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Reagent for detecting COVID-19 through chemiluminescence immunoassay and detection method thereof

A technology for COVID-19 and chemiluminescence immunity, which is applied in the direction of chemiluminescence/bioluminescence, analysis by making materials undergo chemical reactions, and analysis of materials, which can solve problems such as narrow detection range, low sensitivity, and missed detection

Pending Publication Date: 2020-10-30
山东康华生物医疗科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, there are clinical detection methods for COVID-19: PCR amplification method, gold standard method, and enzyme immunoassay. Enzyme immunoassay has low sensitivity, narrow detection range, and there is a great risk of missed detection

Method used

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  • Reagent for detecting COVID-19 through chemiluminescence immunoassay and detection method thereof
  • Reagent for detecting COVID-19 through chemiluminescence immunoassay and detection method thereof
  • Reagent for detecting COVID-19 through chemiluminescence immunoassay and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1: A kind of chemiluminescence immunoassay detects the reagent of COVID-19, and the preparation method of described reagent is as follows:

[0081] (1) Preparation of COVID-19 superparamagnetic nanosphere working solution

[0082] 1) Magnetic bead washing

[0083] At room temperature, vortex and mix the reagent bottle containing superparamagnetic nanospheres, vortex and mix for 1 min, until the magnetic bead suspension is mixed, draw 0.24mL magnetic bead labeling buffer C1 into the coating tube, add 10 μL nanosphere mother solution, tighten the tube cap, vortex and mix for 1min.

[0084] 2) Magnetic bead coating

[0085] At room temperature, put the coated tube on the magnetic separation rack for 1 min and suck up the liquid, remove the coated tube from the magnetic separation rack, add 0.08mL magnetic bead labeling buffer C1 to the coated tube, tighten the cap, Vortex and mix for 1 min, add 0.02 mg of COVID-19 antigen to the coated tube, tighten the cap o...

Embodiment 2

[0132] Embodiment 2: A kind of detection method that chemiluminescent immunoassay detects COVID-19, described detection method comprises the following steps:

[0133] The reagent prepared in Example 1 was taken out from the refrigerated environment, and the reagent was equilibrated at room temperature for more than 15 minutes.

[0134] Dilute the concentrated washing solution at a ratio of 1:40, shake well and use it as the application washing solution.

[0135] Put the COVID-19 calibrators, quality controls and samples to be tested on the chemiluminescence analyzer, complete the setting of relevant measurement parameters, and then perform the detection.

[0136] The measurement parameters are:

[0137]

[0138] Fitting Type: Four-parameter Logistic Fitting

[0139] Coordinate selection: X-Y.

[0140] Performance indicators of the kit

[0141] 1) Minimum detection limit

[0142] Use the zero-concentration calibrator or sample diluent as the sample for detection, repeat t...

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Abstract

The invention provides a reagent for detecting COVID-19 through chemiluminescence immunoassay and a detection method thereof. An indirect process is used, a COVID-19 antigen is coated on a magnetic microsphere, the anti-human IgG / IgM is labeled with acridinium ester, and the acridinium ester is excited by the excitation liquid to emit light so as to detect the COVID-19 antibody, and the detectionmethod combining the acridinium ester or acridinium sulfonamide compound labeling technology and the superparamagnetic nano-microsphere labeling technology is adopted; the superparamagnetic nano-microsphere labeling technology is a technology of coating nano-microspheres with antigens or antibodies, and the superparamagnetic nano-microsphere labeling technology can enlarge the reaction surface area by 10 to 50 times and accelerate the reaction efficiency; the reaction process is suspended in a reaction solution and belongs to homogeneous reaction, so that the reaction speed can be increased; connection belongs to chemical connection of bioactive substances, so that the coating efficiency is higher, and the coating is more stable in a liquid environment. The detection reagent disclosed by the invention is high in specificity, high in sensitivity, simple and convenient to separate, rapid, non-toxic, safe and stable, short in detection time by adopting the reagent, high in efficiency andgood in stability.

Description

technical field [0001] The invention relates to the field of in vitro diagnostic immunological determination and analysis, in particular to a reagent for detecting COVID-19 by chemiluminescence immunoassay and a detection method thereof. Background technique [0002] At present, there are clinical detection methods for COVID-19: PCR amplification method, gold standard method, and enzyme immunoassay. Enzyme immunoassay has low sensitivity, narrow detection range, and there is a great risk of missed detection. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a reagent for the detection of COVID-19 by chemiluminescent immunoassay with high specificity, high sensitivity, easy separation, fast, non-toxic, safe and stable for the above deficiencies, and also provide a reagent using the The detection method of the reagent, the reagent can automatically detect COVID-19 on a chemiluminescence analyzer. [0004] In order ...

Claims

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Application Information

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IPC IPC(8): G01N33/569G01N33/543G01N21/76
CPCG01N33/56983G01N33/54326G01N21/76G01N2333/165
Inventor 杨致亭杨帆马东霄田永帅刘云
Owner 山东康华生物医疗科技股份有限公司
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