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Quantitative measuring kit for free prostate specific antigen (FPSA) and detection method thereof

A kit and antigen technology, applied in the field of determination of free prostate-specific antigen content in serum, can solve problems such as elevated PSA

Inactive Publication Date: 2012-03-28
INNER MONGOLIA KEHUI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

PSA is tissue-specific, but not tumor-specific. Prostatitis, benign prostatic hyperplasia, and prostate cancer can all lead to increased PSA

Method used

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  • Quantitative measuring kit for free prostate specific antigen (FPSA) and detection method thereof
  • Quantitative measuring kit for free prostate specific antigen (FPSA) and detection method thereof
  • Quantitative measuring kit for free prostate specific antigen (FPSA) 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

[0099] 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:

[0100] 1. Take Tris 6.06g, NaCl 13.0g, Zncl 2 0.05g, Proclin-3000.2ml 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;

[0101] 2. Use HCl or NaOH to adjust the pH, and measure the pH to be in the range of 7.35-7.45;

[0102] 3. Weigh 3g of BSA and pour it into the above container;

[0103] 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;

[0104] Enzyme reactant diluent Table 2

[0105]

[0106] 2. Coupling of alkaline phosphatase (ALP) and anti-FPSA monoclonal antibody

[0107] 1. Add 10 mg of ALP to 5 ml of norma...

Embodiment 3

[0114] Reaction enhancer preparation operating procedures: see the formula (Table 3), taking the preparation of 1L as an example:

[0115] 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;

[0116] 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;

[0117] 3. Weigh 30.9g of Mak into the above 1L container;

[0118] 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;

[0119] Preparation of reaction en...

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Abstract

The invention discloses a quantitative measuring kit for a free prostate specific antigen (FPSA). The kit is characterized by comprising an FPSA magnetic separation reagent, an enzyme reactant, a reaction enhancing agent, a diluent, an FPSA standard substance, an FPSA control material, a concentrated cleaning liquid and a substance solution. The invention further discloses a preparation method for the kit. In the kit, a chemiluminescence technology is combined with immune magnetic particles, so that an approximately homogeneous reaction system is provided. Compared with the prior art, the kit has the advantages of higher detection sensitivity, higher specificity, resulting time which is shortened by at least 10 minutes, better performance parameters and great reduction in the production cost.

Description

technical field [0001] The invention relates to a test kit for measuring serum and a testing method thereof, in particular to a kit for measuring free prostate-specific antigen (FPSA) content in serum and a testing method thereof. Background technique [0002] Prostate-specific antigen (PSA) is a single-chain glycoprotein molecule with a molecular weight of 30-33 kDa secreted by human prostate epithelial tissue cells. In the human body, it mainly exists in male prostate tissue, semen and serum. PSA in serum exists in different molecular forms, and the forms of serum PSA commonly used in clinical practice mainly include FPSA and FPSA. FPSA is the molecular form of all PSA that can be detected in serum, mainly PSA-α1-antichymotrypsin (accounting for 70% to 85%) and FPSA, and FPSA is a free non-complexed form that exists in serum PSA is inactive in serum. Total PSA (free PSA plus complex PSA) is elevated in both benign prostatic hyperplasia and malignant prostate cancer, and...

Claims

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Application Information

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IPC IPC(8): G01N33/577G01N33/531
Inventor 不公告发明人
Owner INNER MONGOLIA KEHUI BIOLOGICAL TECH
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