CN207198168U - Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit - Google Patents
Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit Download PDFInfo
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- CN207198168U CN207198168U CN201720624221.5U CN201720624221U CN207198168U CN 207198168 U CN207198168 U CN 207198168U CN 201720624221 U CN201720624221 U CN 201720624221U CN 207198168 U CN207198168 U CN 207198168U
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- helicobacter pylori
- test
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- chamber
- hemorrhage
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Abstract
It the utility model is related to stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit,Kit includes dilution chamber and test chamber,Dilution is filled with cavity,Sampling lid is provided with upper opening,Dilution chamber bottom is provided with connection outlet,Envelope has barrier film at connection outlet,Probe tube is provided with described sampling lid,The connecting portion of two sections of depths is provided with opening,Sampling lid is connected by connecting portion with dilution chamber,Test chamber top has the undertaking import coordinated with connection outlet,The fixed part of vertical fixed test strips is provided with the side inner walls of test chamber,Test chamber is fixed with helicobacter pylori immuno-chromatographic test paper strip by fixed part,Hemoglobin immune chromatograph test strip and transferrins immuno-chromatographic test paper strip,The utility model is cleverly by sample collection,Dilution and detection a step in obturator are completed,It instead of the sampling of classics,Dilution,Detect many more manipulations,Greatly reduce working strength,Reduce potential infection risk.
Description
[technical field]
It the utility model is related to immune chromatography reagent kit, and in particular to stomach Helicobacter pylori and hemorrhage of digestive tract joint inspection
Test agent box.
[background technology]
Hemorrhage of gastrointestinal tract can be caused by a variety of diseases, and carninomatosis association of the U.S. is proposed in early diagnosis and situation about treating in time
Under, dying from the people 2/3rds of such disease every year can save.Stomach Helicobacter pylori is to cause chronic gastritis, peptic ulcer
Important virulence factor, stomach Helicobacter pylori is classified as I class carcinogen in IARC in 1994.Clinic is ground
Study carefully confirmation, the micro bleeding with cancerous swelling is that early stage digestive system cancer (cancer of the esophagus, stomach cancer, colorectal cancer) can uniquely be looked into excrement
The anomaly gone out.Digestive system cancer is one of most common malignant tumour.In recent years, its incidence of disease worldwide present by
Gradually downward trend, but be still global incidence and case fatality rate highest area in East Asia Region.Chinese cities in 2011 and agriculture
Village's case fatality rate is respectively 19.66/10 ten thousand and 22.09/10 ten thousand, occupies the malignant tumour cause of the death the 3rd.It is different from other cancers, disappear
Change that road cancer early symptom is hidden and easy to be ignored, and the symptoms such as have blood in stool, suffer from abdominal pain occur in most patients, and majority is late period when making a definite diagnosis,
Operation and inequality the effect of medicine, or even lose therapy apparatus meeting.Therefore early diagnosis, early operation are to improve the pass of survival
Key.Rely primarily on the inspection of feces occult blood mark and endoscopy at present.Because endoscopy is expensive, and easily to patient
Cause discomfort, especially children, pregnant woman, old man and other people, be unfit to do endoscopy, therefore it is difficult to apply to early stage
The examination of digestive system cancer.And feces occult blood inspection need to only check the fecal sample of patient, have detect it is easy, quick, cheap,
The features such as accurate, it is adapted to the examination of all groups, but traditional feces occult blood checks that inspection project is more single, in detection process
Middle operation is excessively cumbersome and easily operating personnel are caused with the possibility potentially infected, therefore proposes a energy one step detection entry
Kit it is necessary.
Hemoglobin and transferrins are the important symbol things of upper hemorrhage of lower digestive tract disease, are that early stage alimentary canal is pernicious
The important indicator of tumor screening, stomach Helicobacter pylori are the Major Risk Factors that stomach cancer occurs, therefore joint-detection stomach pylorus
Pylori, hemoglobin and transferrins are advantageous to the state of an illness and therapeutic intervention for helping clinician to find patient in time,
Medical resource can be greatlyd save, reduces slight illness and the financial burden of patient.In digestive system cancer early screening, clinical diagnosis etc.
