Cleaning solution or diluent thereof special for full-automatic chemiluminescence tester and preparation method thereof

An automatic chemistry and cleaning solution technology, which is applied in chemical instruments and methods, chemiluminescence/bioluminescence, and analysis through chemical reactions of materials, etc. It can solve the problems of unsatisfactory anti-corrosion effects, unsuitable cleaning solutions, and increased detection costs, etc. problem, to achieve the effect of good accuracy, low cost and high precision

Active Publication Date: 2020-03-06
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 orig

Method used

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  • Cleaning solution or diluent thereof special for full-automatic chemiluminescence tester and preparation method thereof
  • Cleaning solution or diluent thereof special for full-automatic chemiluminescence tester and preparation method thereof
  • Cleaning solution or diluent thereof special for full-automatic chemiluminescence tester and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0056] 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.

[0057] Table 1 Example 1-4 formula table and dilution factor during use

[0058]

[0059] Taking the example 1 cleaning solution of preparing 1L as an example, the preparation method is as follows:

[0060] 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.

[0061] The preparation technical parameter of embodiment 2-4 is the same as embodiment 1.

Embodiment 1

[0074] The deviations of the measured values ​​of the cleaning solution in Example 1 and the original cleaning solution sample are 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.

[0075] 2. Precision experiment

[0076] Abbott i2000SR chemiluminescence immunoassay analyzer is used to measure the original cleaning solution and the cleaning solution of Example 1 respectively, and each item measures the corresponding precision quality control product (repeated 20 times), and the selected items are respectively the surface of hepatitis B virus of 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.

[007...

Embodiment 2

[0108] The deviations of the measured values ​​of the cleaning solution in Example 2 and the original cleaning solution samples are 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.

[0109] 2. Precision experiment

[0110] Abbott i2000SR chemiluminescence immunoassay analyzer is used to measure the original cleaning solution and the cleaning solution of Example 2 respectively, and each item measures the corresponding precision quality control product (repeated 20 times), and the selected items are respectively the surface of hepatitis B virus of 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.

...

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Abstract

The invention relates to the field of medical instrument in-vitro diagnostic reagents, in particular to a cleaning solution or diluent thereof special for a full-automatic chemiluminescence tester anda preparation method thereof. The cleaning solution comprises an inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, a preservative and water; the inorganic salt consists of sodium chloride and potassium chloride; the phosphate buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and sodium dihydrogen phosphate-dipotassium hydrogen phosphate; the surfactant 1 is one of tween-20 and tween-80; the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate; and the preservative is composed of Proclin300 and Bronidox. The cleaning solution provided by the invention has the characteristics of simple preparation process and low cost, is suitable for full-automatic chemiluminescence testers of different manufacturers, at the same time is suitable for detection of items with different detection principles, and has good accuracy, high precision and good corrosion resistance.

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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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 马沛燃马建军付光宇渠海杨书彬
Owner AUTOBIO DIAGNOSTICS CO LTD
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