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Stable beta2 microglobulin solution and preparation method and application thereof

A technology of β2 microglobulin and protease inhibitors, which is applied in the field of medical testing, can solve the problems of long-term storage, waste, and high price, and achieve the effects of reducing the risk of protein degradation, reducing production costs, and simplifying operations

Active Publication Date: 2017-10-24
威海威仕泰医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The calibrator has poor stability after repeated dilution with normal saline, and cannot be stored for a long time. It needs to be re-prepared for the next calibration, which is time-consuming, expensive, and wasteful.

Method used

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  • Stable beta2 microglobulin solution and preparation method and application thereof
  • Stable beta2 microglobulin solution and preparation method and application thereof
  • Stable beta2 microglobulin solution and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. With Good's buffer solution at pH 8.0, NaCl 150mmol / L, glycerol 10%, bovine serum albumin 2g / L, sodium azide 0.1% and β2-MG 2.0mg / L as the basic formula A, in the basic formula A Based on the addition of stabilizers, etc., the improvement effect of the β2-MG test value in each formula was investigated after being stored at 4°C for 12 months. Urinary trace β2-MG was determined using β2-microglobulin assay kit (latex-enhanced immune turbidimetry) from Ningbo Ruiyuan Biotechnology Co., Ltd., and Olympus AU400 was used as a biochemical instrument. Set according to the instructions, the dominant wavelength is 546nm, add 3 μl of sample to 240 μl of reagent R1, mix and incubate for 5 minutes, then add R2, mix and incubate for 10 seconds to read absorbance A1, and read absorbance A2 after 3 minutes. Establish a standard curve with the concentration of the multi-point calibrator and the corresponding absorbance change value (ΔA=A2-A1), and then test the sample value. After 1...

Embodiment 2

[0023] With the preferred formula: Good's buffer (PIPES 50mmol / L, pH8.0), NaCl 150mmol / L, sodium cholate 0.5mmol / L, magnesium aspartate 50mmol / L, alanine 50mmol / L, glycine 50mmol / L L, glycerol 10%, bovine serum albumin 2g / L, PMSF1mmol / L, EDTA 1mmol / L, sodium azide 0.1%, PEG6000 2g / L, β2-microglobulin concentrations were 0.2mg / L, 2mg / L And 18mg / L carries out the comparative analysis of stability.

[0024] In this example, the bottle-opening stability and long-term stability of the prepared reagents were investigated.

[0025] 1. Use the calibration solution in the β2-microglobulin assay kit (latex-enhanced immune turbidimetric method) of Ningbo Ruiyuan Biotechnology Co., Ltd. to calibrate the samples with 3 concentration levels prepared by the above method (concentrations are respectively 0.2mg / L, 2mg / L and 18mg / L) were measured 10 times each time, and the average value was taken to calculate the relative deviation. As a comparison, a manufacturer's lyophilized powder was di...

Embodiment 3

[0036] Accuracy analysis of β2-MG calibrator

[0037] In this example, the invented stable β2 microglobulin solution was used as the calibrator for calibration, and 100 cases of clinical serum were tested, and then the Randox calibrator (BM1362) was used for calibration, and the 100 samples were tested. The two sets of results are compared, such as figure 1 shown. The calibration solution of the present invention has the same accuracy as the Landau calibration solution.

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Abstract

The invention discloses a stable beta2 microglobulin solution and a preparation method and application thereof. The stable beta2 microglobulin solution comprises beta2 microglobulin for detecting the concentration level, a Good's buffer solution, sodium chloride, glycerin, bovine serum albumin, a stabilizer, a preservative and a protease inhibitor, wherein the pH value of the Good's buffer solution is 7.5-9.0; and the concentration of the sodium chloride is 20-250mmol / L. The beta2 microglobulin solution can be applied to a calibration product and a quality control substance, and is capable of accurately measuring the content of beta2 microglobulin in a human tissue by combining with an in-vitro diagnosis kit. The validity period of the stable beta2 microglobulin solution at 4 DEG C exceeds a year, the open bottle stability exceeds a month, and the stable beta2 microglobulin solution is accurate in result, good in repeatability, ready to use after a bottle is opened and convenient to operate.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a stable β2 microglobulin solution, its preparation method and application. Background technique [0002] β2-microglobulin (β2-MG) was first isolated and purified from urine by Swedish scientist Berggard in 1968, with a molecular weight of 11,800 and an isoelectric point of 5.7. It was named after electrophoresis in the β2 zone. β2-MG is a small molecular globular structural protein that exists on the surface of nucleated cells and combines with protein complexes such as MHCI and CD1, and plays an important role in protein transportation and recognition of immune responses. β2-MG can be excreted from cells and exists in the blood and urine in the form of monomer, usually at a lower concentration level. Diabetic patients or hypertensive patients often have complications of kidney damage, decreased renal recovery and metabolic function, and abnormal increase of β2-MG in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/531
CPCG01N33/531G01N33/68G01N2333/47
Inventor 王新刚刘心田于颖颖刘秀萌
Owner 威海威仕泰医疗科技有限公司