There are preferable clinical value and social value.
It is chemical method, immunizing monoclonal method currently used for examination early stage digestive system cancer main method.
Chemical method：Mainly there are Ortho-tolidine method, phenolphthalin method, benzidine method, aminopyrine method, guaiac method
Deng.Its principle is made it discharge nascent oxygen, supported based on the hydrogen peroxide in iron content ferroheme energy catalytic reagent in hemoglobin
Above-mentioned chromogen substance and develop the color.The depth of colour developing reflects the number of hemoglobin.Though chemical method is simple and easy, it is vulnerable to it
His disturbing factor is more, and false positive rate is high, and specificity is lacked in method.
Immunizing monoclonal method：Mainly include the detection of stomach Helicobacter pylori antigen and feces occult blood detection, its principle is with anti-
The double-antibody sandwich collaurum developing technology of people's stomach Helicobacter pylori (or hemoglobin) monoclonal, it can detect in fecal sample
Stomach Helicobacter pylori (or hemoglobin).Compared with chemical method, monoclonal antibody method sensitiveness is high, high specificity, and not by diet and
The influence of some drugses.But the infection rate of stomach Helicobacter pylori is high, in developed country, 30%~50% adult has
Helicobacter pylori infections, and the stomach Helicobacter pylori infection rate of developing country is then up to 80%.China belongs to stomach pylorus spiral shell
The high country of swing arm bacterium infection rate, stomach Helicobacter pylori average rate is 58.07% in general population, therefore single inspection
The clinical meaning unobvious of stomach Helicobacter pylori or hemoglobin are surveyed, and deficiency is individually present.
Joint-detection stomach Helicobacter pylori, hemoglobin and transferrins, be advantageous to save medical resources, reduce doctor
The working strength of business personnel, reduces the medical testing cost of patient, while is available for clinician to combine the clinical symptoms of patient and enters
The systematic auxiliary diagnosis of row.Generally investigated particularly suitable for vast basic unit reviewer and mass detection and large area etc., tool
There are huge development potentiality and wide application prospect, be particularly suitable for China's national situation.
[content of the invention]
In order to solve the above-mentioned problems of the prior art, the utility model provides one kind and detected simultaneously in same device
The Rapid test cassette method of stomach Helicobacter pylori, hemoglobin and transferrins, while to coordinate joint-detection also to provide
A kind of device for gathering and detecting integration for fecal sample.
To achieve these goals, there is provided a kind of stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit, bag
Dilution cavity and test chamber are included,
A. dilution chamber, upper opening, cavity is interior to be filled with dilution, sampling lid is provided with opening, dilution chamber bottom is set
Connection outlet is equipped with, envelope has barrier film at connection outlet, and probe tube is provided with described sampling lid, two sections of depths are provided with opening
Connecting portion, sampling lid is connected by connecting portion with dilution chamber, samples lid when being connected to first paragraph connecting portion position, probe tube quilt
It is contained in completely in dilution chamber, when sampling lid is connected to second segment connecting portion position, sampling tube end wears out described barrier film,
B. test chamber, top have the undertaking import coordinated with connection outlet, are provided with the side inner walls of test chamber perpendicular
To the fixed part of fixed test strips, test chamber is fixed with helicobacter pylori immuno-chromatographic test paper strip, blood red egg by fixed part
White immuno-chromatographic test paper strip and transferrins immuno-chromatographic test paper strip, the sampling end of each test strips is close to bottom of chamber.
The kit further has following scheme：
Described helicobacter pylori immunity test strip includes the anti-human stomach Helicobacter pylori list of the mouse containing revealing label
The gold pad of clonal antibody, and the detection line containing the anti-human stomach Helicobacter pylori monoclonal antibody of mouse and contain sheep anti-mouse igg
Nature controlling line nitrocellulose filter.
