CN113009024B - Method for measuring elution condition in glycosylated hemoglobin - Google Patents
Method for measuring elution condition in glycosylated hemoglobin Download PDFInfo
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- CN113009024B CN113009024B CN202110216395.9A CN202110216395A CN113009024B CN 113009024 B CN113009024 B CN 113009024B CN 202110216395 A CN202110216395 A CN 202110216395A CN 113009024 B CN113009024 B CN 113009024B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention relates to the field of clinical in-vitro diagnosis and detection, and discloses a method for measuring elution conditions in glycosylated hemoglobin, which comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant and an additive, the hemolytic agent comprises the surfactant and the additive, and the additive is one or more of threonine, beta-alanine and glycine; a method of assaying glycated hemoglobin in whole blood is also disclosed. The glycosylated hemoglobin kit provided by the invention can avoid the change of the measured value of the sample along with the storage time of the sample, and simultaneously reduces the complex process of sample pretreatment, thereby realizing the efficient and accurate detection of glycosylated hemoglobin. In addition, the determination method provided by the invention can realize rapid and accurate detection on the stored sample.
Description
Technical Field
The application of the invention is the application date 2018, 12 month and 29 days, and the application number is: 201811635299.2A divisional application of an invention patent application entitled "kit and method for measuring glycosylated hemoglobin in whole blood".
The invention relates to the field of clinical in-vitro diagnosis and detection, in particular to a method for measuring elution conditions in glycosylated hemoglobin.
Background
The global diabetic patients in 2017 were about 4.25 million people based on international diabetes alliance (Internationale Diabetes Federation, IDF) statistics. The United states diabetes control and complications trial (Diabetes Control and Complication Trial, DCCT) and British diabetes control and complications relationship study (UK Prospective Diabetes Study, UKPDS) found glycosylated hemoglobin (HbA 1 c) to be a good indicator of the extent of disease control in diabetics, reflecting the average blood glucose level of the patient over the 120 days prior to testing, independent of blood withdrawal time, whether the patient is empty, whether insulin is used, and the like. At the 59 th annual meeting of the american diabetes association (American Diabetes Association, ADA), ADA uses HbA1c as the gold standard for glycemic control, suggesting that all diabetics should routinely measure HbA1c at least twice a year and require that in clinical applications, whatever the method used to react to changes in blood glucose, the change in HbA1c be ultimately used as an effective test indicator for the ultimate assessment of a drug or a therapeutic regimen. Therefore, the clinical significance of HbA1c detection is very important.
Current methods for detecting HbA1c mainly include chromatography, immunoassay and electrophoresis. Wherein the chromatography comprises high performance liquid cation exchange chromatography and high performance liquid boric acid affinity chromatography. As a gold standard for HbA1c detection, high performance liquid cation exchange chromatography is always the most practical and accurate method in clinic.
The principle of measuring HbA1c in whole blood by using high performance liquid cation exchange chromatography is as follows: hemolysis of whole blood sample with hemolytic agent to release target protein, and as the isoelectric points of glycosylated hemoglobin (HbA 1 c) and non-glycosylated hemoglobin (HbA 0) in the sample are different, the positive charges of the glycosylated hemoglobin and the non-glycosylated hemoglobin are different under weak acid condition, so that when the sample passes through glycosylated hemoglobin analysis column, the adsorption and exchange capacity of ion exchange stationary phase with negative charges in the analysis column are different, and then the eluent (eluent A and eluent B) with two different salt concentrations are adopted to separate the components; firstly, eluting HbA1c by using an eluent A with low salt concentration, and then eluting HbA0 by using an eluent B with high salt concentration; the eluted protein sequentially passes through a detector, the detector automatically records the light absorption intensity change at 415nm, an optical signal is converted into an electric signal, a substance signal spectrogram is obtained, the collected spectrogram data are analyzed and calculated to obtain HbA1c and HbA0 peak areas, and the percentage of the HbA1c peak area to the total hemoglobin Hb peak area is the detection result of HbA1c in the human whole blood sample.
However, in the case of the above-mentioned research for measuring HbA1c by the liquid-phase ion exchange chromatography, when HbA1c is detected after a sample (for example, a whole blood sample, a whole blood diluted sample, a whole blood lyophilized sample, or the like) is stored, the measured value fluctuates with the lapse of the storage time of the sample.
