Immunofluorescence test strip module for rapidly and quantitatively testing microalbumin, test card module made of same and preparation method thereof

A microalbumin and quantitative detection technology, applied in the field of medical testing, can solve the problems of false positives of markers, limit the application scope of immunochromatography technology, false negatives, etc., and achieve reliable and stable specificity, low detection cost, and simple operation. Effect

Active Publication Date: 2012-09-19
GUANGZHOU HONGQI OPTICAL INSTR TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the characteristics of physical adsorption labeling (that is, hydrophobic and electrostatic adsorption principles) make it easy to form non-specific interference, and it is necessary to add non-specific interference elimination reagents to the production process formula, such as surfactants such as Tween 20, etc., but using this At the same time, it is easy to cause false positive or false negative results based on such markers
In addition, the results of color interpretation must be subject to the subjective influence of the observer when used, especially weak positive results, and can only make qualitative judgments, but cannot achieve accurate quantitative judgments
These shortcomings greatly limit the scope of application of immunochromatography in clinical testing

Method used

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  • Immunofluorescence test strip module for rapidly and quantitatively testing microalbumin, test card module made of same and preparation method thereof
  • Immunofluorescence test strip module for rapidly and quantitatively testing microalbumin, test card module made of same and preparation method thereof
  • Immunofluorescence test strip module for rapidly and quantitatively testing microalbumin, test card module made of same and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] see figure 1 As shown, an immunofluorescence test strip assembly for rapid quantitative detection of microalbumin (MA) based on platinum porphyrin luminescence technology of the present invention comprises a test strip and a platinum porphyrin independently packaged and used in conjunction with the test strip. morpholino-labeled specific antibody 15. The test strip includes a substrate 1 , a coated analysis film 3 adhered to the middle of the substrate 1 , a water absorbing pad 2 and a sample pad 6 located at both ends of the coated analysis film 3 and overlapping it by 1-2 mm. The coating analysis membrane 3 is provided with a detection line 4 and a quality control line 5 formed by spray printing with a film sprayer. The specific antibody coated on the detection line 4 is anti-microalbumin monoclonal antibody, and the quality control line 5 is coated with The specific antibody is a rabbit IgG antibody. The platinum-porphyrin-labeled specific antibodies were anti-micr...

Embodiment 2

[0101] The preparation method of the present embodiment is basically the same as that of Example 1, the difference is:

[0102] In step 2, the method for preparing the detection line coating buffer is: dilute with 20mM pH7.6 phosphate buffer to make the concentration of the anti-microalbumin monoclonal antibody containing 1.0% methanol, 1.5% sucrose, and 0.6% bovine serum albumin to 1 mg / ml. Preparation of quality control line coating buffer: dilute with 50mM pH7.6 phosphate buffer to make the concentration of rabbit IgG antibody containing 0.7% methanol and 0.5% bovine serum albumin reach 0.5mg / ml. Preparation of the coating film: debug the film spraying machine, the film liquid volume is 25ul / 40cm, the machine scribes, the capture line and the quality control line are separated by 5mm, the scribe line is fine and uniform, and it is placed in a vacuum oven at 25°C-37°C for 1.5 hours. The bag is sealed for later use.

Embodiment 3

[0104] The preparation method of the present embodiment is basically the same as that of Example 1, the difference is:

[0105] In step 3, the anti-microalbumin monoclonal antibody 1 and the anti-rabbit IgG antibody were diluted to 1 mg / ml with 0.1 M sodium bicarbonate solution respectively, and 5 ml of the antibody solution was taken respectively, and 40 mg of the fluorescent material platinum porphyrin solution was added respectively, Stir well, incubate at room temperature for 1.5 hours, and mix once every 15 minutes; finally use a G25 gel column for separation and purification, collect the labeled fluorescent material platinum porphyrin-labeled antibody, and use 0.01%-0.5% poly Ethylene glycol, 1%-5% bovine serum albumin, 5%-20% glycerin, and 0.01%-0.05% surfactant are diluted with 0.01M phosphate buffer solution, sealed in plastic bottles, and stored at 4°C.

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Abstract

The invention discloses an immunofluorescence test strip module for rapidly and quantitatively testing microalbumin, a test card module made of the same and a preparation method thereof. The test strip module consists of a test strip and separately packaged Pt-Porphyrin-marked specific antibodies, the test strip comprises a substrate, an absorbent pad, an envelope analysis film and a sample pad, a test line and a control line are arranged on the envelope analysis film, the test line-enveloped specific antibody is an anti-microalbumin monoclonal antibody, and the control line-enveloped specific antibody is an anti-rabbit IgG antibody; the Pt-Porphyrin-marked specific antibodies are the anti-microalbumin monoclonal antibody and the anti-rabbit IgG antibody; the test card module comprises the test strip, a card box and the separately packaged Pt-Porphyrin-marked specific antibodies, and the card box comprises a cover board and a back board. The invention is used for testing the microalbumin in human urine, is easy to operate, is rapid, sensitive and highly specific, and has a good clinical application prospect.

Description

technical field [0001] The invention belongs to the field of medical testing, and in particular relates to an immunofluorescence test strip component for rapid and quantitative detection of trace albumin and a preparation method thereof. Background technique [0002] Serum albumin can pass through the glomerulus, but almost all of it is reabsorbed by the renal tubules. When the glomerulus is damaged, the amount of filtration increases, so that it exceeds the reabsorption of the renal tubules and is excreted from the urine, forming urinary microalbumin ( MA). Urinary microalbumin refers to the excretion rate of albumin in urine exceeding 20 g per minute or exceeding 30 mg in 24 hours, with a concentration of 30-200 mg / L, which cannot be detected by conventional methods. A large number of studies have proved that positive urinary microalbumin is an early sign of renal injury, especially glomerular injury, and its excretion is positively correlated with the degree of glomerula...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/558
Inventor 罗琪谢爱武梁万兴李必松
Owner GUANGZHOU HONGQI OPTICAL INSTR TECH
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