Described hemoglobin immune chromatograph test strip includes the gold of the mouse antihuman hemoglobin antibody containing revealing label
Pad, and the nitrocellulose filter of the detection line containing mouse antihuman hemoglobin antibody and the nature controlling line containing sheep anti-mouse igg.
Described transferrins immuno-chromatographic test paper strip includes the gold of mouse anti-human transferrin's antibody containing revealing label
Pad, and the nitrocellulose filter of the detection line containing mouse anti-human transferrin's antibody and the nature controlling line containing sheep anti-mouse igg.
The fixed part of described test strips is dovetail groove.
The threaded connection by the two-part in opening with dilution chamber is covered in sampling, passes through groove mistake between two sections of screw threads
Cross.
Described sampling tube end has the point of application of protrusion.
The utility model cleverly by sample collection, dilution and detection, complete in obturator by a step, a sample
Fully diluted by the dilution in device after sampling, under single stepping, the sample of dilution enters reaction zone, completes sample
This detection.The device have the characteristics that it is easy to operate, safe, quick, be adapted in the occasion onsite application such as family, hospital, greatly
Working strength is reduced greatly, reduces potential infection risk.
[brief description of the drawings]
Fig. 1 is structural representation of the present utility model,
Fig. 2 is Fig. 1 Longitudinal cross section schematic；
Fig. 3 is test paper interpretation illustration；
Fig. 4 is the structural representation of test paper；
The dovetail groove 7. of 1. sampling lid 2. probe tube, 3. dilution chamber, 4. barrier film 5. test chamber 6. accepts import screw thread a. the in figure
One section of blotting paper of 11. sample pad of screw thread b. second segment screw thread 8.PVC plate 9. nitrocellulose filter, 10. gold pads 12..
[embodiment]
Hereinafter, it is described further in conjunction with the embodiments with accompanying drawing for the utility model, it will be appreciated that embodiment and accompanying drawing
It is only used for illustrating rather than limiting the scope of protection of the utility model.
Test paper prepares embodiment：
Minimum detection limit determines
Stomach Helicobacter pylori lowest detection is limited to 200cfu/ml；Hemoglobin lowest detection is limited to 200ng/ml；Turn iron
Albumen lowest detection is limited to 40ng/ml.Stomach Helicobacter pylori, hemoglobin are prepared according to above-mentioned minimum detection limit and turn iron
The technique of Protein Detection test paper is as follows：
1 main material
Anti-human stomach Helicobacter pylori monoclonal antibody A1, A2 of 1.1 mouse, BBI Products；Mouse antihuman hemoglobin Dan Ke
Grand antibody B1, B2, mouse anti-human transferrin's monoclonal antibody C1, C2, Medix Products；By transfected expression and purification
Obtain, be respectively used to mark and detect；Sheep anti-mouse igg antibody：Arista Products, for nitrocellulose filter nature controlling line or
Person's Quality Control spot is coated with；Nitrocellulose filter (NC films)：MILLIPORE Products；Sample pad, pad, blotting paper, PVC
Bottom plate and duplex get stuck：Shanghai Jie Ning Bioisystech Co., Ltd
2 methods
The mark of 2.1 stomach Helicobacter pylori antibody A 1s, hemoglobin antibodies B1 and transferrin antibodies C1
With collaurum, latex particle, fluorescent microsphere, quantum dot, chemiluminescence or enzyme marker and can by naked eyes or
The molecule or particulate matter that person's instrument is detected mark the anti-human stomach Helicobacter pylori monoclonal antibody A1 of mouse, mouse anti-human respectively
Hemoglobin antibodies B1, mouse anti-human transferrin's monoclonal antibody C1；With PEG, BSA of various concentrations and other have sealing effect
Albumen or high molecular polymer label is closed respectively；Mark is centrifuged after terminating with 9000rpm, abandons supernatant, is sunk
Form sediment and be diluted to the 1/20 of original solution volume with borate buffer solution (0.01M BB+3%BSA+4% sucrose)；Then drawn with metal spraying
The label solution handled well is sprayed on non-woven fabrics or glass fibers by 2ul/cm by film instrument XYZ3050 (BIODOT companies) respectively
Stomach Helicobacter pylori gold reacting pad, hemoglobin gold reacting pad, transferrins gold reacting pad is made on dimension or polyester film, often
(25 DEG C) of temperature is dried in vacuo 12 hours by label immobilization.