The invention of publication No. CN101595230A discloses a method for measuring HbA1c, and also indicates that when HbA1c is measured after the Hb-containing sample is stored, a value lower than the measurement value obtained by using the Hb-containing sample that has just been collected is obtained. The patent adopts a method of adding an inhibitor to a sample to avoid fluctuation of HbA1c measurement values caused by preservation of the sample, but the method requires direct participation of a measurer, complicates a measurement process, and greatly reduces detection efficiency.
Disclosure of Invention
The invention provides a kit and a method for measuring glycosylated hemoglobin in whole blood, which can be used for efficiently and accurately quantitatively measuring the glycosylated hemoglobin in a human whole blood sample in vitro without influencing the preservation time of the sample, aiming at the defect that the measurement value of HbA1c after the preservation of the sample in the prior art can change along with the preservation time of the sample.
In order to solve the technical problems, the invention is solved by the following technical scheme:
a kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant and an additive, the hemolytic agent comprises the surfactant and the additive, and the additive is one or more of threonine, beta-alanine and glycine.
Preferably, the addition amount of the additive in the eluent A, the eluent B and the hemolysis agent is 0.01g/L to 1.00g/L, preferably 0.05g/L to 0.50g/L.
Preferably, the buffer solution is one or more of phosphate buffer solution, citrate buffer solution and succinate buffer solution. Because the phosphate buffer, the citrate buffer and the succinate buffer have a wider pH buffer range, the buffer can achieve good eluting effect when being added into the eluent A and the eluent B.
Preferably, the molar concentration of the buffer solution in the eluent A is 0.01mol/L to 0.50mol/L, preferably 0.05mol/L to 0.50mol/L, and the buffer solution at the molar concentration not only has a proper pH buffer range, but also can achieve a proper eluting effect.
Preferably, the molar concentration of the buffer in the eluent B is 0.02mol/L to 1.00mol/L, preferably 0.06mol/L to 1.00mol/L, and the buffer at the molar concentration not only has a proper pH buffer range, but also can achieve a proper eluting effect.
Preferably, the surfactant is one or two of Tween 20 and triton X-100, and the addition of the surfactant is beneficial to increasing the permeability of the biological membrane to small molecules and facilitating cell lysis. The amount of the surfactant to be added is 1.00g/L to 20.00g/L, preferably 5.00g/L to 9.00g/L.
Preferably, the eluent A, the eluent B and the hemolytic agent also comprise a preservative, and the preservative can inhibit the growth of microorganisms and prolong the storage time of the eluent A, the eluent B and the hemolytic agent. The preservative is preferably sodium azide, which has the effect of inhibiting the synthesis of basal metabolic enzymes in cells, thereby inhibiting the growth of microorganisms and serving as a preservative. The addition amount of the preservative in the eluent A, the eluent B and the hemolytic agent is less than or equal to 5.00g/L, and at the moment, the growth of microorganisms can be effectively inhibited.
Preferably, the device also comprises an analysis column, a quality control product and a calibrator, wherein the filler of the analysis column is a cation exchange stationary phase, the particle size of the filler is 3-10 mu m, the length of the column is 10-50 mm, and the inner diameter of the column is 4.0-4.6 mm; the quality control product and the calibrator are glycosylated hemoglobin blood sample lyophilized powder, and the glycosylated hemoglobin blood sample lyophilized powder of the calibrator can be traced by IFCC (International Union of clinical chemistry and laboratory medicine).
A method for assaying glycosylated hemoglobin in whole blood comprising the steps of: adding a hemolyzing agent into the sample for hemolysis, eluting the hemolyzed sample in an analysis column by using an eluent to obtain HbA1c component and HbA0 component, detecting, and calculating to obtain a detection result of HbA1 c; the eluent is the eluent A and the eluent B.
Preferably, the elution conditions are: the packing of the analysis column is cation exchange stationary phase, the grain diameter of the packing is 3 mu m-10 mu m, the column length is 10 mm-50 mm, and the inner diameter of the column is 4.0 mm-4.6 mm; detection wavelength: 415nm; column temperature is 37 ℃; elution gradient: 0-45 s of eluent A100% by volume and eluent B0% by volume; 46 s-75 s of eluent A0% by volume and eluent B100% by volume; 100% of the volume of the eluent A from 76s to 120s and 0% of the volume of the eluent B; the flow rate is 1.5mL/min, and the sample injection amount is 10 mu L.
Preferably, the sample is a whole blood sample, a whole blood diluted sample or a whole blood lyophilized sample.
