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Special protein liquid compound quality control serum with high stability for biochemistry

A technology with strong stability and special protein, which is applied in biological testing, reference solutions, material inspection products, etc., can solve problems such as different performance, inability to store for a long time, easy attenuation or cross-reaction, etc., to improve stability and stability PH value, effect of preventing turbidity

Inactive Publication Date: 2017-01-11
BIOBASE BIODUSTRY (SHANDONG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Special protein control substances for biochemistry refer to a kind of quality control substance to grasp and control the detection system in the process of carrying out special protein detection projects in the process of clinical biochemical detection; it is widely used in clinical practice, and special protein in biochemical clinical detection There are many detection items, common ones include antistreptococcal O, alpha-fetoprotein, C-reactive protein, complement C3, complement C4, immunoglobulin IGA, immunoglobulin IgG, immunoglobulin IGM, prealbumin and other biochemical project; the quality control of special proteins currently used is mostly one-to-one single project, or the quality control of special protein compounded by dry powder, and there are few quality control products of special protein compounded by liquid, while the compound calibration of liquid Since the product contains a variety of special protein substances, it can be used directly without pre-treatment, which saves the cost and process of configuration, and also greatly facilitates clinical operation and use. However, due to the different performance of different special protein items, stable The conditions are not the same, and it is very easy to attenuate or cross-react when mixed together in a liquid state, and it cannot be stored for a long time; therefore, a stable liquid special protein composite quality control product can be invented, which has very good clinical practicability. It is also very conducive to the promotion and development of clinical

Method used

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  • Special protein liquid compound quality control serum with high stability for biochemistry
  • Special protein liquid compound quality control serum with high stability for biochemistry
  • Special protein liquid compound quality control serum with high stability for biochemistry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The components of a highly stable biochemical special protein liquid composite quality control product are as follows:

[0051] Quality Control Composition:

[0052] PIPES 50mmol / L

[0053] EDTA 1mmol / L

[0054] Hydroxyethylidene diphosphate 0.1ml / L

[0055] Triton-100 1ml / L

[0056] Alkyl glucoside 0.5ml / L

[0057] Bovine serum albumin 30g / L

[0058] Magnesium sulfate heptahydrate 7.5mmol / L

[0059] Dithiothreitol 1mmol / L

[0060] Sodium chloride 10g / L

[0061] Potassium chloride 0.5g / L

[0062] Methylisothiazolinone 0.5g / L

[0063] Anti-streptococcal O 250KU / L

[0064] C reactive protein 50mg / L

[0065] Complement C3 140mg / dL

[0066] Complement C4 30.0mg / dL

[0067] IgM 185mg / dL

[0068] IgA 240mg / dL

[0069] IgG 12g / L

[0070] Prealbumin 30mg / dL

[0071] Rheumatoid factor 55U / mL

[0072] Transferrin 260mg / dL.

Embodiment 2

[0074] This example describes a highly stable biochemical special protein liquid composite quality control product after the addition of materials. The composition is as follows:

[0075] Quality Control Composition:

[0076] Buffer 50mmol / L

[0077] Metal chelating agent 1 5mmol / L

[0078] Metal chelating agent 2 0.5 ml / L

[0079] Surfactant 1 3ml / L

[0080] Surfactant 2 1ml / L

[0081] Protective agent 1 50g / L

[0082] Protectant 2 10mmol / L

[0083] Protective agent 3 3mmol / L

[0084] Ion balance agent 1 20g / L

[0085] Ion balance agent 2 1g / L

[0086] Preservative 1g / L

[0087] Anti-Strep O 300kU / K

[0088] C reactive protein 55mg / L

[0089] Complement C3 148mg / dL

[0090] Complement C4 35mg / dL

[0091] IgM 190mg / dL

[0092] IgA 250mg / dL

[0093] IgG 15g / L

[0094] Prealbumin 50mg / dL

[0095] Rheumatoid factor 60u / mL

[0096] Transferrin 80mg / dL.

Embodiment 3

[0098] This example describes the verification method of the stability of the quality control product of the compound special protein with strong stability of the present invention,

[0099] The specific verification methods and steps are as follows:

[0100] Divide the liquid quality control products prepared in Example 1 or Example 2 into 13 parts, store them in an environment of 2-8°C, and select the corresponding total protein, albumin, anti-streptococcal O and C-reactive protein , complement C3, complement C4, IgA, IgM, IgG, prealbumin, rheumatoid factor, transferrin 12 kinds of biochemical reagents (all 12 kinds of reagents are selected from the kit produced by Shandong Boke Biological Industry Co., Ltd.), fully automatic The biochemical analysis instrument is first calibrated. After the calibration is successful, the configured quality control products in Example 1 and Example 2 are detected every month, and continuously detected for 13 months to observe the changes in ...

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Abstract

The invention relates to a special protein liquid compound quality control serum with high stability for biochemistry, and belongs to the technical field of clinical in-vitro detection. The quality control serum is a compound liquid quality control serum which is mainly prepared from protective substances such as a buffer solution, a metal chelating agent, a surfactant, a protective agent, an ionic equilibrium agent and a preservative, and the quality control serum can detect 12 substances of antistreptococcic O, C reactive protein, a complement C3, a complement C4, IgM, IgA, IgG, prealbumin, rheumatoid factors, transferrin, total protein and albumin. Serving as the quality control serum of the 12 substances, the quality control serum has the advantages of being convenient to use and high in stability.

Description

technical field [0001] The invention relates to a highly stable biochemical special protein liquid composite quality control product, which belongs to the technical field of clinical in vitro detection. Background technique [0002] Special protein control substances for biochemistry refer to a kind of quality control substance to grasp and control the detection system in the process of carrying out special protein detection projects in the process of clinical biochemical detection; it is widely used in clinical practice, and special protein in biochemical clinical detection There are many detection items, common ones include antistreptococcal O, alpha-fetoprotein, C-reactive protein, complement C3, complement C4, immunoglobulin IGA, immunoglobulin IgG, immunoglobulin IGM, prealbumin and other biochemical project; the quality control of special proteins currently used is mostly one-to-one single project, or the quality control of special protein compounded by dry powder, and...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/68G01N2496/00
Inventor 甘宜梧罗维晓谭柏清
Owner BIOBASE BIODUSTRY (SHANDONG) CO LTD
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