Hepatitis B virus e antigen (HBeAg) detection kit and preparation method thereof

A hepatitis B virus and reagent kit technology, applied in biological testing, measuring devices, material inspection products, etc., can solve problems such as high testing costs, achieve high accuracy, meet the needs of fully automated testing, and increase the effect of contact surface area

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 defects in the prior art and the high detection

Method used

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  • Hepatitis B virus e antigen (HBeAg) detection kit and preparation method thereof
  • Hepatitis B virus e antigen (HBeAg) detection kit and preparation method thereof
  • Hepatitis B virus e antigen (HBeAg) detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] A kit for detecting hepatitis B virus e antigen, said kit comprising: magnetic microspheres coated with HBeAg antibody, HBeAg calibrator, europium-labeled HBeAg antibody marker, analysis buffer, concentrated washing solution and enhancement solution , RFID card.

[0041] The present invention also provides the preparation method of above-mentioned detection kit of hepatitis B virus e antigen, described method comprises the following steps:

[0042](1) Preparation of magnetic microspheres coated with HBeAg antibodies: After replacing the buffer system with HBeAg antibodies in an ultra-fast refrigerated centrifuge at 2-8°C, mix them with washed and activated carboxyl magnetic microspheres with a diameter of 1 μm and incubate at a constant temperature for 1 ~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 supernatant ...

Embodiment 2

[0066] A detection kit for hepatitis B virus e antigen, which is basically the same as the detection kit described in Example 1, except that:

[0067] (1) The components of the kit for detecting hepatitis B virus e antigen only include: reagent strips, HBeAg calibrator, and RFID card.

[0068] (2) In this embodiment, the reagent strips in the detection kit are composed of magnetic microspheres coated with HBeAg antibodies, europium-labeled HBeAg antibody markers, analysis buffer, cleaning solution and enhancement solution, and are subpackaged into reagents. The holes corresponding to the strips are sealed with film. Wherein the cleaning solution is concentrated and washed in Example 1 and diluted 25 times with purified water; the rest of the components are the same as in Example 1.

[0069] In this example, as figure 1 , figure 2 As shown, the functions of each well of the reagent strip in the detection kit are described as follows:

[0070] The reagent strips are arrange...

Embodiment 3

[0075] The performance evaluation of the detection kit of hepatitis B virus e antigen of the present invention:

[0076] According to the kits and detection methods prepared in the examples, the National Reference Material of Hepatitis B Virus e Antigen purchased from China National Institute for Food and Drug Control was detected, and 300 cases of clinical samples were collected from Abbott Architect i2000 of the hospital to detect HBeAg.

[0077] Embodiment 1, embodiment 2 detect hepatitis B virus e antigen national reference product, the result is as follows:

[0078] (1) Negative coincidence rate: 15 negative national reference materials N1-N15, the detection coincidence rate (- / -) of Example 1 and Example 2 is 15 / 15;

[0079] (2) Positive coincidence rate: 10 positive national reference products P1-P10, the detection coincidence rate (+ / +) of Example 1 and Example 2 is 10 / 10;

[0080] (3) precision: the precision reference product is repeatedly detected 10 times, and the...

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Abstract

The invention discloses a hepatitis B virus e antigen (HBeAg) detection kit and a preparation method thereof. The hepatitis B virus e antigen (HBeAg) detection kit is composed of the following components: HBeAg antibody-coating magnetic microspheres, an HBeAg calibrator, an HBeAg antibody 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 an enzyme label plateare 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 ofa time-resolved detection technology can also be realized. The magnetic microspheres are coated with corresponding antigens or antibodies, due to the stereoscopic characteristic of the magnetic microspheres, the contact surface area of an immune response is greatly increased, the detection time is greatly shortened, and further optimization is made for the traditional two-step method detection, HBeAg detection only requires a one-step method, and a result can be obtained within 30 minutes.

Description

technical field [0001] The invention relates to a test kit for detecting hepatitis B virus e antigen and a preparation method thereof, in particular to a preparation method for a test kit for detecting hepatitis B virus e antigen based on the combination of magnetic microspheres and time-resolved immunoassay. Background technique [0002] Hepatitis B (hepatitis B for short) is an infectious disease caused by hepatitis B virus (HBV) that can lead to liver inflammation and liver function damage. HBeAg is a soluble protein that is generally only found in HBsAg-positive sera. HBeAg appears slightly later than HBsAg in acute HBV infection. The presence of HBeAg indicates that the patient is in a period of high infection and low response. The offspring of HBeAg disappearance are anti-HBe. [0003] Currently, serological examination items for hepatitis B virus generally include HBsAg, Anti-HBs, HBeAg, Anti-HBe, and Anti-HBc, commonly known as "hepatitis B two-and-a-half". The c...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/543
CPCG01N33/54326G01N33/6854
Inventor 李根平
Owner GUANGZHOU BIOKEY HEALTH TECH CO LTD
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