Treponema pallidum antibody detection kit and preparation method thereof

A technology of Treponema pallidum and kits, applied in biological testing, measuring devices, material inspection products, etc., can solve problems such as high detection costs, achieve high accuracy, shorten reaction time, and shorten detection time.

Inactive Publication Date: 2019-03-29
GUANGZHOU BIOKEY HEALTH TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Based on this, the purpose of the present invention is to overcome the disadvantages of high detection costs in the prior art and related technologies, to provide a test kit for detecting Treponema pallidum antibodies, and a preparation method for the kit

Method used

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  • Treponema pallidum antibody detection kit and preparation method thereof
  • Treponema pallidum antibody detection kit and preparation method thereof
  • Treponema pallidum antibody detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A kit for detecting Treponema pallidum antibody, the kit comprising: magnetic microspheres coated with TP antigen, negative control substance, positive control substance, europium-labeled TP antigen marker, analysis buffer, concentrated washing solution and enhancement Liquid, RFID card.

[0035] The present invention also provides a preparation method of the above-mentioned Treponema pallidum antibody kit, the method comprising the following steps:

[0036] (1) Preparation of magnetic microspheres coated with TP antigen: After the TP antigen is subjected to a 2~8℃ ultra-speed refrigerated centrifuge to replace the buffer system, it is mixed with washed and activated carboxyl magnetic microspheres with a diameter of 1 μm and incubated at a constant temperature For 1 to 3 hours, after incubation, wash the magnetic beads with magnetic bead cleaning solution and discard the supernatant, then block with magnetic bead blocking solution, wash the magnetic beads and discard the sup...

Embodiment 2

[0060] A kit for detecting Treponema pallidum antibody, which is basically the same as the detection kit described in Example 1, except that:

[0061] (1) The components of the kit for detecting Treponema pallidum antibody include: a reagent strip, a negative control substance, a positive control substance, and an RFID card.

[0062] (2) In this embodiment, the reagent strip in the detection kit is composed of magnetic microspheres coated with TP antigen, europium-labeled TP antigen marker, analysis buffer, cleaning solution, and enhancement solution. It is formed after sealing film in the corresponding hole. The cleaning solution is obtained by diluting the concentrated washing and purified water 25 times in Example 1; the remaining components are the same as those in Example 1.

[0063] In this embodiment, as figure 1 , figure 2 As shown, the function description of each hole position of the reagent strip in the detection kit is as follows:

[0064] The reagent strips are arranged...

Embodiment 3

[0069] The performance evaluation of the Treponema pallidum antibody kit of the present invention:

[0070] According to the kits and detection methods prepared in the examples, the national reference product of Treponema pallidum antibody purchased from China Food and Drug Control Institute was tested, and 241 clinical samples were collected from the hospital Abbott Architect i2000 for Treponema pallidum antibody detection.

[0071] Example 1 and Example 2 tested the national reference product of Treponema pallidum antibody, the results are as follows:

[0072] (1) The coincidence rate of negative reference products: 20 negative reference products N1~N20, the detection coincidence rates (- / -) of Example 1 and Example 2 are all 20 / 20;

[0073] (2) The coincidence rate of positive reference products: 10 positive reference products P1~P10, the detection coincidence rates (+ / +) of Example 1 and Example 2 are all 10 / 10;

[0074] (3) Precision: The precision reference product was tested repe...

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Abstract

The invention discloses a Treponema pallidum antibody detection kit and a preparation method thereof. The Treponema pallidum antibody detection kit is composed of the following components: TP antigen-coating magnetic microspheres, a negative reference substance, a positive reference substance, a TP antigen marker bound to lanthanides, an analytical buffer, a cleaning solution, an enhancement solution and an RFID card. Based on combination of the magnetic microspheres and a time-resolved immunoassay method, the drawbacks of long physical adsorption reaction time and slow detection result of anenzyme label plate are overcome, and the reaction time is greatly shortened; and besides, the advantages of high accuracy, high sensitivity, strong specificity, wide linear range, and stable and convenient detection of a time-resolved detection technology can also be realized. The magnetic microspheres are coated with corresponding antigens or antibodies, due to the stereoscopic characteristic ofthe magnetic microspheres, the contact surface area of an immune response is greatly increased, the detection time is greatly shortened, and a result can be obtained through detection in 30 minutes.

Description

Technical field [0001] The invention relates to a Treponema pallidum antibody detection kit and a preparation method thereof, in particular to a preparation method of a Treponema pallidum antibody detection kit based on a combination of magnetic microspheres and a time-resolved immunoassay method. Background technique [0002] Syphilis is a highly infectious and harmful human sexually transmitted disease caused by Treponema pallidum (TP) infection. Under natural circumstances, syphilis only infects humans, and humans are the only source of syphilis. Syphilis can cause damage to multiple systems such as nerves and cardiovascular systems, and even life-threatening. Syphilis can infect the fetus through the placenta, leading to spontaneous abortion, stillbirth, or congenital syphilis. Infection with syphilis can promote the spread of AIDS. With economic development, sexually transmitted diseases have also increased. [0003] At present, syphilis non-specific lipid-like antibody ser...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/543
CPCG01N33/54326G01N33/6854
Inventor 李根平解巧丽
Owner GUANGZHOU BIOKEY HEALTH TECH CO LTD
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