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Stable urine microalbumin quality control material and preparation method thereof

A technology for urine microalbumin and quality control products, which is applied in the preparation of test samples, measuring devices, sampling, etc., can solve the problems of urine microalbumin control products attenuation and long-term storage, and achieve increased permeability, Avoid protein attenuation and apply to a wide range of pH

Inactive Publication Date: 2018-11-30
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention aims at the technical problem that the existing urinary microalbumin control product is prone to attenuation and cannot be preserved for a long time, and provides a stable urinary microalbumin control product with a validity period of up to 24 months

Method used

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  • Stable urine microalbumin quality control material and preparation method thereof
  • Stable urine microalbumin quality control material and preparation method thereof
  • Stable urine microalbumin quality control material and preparation method thereof

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preparation example Construction

[0049] The preparation method of the above-mentioned stable urine microalbumin protein control product comprises the following steps: respectively take 1L of purified water, add buffer salts of the stated concentration, protective agent A, protective agent B and surfactant in sequence, and stir in turn until completely Dissolve; filter once with a 0.22μm filter; adjust the pH value to 7.2-7.4 with concentrated HCl or 40mmol / LNaOH, the pH value is the value measured at 20±0.5°C, and then add albumin according to the concentration calculation , to obtain the urine microalbumin high-value quality control product and urine microalbumin low-value quality control product.

[0050] The buffer is phosphate buffer, HEPES buffer, PIPES buffer, MOPS buffer, disodium hydrogen phosphate-citric acid buffer, TRIS buffer, TRIS-HCl buffer, barbiturate sodium-hydrochloric acid buffer One or more of the above-mentioned buffer solutions can effectively stabilize the pH value of the quality contro...

Embodiment 1

[0056] A stable urine microalbumin low-value quality control product consists of the following components:

[0057]

[0058] The preparation process is as follows: add 1L of purified water into a clean preparation container, then add the above-mentioned buffer solution, salt, protective agent A, protective agent B and surfactant in sequence, and stir until completely dissolved; use Filter once with a 0.22um filter membrane; adjust the pH value to 7.2-7.4 (20±0.5°C) with concentrated HCl or 40mmol / LNaOH, and add albumin according to the concentration calculation. Pack according to the specification of 1ml / bottle.

[0059] The details of the equipment used are high-density polyethylene barrels or bottles, 100,000-grade electronic balances, pH meters and matching calibration buffers, 1000mL graduated cylinders and special filters.

Embodiment 2

[0061] A stable urine microalbumin low-value quality control product consists of the following components:

[0062]

[0063]

[0064] The preparation process is as follows: add 1L of purified water into a clean preparation container, then add the above-mentioned buffer solution, salt, protective agent A, protective agent B and surfactant in sequence, and stir until completely dissolved; use Filter once with a 0.22um filter membrane; adjust the pH value to 7.2-7.4 (20±0.5°C) with concentrated HCl or 40mmol / LNaOH, and add albumin according to the concentration calculation. Pack according to the specification of 1ml / bottle.

[0065] The details of the equipment used are high-density polyethylene barrels or bottles, 100,000-grade electronic balances, pH meters and matching calibration buffers, 1000mL graduated cylinders and special filters.

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Abstract

The invention discloses a stable urine microalbumin quality control material and a preparation method thereof. The stable urine microalbumin quality control material solves the technical problem thatthe existing urine microalbumin quality control material easily produces attenuation and cannot be preserved for a long time. The stable urine microalbumin quality control material belongs to the technical field of medical device biochemical in-vitro diagnosis. The stable urine microalbumin quality control material comprises 1-50mmol / L of a buffer with pH of 7.2-7.4, 5-15g / L of salt, 0.01-0.1% ofa protective agent A, 1-10% of a protective agent B, 1-10mL / L of a surfactant and 8.67-21.33mg / L or 45.2-62.8mg / L of albumin. The stable urine microalbumin quality control material has broad-spectrumantibacterial activity, has a wide application range, prevents microbial damage to quality control products, prevents protein attenuation, improves product stability and has an effect period of 24 months.

Description

technical field [0001] The invention relates to the technical field of biochemical in vitro diagnosis of medical devices, in particular to a quality control product for evaluating the accuracy of a kit for detecting urine microalbumin content in urine based on the principle of immunoturbidimetry. Background technique [0002] Urine Microalbumin Assay Kit (Immunoturbidimetric Assay) is used for the quantitative detection of microalbumin in human urine samples in vitro. In clinical practice, urinary microalbumin indicators are usually used to monitor the occurrence of nephropathy. The detection of urinary microalbumin is the most sensitive and reliable diagnostic index for early detection of nephropathy. A more accurate diagnosis of the disease can be made through the value of urinary microalbumin, combined with the onset, symptoms, and medical history statement. Therefore, regular detection of urinary microalbumin can play a positive role in the prevention and early treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28
CPCG01N1/28G01N2001/2893
Inventor 韩亚杰刘阳高威孙成艳何浩会
Owner DIRUI MEDICAL TECH CO LTD
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