Immunodiagnostic device for detecting patient sample and kit of immunodiagnostic device

An immunodiagnosis and sample technology, applied in the field of immunodiagnosis device and multifunctional reconstitution buffer, can solve the problems of harsh transportation conditions and short storage time of gold standard solution, and achieve the effect of simple kit, simple operation and simple composition.

Inactive Publication Date: 2019-05-17
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

[0004] The technical problem to be solved by the present invention is to provide a gold standard diafiltration diagnostic device and a kit composed of a multifunctional reconstitution buffer to quickly and quantitatively detect w

Method used

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  • Immunodiagnostic device for detecting patient sample and kit of immunodiagnostic device
  • Immunodiagnostic device for detecting patient sample and kit of immunodiagnostic device
  • Immunodiagnostic device for detecting patient sample and kit of immunodiagnostic device

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A gold-labeled diafiltration device for whole blood testing and a test kit thereof, which consist of a detection plate, a gold-labeled antibody working solution and a washing solution. Such as Figure 1-3 As shown, the detection plate includes an upper cover 1 and a bottom groove 2 that are fastened to each other. The upper cover 1 is provided with a sample injection hole 3 and a reaction well 4. The reaction well 4 includes an inverted table-shaped drainage formed by a top window 41 and a bottom window 42. A nitrocellulose membrane 6 and a water-absorbing pad 10 are arranged successively below the bottom window 42 . Below the sample hole 3 are successively whole blood filter pads 5, glass fiber 7, PVC plate 8, solid-phase matrix support 9, and the PVC plate is fixed in the solid-phase matrix support. The sample loading hole and the reaction hole are connected through the glass fiber supported by the PVC plate, and the end of the glass fiber and the nitrocellulose memb...

Embodiment 2

[0034] Such as Figure 4-5As shown, a gold-labeled diafiltration diagnostic device and its kit for quantitative detection and analysis are composed of a detection plate, a detachable gold-labeled solid-phase device and a multifunctional reconstitution buffer. The detection plate includes an upper cover 1 and a bottom tank 2 that are fastened to each other. The upper cover 1 is provided with a reaction hole 4. The reaction hole 4 includes an inverted table-shaped drainage hole formed by a top window 41 and a bottom window 42. Nitric acid Cellulose film 6, absorbent pad 10.

[0035] In this embodiment, the Mycoplasma pneumoniae IgM antibody detection kit is taken as an example. The detection board is 42mm long, 31mm wide and 13.5mm high. The diameter of the top window is 20 mm, the diameter of the bottom window is 13 mm, and the height of the reaction well is 5.5 mm. The detection area of ​​the detection plate is coated with Mycoplasma pneumoniae specific antigen, and the qua...

Embodiment 3

[0039] A gold-labeled diafiltration diagnostic device for whole blood testing and a kit thereof, which consist of a detection plate, a gold-labeled solid-phase device, and a multifunctional reconstitution buffer. Such as Figure 6 As shown: the detection plate includes an upper cover 1 and a bottom groove 2 that are fastened to each other. The upper cover 1 is provided with a sample injection hole 3 and a reaction well 4. The reaction well 4 includes an inverted table-shaped drainage formed by a top window 41 and a bottom window 42. A nitrocellulose membrane 6 and a water-absorbing pad 10 are arranged successively below the bottom window 42 . Below the sample hole 3 are successively whole blood filter pads 5, glass fiber 7, PVC plate 8, solid-phase matrix support 9, and the PVC plate is fixed in the solid-phase matrix support. The sample well and the reaction well are connected through glass fibers supported by PVC plates, and the ends of the glass fibers overlap with the nit...

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PUM

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Abstract

The invention discloses an immunodiagnostic device for detecting a patient sample. The immunodiagnostic device comprises a percolation detecting plate, a detachable colloidal-gold solid phase device and a multifunctional compounded solution, wherein the percolation detecting plate comprises a whole blood filtering device region and a central reaction device region, the detecting plate can be subjected to interpretation by a colloidal-gold percolation quantometer, a capture agent is fixed to a microporous membrane of a reaction region, a sample to be inspected is added to a sample adding region, and red blood cells and the like which affect detection of a target object are removed by the whole blood filtering device; and components including sample analyte are transferred to the central reaction device region, the capture agent and a substance to be detected on the membrane form a specific compound, a redissolved buffer solution is taken out and dropwise added to a colloidal-gold solidphase region, the redissolved solution buffer solution dissolves the solid phase colloidal-gold antibody instantaneously and transfers the solid phase colloidal-gold antibody to the reaction region, the solid phase colloidal-gold antibody reacts with the antigen-antibody complex on the membrane to form a red color visible to the naked eye, the colloidal-gold antibody solid phase device is removed,and results are subjected to interpretation by the colloidal-gold percolation quantometer. The immunodiagnostic device is simple, rapid and high in sensitivity.

Description

technical field [0001] The invention relates to the field of in vitro immunodiagnostic tests, in particular to an immunodiagnostic device, a multifunctional reconstitution buffer, and a test kit for testing patient samples. It can be used in the fields of scientific research, disease diagnosis and food safety. Background technique [0002] Immunodiagnostic analysis occupies an irreplaceable position in the field of clinical in vitro diagnostics, and it is used to detect components in liquid test samples, such as antibodies, enzymes, hormones, etc. The basic principle in the reaction process is that specific recognition and binding reactions occur between the components, thereby forming a complex for detection. Over the years, immunoassays based on antibody recognition and specific binding reactions to antigens have been of great significance in the field of clinical diagnosis. Among them, the gold standard immunofiltration technology is a mature immunoassay technology, whi...

Claims

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Application Information

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IPC IPC(8): G01N33/531G01N33/543
Inventor 杨致亭隋振国任洪胜孙树凯杨金红
Owner 山东康华生物医疗科技股份有限公司
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