2.2 stomach Helicobacter pylori antibody As 2, hemoglobin antibodies B2, transferrin antibodies C2 coating
With phosphate buffer (0.01M PBS+1% sucrose) by the anti-human stomach Helicobacter pylori monoclonal antibody A2 of mouse,
Mouse antihuman hemoglobin antibody B2, mouse anti-human transferrin's antibody C2 and sheep anti-mouse igg antibody are diluted to 1mg/ml respectively, then
With metal spraying draw film instrument XYZ3050 (BIODOT companies) the anti-human stomach Helicobacter pylori monoclonal antibody A2 (detection line T1) of mouse and
Sheep anti-mouse igg antibody (nature controlling line C), which is sprayed on NC films, is made stomach Helicobacter pylori film；Mouse antihuman hemoglobin antibody B2
(detection line T2) and sheep anti-mouse igg antibody (nature controlling line C) are sprayed on NC films composition hemoglobin film；Mouse anti-human transferrin's antibody
C2 (detection line T3) and sheep anti-mouse igg antibody (nature controlling line C) are sprayed on NC films composition transferrins film；By stomach pylorus after being coated with
Screw rod mycoderm, hemoglobin film and transferrins film are dried in vacuo 12 hours by label immobilization for (25 DEG C) in normal temperature.
Hereinafter, the assembling of test strips is carried out, the structure of test strips may refer to Fig. 4, and the structure of this test strips is for this
The technical staff in field is clear.
2.3 stomach Helicobacter pylori test strips assemble
Coated stomach Helicobacter pylori film (9) is placed on PVC bottom plates in the operating room of relative humidity≤30%
(8) middle part is pasted；In stomach Helicobacter pylori film T1 lines side overlap joint stomach Helicobacter pylori gold reacting pad (10), (overlap joint stomach is imprisoned
Door screw rod mycoderm 1.5mm)；Sample pad (11) (overlap joint stomach is pasted in stomach Helicobacter pylori gold reacting pad opposite side overlap joint
Helicobacter pylori gold reacting pad 1/3), and paste lower adhesive sticker；Blotting paper is overlapped in stomach Helicobacter pylori film C lines side
(12) (overlap joint stomach Helicobacter pylori film 1.5mm), and paste upper adhesive sticker；Then the big plate pasted is cut with strip cutting machine
Into the test strips (3-5mm) in certain broadband, stomach Helicobacter pylori test strips are made.
2.4 hemoglobin test strips assemble
Coated hemoglobin film is placed in the middle part of PVC bottom plates in the operating room of relative humidity≤30% and pasted；
Overlap joint hemoglobin gold reacting pad (the overlap joint hemoglobin film 1.5mm) in hemoglobin film T2 lines side；It is anti-in hemoglobin gold
Opposite side overlap joint should be padded and paste upper sample pad (overlap joint hemoglobin gold reacting pad 1/3), and paste lower adhesive sticker；In hemoglobin
Film C lines side overlap joint blotting paper (overlap joint hemoglobin film 1.5mm), and paste upper adhesive sticker；Then will be pasted with strip cutting machine
Big plate be cut into the test strips (3-5mm) in certain broadband, hemoglobin test strips are made.
