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Rapid hepatitis A virus IgM antibody detection kit and preparation method thereof

A technology of hepatitis A virus and kits, applied in the direction of measuring devices, diseases resistant to vector transmission, instruments, etc., can solve the problems of unfavorable emergency cases and epidemic control, and achieve the effect of delaying the diagnosis time

Active Publication Date: 2012-09-26
上海优晶生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is not conducive to the control of emergency cases and epidemics

Method used

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  • Rapid hepatitis A virus IgM antibody detection kit and preparation method thereof
  • Rapid hepatitis A virus IgM antibody detection kit and preparation method thereof
  • Rapid hepatitis A virus IgM antibody detection kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment one: kit preparation process

[0032] The kit preparation process includes the following steps:

[0033] 1. Preparation of solid phase membrane;

[0034] 2. Colloidal gold coupling;

[0035] 3. Quality control mobile phase preparation;

[0036] 4. Paste and prepare large boards;

[0037] 5. Slitting strips;

[0038] 6. Assemble the plastic card holder as needed;

[0039] (1) Preparation of solid phase membrane

[0040] 1. Detection line drawing solution: Dilute mouse anti-human IgM to 1-2mg / ml with 0.02M (PH=7.4) PB, mix well, filter with 40μm filter membrane and set aside.

[0041] 2. Quality control line drawing solution: Dilute goat anti-mouse IgG to 2-4mg / ml with 0.02M (PH=7.4) PB, mix well, filter with 40μm filter membrane and set aside.

[0042] 3. Draw a line in the middle of the nitrocellulose membrane with a scriber. The film marking parameters are: the height of the marking head is 4.8cm, the spacing between the marking pens is 0.5-1cm, the ...

Embodiment 2

[0091] Embodiment two: test strip detection operation process:

[0092] 1. Dilute the sample 1:100. (Take a disposable test tube, first add 10 μl of sample, then add 1000 μl of normal saline, and mix well).

[0093] 2. Open the aluminum foil bag and take out the test strip / card for later use.

[0094] 3. Test strip: The sample loading area is below the MAX line. Dip the test strip MAX into the 1:100 diluted sample until the marked line in the direction indicated by the MAX arrow, make sure that the soaking time is not less than 15 seconds, then place the test strip flat on the recording paper (A4 paper can be used instead), and at the same time start the timer.

[0095] 4. Test card: draw 100 μl of the sample diluted with 1:100, and add it to the sample hole of the test paper card.

[0096] 5. It can be observed that the red liquid flows upward and deposits into a red line in the observation area.

[0097] 6. The test result should be judged within 15 minutes. After 15 m...

Embodiment 3

[0098] Example Three: Result Judgment

[0099] 1. Positive (+): Two red bands appear. One is at the test line (T) and the other is at the control line (C).

[0100] 2. Negative (-): Only a red band appears in the quality control line (C), and no red band appears in the test line (T).

[0101] 3. Invalid: There is no red band on the quality control line (C), indicating that the test is invalid.

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Abstract

The invention discloses a rapid hepatitis A virus IgM antibody detection kit which is realized by using reaction principles of a capture method and combinedly using colloidal gold immunochromatographic assay technology. The kit comprises anti-human IgM, antigen antibody complexes coupled with colloidal gold, supportive materials and a quality control reaction system. According to a technical scheme, anti-human IgM is coated on a detection line (T). The virus antigen antibody complexes are coupled with the colloidal gold and coupled matters are dried and placed on a gold label pad. Mouse anti-human IgM of the detection line is immobilized, and antigen antibody complexes of the gold label pad are movable. The kit further comprises the quality control system composed of one couple of an antigen and an antibody which can have specific reaction, wherein one of the couple is coupled with the colloidal gold and then placed on the gold label pad as a mobile phase; the other one is immobilized at a quality control line (C) as an immobile phase. The kit provided by the invention can assist in obtaining detection results in 2-15 minutes and can be conveniently applied to single specimen detection.

Description

technical field [0001] The invention relates to the field of in vitro diagnostic reagents, in particular to a kit for detecting hepatitis A virus IgM antibody in human serum, body fluid or other samples by a colloidal gold chromatography capture method and a preparation method thereof. Background technique [0002] Viral hepatitis A (referred to as hepatitis A, HA) is an intestinal infectious disease caused by hepatitis A virus (HAV), which is mainly caused by inflammatory damage of liver parenchymal cells. The outbreak and prevalence of influenza virus and drinking water virus are still a common public health problem in the world so far. The number of global annual incidence is about 1.4 million, and the actual number of cases is 3 to 10 times that of the reported number. At present, the incidence and infection rate of hepatitis A in my country still rank first among other types of viral hepatitis. The results of the national viral hepatitis seroepidemiological survey in th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576
CPCY02A50/30
Inventor 郑嘉庚潘国华秦伟涛李玉彬张旭东王学前徐菲
Owner 上海优晶生物科技有限公司