CN2482085Y - Quick helicobacter pylori antigen testing kit - Google Patents

Quick helicobacter pylori antigen testing kit Download PDF

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Publication number
CN2482085Y
CN2482085Y CN 01223042 CN01223042U CN2482085Y CN 2482085 Y CN2482085 Y CN 2482085Y CN 01223042 CN01223042 CN 01223042 CN 01223042 U CN01223042 U CN 01223042U CN 2482085 Y CN2482085 Y CN 2482085Y
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China
Prior art keywords
antibody
pylori antigen
box body
fast detecting
heliobacter pylori
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Expired - Lifetime
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CN 01223042
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Chinese (zh)
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伊庆燧
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Individual
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Individual
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Priority to HK02103038A priority patent/HK1042211A2/en
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Abstract

The utility model discloses a helicobacter pylori antigen quick testing box, which comprises a box body. The box body is formed by buckling an upper box body and a lower box body, at least one sample adding hole and a test and observation window are arranged on the upper box body, a marking cushion of a colloidal gold combination containing a Hp antigen is nipped in the box body, the marking cushion is connected with a test area containing the Hp antigen, and the test area corresponds to the test and observation window. The utility model can directly test a living Hp infected bacterium antigen, an Hp is not required to be exposed or an enzyme immune testing method is not required to be depended, thereby a simple, quick, accurate, and cheap diagnosis method is provided for a doctor to test the Hp infection.

