Diagnostic kit for combined diagnosis of mycoplasma pneumonia and application of diagnostic kit

A technology for mycoplasma pneumonia and diagnostic kits, which is applied in biological testing, material testing products, measuring devices, etc., can solve the problems of low sensitivity, poor specificity and high detection cost of the colloidal gold method, and achieve a short detection window period, simple operation, Strong specific effect

Active Publication Date: 2020-08-07
厦门万渤生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The clinical manifestations and chest X-ray examination of mycoplasma pneumonia are not characteristic, and the diagnosis cannot be made based on the clinical manifestations of chest X-ray alone. The diagnosis is mainly based on the detection of selected pathogens. At present, the diagnosis of mycoplasma pneumonia in China mainly relies on serological testing.
[0003] In view of the window period of serological testing and the influence of immune conditions on the body, as well as the sensitivity and specificity of different testing methods, the final diagnosis cannot be achieved with one testing method. Therefore, the combined diagnosis of etiology and serology is still currently advocated for the diagnosis of MP infection. Strategy
[0004] At present, the colloidal gold method is mainly used to detect Mycoplasma pneumoniae IgM or Mycoplasma pneumoniae IgG, but the colloidal gold method has low sensitivity and poor specificity
Nucleic acid PCR method has high requirements for testing personnel and high testing costs

Method used

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  • Diagnostic kit for combined diagnosis of mycoplasma pneumonia and application of diagnostic kit
  • Diagnostic kit for combined diagnosis of mycoplasma pneumonia and application of diagnostic kit
  • Diagnostic kit for combined diagnosis of mycoplasma pneumonia and application of diagnostic kit

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Embodiment approach 1

[0039] like figure 1 As shown, the present embodiment provides a diagnostic kit for the combined diagnosis of mycoplasma pneumonia, which includes a single unit that is provided with a bottom plate and sequentially connected sample pad 6, binding pad 4, reaction membrane 5 and water-absorbent pad 3 arranged on the bottom plate. Side test test strip and double test test strip 2;

[0040] A time-resolved fluorescent microsphere-labeled Mycoplasma pneumoniae antibody is immobilized on the binding pad 4 of the single test test strip 1,

[0041] The reaction membrane 5 of the single test test strip 1 is provided with a first detection line 51 and a first quality control line 52, the first detection line 51 is coated with Mycoplasma pneumoniae antibody, and the first quality control line 52 is coated with sheep antibody Mouse IgG antibody;

[0042] Time-resolved fluorescent microspheres labeled mouse anti-human IgM monoclonal antibody and mouse anti-human IgG antibody are immobili...

Embodiment approach 2

[0056] This embodiment also provides the application of the above-mentioned detection kit for the joint detection of mycoplasma pneumoniae in the joint detection of mycoplasma pneumoniae and its IgM / IgG. The sample is first added to the sample pad at 6 places, and then the diluent is added, and the reaction film is left to observe Color reaction on 5.

[0057] Further, the diluent is one or two of phosphate, Tris, hepes, boric acid, surfactant Tween 20, inert protein and sodium chloride and a combination thereof.

[0058] The sample diluent contains the following components in mass concentrations: 0.02M phosphate buffer, 0.02-0.05% surfactant Tween 20, 0.2-0.5% inert protein BSA and 0.85% sodium chloride.

Embodiment 1

[0061] The following kits were prepared:

[0062] Obtain the single-side detection test strip and the double-test detection test strip 2 of the sample pad 6, the binding pad 4, the reaction film 5 and the water-absorbing pad 3 that are all provided with the base plate and the sequentially connected sample pads arranged on the base plate; The binding pad 4 of strip 1 is immobilized with time-resolved fluorescent microsphere-labeled Mycoplasma pneumoniae antibody,

[0063] The reaction membrane 5 of the single test test strip 1 is provided with a first detection line 51 and a first quality control line 52, the first detection line 51 is coated with Mycoplasma pneumoniae antibody, and the first quality control line 52 is coated with sheep antibody Mouse IgG antibody;

[0064] Time-resolved fluorescent microspheres labeled mouse anti-human IgM monoclonal antibody and mouse anti-human IgG antibody are immobilized on the binding pad 4 of the double test test strip 2,

[0065] The ...

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Abstract

The invention relates to a diagnostic kit, in particular to the diagnostic kit for the combined diagnosis of mycoplasma pneumonia. The kit comprises a single-side detection test strip and a double-side detection test strip, a mycoplasma pneumoniae antibody marked by time-resolved fluorescent microspheres is fixed on a combination pad of the single-side detection test strip, a mycoplasma pneumoniaeantibody is coated on a first detection line, and a goat-anti-mouse IgG antibody is coated on a first quality control line. A time-resolved fluorescent microsphere labeled mouse anti-human IgM monoclonal antibody and a mouse anti-human IgG antibody are fixed on a combination pad of the double-detection test strip, a second detection line and a third detection line are both coated with natural MP-Ag, and the second quality control line is coated with a goat anti-mouse IgG antibody. According to the invention, the time-resolved fluorescent microsphere is used as a chromogenic marker, the detection test strip for detecting the mycoplasma pneumoniae IgM and IgG three times is combined into a whole, and the human mycoplasma pneumoniae antigen and the mycoplasma pneumoniae IgM and IgG are simultaneously detected, so that the kit has higher sensitivity and stronger specificity compared with a colloidal gold method.

Description

technical field [0001] The invention relates to a diagnostic kit, in particular to a diagnostic kit for combined diagnosis of mycoplasma pneumonia and its application. Background technique [0002] Mycoplasma pneumoniae is a pathogenic microorganism between viruses and bacteria. It is the smallest prokaryotic cell-type microorganism that can grow and reproduce on an inanimate medium. It can occur at any age, and its infection method can be transmitted in the form of aerosol particles. It is easy to spread in dense crowds, produces respiratory tract infections in adults and children, and causes diseases such as pneumonia and bronchitis. The clinical manifestations and chest X-ray examination of mycoplasma pneumonia are not characteristic, and the diagnosis cannot be made based on the clinical manifestations of chest X-ray alone. The diagnosis is mainly based on the detection of selected pathogens. At present, the diagnosis of mycoplasma pneumonia in China mainly relies on ser...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/58G01N33/577G01N33/569G01N33/558
CPCG01N33/6854G01N33/582G01N33/587G01N33/577G01N33/56933G01N33/558G01N2469/10G01N2469/20
Inventor 范文丽
Owner 厦门万渤生物技术有限公司
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