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Clinical biochemical composite quality control product and preparation method thereof

A quality control, biochemical technology, applied in the preparation, sampling, and instrumentation of test samples, which can solve the problem of inability to clinical use, provide greater convenience, fail to solve product stability, and increase the risk of enzyme damage, etc. problems, to achieve the effect of easy reconstitution and mixing, ensuring the correctness of the test and high accuracy

Pending Publication Date: 2022-06-10
广西康柏莱科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are few compound quality control products on the market, most of which are quality control products for a single test item. However, the use of single quality control products will bring some inconvenience to the operation and use. The main problems are: 1. Compound types Few: Due to the high price and the inability to solve problems such as product stability, most quality control products on the market have fewer composite items, which cannot provide greater convenience for clinical use
2. Poor stability and insufficient uniformity: Most of the biochemical reactions in biochemical reagents are catalyzed by enzymes, and the stability of enzymes determines the stability of reagents
Especially in the composite quality control product, the composition is complex, which increases the risk of enzyme damage, resulting in poor stability and inhomogeneity of the quality control product

Method used

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  • Clinical biochemical composite quality control product and preparation method thereof
  • Clinical biochemical composite quality control product and preparation method thereof
  • Clinical biochemical composite quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A clinical biochemical composite quality control product, including testing project raw materials, matrix liquid and protective agent, the specific formula is as follows:

[0034]

[0035]

[0036] The specific preparation method of the clinical biochemical composite quality control product of the present invention comprises the following steps:

[0037] Step 1. Add distilled water to the preparation container according to the preparation amount of the above formula, and set aside.

[0038] Step 2. Add bovine serum albumin and human serum albumin under stirring. After adding the materials, stir at 400 r / min for 30 minutes until completely dissolved.

[0039] Step 3. After the above is completely dissolved, use a filter membrane with a pore size of 0.22 μm to filter into another clean preparation container;

[0040] Step 4. Add dithiothreitol, mannose, trehalose, sodium chloride, compound enzyme stabilizer AES and sodium azide into the above solution in turn, and ...

Embodiment 2

[0053] The difference between this example and Example 1 is that human serum albumin is not added to the formula.

Embodiment 3

[0055] The difference between this example and Example 1 is that the compound enzyme stabilizer AES is not added to the formula.

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Abstract

The invention discloses a clinical biochemical composite quality control product which comprises a detection item raw material, a matrix liquid and a protective agent, a detection item comprises the following raw materials: alkaline phosphatase, amylase, sodium glycochenodeoxycholate, cholinesterase, creatinine, leucine aminopeptidase, lactic dehydrogenase, lipase, triglyceride, cholesterol, uric acid, urea, alanine aminotransferase, asparaginic acid aminotransferase, gamma-glutamyl transferase, glucose, alpha-hydroxybutyrate dehydrogenase and sodium hydrogen phosphate. Magnesium chloride, calcium chloride, ferrous chloride, bilirubin, amylopsin and sodium bicarbonate; the matrix liquid is bovine serum albumin and human serum albumin; the protective agent comprises dithiothreitol (DTT), mannitol, trehalose, sodium chloride, a compound enzyme stabilizer AES and sodium azide. The quality control product disclosed by the invention can realize detection of 27 clinical biochemical items, and the freeze-drying process is adopted, so that the obtained freeze-dried composite quality control product is low in viscosity, easy to redissolve and uniformly mix, strong in stability and relatively small in matrix effect.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic reagents, and in particular relates to a clinical biochemical composite quality control product and a preparation method thereof. Background technique [0002] As biochemical analyzers and their biochemical reagents are widely used in clinical medical testing, a number of supporting clinical biochemical quality control products are particularly important for their quality control. The laboratory monitors the stable state of the supporting testing items in the testing system (instruments, reagents, staff and environment, etc.) of the laboratory by measuring the quality control substances and drawing the quality control chart, and timely discovers the out-of-control state of the testing system, if any If the control is out of control, corresponding measures are taken to correct it in time to ensure that the detection system is in a normal state, and the quality of the quality control pro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N1/42G01N1/38
CPCG01N1/28G01N1/42G01N1/38G01N2001/2893
Inventor 韦佳志李名星刘利民张设熙余强钦苏琴
Owner 广西康柏莱科技有限公司
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