2.5 transferrins test strips assemble
Coated transferrins film is placed in the middle part of PVC bottom plates in the operating room of relative humidity≤30% and pasted；
Overlap joint transferrins gold reacting pad (the overlap joint transferrins film 1.5mm) in transferrins film T2 lines side；It is anti-in transferrins gold
Opposite side overlap joint should be padded and paste upper sample pad (overlap joint transferrins gold reacting pad 1/3), and paste lower adhesive sticker；In transferrins
Film C lines side overlap joint blotting paper (overlap joint transferrins film 1.5mm), and paste upper adhesive sticker；Then will be pasted with strip cutting machine
Big plate be cut into the test strips (3-5mm) in certain broadband, transferrins test strips are made.
3. sampling and detection integrated apparatus embodiment：
The integrated apparatus schematic diagram is shown in Fig. 1, and schematic cross-section is shown in Fig. 2.Including dilution cavity and test chamber：
A. dilution chamber, upper opening, 0.5ml~5ml dilution is filled with cavity, sampling lid is provided with opening,
Dilution chamber bottom is provided with connection outlet, and envelope has barrier film at connection outlet, and probe tube, probe tube are provided with described sampling lid
End has the point of application of protrusion, sampling lid and the threaded connection by the two-part in opening of dilution chamber, two sections of screw threads it
Between pass through groove transition.Sampling lid is connected by connecting portion with dilution chamber, when sampling lid is connected to first paragraph screw position, sampling
Pipe is contained in dilution chamber completely, and when sampling lid is connected to second segment screw position, sampling tube end wears out described barrier film
(such as aluminium film),
B. test chamber, it is made for plastic transparent material (such as PS, PP, PC), top has holds with what connection outlet coordinated
Mouth is tapped into, the dovetail groove of 1-5 equidistant vertical fixed test strips is provided with the side inner walls of test chamber, test chamber passes through swallow
Stern notch is fixed with helicobacter pylori immuno-chromatographic test paper strip, hemoglobin immune chromatograph test strip and transferrins and layer is immunized
Test strips are analysed, the sampling end of each test strips is close to bottom of chamber.
During detection：
A. it is sampled by sampling the probe tube covered,
B. sampling lid is covered back in dilution chamber to the first paragraph depth of connecting portion, by sample acquired by diluted,
C. second segment depth of the lid lid to connecting portion will be sampled, by sample acquired by diluted, samples tube end
Described barrier film is worn out, the sample after dilution flow to test chamber bottom by connection outlet and undertaking import, each test strips
Sampling end absorption sample is detected, interpretation in 5-10min.
4 results
The test paper in tube wall interpretation detection zone inwall dovetail groove A, B, C can be passed through：
When the stomach Helicobacter pylori in sample, hemoglobin and transferrins protein concentration exceed minimum detection limit
When, detection line T1, T2, T3 develop the color (Fig. 3), then for stomach Helicobacter pylori, and with hemorrhage of digestive tract.
When the stomach Helicobacter pylori concentration in sample exceed minimum detection limit and hemoglobin and transferrin concentrations do not have
Prescribed a time limit more than lowest detection, detection line T1 colour developing and T2, T3 do not develop the color (Fig. 3), then for stomach Helicobacter pylori, but not
There is hemorrhage of digestive tract.
When the hemoglobin in sample and transferrin concentrations exceed minimum detection limit and stomach Helicobacter pylori concentration does not have
Prescribed a time limit more than lowest detection, detection line T1 does not develop the color and T2, T3 develop the color (Fig. 3), then only hemorrhage of digestive tract.
When the stomach Helicobacter pylori in sample, hemoglobin and transferrin concentrations are not above minimum detection limit
When, it is then negative and do not occur hemorrhage of digestive tract for stomach Helicobacter pylori that detection line T1, T2 and T3 do not develop the color (Fig. 3).
When quality control region (C) does not occur red stripes, show that incorrect operating process or kit go bad damage.It is in office
What in the case of, should retest.(Fig. 3).
