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Quality controlled microparticles, preparation thereof and uses thereof

A microparticle and quality control technology, which is applied in the field of quality control reagents of instruments, can solve the problems of unfavorable long-term stable observation and large batch-to-batch differences, and achieve the effects of facilitating inter-laboratory quality evaluation, easy control, and reducing sample detection differences

Active Publication Date: 2008-05-21
BEYOND DIAGNOSTICS (SHANGHAI) CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In addition, quality control serum is often mixed with human-derived samples, and there are large differences between batches. When the batch number is changed, statistical analysis needs to be performed again, which is not conducive to long-term stable observation.

Method used

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  • Quality controlled microparticles, preparation thereof and uses thereof
  • Quality controlled microparticles, preparation thereof and uses thereof
  • Quality controlled microparticles, preparation thereof and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1: Preparation of quality control microparticles coated with biotin-labeled γ-globulin (BGG):

[0042] (1) Preparation of biotin-labeled BGG

[0043] Use O.1M NaCNBH 3 Prepare BGG (purchased from Pel-Freez Biological) into a 10mg / ml solution, and use DMSO (dimethylformamide) to configure Biotin-XX-NHS (N-hydroxysuccinimide modified biotin, manufacturer: SIGMA, product No.: B3295) solution to 16.172mg / ml, add 5.4ul Biotin-XX-NHS according to the amount of 1mg antibody to add Biotin-XX-NHS solution to the BGG solution, mix well and place it at 4°C overnight. Use dialysis to remove free unreacted biotin. The dialysate is biotin-labeled antibody dialysis buffer (0.1M Tris, 0.3M NaCl, 0.005M EDTA-Na-2H) 2 O, pH 8.0). After the dialysis, the protein concentration was determined by the BCA method.

[0044] (2) Adopt the above-mentioned labeled protein to coat aldehyde-modified luminescent particles

[0045] Add 6.4μl of 20% Tween-20 solution, 2mg of the biotin-labeled prot...

Embodiment 2

[0049] Example 2: Preparation of quality control microparticles coated with biotin-labeled bovine serum albumin (BSA)

[0050] (1) Preparation of biotin-labeled bovine serum albumin (BSA)

[0051] Use 0.1M NaCNBH 3 Prepare BSA (purchased from EQUITECH-BIO INC) into a 10mg / ml solution, and use DMSO (dimethylformamide) to configure Biotin-XX-NHS (N-hydroxysuccinimide modified biotin, manufacturer: SIGMA, product No.: B3295) solution to 16.172mg / ml, add 13.5ul Biotin-XX-NHS according to the amount of 1mg antibody to add Biotin-XX-NHS solution to the BSA solution, mix well and place at 4°C overnight. Use dialysis to remove free unreacted biotin. The dialysate is biotin-labeled antibody dialysis buffer (0.1M Tris, 0.3M NaCl, 0.005M EDTA-Na-2H) 2 O, pH 8.0). After the dialysis, the protein concentration was determined by the BCA method.

[0052] (2) Adopt the above-mentioned labeled protein to coat aldehyde-modified luminescent particles

[0053] The coating method is the same as in Exa...

Embodiment 3

[0057] Example 3: The maximum count rate of a quality control particle detection instrument

[0058] Add different concentrations of quality control particles to the instrument, and each concentration can be repeatedly measured. The concentration of quality control particles gradually increases. Then add anti-biotin-coated photosensitive particles to the above-mentioned wells, incubate for 15 minutes, and read per unit time. When the concentration of quality control particles increases, the signal value no longer rises or the signal overflow occurs, the highest signal value divided by the unit time is the maximum counting rate of the instrument.

[0059] Using the above method, we used the biotin-labeled BGG-coated quality control particles in Example 1 to detect the maximum count rate of the LiCA HT photoinduced chemiluminescence system (Shanghai Boyang Medical Instrument Co., Ltd.). The concentration of the quality control particles were 20, 40, 60, 80μg / ml, add 30μl to each wel...

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Abstract

The invention relates to an instrument quality control reagent and a quality control method. Disclosed is a quality control microparticle, which is a biotin-labeled protein-coated luminescent microparticle. The present invention further provides a preparation method of the quality control microparticles and a quality control method using the quality control microparticles. The quality control microparticles and the quality control method disclosed by the invention can be used for the performance test of light-excited chemiluminescence instruments, routine laboratory quality control tests and instrument calibration.

Description

Technical field [0001] The invention relates to quality control reagents and methods for instruments. In more detail, it relates to quality control reagents for photo-induced chemiluminescence-based analytical instruments, their preparation and quality control methods. Background technique [0002] The light-induced chemiluminescence instrument can be widely used in the study of the interaction of biomolecules, and it is mainly used in the clinical diagnosis of diseases. Photoinduced chemiluminescence technology is a kind of chemiluminescence technology based on polymer particles. It can combine photosensitive particles and luminescent particles within a certain distance to generate ionized oxygen energy transfer and emit light signals to detect the sample under test. . The photosensitive particles are polymer particles filled with photosensitive compounds, and the luminescent particles are polymer particles filled with luminescent compounds and lanthanides. The core principle of...

Claims

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Application Information

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IPC IPC(8): G01N21/63
Inventor 赵卫国石晓强张向辉
Owner BEYOND DIAGNOSTICS (SHANGHAI) CO LTD
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