Prostate specific antigen homoisomer chemiluminescence immunoassay kit and preparation method thereof

A chemiluminescent immune and prostate-specific technology, which is applied in the direction of measuring devices, scientific instruments, instruments, etc., can solve the problems of unfavorable popularization, high price, and large economic burden of patients, so as to save time and cost, low cost, and reduce manual operations effect of error

Inactive Publication Date: 2020-08-28
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In China, the clinical detection of serum prostate-specific antigen isomer (p2PSA) is mainly based on the application of foreign Beckman reagents. The price of imported reagents is very expensive, which brings a great economic burden to patients and is not conducive to the basic universal

Method used

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  • Prostate specific antigen homoisomer chemiluminescence immunoassay kit and preparation method thereof
  • Prostate specific antigen homoisomer chemiluminescence immunoassay kit and preparation method thereof
  • Prostate specific antigen homoisomer chemiluminescence immunoassay kit and preparation method thereof

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preparation example Construction

[0049] The present invention also provides a preparation method of a prostate-specific antigen isomer (p2PSA) chemiluminescent immunoassay kit, comprising the following steps:

[0050] Step 1: Preparation of magnetic particle reaction solution R1

[0051] Mix buffer and preservative to prepare R1 basic buffer;

[0052] Take commercially available streptavidin magnetic beads (selected from JSR Company, model MS300 / Streptavidin), the magnetic beads have a particle size of 3 μm, wash with PBS (20mmol / L PB and 150mmol / L NaCl) buffer solution with pH 7.2 Three times, then resuspend the magnetic beads into the R1 basic buffer to prepare the magnetic particle reaction solution R1 with a mass concentration of 0.03%-0.1%;

[0053] Step 2: Preparation of tracer conjugate reaction solution R2

[0054] Mix NaCl, buffer, preservative, blocking agent, protein stabilizer and surfactant to prepare R2 basic buffer;

[0055] Take the p2PSA antibody (or tPSA antibody), and label it with the a...

Embodiment 1

[0069] 1.1 Kit composition

[0070]

[0071]

[0072] 1.2 Preparation method of the kit

[0073] (1) Preparation of magnetic particle reaction solution R1

[0074] Take streptavidin magnetic beads with a particle size of 3 μm, wash them three times with PBS buffer at pH 7.2, then resuspend the magnetic beads into an appropriate amount of R1 basic buffer (other components except magnetic beads), and prepare Prepare a magnetic particle reaction solution R1 with a mass concentration of 0.1%.

[0075] (2) Preparation of tracer conjugate reaction solution R2

[0076] a. Preparation of acridinium ester-labeled p2PSA antibody:

[0077] Take an appropriate amount of p2PSA antibody, and label it with acridinium ester (3mg / mL) dissolved in DMF according to the ratio of molar concentration 1:7.5. The labeling buffer is pH7.4PB (20mmol / L), and the labeling time is 4h. The reaction process requires Avoid light. After the labeling reaction, use AKTA purification instrument (G25 g...

Embodiment 2

[0088] 1.1 Kit composition

[0089]

[0090]

[0091] 1.2 Preparation method of the kit

[0092] (1) Preparation of magnetic particle reaction solution R1

[0093] Take streptavidin magnetic beads with a particle size of 3 μm, wash them three times with PBS buffer at pH 7.2, then resuspend the magnetic beads into an appropriate amount of R1 basic buffer (other components except magnetic beads), and prepare Prepare a magnetic particle reaction solution R1 with a mass concentration of 0.1%.

[0094] (2) Preparation of tracer conjugate reaction solution R2

[0095] a. Preparation of acridinium ester-labeled tPSA antibody:

[0096] Take an appropriate amount of tPSA antibody and label it with acridinium ester (3mg / mL) dissolved in DMF at a molar concentration ratio of 1:3. The labeling buffer is pH7.4PB (20mmol / L), and the labeling time is 12h. The reaction process requires Avoid light. After the labeling reaction, use AKTA purification instrument (G25 gel column) to pu...

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Abstract

The invention relates to a prostate specific antigen homoisomer chemiluminiscence immunoassay kit, and belongs to the technical field of in-vitro detection. The kit comprises a calibrator, a magneticparticle reaction solution R1, a tracer conjugate reaction solution R2 and a capture antibody reaction solution R3, wherein the magnetic particle reaction liquid R1 comprises streptavidin magnetic beads, a buffer solution and a preservative; the tracing conjugate reaction liquid R2 comprises an acridinium ester-labeled p2PSA antibody or tPSA antibody, NaCl, a buffer solution, a preservative, a blocking agent, a protein stabilizer and a surfactant; the capture antibody reaction solution R3 comprises a biotin-labeled tPSA antibody or p2PSA antibody, NaCl, a buffer solution, a preservative, a protein stabilizer and a surfactant. The invention also provides a preparation method of the kit. The prostate specific antigen homoisomer chemiluminiscence immunoassay kit is high in detection sensitivity, good in reliability, low in cost and suitable for popularization and application.

Description

technical field [0001] The invention belongs to the technical field of in vitro detection, and in particular relates to a chemiluminescent immunoassay kit for prostate-specific antigen isomers and a preparation method thereof. Background technique [0002] Prostate cancer is a common malignant tumor that endangers the health of middle-aged and elderly men. Serum prostate-specific antigen (PSA) detection combined with digital rectal examination is a preliminary screening method for early detection of prostate cancer. It can be used to screen suspicious cases. Prostate biopsy to aid diagnosis. However, when the total PSA (total PSA, tPSA) of the patient is 4.0-10.0 μg / L, which is the gray area of ​​the traditional view, it is difficult to use PSA to make a clear differential diagnosis. Although free PSA (free PSA, fPSA) can be detected at the same time and the ratio of fPSA to tPSA (f / tPSA) can be calculated for identification, but the effect is not obvious. [0003] Serum p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/543
CPCG01N33/54326G01N33/57434G01N33/57484
Inventor 李磊李冬梅孙成艳高威何浩会
Owner DIRUI MEDICAL TECH CO LTD
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