阅读说明：本技术 一种糖化血红蛋白高压液相色谱分析仪配套试剂 (Reagent matched with glycosylated hemoglobin high-pressure liquid chromatography analyzer ) 是由 庄雷 于 2019-12-21 设计创作，主要内容包括：本发明公开了一种糖化血红蛋白高压液相色谱分析仪配套试剂,本发明配套试剂包括试剂A、试剂B、试剂C、试剂H和层析柱；其中试剂A、试剂B、试剂C为不同梯度浓度的洗脱液,试剂H为溶血剂试剂A、试剂B和试剂C均包括柠檬酸钠、柠檬酸、氯化钠和防腐剂,所述的试剂H包括磷酸二氢钠、磷酸氢二钠、表面活性剂和防腐剂。本发明由试剂A、试剂B、试剂C、试剂H和层析柱组成,层析柱填料为高分子聚合物离子交换剂,本发明对样本既可以不处理也可以前处理,可以直接原始管上架,通过与仪器配套,便可将HbF、L-HbA1c和HbA1c分离开来,同时将检测结果与进口仪器与配套试剂作对比,相关性较好。(The invention discloses a reagent matched with a glycosylated hemoglobin high-pressure liquid chromatography analyzer, which comprises a reagent A, a reagent B, a reagent C, a reagent H and a chromatographic column; the reagent A, the reagent B and the reagent C are eluents with different gradient concentrations, the reagent H is a hemolytic agent, and comprises sodium citrate, citric acid, sodium chloride and a preservative, and the reagent H comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, a surfactant and a preservative. The kit comprises a reagent A, a reagent B, a reagent C, a reagent H and a chromatographic column, wherein the filler of the chromatographic column is a high-molecular polymer ion exchanger, a sample can be directly put on a frame without or before being processed, HbF, L-HbA1C and HbA1C can be separated by matching with an instrument, and meanwhile, the detection result is compared with an imported instrument and a matched reagent, so that the relevance is better.)

1. The reagent matched with the glycosylated hemoglobin high-pressure liquid chromatography analyzer is characterized by comprising a reagent A, a reagent B, a reagent C, a reagent H and a chromatographic column;

wherein the reagent A, the reagent B and the reagent C are eluents with different gradient concentrations, and the reagent H is a hemolytic agent;

reagent A, reagent B and reagent C all include sodium citrate, citric acid, sodium chloride and antiseptic, reagent H include sodium dihydrogen phosphate, disodium hydrogen phosphate, surfactant active and antiseptic.

2. The reagent set for a glycated hemoglobin high pressure liquid chromatography as set forth in claim 1, wherein: the eluent of the reagent A comprises 2-10 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative; the eluent of the reagent B comprises 2-15 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative, and the eluent of the reagent C comprises 2-20 g/L of sodium citrate, 0.1-2 g/L of citric acid, 1-50 g/L of sodium chloride and 0.02-10 g/L of preservative; the reagent H hemolytic agent comprises 0.1-5 g/L of sodium dihydrogen phosphate, 0.1-5 g/L of disodium hydrogen phosphate, 0.1-10 g/L of surfactant and 0.01-4 g/L of preservative.

3. The reagent set for a glycated hemoglobin high pressure liquid chromatography as set forth in claim 2, wherein: the preservative may be sodium azide, methylisothiazolinone, ProClin 300.

4. The reagent set for a glycated hemoglobin high pressure liquid chromatography as set forth in claim 3, wherein: the surfactant may be Triton-X100, Brj-35, polyethylene glycol.

5. The kit for a glycated hemoglobin high pressure liquid chromatography as set forth in claim 1 or 4, wherein: the chromatographic column filler is non-porous or porous polystyrene-divinylbenzene, the particle size range is 1.2-10 mu m, the column length is 1cm-10cm, and the column diameter range is 2-10 mm.

Technical Field

The invention belongs to the technical field of liquid chromatography reagents, and particularly relates to a reagent matched with a glycosylated hemoglobin high-pressure liquid chromatography analyzer.

Background

L-HbA1c (abbreviation of "Labile hemoglobin A1C"), which is an aldimine compound formed by the amino group reaction of glucose with the valine residue at the β chain-N terminal of hemoglobin HbA, is an intermediate product of stable hemoglobin of S-HbA1c (stable hemoglobin A1C), and S-HbA1c (glycated hemoglobin) is a gold marker for the diagnosis and monitoring of the therapeutic effect of diabetes.

HbF (foetal haemoglobin), commonly known as fetal haemoglobin, accounts for only 0.5% of total haemoglobin in normal adults, but certain conditions such as thalassemia, persistent increase in hereditary HbF, etc. contribute to a higher HbF.

