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Glycosylated hemoglobin reference material and preparation method thereof

A technology of glycosylated hemoglobin and standard substances, which is applied in the field of medical testing, can solve the problems of lack of HbA, etc., and achieve the effects of convenient transportation, simple preparation method, and convenient use

Active Publication Date: 2015-07-29
BEIJING HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But there is no HbA in our country 1 cStandard material, lack of HbA 1 The basis of c detection standardization, in order to promote the HbA in my country 1 The detection and clinical application of c will be in line with international standards as soon as possible, and the present invention will prepare human blood matrix HbA with a medically determined level 1 c Candidate standard substance

Method used

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  • Glycosylated hemoglobin reference material and preparation method thereof
  • Glycosylated hemoglobin reference material and preparation method thereof
  • Glycosylated hemoglobin reference material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiment 1: Preparation of glycosylated hemoglobin standard substance

[0049] 1. Materials

[0050] 1. Selection of packaging containers

[0051] The polyethylene material does not absorb and release the components in the candidate standard substance matrix, and is heat-resistant, acid-resistant, alkali-resistant, and water-resistant. Therefore, a sterile polyethylene tube (Axygen Company, USA) was selected as the standard substance container.

[0052] 2. Disinfection

[0053] Before preparation, the aseptic room and ultra-clean bench were sterilized by ultraviolet light.

[0054] 3. Selection of volunteers for blood collection

[0055] Healthy volunteers without diabetes, well-controlled diabetes, and poorly-controlled diabetes, aged 20 to 50 years, half male and half female, negative for human immunodeficiency virus antibody (HIV) and hepatitis B and C surface antigen (HBV, HCV), fill in Informed Consent.

[0056] 4. Reagents

[0057] Acetonitrile, chromatogr...

Embodiment 2

[0070] Example 2: Uniformity Test

[0071] 1. Detection method

[0072] Ion-exchange HPLC method is commonly used in clinical HbA 1c One of the measurement methods, the precision of this method is good, it can meet the requirements of uniformity test, and the detection cost is low, the time is short, and it is suitable for the analysis of large sample size. Therefore, after comprehensive consideration, the research unit adopts the ion-exchange HPLC method as the determination method for the homogeneity test.

[0073] 1. Adopt the random sampling method, number the candidate standard substance that subpackaging embodiment 1 obtains sequentially, each concentration randomly selects 21 bottles to carry out homogeneity test, the method for measuring is ion-exchange HPLC method, and the minimum sampling volume is 5 μ l. All samples were stored at -70°C until assayed.

[0074] 2. Before the measurement, the sample was reconstituted at room temperature, and vortexed on a blood mix...

Embodiment 3

[0100] Embodiment 3: stability test

[0101] 1. Detection method

[0102] According to the description in GB / T15000.3-2008 / ISO Guide35:2006, the stability inspection research is carried out by using the synchronous stability research. For the short-term stability study, a total of 9 temperature time points were designed, which were zero point, 1 day, 2 days, and 4 days at room temperature; 1 week, 2 weeks, and 1 month at 4°C; 2 weeks, 1 month at -20°C and 3 months, 5 temperature time points are designed for long-term stability research, which are zero point, -70 ℃ 1 month, 3 months, 6 months, 9 months and 12 months; Bottle samples were analyzed in triplicate for each bottle. Same as the homogeneity test study, the stability test uses the ion-exchange HPLC method as the analytical method.

[0103] 1. Sample storage for stability testing studies

[0104] The samples at each temperature and time point were randomly selected from the total sample as follows:

[0105] 3 bottle...

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Abstract

The invention discloses a glycosylated hemoglobin reference material and a preparation method thereof and belongs to the field of medical examination. The glycosylated hemoglobin reference material is characterized by comprising human blood matrix HbA1c reference materials with three concentrations and at medical decision levels, the concentrations are as follows: (1) the concentration 1: the IFCC value is in a range of 31-42 mmol / mol or the NGSP value is in a range of 5.0-6.0HbA1c%; (2) the concentration 2: the IFCC value is in a range of 43-58 mmol / mol or the NGSP value is in a range of 6.1-7.5HbA1c%; (3) the concentration 3: the IFCC value is in a range of 69-91 mmol / mol or the NGSP value is in a range of 8.5-10.5HbA1c%. The reference material has good uniformity, stability and interoperability and can be applied to traceability and quality evaluation of conventional glycosylated hemoglobin detection systems, preparation and quality evaluation of glycosylated hemoglobin detection reagents, preparation, valuing and quality evaluation of calibrators and quality assurance in collaborative research and analysis. The reference material can be used for evaluating traceability and quality of conventional methods.

Description

technical field [0001] The invention relates to a glycated hemoglobin standard substance and a preparation method thereof, belonging to the field of medical testing. Background technique [0002] Diabetes has become the world's largest epidemic, and the incidence, disability rate and The mortality rate is extremely high, which seriously threatens the quality of life and even life of diabetic patients, and also imposes a huge burden on medical resources and social economy. Therefore, early diagnosis of diabetes and reasonable control of blood sugar levels in diabetic patients are the key to solving the problem. The occurrence and development of diabetes and its complications depend on the long-term glycosylation state of the protein in the patient's body. An effective method to evaluate this glycosylation state is to detect the stable addition product of glucose and hemoglobin in the blood - glycosylated hemoglobin, of which Hemoglobin A 1c (HbA 1c ) is the main component ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N1/28
CPCG01N33/96
Inventor 王冬环陈文祥张天娇周伟燕汪静闫颖张江涛
Owner BEIJING HOSPITAL