Pepsinogen I detection kit and preparation method thereof

A pepsinogen and kit technology, which is applied in biological testing, measuring devices, material inspection products, etc., can solve problems such as high testing costs, achieve high accuracy, reduce size and equipment costs, and achieve stable and convenient testing. Effect

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 shortcomings of high detection costs in

Method used

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  • Pepsinogen I detection kit and preparation method thereof
  • Pepsinogen I detection kit and preparation method thereof
  • Pepsinogen I detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] A kit for detecting pepsinogen I, the kit comprising: magnetic microspheres coated with PG I antibody, PG I calibrator, europium-labeled PG I antibody marker, analysis buffer, concentrated washing solution and enhancement solution, RFID Card.

[0039] The present invention also provides a preparation method for the above kit for detecting pepsinogen I, the method comprising the following steps:

[0040] (1) Preparation of magnetic microspheres coated with PGⅠantibody: the PGⅠantibody was subjected to an ultra-fast refrigerated centrifuge at 2-8°C to replace the buffer system, and then mixed with the cleaned and activated carboxyl magnetic microspheres with a diameter of 1 μm and incubated at 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 again, and put the coated PGⅠ antibod...

Embodiment 2

[0063] A detection kit for pepsinogen I, which is basically the same as the detection kit described in Example 1, except that:

[0064] (1) The components of the pepsinogen I detection kit only include: reagent strips, PG I calibrator, and RFID card.

[0065] (2) In this embodiment, the reagent strip in the detection kit is composed of magnetic microspheres coated with PGⅠantibody, europium-labeled PGⅠantibody marker, analysis buffer, cleaning solution and enhancement solution, and then packed into the reagent The holes corresponding to the strips are sealed with film. Wherein the cleaning solution is obtained by diluting the concentrated lotion in Example 1 with purified water 25 times; the rest of the components are the same as in Example 1.

[0066] 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:

[0067] The reagent strips are arranged from left to right, and the names are...

Embodiment 3

[0072] Performance evaluation of the detection kit of pepsinogen I of the present invention:

[0073] According to the kits and detection methods prepared in the examples, 240 cases of clinical samples from Abbott Architect i2000 for detection of pepsinogen Ⅰ were obtained from the hospital. The 2.5th percentile value of Examples 1 and 2 was 63.8 ng / mL.

[0074] Example 1 and Example 2 detected 240 clinical samples of Abbott pepsinogen I, and the results were as follows:

[0075] Table 1 embodiment 1,2 clinical sample comparison

[0076]

[0077]

[0078] The detection kits described in Example 1 and Example 2 of the present invention have a negative coincidence rate of 100% and a positive coincidence rate of 100% for the detection of pepsinogen I and the control reagent.

[0079] Combined with the results of pepsinogen Ⅱ detection (PGⅡ critical value 22.5ng / mL, PGⅠ / PGⅡ ratio critical value 3.0), the comparison results of PGⅠ / PGⅡ ratio with Abbott are as follows:

[0...

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Abstract

The invention discloses a pepsinogen I detection kit and a preparation method thereof. The pepsinogen I detection kit is composed of the following components: PGI antibody-coating magnetic microspheres, a PGI calibrator, a PGI antibody marker bound to lanthanides, an analytical buffer, a cleaning solution, an enhancement solution and an RFID card. Based on combination of the magnetic microspheresand a time-resolved immunoassay method, the drawbacks of long physical adsorption reaction time and slow detection result of an enzyme label plate are overcome, and the reaction time is greatly shortened; 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 of the magnetic microspheres, the contact surface area of an immune response isgreatly increased, the detection time is greatly shortened, and further optimization is made for the traditional two-step method detection, pepsinogen I detection only requires a one-step method, anda result can be obtained within 20 minutes.

Description

technical field [0001] The invention relates to a pepsinogen I detection kit and a preparation method thereof, in particular to a preparation method of a pepsinogen I detection kit based on a combination of magnetic microspheres and time-resolved immunoassay. Background technique [0002] Pepsinogen is the inactive precursor of pepsin in gastric juice. It can be divided into two types immunologically: pepsinogen Ⅰ (PGⅠ) and pepsinogen Ⅱ (PGⅡ). PGⅠ is mainly composed of the principal cells of the fundic gland and mucus Neck cells are secreted, while PGII is not only secreted by the principal cells and mucus neck cells of the fundic glands, but also by the mucus neck cells of the cardia glands and pyloric glands of the gastric antrum and the upper duodenum. In the process of fundic gland mucosal atrophy, the principal cells secreting PGⅠ decrease and the pyloric gland cells increase, resulting in a decrease in the ratio of PGⅠ / PGⅡ. The detection of pepsinogen, especially the r...

Claims

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Application Information

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