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A kit for the detection of tetanus antibodies in human plasma by latex-enhanced immune turbidimetry

An immunoturbidimetric and latex-enhanced technology, used in immunoassays, biological tests, measuring devices, etc., can solve the problems of inaccurate measurement of tetanus antibody titer, difference between batches and plates, and short detection time.

Active Publication Date: 2021-05-11
天津安百胜医疗科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The former is an in vivo experiment, which takes a long time and requires specialized technicians and venues
The latter is widely used in practice. Although it is an in vitro test, the test time is shorter than that of mice or guinea pigs. Tetanus antibody titer measurement is inaccurate, which has a great impact on actual production

Method used

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  • A kit for the detection of tetanus antibodies in human plasma by latex-enhanced immune turbidimetry
  • A kit for the detection of tetanus antibodies in human plasma by latex-enhanced immune turbidimetry
  • A kit for the detection of tetanus antibodies in human plasma by latex-enhanced immune turbidimetry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] The preparation of the latex particle that embodiment 1 is coated with tetanus antigen

[0096] The polystyrene latex particles used in the kit of the present invention are all self-produced, by the polymerization method of soap-free emulsion (do not add emulsifier or add a small amount of emulsifier), with persulfate (potassium persulfate, sodium persulfate, persulfate ammonium, etc.) as an initiator to initiate the copolymerization of styrene and vinyl carboxylic acid functional monomers (methacrylic acid, acrylic acid, maleic acid, etc.) to prepare polystyrene microspheres rich in carboxyl groups on the surface. By adjusting parameters such as water-oil ratio, functional monomer ratio, and reaction temperature, it is possible to prepare microspheres with an adjustable particle size in the range of 50nm to 350nm and a controllable carboxyl density in the range of 0-400μmol / g.

[0097] Get particle diameter respectively and be each 6.47mL of the polystyrene latex parti...

Embodiment 2

[0104] The particle diameter of the latex particle of embodiment 2 coating tetanus antigen and the linear correlation coefficient determination of reactivity

[0105] Get the latex particles coated with tetanus antigen with a particle diameter of 180nm, 200nm, 257nm, 350nm, 400nm prepared in Example 1, the concentration is 0.19wt% by mass, test the 5-point reactivity of the calibrator respectively, and fit a straight line .

[0106] Experimental results such as figure 1 As shown, the linear correlation coefficients between the particle size and reactivity of the tetanus antigen-coated latex particles all reach above 0.95. However, under the condition of 180nm particle size, the reaction degree is obviously low, and the linear correlation coefficient is 0.96535. When the latex particle size of the antigen is 180nm and 400nm, it cannot be used for the detection of tetanus antibody. And when the particle size of the latex particles coated with tetanus antigen is 200nm-350nm, t...

Embodiment 3

[0107] The linear correlation coefficient determination of different buffer solutions and reactivity in the embodiment 3 reagent R1

[0108] Select Tris buffer (50mM, pH8.5), phosphate buffer (50mM, pH7.2) glycine buffer (50mM, pH6.5), add 1g / LBSA and 1M / LNaCl respectively, and test as reagent R1. Take latex particles coated with tetanus antigen with a particle size of 257nm, the concentration is 0.19wt% by mass, test the 5-point reactivity of the calibrator, and fit a straight line.

[0109] Experimental results such as figure 2 As shown, the linear correlation coefficients all reached more than 0.98, especially the R1 solution prepared with Tris buffer, the linear correlation coefficient reached 0.99855.

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Abstract

The invention provides a test kit for detecting the content of tetanus antibody in human plasma by latex-enhanced immune turbidimetry, the kit includes reagent R1, reagent R2, and a tetanus antibody calibrator, wherein: the reagent R1 includes the first buffer; the reagent R2 includes latex particles, tetanus antigen and a second buffer; the tetanus antibody calibrator includes a third buffer and a series of tetanus antibodies with different concentrations. The kit of the invention has the advantages of high accuracy, good repeatability, strong specificity, high sensitivity, simple operation and the like.

Description

technical field [0001] The invention relates to a latex-enhanced immune turbidimetric kit, in particular to a latex-enhanced immune turbidimetric kit for detecting tetanus antibodies in human plasma. Background technique [0002] Tetanus is a specific infection in which Clostridium tetani invades the human body through skin or mucous membrane wounds, grows and reproduces in a hypoxic environment, produces toxins, and causes muscle spasms. Tetanus toxin mainly invades the motor neurons in the nervous system, so the clinical features of the disease are trismus, paroxysmal spasms, and tonic spasms. The shorter the incubation period, the worse the prognosis. [0003] The pathogen Clostridium tetani is an absolute anaerobic bacterium with a positive Gram stain. Bacteria can be contained in the feces of domestic animals and humans. After being excreted with the feces, they are distributed in nature in the state of spores, especially in the soil, where they survive for several ye...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68G01N33/569G01N33/543G01N33/531
CPCG01N33/531G01N33/54346G01N33/56911G01N33/6854G01N2333/33G01N2469/20
Inventor 边爱杨伟程海陈晓静刘亚宁刘畅王贻杰
Owner 天津安百胜医疗科技有限公司