Hepatitis B virus surface antigen (HBsAg) detection kit and preparation method thereof
A technology of hepatitis B virus and surface antigen, which is applied in the detection kit of hepatitis B virus surface antigen and its preparation field, can solve the problems of high detection cost, etc., and achieve the effects of high accuracy, shortened reaction time, and shortened detection time
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Embodiment 1
[0040] A kit for detecting hepatitis B virus surface antigen, said kit comprising: magnetic microspheres coated with HBsAg antibody, HBsAg calibrator, europium-labeled HBsAg antibody marker, analysis buffer, concentrated washing solution and enhancement solution , RFID card.
[0041] The present invention also provides a preparation method for the above-mentioned detection kit for hepatitis B virus surface antigen, said method comprising the following steps:
[0042](1) Preparation of magnetic microspheres coated with HBsAg antibody: the buffer system of HBsAg antibody was replaced by an ultra-fast refrigerated centrifuge at 2-8°C, mixed with carboxyl magnetic microspheres with a diameter of 1 μm after cleaning and activation, 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 sup...
Embodiment 2
[0065] A detection kit for hepatitis B virus surface antigen, which is basically the same as the detection kit described in Example 1, except that:
[0066] (1) The components of the HBsAg detection kit only include: reagent strips, HBsAg calibrator, and RFID card.
[0067] (2) In this embodiment, the reagent strip in the detection kit is composed of magnetic microspheres coated with HBsAg antibody, europium-labeled HBsAg antibody 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.
[0068] 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:
[0069] The reagent strips are arranged from left to rig...
Embodiment 3
[0075] Performance evaluation of the detection kit of hepatitis B virus surface 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 Surface 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 for detection of HBsAg.
[0077] Embodiment 1, embodiment 2 detect hepatitis B virus surface antigen national reference substance, the result is as follows:
[0078] (1) Negative coincidence rate: 20 negative national reference materials N1-N20, the detection coincidence rate (- / -) of Example 1 and Example 2 is 20 / 20;
[0079] (2) Positive coincidence rate: 3 negative national reference materials P1~P3, the test coincidence rate (+ / +) of Example 1 and Example 2 is 3 / 3;
[0080] (3) Precision: The precision reference product was repeatedly tested 10 ...
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Abstract
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