Claims (7)
1. a kind of stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit, it is characterised in that including dilution cavity and inspection
Survey cavity,
A. dilution chamber, upper opening, cavity is interior to be filled with dilution, sampling lid is provided with opening, dilution chamber bottom is provided with
Connection outlet, envelope has barrier film at connection outlet, and probe tube is provided with described sampling lid, the company of two sections of depths is provided with opening
Socket part, sampling lid are connected by connecting portion with dilution chamber, and when sampling lid is connected to first paragraph connecting portion position, probe tube is complete
It is contained in dilution chamber, when sampling lid is connected to second segment connecting portion position, sampling tube end wears out described barrier film,
B. test chamber, top have the undertaking import coordinated with connection outlet, are provided with the side inner walls of test chamber vertical solid
Determine the fixed part of test strips, test chamber is fixed with helicobacter pylori immuno-chromatographic test paper strip by fixed part, hemoglobin is exempted from
Epidemic disease chromatograph test strip and transferrins immuno-chromatographic test paper strip, the sampling end of each test strips is close to bottom of chamber.
2. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that institute
The helicobacter pylori immunity test strip stated includes the anti-human stomach Helicobacter pylori monoclonal antibody of the mouse containing revealing label
Gold pad, and the detection line containing the anti-human stomach Helicobacter pylori monoclonal antibody of mouse and the nature controlling line containing sheep anti-mouse igg
Nitrocellulose filter.
3. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that institute
The hemoglobin immune chromatograph test strip stated includes the gold pad of the mouse antihuman hemoglobin antibody containing revealing label, and contains
The nitrocellulose filter of the detection line of mouse antihuman hemoglobin antibody and the nature controlling line containing sheep anti-mouse igg.
4. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that institute
The transferrins immuno-chromatographic test paper strip stated includes the gold pad of mouse anti-human transferrin's antibody containing revealing label, and contains
The nitrocellulose filter of the detection line of mouse anti-human transferrin's antibody and the nature controlling line containing sheep anti-mouse igg.
5. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that institute
The fixed part for the test strips stated is dovetail groove.
6. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that take
The threaded connection by the two-part in opening of sample lid and dilution chamber, pass through groove transition between two sections of screw threads.
7. stomach Helicobacter pylori as claimed in claim 1 and hemorrhage of digestive tract combined detection kit, it is characterised in that institute
The sampling tube end stated has the point of application of protrusion.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201720624221.5U CN207198168U (en) | 2017-06-01 | 2017-06-01 | Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201720624221.5U CN207198168U (en) | 2017-06-01 | 2017-06-01 | Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN207198168U true CN207198168U (en) | 2018-04-06 |
Family
ID=61793829
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201720624221.5U Withdrawn - After Issue CN207198168U (en) | 2017-06-01 | 2017-06-01 | Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107328927A (en) * | 2017-06-01 | 2017-11-07 | 力因精准医疗产品（上海）有限公司 | Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit and application method |
| CN117517680A (en) * | 2024-01-05 | 2024-02-06 | 济南玖方生物科技有限公司 | Method for improving detection accuracy of hemoglobin and transferrin duplex detection colloidal gold immunochromatography kit in feces |
-
2017
- 2017-06-01 CN CN201720624221.5U patent/CN207198168U/en not_active Withdrawn - After Issue
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107328927A (en) * | 2017-06-01 | 2017-11-07 | 力因精准医疗产品（上海）有限公司 | Stomach Helicobacter pylori and hemorrhage of digestive tract combined detection kit and application method |
| CN107328927B (en) * | 2017-06-01 | 2023-06-13 | 力因精准医疗产品（上海）有限公司 | Combined detection kit for helicobacter pylori and gastrointestinal hemorrhage and application method thereof |
| CN117517680A (en) * | 2024-01-05 | 2024-02-06 | 济南玖方生物科技有限公司 | Method for improving detection accuracy of hemoglobin and transferrin duplex detection colloidal gold immunochromatography kit in feces |
| CN117517680B (en) * | 2024-01-05 | 2024-04-05 | 济南玖方生物科技有限公司 | Method for improving detection accuracy of hemoglobin and transferrin duplex detection colloidal gold immunochromatography kit in feces |
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