The invention has the remarkable technical effects due to the adoption of the technical scheme:
according to the glycosylated hemoglobin kit provided by the invention, the additive is added into the eluent A, the eluent B and the hemolytic agent, so that the change of the measured value of the sample along with the storage time of the sample can be avoided, and the complex process of sample pretreatment is reduced, thereby realizing the efficient and accurate detection of glycosylated hemoglobin. In addition, the determination method provided by the invention can realize rapid and accurate detection on the stored sample. Therefore, the kit and the measuring method provided by the invention have very important practical application values for the conditions that the blood sample collection sites and the measuring sites are different, or a certain number of samples are collected and then concentrated to be detected, and the samples are required to be stored and then detected.
Drawings
FIG. 1 is a correlation analysis of the detection results of example 4 and comparative example 2.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and examples.
Example 1
A kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant, a preservative and an additive, the hemolytic agent comprises the surfactant, the preservative and the additive, and the additive is threonine.
The addition amount of the additive in the eluent A, the eluent B and the hemolytic agent is 0.01g/L.
The buffer solution is succinate buffer solution, and the succinate buffer solution in the eluent A comprises succinic acid with the mass volume concentration of 2.70g/L and sodium succinate with the mass volume concentration of 18.50 g/L; the succinate buffer of the eluent B comprises succinic acid with the mass volume concentration of 1.40g/L and sodium succinate with the mass volume concentration of 22.90 g/L.
The molar concentration of the succinate buffer in the eluent A is 0.09mol/L.
The molar concentration of the succinate buffer in the eluent B is 0.10mol/L.
The surfactant is triton X-100, and the addition amount of the surfactant in the eluent A, the eluent B and the hemolytic agent is 9.00g/L.
The preservative is sodium azide, and the addition amount of the sodium azide in the eluent A, the eluent B and the hemolytic agent is 0.50g/L.
The device also comprises an analysis column, a quality control product and a calibrator, wherein the filler of the analysis column is a cation exchange stationary phase, the particle size of the filler is 5 mu m, the column length is 33mm, and the inner diameter of the column is 4.0mm; the quality control product and the calibrator are glycosylated hemoglobin blood sample freeze-dried powder, and the glycosylated hemoglobin blood sample freeze-dried powder of the calibrator can be traced through IFCC.
Comparative example 1
The same as in example 1, except that no additive was included in the kit of comparative example 1.
The formulation of eluent A, eluent B and haemolytic agent in the kits of example 1 and comparative example 1 is specifically shown in Table 1.
TABLE 1 Table 1 formulation of eluent A, eluent B and hemolytic agent
Example 2
A method for assaying glycosylated hemoglobin in whole blood comprising the steps of: adding a hemolyzing agent into the sample for hemolysis, eluting the hemolyzed sample in an analysis column by using an eluent to obtain HbA1c component and HbA0 component, then detecting, and calculating to obtain a detection result of HbA1c.
The sample is a quality control product, and the quality control product is glycosylated hemoglobin blood sample freeze-dried powder.
HbA1c in the quality control product was measured using the kit of example 1 and comparative example 1, and the measuring instrument was a glycosylated hemoglobin meter.
Taking different quality control products, namely quality control product 1 and quality control product 2, re-dissolving the quality control products to obtain quality control product solutions, and respectively adding the hemolysis agents in the example 1 and the comparative example 1 into two groups of quality control product solutions with the volume ratio of 1:200 for hemolysis; and immediately eluting, separating and detecting the quality control product after hemolysis by using an analytical column to obtain a detection result of HbA1c, and detecting HbA1c on the 3 rd day and the 7 th day after the quality control product is stored in a refrigerator at the temperature of 2-8 ℃. The detection results are shown in Table 2.
The elution conditions were: the packing of the analytical column is cation exchange stationary phase, the particle size of the packing is 5 mu m, the column length is 33mm, and the inner diameter of the column is 4.0mm; detection wavelength: 415nm; column temperature is 37 ℃; elution gradient: 0-45 s of eluent A100% by volume and eluent B0% by volume; 46 s-75 s of eluent A0% by volume and eluent B100% by volume; 100% of the volume of the eluent A from 76s to 120s and 0% of the volume of the eluent B; the flow rate is 1.5mL/min, and the sample injection amount is 10 mu L.