However, the existing low-pressure liquid chromatography can not completely separate HbF, L-HbA1c and HbA1c, and when some clinical samples HbF or L-HbA1c are abnormal, the measured value of HbA1c is falsely increased, so that the test result is inaccurate.

Disclosure of Invention

Aiming at the problems in the prior art, the invention aims to provide a reagent matched with a glycosylated hemoglobin high-pressure liquid chromatography analyzer.

Therefore, the invention adopts the following technical scheme: a reagent matched with a glycosylated hemoglobin high-pressure liquid chromatography analyzer is characterized in that the matched reagent comprises a reagent A, a reagent B, a reagent C, a reagent H and a chromatographic column;

wherein the reagent A, the reagent B and the reagent C are eluents with different gradient concentrations, and the reagent H is a hemolytic agent;

the reagent A, the reagent B and the reagent C respectively comprise sodium citrate, citric acid, sodium chloride and a preservative, and the reagent H comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, a surfactant and a preservative;

in addition to the above technical solutions, the present invention also includes the following technical features.

The eluent of the reagent A comprises 2-10 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative; the eluent of the reagent B comprises 2-15 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative, and the eluent of the reagent C comprises 2-20 g/L of sodium citrate, 0.1-2 g/L of citric acid, 1-50 g/L of sodium chloride and 0.02-10 g/L of preservative; the reagent H hemolytic agent comprises 0.1-5 g/L of sodium dihydrogen phosphate, 0.1-5 g/L of disodium hydrogen phosphate, 0.1-10 g/L of surfactant and 0.01-4 g/L of preservative

The preservative may be sodium azide, methylisothiazolinone, ProClin 300.

The surfactant may be Triton-X100, Brj-35, polyethylene glycol.

The chromatographic column filler is non-porous or porous polystyrene-divinylbenzene, the particle size range is 1.2-10 mu m, the column length is 1cm-10cm, and the column diameter range is 2-10 mm.

The invention can achieve the following beneficial effects: the kit comprises a reagent A, a reagent B, a reagent C, a reagent H and a chromatographic column, wherein the filler of the chromatographic column is a high-molecular polymer ion exchanger, a sample can be directly put on a frame without or before being processed, HbF, L-HbA1C and HbA1C can be separated by matching with an instrument, and meanwhile, the detection result is compared with an imported instrument and a matched reagent, so that the relevance is better. The reagent A, B, C is eluent with 3 kinds of gradient concentration, and the reagent H is hemolytic agent to break cell wall and release glycosylated hemoglobin.

Drawings

FIG. 1 is a comparative sample of the test conducted according to the present invention.

Detailed Description

The reagent A, B, C is eluent with 3 different gradient concentrations, and the reagent H is hemolytic agent, which plays a role in breaking cell walls and releasing glycosylated hemoglobin; the chromatographic column filler is a high molecular polymer ion exchanger; the chromatographic column filler is non-porous or porous polystyrene-divinylbenzene, the particle size range is 1.2-10 μm, the column length is 1cm-10cm, and the column diameter range is 2-10 mm.

The main components of the eluent A are 2-10 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative;

the main components of the eluent B are 2-15 g/L of sodium citrate, 0.1-5 g/L of citric acid, 0-1 g/L of sodium chloride and 0.02-10 g/L of preservative,

the main components of the eluent C are 2-20 g/L of sodium citrate, 0.1-2 g/L of citric acid, 1-50 g/L of sodium chloride and 0.02-10 g/L of preservative;

the hemolytic agent mainly comprises 0.1-5 g/L sodium dihydrogen phosphate, 0.1-5 g/L disodium hydrogen phosphate, 0.1-10 g/L surfactant and 0.01-4 g/L preservative.

The invention, a BRD-D10 instrument and a matched reagent test linear samples with different concentrations, the correlation coefficient is more than 0.995, the correlation is better proved, and the specific test results are shown in the following table and figure 1.

Instrumental measurement of BRD-D10	Measured value of the present technique 1	Measured value of the present technique 2	Measured value of the present technique 3	Mean value of
					4	4.19	4.22	4.23	4.21
5.2	4.96	4.99	4.86	4.94
					5.3	5.29	5.37	5.2	5.29
6.8	6.58	6.24	6.53	6.45
					7	6.87	6.74	6.82	6.81
8.2	7.68	7.77	7.67	7.71
					8.7	8.72	8.75	8.68	8.72
9.3	8.92	8.75	8.59	8.75
					13.9	13.44	13.22	13.22	13.29
14.3	14.77	14.23	14.19	14.40
					15	15.51	15.93	15.88	15.77

Correlation coefficient 0.9951271

The foregoing shows and describes the general principles and broad features of the present invention and advantages thereof. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.