WO2021012469A1 - 转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置 - Google Patents

转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置 Download PDF

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WO2021012469A1
WO2021012469A1 PCT/CN2019/116161 CN2019116161W WO2021012469A1 WO 2021012469 A1 WO2021012469 A1 WO 2021012469A1 CN 2019116161 W CN2019116161 W CN 2019116161W WO 2021012469 A1 WO2021012469 A1 WO 2021012469A1
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Prior art keywords
detection
test strip
sample
transferrin
hemoglobin
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PCT/CN2019/116161
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English (en)
French (fr)
Inventor
万志强
吴丽金
贾文刚
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万华普曼生物工程有限公司
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Publication of WO2021012469A1 publication Critical patent/WO2021012469A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56911—Bacteria
    • G01N33/56916—Enterobacteria, e.g. shigella, salmonella, klebsiella, serratia
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721—Haemoglobin
    • G01N33/726—Devices

Definitions

  • the present invention claims the priority of the invention patent application filed in China on July 25, 2019, titled “Transferrin, Hemoglobin, and Helicobacter Pylori Antigen Combined Detection Device", with the application number 201910676651.5, the entire content of the application Incorporated herein by reference.
  • the invention relates to the technical field of in vitro diagnostics, in particular to a combined detection device for transferrin, hemoglobin and Helicobacter pylori antigen.
  • the detection of fecal occult blood is of great value for the diagnosis of chronic gastrointestinal bleeding and the screening of colorectal malignancies.
  • the commonly used immunoassay methods for detecting fecal occult blood are hemoglobin and transferrin.
  • the combined immunoassay method can simultaneously detect hemoglobin and transferrin in feces, and the positive detection rate of gastrointestinal bleeding diseases has been significantly improved.
  • Helicobacter pylori is a gram-negative microaerobic bacteria that parasitizes the stomach and duodenum. Its infection is very common. The infection rate of the global natural population exceeds 50%. The transmission route is presumed to be oral infection.
  • Helicobacter pylori infection is an infectious disease that can cause chronic gastritis and peptic ulcers. Common symptoms include upper stomach discomfort and pain, flatulence, anorexia, nausea, vomiting, and dark or tar-colored stools, among which 70% Those infected above have no obvious symptoms.
  • Helicobacter pylori is the main pathogenic factor of gastritis and peptic ulcer, and is closely related to the occurrence of functional dyspepsia, gastric mucosal-associated lymphoid tissue lymphoma and gastric cancer. The International Agency for Research on Cancer of the World Health Organization has listed it as I Carcinogenic factors.
  • Helicobacter pylori Eradication of Helicobacter pylori can significantly reduce the incidence of gastric and duodenal diseases, and may reduce new cases of Helicobacter pylori infection in the future.
  • the current gold standard for Helicobacter pylori detection is bacterial isolation and culture technology, but it is not easy to be popularized due to its high experimental conditions and technical requirements.
  • the detection of Helicobacter pylori antigen in feces requires no expensive equipment, convenient operation and result interpretation, good sensitivity and specificity, and is becoming more and more popular.
  • stool detection devices have combined detection devices for transferrin and hemoglobin, but lack a combined detection device capable of simultaneously detecting transferrin, hemoglobin and Helicobacter pylori antigen.
  • the purpose of the present invention is to provide a combined detection device capable of simultaneously detecting transferrin, hemoglobin and Helicobacter pylori antigen.
  • the present invention provides the following technical solutions.
  • the present invention provides a combined detection device for transferrin, hemoglobin and Helicobacter pylori antigen.
  • the combined detection device includes a sample collection and containment part and a sample detection part,
  • the sample collection and containment portion is used to collect and contain the sample to be tested, and the bottom of the sample collection and containment portion is provided with a sealing element,
  • the sample detection part includes a detection container, a detection test strip assembly and a piercing mechanism
  • the detection test strip assembly is arranged in the detection container for simultaneous detection of the transferrin, the hemoglobin and the Helicobacter pylori antigen,
  • the piercing mechanism is arranged in the detection container,
  • the sample collection container can be inserted into the detection container along the axial direction of the detection container, and
  • the puncture mechanism can puncture the sealing element, so that the sample to be tested in the sample containment and collection portion enters the In the test container, the sample to be tested can contact the test strip assembly.