The quality control product for hemolysis with the hemolysis agent of example 1 was eluted with eluent a and eluent B of example 1, and the quality control product for hemolysis with the hemolysis agent of comparative example 1 was eluted with eluent a and eluent B of comparative example 1.
TABLE 2 detection results of HbA1c (HbA 1 c%) in example 1 and comparative example 1
As is clear from table 2, the results of HbA1c were not substantially changed when the quality control product was detected by the kit of example 1 and the measurement method of this example, while the results of HbA1c were changed when the kit of comparative example 1 was used for detection. Therefore, threonine added in example 1 effectively prevents fluctuation of measurement results of HbA1c.
Example 3
The kit of example 1 was used to detect HbA1c in a sample under the method provided in example 2, wherein the sample was 24 cases of frozen whole blood samples traced by IFCC, the sample was sampled from the netherlands, the whole air transport was kept frozen with dry ice, the sample was kept at an ambient temperature of not higher than-40 ℃, and then stored in an ultra-low temperature refrigerator at-80 ℃, before the sample was detected, the frozen sample was returned to room temperature, 20 μl of each sample was taken, and the hemolysis agent of example 1 was added in a volume ratio of 1:200, respectively, for hemolysis. Samples were taken from the netherlands until the test run was performed for 26 days.
The results of the assay were compared to IFCC targets given in IFCC standards laboratory, as shown in table 3.
TABLE 3 comparison of the detection results of the kit of example 3 with IFCC target values
As can be seen from Table 3, the HbA1c values detected by the kit of example 1 substantially match the IFCC target values given by the IFCC standard laboratory. Thus, the kit provided in example 1 and the detection method provided in example 2 can accurately measure frozen samples after a period of storage.
Example 4
The kit of the embodiment 1 is used for detecting HbA1c in a sample under the measuring method provided by the embodiment 2, wherein the sample is EDTA anticoagulated venous whole blood, and the sample is stored for not less than 7 days at the temperature of 2-8 ℃. A total of 49 samples were taken, 20. Mu.L of each sample was hemolyzed by adding the hemolysis agent of example 1 in a ratio of 1:200, respectively.
Comparative example 2
The measurement method used was an HPLC analysis method of a G8 glycosylated hemoglobin test system of Tosoh Corp, japan, and the kit was a G8 glycosylated hemoglobin test kit of Tosoh Corp. The sample is EDTA anticoagulated venous whole blood, and detection is performed immediately after the sample is collected. A total of 49 samples were taken, 20. Mu.L of each sample was automatically hemolyzed by the G8 glycosylated hemoglobin test system by adding the hemolyzing agent of example 1 in a ratio of 1:200.
The results of the tests of example 4 and comparative example 2 are shown in Table 4. Correlation analysis was performed on the detection results of example 4 and comparative example 2 to obtain a unitary linear equation: y= 1.0092x-0.1092, r2= 0.9899, as shown in fig. 1.
TABLE 4 detection results of HbA1c in example 4 and comparative example 2
As is clear from Table 4 and FIG. 1, the results obtained by the measurement of the whole blood sample stored at 2℃to 8℃for 7 days by the kit of example 1 and the measurement method of example 2 are substantially identical to those of comparative example 2, and the correlation is excellent. Therefore, the kit and the determination method have high clinical application value.
Example 5
A kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant, a preservative and an additive, the hemolytic agent comprises the surfactant, the preservative and the additive, and the additive is beta-alanine.
The addition amount of the additive in the eluent A, the eluent B and the hemolytic agent is 1.00g/L.
The buffer solution is phosphate buffer solution, and the phosphate buffer solution in the eluent A comprises disodium hydrogen phosphate with the mass volume concentration of 1.88g/L and sodium dihydrogen phosphate with the mass volume concentration of 4.41 g/L; the phosphate buffer of eluent B comprises disodium hydrogen phosphate with the mass volume concentration of 6.90g/L and sodium dihydrogen phosphate with the mass volume concentration of 1.37 g/L.
The molar concentration of the phosphate buffer in the eluent A was 0.05mol/L.
The molar concentration of the phosphate buffer in the eluent B is 0.06mol/L.
The surfactant is Tween 20, and the addition amount of the surfactant in the eluent A, the eluent B and the hemolytic agent is 1g/L.
The preservative is sodium azide, and the addition amount of the sodium azide in the eluent A, the eluent B and the hemolytic agent is 5.00g/L.
