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A special cleaning solution for fully automatic chemiluminescence measuring instrument or its diluent and preparation method thereof

An automatic chemistry, cleaning solution technology, applied in chemical instruments and methods, chemiluminescence/bioluminescence, analysis by chemical reaction of materials, etc., can solve the problem of inability to meet the anti-corrosion effect, the cleaning solution cannot be used universally, and increase the detection cost, etc. problem, to achieve the effect of good accuracy, low cost and high precision

Active Publication Date: 2021-05-28
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the preservatives Proclin300 and Proclin950 used in this cleaning solution are the same series of preservatives, which cannot meet the requirements of antiseptic effect
[0008] At present, the cleaning solution used in major domestic hospitals is the original cleaning solution, which consumes a lot of money and is expensive, which greatly increases the cost of testing. Moreover, the cleaning solution used by different manufacturers and different models of automatic chemiluminescence analyzers is often not universal.

Method used

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  • A special cleaning solution for fully automatic chemiluminescence measuring instrument or its diluent and preparation method thereof
  • A special cleaning solution for fully automatic chemiluminescence measuring instrument or its diluent and preparation method thereof
  • A special cleaning solution for fully automatic chemiluminescence measuring instrument or its diluent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0112] Table 1 shows the formula ratio of the cleaning solution of Examples 1-4 of the present invention and the multiple of dilution during use.

[0113] Table 1 Example 1-4 formula table and dilution factor during use

[0114]

[0115] Taking the example 1 cleaning solution of preparing 1L as an example, the preparation method is as follows:

[0116] Weigh 35g sodium chloride g, 185g potassium chloride, 53.72g disodium hydrogen phosphate dodecahydrate, 0.13g potassium dihydrogen phosphate, 24g Tween-20, 0.5g sodium laurate, 10g Proclin300, 0.4g Bronidox plus purification After stirring and dissolving in water, dilute to 1L. The pH value of the cleaning solution is 7.2~8.3. Dilute 15 times with purified water when used as a working solution.

[0117] The preparation technical parameter of embodiment 2-4 is the same as embodiment 1.

Embodiment 1

[0129] The deviations of the measured values ​​of the cleaning solution in Example 1 and the original cleaning solution samples were all within 3%, indicating that the cleaning solution of the present invention has good test accuracy and is consistent with the measurement results of the original cleaning solution.

[0130] Precision experiment

[0131] The Abbott i2000SR chemiluminescence immunoassay analyzer was used to measure the original cleaning solution and the cleaning solution of Example 1 respectively, and each item was tested for the corresponding precision quality control (repeated 20 times), and the selected items were the surface of hepatitis B virus by the sandwich method Antigen (HBsAg) and thyroid-stimulating hormone (TSH), estradiol (E2) in the competition method, herpes simplex virus type 2 IgG antibody (HSV-2 IgG) in the indirect method, rubella virus antibody (IGM) precision in the capture method The measurement results are shown in Table 3.

[0132] Table...

Embodiment 2

[0163] The deviations of the measured values ​​of the cleaning solution in Example 2 and the original cleaning solution samples were all within 3%, indicating that the cleaning solution of the present invention has a good test accuracy and is consistent with the measurement results of the original cleaning solution.

[0164] Precision experiment

[0165] The Abbott i2000SR chemiluminescence immunoassay analyzer was used to measure the original cleaning solution and the cleaning solution of Example 2 respectively, and each item was tested for the corresponding precise quality control (repeated 20 times), and the selected items were the surface of hepatitis B virus by the sandwich method Antigen (HBsAg) and thyroid-stimulating hormone (TSH), estradiol (E2) in the competition method, herpes simplex virus type 2 IgG antibody (HSV-2 IgG) in the indirect method, rubella virus antibody (IGM) precision in the capture method The measurement results are shown in Table 7.

[0166] Table...

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Abstract

The invention relates to the field of in vitro diagnostic reagents for medical devices, in particular to a cleaning solution or a dilution thereof dedicated to a fully automatic chemiluminescence measuring instrument and a preparation method thereof. The cleaning solution contains inorganic salt, phosphate buffer system, surfactant 1, surfactant 2, preservative and water; the inorganic salt is composed of sodium chloride and potassium chloride; the phosphate buffer system is disodium hydrogen phosphate-phosphoric acid One of potassium dihydrogen system, sodium dihydrogen phosphate-dipotassium hydrogen phosphate; surfactant 1 is one of Tween-20, Tween-80; surfactant 2 is sodium lauryl sulfate, One of sodium laurate; preservative consists of Proclin300 and Bronidox. The cleaning liquid provided by the invention has simple preparation process and low cost, is suitable for automatic chemiluminescence measuring instruments of different manufacturers, and is also suitable for detection of items with different detection principles, and has good accuracy, high precision and good anti-corrosion performance.

Description

technical field [0001] The invention relates to the field of in vitro diagnostic reagents for medical devices, in particular to a cleaning solution or a dilution thereof dedicated to a fully automatic chemiluminescence measuring instrument and a preparation method thereof. Background technique [0002] Chemiluminescence immunoassay (CLIA) is a combination of highly sensitive chemiluminescent assay technology and highly specific immune response for various antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins and drugs It is a new immunoassay technology developed after enzyme immunoassay, radioimmunoassay, fluorescent immunoassay and time-resolved fluorescent immunoassay, and has important and extensive applications in the field of in vitro diagnosis. [0003] Based on the above principles, the application of the automatic chemiluminescence analyzer was born. The automatic chemiluminescence analyzer has become one of the most frequently used instruments in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C11D1/83C11D3/04C11D3/06C11D3/24C11D3/34C11D3/60G01N21/76G01N35/00
CPCC11D1/04C11D1/146C11D1/74C11D1/83C11D3/0073C11D3/046C11D3/06C11D3/24C11D3/349G01N21/76G01N35/00
Inventor 冯志山马沛燃马建军陈静付光宇渠海杨书彬
Owner AUTOBIO DIAGNOSTICS CO LTD