  • the sample collection container includes a collection rod and a sample container, the collection rod is inserted into the sample container, and the sealing element is disposed at the bottom of the sample container.
  • the sample detection part further includes a test strip mounting frame, the test strip mounting frame is inserted into the detection container, and the detection test strip assembly is disposed on the test strip Mount the rack.
  • the test strip mounting frame is provided with a mounting groove, the mounting groove extends along the axial direction, and the detection test strip assembly is disposed in the mounting groove.
  • the piercing mechanism is provided at the bottom of the detection container.
  • At least a wall of the detection container corresponding to the detection test strip assembly is a transparent wall.
  • the detection test strip component includes a transferrin and hemoglobin combined detection test strip and a Helicobacter pylori antigen detection test strip, and the transferrin and hemoglobin combined detection test strip is used for detection
  • the transferrin, the hemoglobin, and the Helicobacter pylori antigen test strip are used to detect the Helicobacter pylori antigen.
  • the transferrin and hemoglobin combined detection test strip includes a first bottom plate, a first absorbent plate, a first nitrocellulose membrane, a first sample absorbent layer, and a transferrin-containing monoclonal antibody And the first color particle storage pad of hemoglobin monoclonal antibody,
  • the first nitrocellulose membrane is loaded with separate transferrin monoclonal antibody detection lines, hemoglobin monoclonal antibody detection lines and goat anti-mouse polyclonal antibody control lines separated from each other.
  • the test strip assembly includes a transferrin test strip, a hemoglobin test strip, and a Helicobacter pylori antigen test strip,
  • the transferrin detection test strip is used to detect the transferrin
  • the hemoglobin detection test strip is used to detect the hemoglobin
  • the Helicobacter pylori antigen detection test strip is used to detect the Helicobacter pylori antigen.
  • the Helicobacter pylori antigen detection test strip includes a second bottom plate, a second absorbent plate, a second nitrocellulose membrane, a second sample absorption layer, and a monoclonal antibody containing Helicobacter pylori antigen and a biological
  • the second color particle storage pad of the gluten-bovine serum albumin conjugate
  • the second nitrocellulose membrane is loaded with separate Helicobacter pylori antigen monoclonal antibody detection lines, goat anti-mouse polyclonal antibodies, and streptavidin control lines.
  • the present invention provides a combined detection device for transferrin, hemoglobin, and Helicobacter pylori antigen.
  • a test strip assembly that can simultaneously detect transferrin, hemoglobin and Helicobacter pylori antigen, It can simultaneously detect transferrin, hemoglobin and Helicobacter pylori antigen.
  • Fig. 1 shows a schematic structural diagram of a first embodiment of a combined detection device for transferrin, hemoglobin and Helicobacter pylori antigen according to the present invention.
  • Fig. 2 shows an exploded view of the sample collection container in Fig. 1.
  • FIG. 3 shows a cross-sectional view of the sample collection container in FIG. 1.
  • Fig. 4 shows an exploded view of the sample detection part in Fig. 1.
  • FIG. 5 shows a cross-sectional view of the detection container in FIG. 4.
  • FIG. 6 shows a schematic diagram of the structure of the test strip for combined detection of transferrin and hemoglobin in FIG. 4.
  • Fig. 7 shows a cross-sectional view of Fig. 6.
  • FIG. 8 shows a schematic diagram of the structure of the Helicobacter pylori antigen detection test strip in FIG. 4.
  • Fig. 9 shows a cross-sectional view of Fig. 8.
  • FIG. 10 shows a schematic diagram of the structure of the test strip assembly and the test strip mounting frame in the second embodiment of the combined detection device for transferrin, hemoglobin and Helicobacter pylori antigen according to the present invention.
  • Helicobacter pylori antigen test strip 2321 Second bottom plate; 2322 Second water-absorbing plate; 2323 Second nitrocellulose membrane; 23231 Helicobacter pylori antigen monoclonal antibody test line; 23232 Goat anti-mouse polyclonal antibody, streptavidin Hesu control line; 2324 second sample liquid absorption layer; 2325 second color particle storage pad;
  • test strip components 251 transferrin test strips; 252 hemoglobin test strips; 253 helicobacter pylori antigen test strips.
