting and fully mixing goat anti-fluorescein isothiocyanate antibody labeled magnetic particles through a third buffer solution; the chemiluminiscence substrate solution is prepared by diluting APLS in a dark place through a fourth buffer solution and fully mixing; the cleaning solution is prepared by diluting a fifth buffer solution with purified water; results are sensitive, and use is convenient.

Description

technical field [0001] The invention relates to the related technical field of medical detection reagents, in particular to a composite prostate-specific antigen kit and a use method thereof. Background technique [0002] Prostate-specific antigen (PSA), a tissue-specific chymotrypsin-like serine protease, is synthesized and secreted into semen by prostate epithelial cells. PSA in serum mainly exists in two forms: free state (F-PSA) and bound state (c-PSA), the latter including ACT-PSA and α2M-PSA (without immunoreactivity). Therefore, the clinically detected T-PSA is usually F-PSA and ACT-PSA. In healthy men, only a very small amount of PSA will leak into the circulating blood, and the PSA concentration in the serum is usually less than one millionth of the seminal plasma; in prostate diseases, due to increased leakage of PSA or abnormal secretion to the circulating blood, thus usually increasing the serum level of PSA. [0003] Prostate cancer (PC) and benign prostatic ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/533G01N33/577G01N33/543
CPCG01N33/533G01N33/577G01N33/54326
Inventor 江川刘振世吴晓瑜林洁
Owner JIANGSU ZECEN BIOTECH CO LTD