Kit and method for determination of glycosylated hemoglobin in whole blood

A technology of glycosylated hemoglobin and kits, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of complicating the measurement process and reducing the detection efficiency, and achieve the effect of avoiding changes, reducing complex processes, and accurate detection

Active Publication Date: 2019-04-16
江山德瑞医疗科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent uses the method of adding inhibitors to the sample to avoid the change of the HbA1c measurement value caused by the preservation of the sample. However, this method requires the direct participation of the measurer, which complicates the measurement process and greatly reduces the detection efficiency.

Method used

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  • Kit and method for determination of glycosylated hemoglobin in whole blood
  • Kit and method for determination of glycosylated hemoglobin in whole blood
  • Kit and method for determination of glycosylated hemoglobin in whole blood

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A kit for measuring glycosylated hemoglobin in whole blood, comprising eluent A, eluent B and hemolytic agent, eluent A and eluent B respectively include buffer, surfactant, preservative and additives, hemolytic The agent includes a surfactant, a preservative and an additive, and the additive is threonine.

[0026] The amount of additive added in eluent A, eluent B and hemolytic agent was all 0.01g / L.

[0027] The buffer is a succinate buffer, and the succinate buffer in the eluent A includes succinic acid with a mass volume concentration of 2.70 g / L and sodium succinate with a mass volume concentration of 18.50 g / L; The succinate buffer solution of eluent B includes succinic acid with a mass volume concentration of 1.40 g / L and sodium succinate with a mass volume concentration of 22.90 g / L.

[0028] The molar concentration of succinate buffer in eluent A is 0.09mol / L.

[0029] The molar concentration of succinate buffer in eluent B is 0.10mol / L.

[0030] The surfact...

Embodiment 2

[0039] A method for measuring glycosylated hemoglobin in whole blood, comprising the following steps: add a hemolytic agent to the sample and then hemolyze, and the sample after hemolysis is eluted with an eluent in an analysis column to obtain HbA1c components and HbA0 components, and then perform Detect and calculate the detection result of HbA1c.

[0040] The sample is a quality control product, and the quality control product is lyophilized powder of glycated hemoglobin blood sample.

[0041] The HbA1c in the quality control product was detected by using the kits of Example 1 and Comparative Example 1, and the detection instrument was a glycated hemoglobin meter.

[0042] Take different quality control products, coded as quality control product 1 and quality control product 2. After the quality control product is reconstituted, the quality control product solution is obtained, and the volume ratio is 1:200. The hemolytic agent in Example 1 and Comparative Example 1 was ad...

Embodiment 3

[0049] The kit in Example 1 was used to detect HbA1c in the sample under the assay method provided in Example 2, wherein the samples were 24 cases of frozen whole blood samples used for traceability by IFCC, sampled from the Netherlands, and stored in dry ice throughout the air transport. The ambient temperature is not higher than -40°C, and then stored in a -80°C ultra-low temperature refrigerator. Before the sample test, return the frozen sample to room temperature, take 20 μL for each case, and add it according to the volume ratio of 1:200. The hemolytic agent of Example 1 performed hemolysis. It took 26 days from the sampling of the samples in the Netherlands to the detection test.

[0050] The test results are compared with the IFCC target values ​​given by the IFCC standard laboratory, as shown in Table 3.

[0051] The detection result of the kit of table 3 embodiment 3 is compared with IFCC target value

[0052]

[0053] It can be seen from Table 3 that the HbA1c v...

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Abstract

The invention relates to the field of clinical in vitro diagnosis and detection, and discloses a kit for the determination of glycosylated hemoglobin in whole blood. The kit comprises eluent A, eluentB and a hemolytic agent, wherein the eluent A and eluent B include buffer solutions, surfactants and additives respectively; the hemolytic agent includes a surfactant and an additive; and the additive is one or more of threonine, beta-alanine and glycine. A method for the determination of glycosylated hemoglobin in whole blood is also disclosed. The glycosylated hemoglobin kit provided by the invention can avoid the change of the measured value of a sample with the time of sample storage, and 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 also realize fast and accurate detection of saved samples.

Description

technical field [0001] The invention relates to the field of clinical in vitro diagnosis and detection, in particular to a kit and method for measuring glycosylated hemoglobin in whole blood. Background technique [0002] According to the statistics of the International Diabetes Federation (Internationale Diabetes Federation, IDF), there were approximately 425 million people with diabetes worldwide in 2017. The American Diabetes Control and Complication Trial (DCCT) and the UK Diabetes Control and Complications Study (UK ProspectiveDiabetes Study, UKPDS) found that glycosylated hemoglobin (HbA1c) is a good indicator of the degree of disease control in diabetic patients. It reflects the average blood glucose level of the patient in the 120 days before the test, which has nothing to do with blood drawing time, whether the patient is fasting, whether insulin is used or not, and other factors. At the 59th American Diabetes Association (ADA) annual meeting, ADA regards HbA1c as ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N30/34Y02A50/30
Inventor 孙旭东鲍高明王植吕志刚
Owner 江山德瑞医疗科技有限公司
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