Description

Heliobacter pylori antigen fast detecting box
The relevant a kind of pick-up unit that is used for diagnostic purpose of the utility model is a kind of Heliobacter pylori antigen fast detecting box that utilizes colloidal gold method specifically.
Helicobacter pylori (Hp) infects gastric epithelial cell, causes acute chronic inflammation.Hp is acknowledged as the cause of disease of acute and chronic superficial gastritis and atrophic gastritis.It also is considered to the possible cause of disease of gastric duodenal ulcer, peptic ulcer, gland cancer and elementary B cell lymphoma.
The Hp infection rate surpasses 50% in normal population, infect Hp have an appointment 35% adult of the U.S..Its infection rate has nothing in common with each other between the different groups of different countries and same country.The socioeconomic status difference, and is densely populated, and health care state condition is poor, and its infection rate of place that supplies water unclean is just high.
Peptic ulcer is a kind of worldwide very general disease.The possibility that people suffers from peptic ulcer in life in western countries is about about 10%.Annual surpass 500,000 newly-increasedly make a definite diagnosis patient and 4,000,000 recidivists.For so big quantity, the cost burden that peptic ulcer causes to society is surprising, also is huge, and it also may cause the spending of huge direct medical cost simultaneously, labour's forfeiture even dead., most of peptic ulcer disease cause that simultaneously, Hp infects and may treat, and in fact also is easy healing because being infected by Hp.Yet the Hp diagnosis of infection does not belong to the routine inspection project, its reason be existing Hp diagnosis of infection method to the doctor, especially very dissatisfied for the PCP.
Hp Infect And Diagnose commonly used at present is divided into two kinds: the intrusive mood method and the non-intrusion type method that need not endoscope that need endoscope.According to patient's severity of symptom, hazards, medical history, medicining condition, the characteristics of detection method and correlative charges etc. can be selected diverse ways.
Invasive method: traditional intrusive mood method generally need rely on endoscope and biopsy to draw materials.The Hp that microbe growth, histological examination, RUT method can directly detect in the sample exists.
Tissue culture is the goldstandard of Hp Infect And Diagnose.Yet because that Hp cultivates difficulty is bigger, even therefore in good laboratory, biopsy Hp culture success ratio is also only at 70%-80%.The positive evidence that histological examination (biopsy specific stain) can provide mucomembranous cell active chronic inflammation HP thalline to exist.But this detection is peeped expert and pathology expert in needing.
It is the variation that causes the pH value in the medium according to urease hydrolyze urea generation ammonia that fast furosemide speed enzyme detects.Under the situation that urea exists, the urease hydrolyze urea produces ammonia, and ammonia can increase PH values, and this method is come compared with Histological method or cultivation, cheaply, conveniently but need that higher cell density is arranged in the biopsy sample, the factor of any minimizing bacterium amount all can produce false negative result
Noninvasive method: the noninvasive method that occurs a series of inspection Hp infection to nineteen ninety.
Serological testing Hp1gG antibody is the most frequently used method, and it provides a kind of Hp the reliable assessment method that existing disease is infected or infected in the past.Sensitivity and specificity are all higher, but major defect is can't distinguish existing disease to infect and infect in the past.1gG continues to keep high level for a long time in the serum of back owing to infect to cure at Hp, so this method only infects sieve to initial stage of medication patient not to dye inspection useful, and urea breath test is based on the Hp urease activity, urine enzyme element can with 13C and 14The urea decomposition of C mark becomes cold 13CO 2With 14CO 2Urea breath test is widely used in treating the judgement of 4 weeks back elimination Hp.
The purpose of this utility model is to provide a kind of Heliobacter pylori antigen fast detecting box, realization utilizes the existing disease of a kind of convenient, fast and reliable Hp of Detection of antigen to infect detection method, it directly detects the bacterial antigens that the Hp that lives infects, and the enzyme that need not to be exposed to Hp or to depend on its enzyme activity is exempted from detection method.Thereby, the doctor infects for providing a kind of simple, quick, accurate and cheap diagnostic method to detect Hp.
The purpose of this utility model is to realize like this, a kind of Heliobacter pylori antigen fast detecting box, include a box body, this box body is fastened by upper cartridge body and lower box body and forms, at least be provided with a well on this upper cartridge body and detect watch window, folder is established the label pad that contains Hp antibody-collaurum bond in this box body, and this label pad is connected in and contains Hp detection of antibodies district, and this detection zone is corresponding to detecting watch window.
The purpose of this utility model can also be achieved in that the Hp antibody of combination on the label pad of the described Hp of containing antibody-collaurum bond constitutes and detect antibody.The antibody of institute's combination constitutes the auxilliary antibody that obtains of Hp solid phase in the described Hp of the containing antibody test district, and this contains Hp antibody test district and can be made of nitrocellulose filter, and the auxilliary antibody that obtains of the Hp solid phase of institute's combination is linearity and is fixed in detection zone to form detection line on this detection zone; This contains Hp antibody test district tail end can be provided with the moisture absorption body.
Describedly be provided with absorbing film corresponding to the well place, this absorbing film one end carrying contains Hp and detects antibody-collaurum bond, to constitute described label pad.The described label pad that contains Hp antibody-collaurum bond, and be attached thereto contain Hp antibody test district, be banded and be provided with, constitute the banded path of detecting.Be fastened and connected with embedded structure between described upper cartridge body and lower box body.
Principle of the present utility model is, use the anti-Hp antibody of polyclone as solid-phase capture antibody and detection antibody at the utility model, and will detect antibodies on the label pad of collaurum, solid-phase capture antibody is fixed in the detection zone of nitrocellulose filter formation with linearity.During detection, sample is joined on the detection box from window.Sample flow is through containing the label pad of Hp antibody-collaurum bond, and sample and bond move to detection zone by capillary action on film after mixing.If contain Hp antigen, then antigen and antibody-collaurum combination in the sample, form antigen-antibody-collaurum complex.When complex arrives the detection line of detection zone, form the antibodies on red line demonstration antigen-antibody-collaurum complex and the detection line, explanation is a positive antibody.If detection zone red line do not occur then illustrates is negative sample (not containing Hp antigen).