The device also comprises an analysis column, a quality control product and a calibrator, wherein the filler of the analysis column is a cation exchange stationary phase, the particle size of the filler is 3 mu m, the column length is 10mm, and the inner diameter of the column is 4.0mm; the quality control product and the calibrator are glycosylated hemoglobin blood sample freeze-dried powder, and the glycosylated hemoglobin blood sample freeze-dried powder of the calibrator can be traced through IFCC.
Example 6
A kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant, a preservative and an additive, the hemolytic agent comprises a surfactant, a preservative and an additive, the additive is threonine, beta-alanine and glycine, and the mass ratio of the threonine, the beta-alanine and the glycine is 1:1:1.
The addition amount of the additive in the eluent A, the eluent B and the hemolytic agent is 0.50g/L.
The buffer solution is citrate buffer solution, and the citrate buffer solution in the eluent A comprises citric acid monohydrate with the mass volume concentration of 0.40g/L and trisodium citrate dihydrate with the mass volume concentration of 2.38 g/L; the citrate buffer of eluent B included 0.29g/L citric acid monohydrate and trisodium citrate dihydrate at a mass-to-volume concentration of 5.47 g/L.
The molar concentration of citrate buffer in eluent A was 0.01mol/L.
The molar concentration of citrate buffer in eluent B was 0.02mol/L.
The surfactant is a mixture of triton X-100 and Tween 20, the mass ratio of the triton X-100 to the Tween 20 is 1:1, and the addition amount of the surfactant in the eluent A, the eluent B and the hemolytic agent is 20.00g/L.
The preservative is sodium azide, and the addition amount of the sodium azide in the eluent A, the eluent B and the hemolytic agent is 0.20g/L.
The device also comprises an analysis column, a quality control product and a calibrator, wherein the filler of the analysis column is a cation exchange stationary phase, the particle size of the filler is 10 mu m, the column length is 50mm, and the inner diameter of the column is 4.6mm; the quality control product and the calibrator are glycosylated hemoglobin blood sample freeze-dried powder, and the glycosylated hemoglobin blood sample freeze-dried powder of the calibrator can be traced through IFCC.
Example 7
A kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant, a preservative and an additive, the hemolytic agent comprises a surfactant, a preservative and an additive, the additive is beta-alanine and glycine, and the mass ratio of the beta-alanine to the glycine is 1:2.
The addition amount of the additive in the eluent A, the eluent B and the hemolytic agent is 0.30g/L.
The buffer solution is a mixed buffer solution of phosphate and succinate, and the buffer solution in the eluent A comprises succinic acid with the mass volume concentration of 35.43g/L and sodium dihydrogen phosphate with the mass volume concentration of 24.00 g/L; the buffer in eluent B included succinic acid with a mass volume concentration of 64.95g/L and disodium hydrogen phosphate with a mass volume concentration of 63.88 g/L.
The molar concentration of the mixed buffer solution of the phosphate and the succinate in the eluent A is 0.50mol/L.
The molar concentration of the mixed buffer solution of the phosphate and the succinate in the eluent B is 1.00mol/L.
The surfactant is Tween 20, and the addition amount of the surfactant in the eluent A, the eluent B and the hemolytic agent is 5.00g/L.
The preservative is sodium azide, and the addition amount of the sodium azide in the eluent A, the eluent B and the hemolytic agent is 0.50g/L.
Example 8
A kit for measuring glycosylated hemoglobin in whole blood comprises an eluent A, an eluent B and a hemolytic agent, wherein the eluent A and the eluent B respectively comprise a buffer solution, a surfactant, a preservative and an additive, the hemolytic agent comprises the surfactant, the preservative and the additive, and the additive is glycine.
The addition amount of the additive in the eluent A, the eluent B and the hemolytic agent is 0.05g/L.
The buffer solution is a mixed buffer solution of phosphate, citrate and succinate, and the buffer solution in the eluent A comprises succinic acid with the mass volume concentration of 23.62g/L, citric acid monohydrate with the mass volume concentration of 21.01g/L and sodium dihydrogen phosphate with the mass volume concentration of 24.00 g/L; the buffer solution in eluent B comprises sodium succinate with the mass volume concentration of 108.06g/L, trisodium citrate with the mass volume concentration of 58.82g/L and disodium hydrogen phosphate with the mass volume concentration of 56.78 g/L.
The molar concentration of the phosphate buffer solution, the citrate buffer solution and the succinate buffer solution in the eluent A is 0.50mol/L.
