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Urine special protein composite quality control substance and preparation method thereof

A technology of special proteins and quality control substances, which is applied in the field of urine special protein detection, can solve problems such as error-prone, poor stability of quality control substances, difficult to store, etc., and achieve low error probability, small uncontrollable risk, and stable performance Effect

Pending Publication Date: 2019-10-15
URIT MEDICAL ELECTRONICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the commonly used quality control products are mostly single-item quality control products. In the process of use, customers need to open multiple bottles of quality control products to carry out multiple special protein control projects. The operation is cumbersome, error-prone, and non-urine-based quality control products. There is a certain matrix effect
[0004] An existing patent number is "CN201610674109.2", and the patent name is a Chinese invention patent titled "a highly stable biochemical special protein liquid composite quality control product". The disclosed quality control product can detect anti-streptococcus O, C-reactive protein, complement C3, complement C4, IgM, IgA, IgG, prealbumin, rheumatoid factor, transferrin, total protein, albumin 12 substances, as the quality control of these 12 substances, is The quality control is carried out based on the corresponding protein content in serum, and the content of various proteins is relatively high. Taking the transferrin project as an example, the content range of transferrin is 2600-2800mg / L, and the protein content is high, which is similar to that of special Compared with the protein content value, there is a large difference, the probability of detection error is high, and the protein content is high, and the storage stability is relatively easy to achieve. However, if the corresponding protein content in urine is used as the benchmark, due to the low corresponding protein content, the corresponding Poor stability of quality control substances, difficult to store

Method used

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  • Urine special protein composite quality control substance and preparation method thereof
  • Urine special protein composite quality control substance and preparation method thereof
  • Urine special protein composite quality control substance and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Low-value positive quality controls include in the present embodiment:

[0034]

[0035]

[0036] High positive controls include:

[0037]

[0038] Among them, phosphate buffer is selected as buffer, potassium chloride is selected as salt, potassium sorbate is selected as preservative, gelatin is selected as protein protection agent, lysine is selected as stabilizer, and albumin is selected as human albumin.

[0039] Preparation of low-value positive quality control substances: at room temperature, according to the formula of low-value positive quality control substances in this example, add buffer, urea, salts, preservatives, creatinine, protein protectant, stabilizer Agent, human albumin, transferrin, retinol binding protein, α1-microglobulin, β2-microglobulin, immunoglobulin G, neutrophil gelatinase-associated lipocalin, adjust the pH value to 5.0-8.0, a low-value positive quality control was obtained.

[0040] Preparation of high-value positive quality co...

Embodiment 2

[0050] Low-value positive quality controls include in the present embodiment:

[0051]

[0052]

[0053] High positive controls include:

[0054]

[0055] Among them, citrate buffer is selected as buffer, sodium chloride is selected as salt, sodium benzoate is selected as preservative, polyvinylpyrrolidone is selected as protein protection agent, trehalose is selected as stabilizer, and albumin is selected as human albumin.

Embodiment 3

[0057] Low-value positive quality controls include in the present embodiment:

[0058]

[0059]

[0060] High positive controls include:

[0061]

[0062]

[0063] Among them, the glycine-sodium hydroxide buffer is selected as the buffer, sodium carbonate is selected as the salt, dehydroacetic acid is selected as the preservative, globulin is selected as the protein protection agent, hexokinase is selected as the stabilizer, and albumin is selected as the human albumin.

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PUM

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Abstract

The invention relates to the technical field of urine special protein detection, in particular to a urine special protein composite quality control substance and a preparation method thereof, the quality control substance comprises a low-value positive quality control substance and a high-value positive quality control substance, and the low-value positive quality control substance and the high-value positive quality control substance respectively comprise a buffer agent, urea, salts, a preservative, creatinine, PH, a protein protective agent, a stabilizer, human albumin, transferrin, retinolconjugated protein, alpha1-microglobulin, beta2-microglobulin, immune globulin G, neutrophil gelatinase associated lipocalin. The urine special protein composite quality control substance and the preparation method thereof provided by the invention have the advantages of simple operation, instant use after decapping, good stability, low production cost and easiness to achieve the quality control of a urine special protein detection system.

Description

technical field [0001] The invention relates to the technical field of urine special protein detection, in particular to a urine special protein composite quality control substance and a preparation method. Background technique [0002] With the increasing incidence of kidney disease patients, kidney disease has become a global public health problem. Patients with kidney disease have a long asymptomatic period before the appearance of obvious clinical symptoms, and it is difficult to detect relatively early kidney damage without screening. Renal puncture histopathological examination is the most reliable method for diagnosing renal injury, but it is technically demanding and traumatic, so it is not easy to popularize. The detection of urinary specific protein is one of the hotspots in the diagnosis and treatment of kidney diseases, and the detection of specific protein content in urine has important clinical diagnostic value for the diagnosis of kidney disease. [0003] In...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/531
CPCG01N33/68G01N33/531G01N2496/00G01N2800/347
Inventor 蒋泽军刘云鹏冼庆勇安杰付林春
Owner URIT MEDICAL ELECTRONICS CO LTD
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