Effect of the present utility model is significant: at first, the utility model directly detects the bacterial antigens that Hp alive infects, and the enzyme that need not to be exposed to Hp or to depend on basic enzyme activity is exempted from detection method, therefore promptly have the sensitivity and the high advantage of specificity of antibody test, can overcome effectively again and can't distinguish the defective that existing disease is infected and infected in the past in the antibody test.In addition, the utility model is owing to adopt the principle of Detection of antigen, therefore can directly utilize human faecal mass as test sample, carry out fast Hp Detection of antigen qualitatively, reduced the difficulty that Hp detects widely,, the disconnected information of these diagnosis has been arranged even therefore elementary doctor also can grasp patient's infection conditions easily, when they readily appreciate that patient and how when should look for the stomach and intestine expert, make patient obtain suitable processing.
The effect that the utility model and above-mentioned existing two kinds of helicobacter pyloris detect compares:
Method PUMC Hp antigen fast detecting RUT detects Serum Antibody Detection
Purposes Detect the Hp antigen in patient's ight soil Detect the Hp urease activity in patient's gastric mucosa biopsy sample Detect the Hp LgG antibody in serum or the blood plasma
The result Qualitative detection Qualitative detection Qualitative detection
Sample Ight soil Stomach or duodenum biopsy specimen Serum or blood plasma
Principle Immunochromatography The PH that the Hp urease causes changes Enzyme immunoassay
The technical ability requirement The Laboratory Technician Stomach and intestine expert and Laboratory Technician Vein doctor and Laboratory Technician
Operation 1, in well, adds observations in the sample 2,15 minutes of dilution 1, gets the gastric mucosa sample and put into the medium 2 of urea, room temperature incubation (1-24 hour) 3, visual inspection change color result of determination 1, added dilute sample 2, room temperature incubation (20-60 minutes) 3 in the micropore of antigen, washed 3-5 time to bag
The explanation of accompanying drawing drawing:
Fig. 1 is a three-dimensional exploded view of the present utility model:
The A-A sectional view of Fig. 2 Fig. 1 of the present utility model.
It is as follows to describe the utility model in detail below in conjunction with embodiment and accompanying drawing thereof;
See also shown in Figure 1, the utility model includes a box body, this box body is fastened by upper cartridge body 11 and lower box body 12 and forms, in the present embodiment, 12 of upper cartridge body 11 and lower box bodies are fastened and connected with embedded structure, combination is very convenient, and wherein lower box body 12 is provided with protruding pin 121, and establishes convex edge 122 in Zhou Bianhuan.On protruding pin 121 opposite positions upper cartridge body 11 and lower box body 12, be provided with hollow pin 111.The protruding pin 121 of lower box body 12 can be inserted in the hollow pin 111 of this upper cartridge body 11, thereby upper cartridge body 11 and lower box body 12 are fastened the location.
As shown in Figure 1, be provided with a well 112 and detection watch window 113 on the described upper cartridge body 11 at least.Folder is established the label pad 2 that contains Hp antibody-collaurum bond in lower box body 12, and this label pad 2 is connected in and contains Hp antibody test district 3.Label pad 2 includes an absorbing film 5, and this absorbing film 5 one ends carrying contains Hp and detects antibody-collaurum bond.After upper cartridge body 11 and lower box body 12 fasten, the other end of this absorbing film corresponding to well 112, this detection zone 3 is corresponding to detecting watch window 113.When detecting, sample can be added on the label pad 2 by well 112, and can observe the variation of detection zone 3, thereby determine whether contain Hp antigen in the sample by detecting watch window 113.
In the present embodiment, on the described label pad 2 that contains Hp antibody-collaurum bond the Hp antibody of combination for detecting antibody.The described Hp of containing antibody test district 3 can be made of nitrocellulose filter, and this antibody that contains institute's combination in the Hp antibody test district 3 can be the auxilliary antibody that obtains of Hp solid phase.The Hp of containing antibody test of the present utility model district 3 also can be made of other tunica fibrosa with capillary conduction function.As Fig. 1 or shown in Figure 2, the auxilliary antibody that obtains of the Hp solid phase of institute's combination is linearity and is fixed in detection zone 3 in the described Hp of the containing antibody test district 3.At least be the linear auxilliary antibody detection line 31 that obtains of a Hp solid phase that is fixed with on the detection zone 3.In addition, also be provided with display line 32 containing in the Hp antibody test district 3, this display line 32 can show the state that sample passes.
The label pad 2 of the described Hp of containing antibody-collaurum bond and be attached thereto contain Hp antibody test district, be banded and be provided with, form banded detection path.When add sample in well 112 after, this sample stream is through containing the label pad 2 of Hp antibody-collaurum bond, and sample and bond move to containing Hp detection of antibodies district 3 by capillary action on film after mixing.If contain Hp antigen, then antigen and antibody-collaurum combination in the sample, form antigen-antibody-collaurum complex.When complex arrived the detection line 31 of detection zone 3, the Hp solid phase on formation red line demonstration antigen-antibody-collaurum complex and the detection line 31 is auxilliary to obtain antibodies, and explanation is that sample is positive, and promptly contains Hp antigen.
Because the utility model directly detects the bacterial antigens that Hp alive infects, and the enzyme that need not to be exposed to Hp or to depend on its enzyme activity is exempted from detection method, therefore both had the sensitivity and the high advantage of specificity of antibody test, and can overcome effectively again and can't distinguish the defective that existing disease is infected and infected in the past in the antibody test.In addition, therefore the utility model can directly utilize human faecal mass as test sample owing to adopt the principle of Detection of antigen, carries out fast Hp Detection of antigen qualitatively, has reduced the difficulty that Hp detects widely, thereby has reduced state of an illness diagnosis difficulty.Utilize Detection of antigen principle of the present utility model, the utility model also can adopt other sample sample, as stomach or duodenum biopsy specimen, serum or blood plasma.
As shown in Figure 2, the tail end in the described Hp of containing antibody test district 3 can be provided with moisture absorption body 4.When antigen-antibody-collaurum complex moving to by capillary action on the film contain Hp detection of antibodies district 3 after, the moisture absorption body 4 of the tail end of this detection zone 3 can absorb unnecessary antigen-antibody-collaurum complex, in order to avoid this antigen-antibody-collaurum complex flows out, pollute this Heliobacter pylori antigen fast detecting box and surrounding enviroment.
The foregoing description is a better embodiment of the present utility model, only is used to describe in detail the utility model, but not is used to limit the utility model.