The molar concentration of the phosphate buffer solution, the citrate buffer solution and the succinate buffer solution in the eluent B is 1.00mol/L.
The surfactant is Tween 20, and the addition amount of the surfactant in the eluent A, the eluent B and the hemolytic agent is 7.00g/L.
The preservative is sodium azide, and the addition amount of the sodium azide in the eluent A, the eluent B and the hemolytic agent is 0.20g/L.
In summary, the foregoing description is only of the preferred embodiments of the present invention, and all equivalent changes and modifications made in accordance with the claims should be construed to fall within the scope of the invention.
Claims (1)
1. A method for assaying glycosylated hemoglobin, characterized by:
adding a hemolyzing agent into the sample for hemolysis, eluting the hemolyzed sample in an analysis column to obtain HbA1c component, and detecting the HbA1c component, wherein the eluent comprises eluent A and eluent B;
the sample comprises a quality control product, a calibrator and a detection sample; the detection sample is a whole blood sample, a whole blood dilution sample, a whole blood freeze-dried sample and EDTA anticoagulation venous whole blood; the quality control product and the calibrator are glycosylated hemoglobin blood sample freeze-dried powder;
the hemolysis agent comprises a surfactant, a preservative and an additive;
the eluent A comprises a buffer solution, a surfactant, a preservative and an additive;
the eluent B comprises a buffer solution, a surfactant, a preservative and an additive;
the preservative is sodium azide;
the additive is threonine, and the threonine can effectively prevent the change of the measurement result of HbA1 c;
the packing of the analysis column used for elution is cation exchange stationary phase; the particle size of the filler of the analysis column is 3-10 mu m, the column length is 10-50 mm, and the inner diameter of the column is 4.0-4.6 mm; detection wavelength: 415nm; column temperature is 37 ℃; the elution flow rate is 1.5mL/min, and the sample injection amount is 10 mu L;
elution gradient: 0-45 s of eluent A100% by volume and eluent B0% by volume; 46 s-75 s of eluent A0% by volume and eluent B100% by volume; 100% of the volume of the eluent A from 76s to 120s and 0% of the volume of the eluent B; the flow rate is 1.5mL/min, and the sample injection amount is 10 mu L;
the eluent A comprises succinic acid with the concentration of 2.70g/L, sodium succinate with the concentration of 18.50g/L, triton X-100 with the concentration of 9.00g/L, sodium azide with the concentration of 0.50g/L and threonine with the concentration of 0.01 g/L;
the eluent B comprises succinic acid with the concentration of 1.40g/L, sodium succinate with the concentration of 22.90g/L, triton X-100 with the concentration of 9.00g/L, sodium azide with the concentration of 0.50g/L and threonine with the concentration of 0.01 g/L;
the hemolytic agent comprises triton X-100 with the concentration of 9.00g/L, sodium azide with the concentration of 0.50g/L and threonine with the concentration of 0.01g/L.
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| CN110887916A (en) * | 2019-12-21 | 2020-03-17 | 江苏奥迪康医学科技股份有限公司 | Reagent matched with glycosylated hemoglobin high-pressure liquid chromatography analyzer |
| CN111551410A (en) * | 2020-05-21 | 2020-08-18 | 四川赛尔医学检验有限公司 | Glycosylated hemoglobin quality control material and preparation method thereof |
| CN111562339B (en) * | 2020-06-17 | 2022-11-15 | 深圳普门科技股份有限公司 | Method and equipment for detecting hemoglobin substances |
| CN113075143B (en) * | 2021-03-31 | 2023-01-03 | 奥研生物科技(南京)有限公司 | Glycosylated hemoglobin detection reagent and detection method thereof |
| CN115372486A (en) * | 2021-05-18 | 2022-11-22 | 深圳市帝迈生物技术有限公司 | Glycosylated hemoglobin detection kit and application thereof |
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| CN113009024A (en) | 2021-06-22 |
| CN113009025A (en) | 2021-06-22 |
| CN113009027B (en) | 2023-06-06 |
| CN113009022A (en) | 2021-06-22 |
| CN113219075A (en) | 2021-08-06 |
| CN113009021A (en) | 2021-06-22 |
| CN113009021B (en) | 2023-04-14 |
| CN113009026A (en) | 2021-06-22 |
| CN113009022B (en) | 2023-04-28 |
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| CN109633010A (en) | 2019-04-16 |
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