Claims (10)

1, a kind of Heliobacter pylori antigen fast detecting box, include a box body, this box body is fastened by upper cartridge body and lower box body and forms, at least be provided with a well on this upper cartridge body and detect watch window, it is characterized in that, folder is established the label pad that contains Hp antibody-collaurum bond in this box body, and this label pad is connected in and contains Hp detection of antibodies district, and this detection zone is corresponding to detecting watch window.
According to a kind of Heliobacter pylori antigen fast detecting box of claim 1, it is characterized in that 2, the Hp antibody of combination constitutes and detects antibody on the described label pad that contains Hp antibody-collaurum bond.
According to a kind of Heliobacter pylori antigen fast detecting box of claim 1, it is characterized in that 3, the antibody of institute's combination constitutes the auxilliary antibody that obtains of Hp solid phase in the described Hp of the containing antibody test district.
According to a kind of Heliobacter pylori antigen fast detecting box of claim 1 or 3, it is characterized in that 4, the described Hp of containing antibody test district can be made of nitrocellulose filter.
According to a kind of Heliobacter pylori antigen fast detecting box of claim 1 or 3 or 4, it is characterized in that 5, the auxilliary antibody that obtains of the Hp solid phase of institute's combination is linearity and is fixed in detection zone to form detection line in the described Hp of the containing detection of antibodies district.
According to a kind of Heliobacter pylori antigen fast detecting box of claim 1 or 3, it is characterized in that 6, the described Hp of containing antibody test district tail end can be provided with the moisture absorption body.
7, according to a kind of Heliobacter pylori antigen fast detecting box of claim 5, it is characterized in that, described constitute by nitrocellulose filter contain Hp antibody test district tail end and can be provided with the moisture absorption body.
8, according to a kind of Heliobacter pylori antigen fast detecting box of claim 1 or 2, it is characterized in that, describedly be provided with absorbing film corresponding to the well place, this absorbing film one end carrying contains Hp and detects antibody-collaurum bond, to constitute described label pad.
9, according to a kind of Heliobacter pylori antigen fast detecting box of claim 1, it is characterized in that, the described label pad that contains Hp antibody-collaurum bond, and be attached thereto contain Hp antibody test district, be banded and be provided with, constitute the banded path of detecting.
10, according to a kind of Heliobacter pylori antigen fast detecting box of claim 1, it is characterized in that, be fastened and connected with embedded structure between described upper cartridge body and lower box body.
CN 01223042 2001-04-29 2001-04-29 Quick helicobacter pylori antigen testing kit Expired - Lifetime CN2482085Y (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN 01223042 CN2482085Y (en) 2001-04-29 2001-04-29 Quick helicobacter pylori antigen testing kit
HK02103038A HK1042211A2 (en) 2001-04-29 2002-04-23 A kit for fast testing helicobacter pylori antigen

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Application Number Priority Date Filing Date Title
CN 01223042 CN2482085Y (en) 2001-04-29 2001-04-29 Quick helicobacter pylori antigen testing kit

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CN2482085Y true CN2482085Y (en) 2002-03-13

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CN 01223042 Expired - Lifetime CN2482085Y (en) 2001-04-29 2001-04-29 Quick helicobacter pylori antigen testing kit

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102393460A (en) * 2011-08-22 2012-03-28 万积成 Rapid detection device for helicobacter pylori
CN104833804A (en) * 2015-04-30 2015-08-12 必欧瀚生物技术(合肥)有限公司 Helicobacter pylori IgG antibody ELISA semi-quantitative detection kit and application thereof
CN104897892A (en) * 2015-06-01 2015-09-09 上海凯创生物技术有限公司 Helicobacter pylori antigen colloidal gold detection kit

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102393460A (en) * 2011-08-22 2012-03-28 万积成 Rapid detection device for helicobacter pylori
CN104833804A (en) * 2015-04-30 2015-08-12 必欧瀚生物技术(合肥)有限公司 Helicobacter pylori IgG antibody ELISA semi-quantitative detection kit and application thereof
CN104897892A (en) * 2015-06-01 2015-09-09 上海凯创生物技术有限公司 Helicobacter pylori antigen colloidal gold detection kit

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GR01 Patent grant
C17 Cessation of patent right
CX01 Expiry of patent term

Expiration termination date: 20110429

Granted publication date: 20020313