  • the first embodiment of the combined detection device for transferrin, hemoglobin, and Helicobacter pylori antigen according to the present invention will be described in detail below with reference to FIGS. 1-9.
  • the combined detection device of transferrin, hemoglobin, and Helicobacter pylori antigen includes a sample collection accommodating part 1 and a sample detection part 2.
  • the sample collection and containment part 1 can be inserted in the sample detection part 2 along the axial direction (length direction) of the sample detection part 2 for collecting and accommodating the sample (for example, stool) to be tested.
  • the sample collection container 1 includes a collection rod 11, a sample container 12, a sealing ring 13 and a sealing element 14. Among them, the collection rod 11 is used to collect samples to be tested.
  • the collection rod 11 is inserted into the sample container 12.
  • the sample container 12 has a chamber 121 for containing the diluted solution, and a sealing ring is arranged between the collection rod 11 and the sample container 12 13.
  • the sealing ring 13 can seal the cavity 121 of the sample container 12 to prevent the diluted solution in the cavity 121 from entering the cavity above the cavity 121 during transportation, thereby ensuring that the amount of the diluted solution is sufficient.
  • the sealing element 14 is provided at the bottom of the sample container 12 for sealing the cavity 121.
  • the sealing element 14 may be a sealing aluminum foil, and the sealing aluminum foil may be hot-sealed to the bottom of the sample container 12.
  • the sample detection unit 2 includes a detection container 21, a test strip mounting frame 22, a detection test strip assembly 23 and a piercing mechanism 24.
  • the detection container 21 has a cylindrical shape, and the cross section of the detection container 21 has a substantially rectangular shape.
  • the test strip mounting frame 22 is provided with two mounting grooves 221, and the two mounting grooves 221 extend in parallel along the axial direction (length direction) of the detection container 21.
  • the test strip mounting frame 22 is inserted into the detection container 21.
  • the detection test strip assembly 23 includes a transferrin and hemoglobin combined detection test strip 231 and a Helicobacter pylori antigen detection test strip 232.
  • the transferrin and hemoglobin combined detection test strip 231 and the Helicobacter pylori antigen detection test strip 232 are respectively set in the corresponding installation grooves 221.
  • the wall portion of the detection container 21 corresponding to the detection test strip assembly 23 is a transparent wall portion.
  • the present invention is not limited to this, and the entire side wall of the detection container 21 may be transparent.
  • one end of the test strip assembly 23 extends to the bottom of the test container 21. In this way, the test strip assembly 23 can easily contact the sample solution, thereby reducing the requirement on the amount of the sample solution.
  • the piercing mechanism 24 is provided at the bottom of the detection container 21.
  • the piercing mechanism 24 has a sharp portion 241 (blade portion) and a through hole 242.
  • the sharp portion 241 is used to pierce the sealing element 14
  • the through hole 242 is used to accommodate the lower portion of the collection rod 11, and the outer periphery of the piercing mechanism 24 and the inner wall surface of the detection container 21 are provided with a sample container 12 Side wall space. In this way, the axial size of the sample collection accommodating portion can be reduced, thereby reducing the axial size of the entire combined detection device.
  • the transferrin and hemoglobin combined detection test strip 231 includes a first bottom plate 2311, a first water absorption plate 2312, a first nitrocellulose membrane 2313, a first sample A liquid absorption layer 2314 and a first color particle storage pad 2315 containing transferrin monoclonal antibody and hemoglobin monoclonal antibody.
  • the first water-absorbing plate 2312 and the first sample liquid-absorbing layer 2314 are respectively disposed on both ends of the first bottom plate 2311, and the two ends of the first nitrocellulose membrane 2313 are respectively connected with the first water-absorbing plate 2312 and the first color particle storage
  • the pad 2315 is connected, one end of the first sample absorbing layer 2314 is connected to the first color particle storage pad 2315, and the first nitrocellulose membrane 2313 carries separate transferrin monoclonal antibody detection lines 23131 and hemoglobin monoclonal antibody detection lines 23132 and goat anti-mouse polyclonal antibody control line 23133.
  • the Helicobacter pylori antigen detection test strip 232 includes a second bottom plate 2321, a second water absorption plate 2322, a second nitrocellulose membrane 2323, and a second sample absorbent layer 2324 and the second color particle storage pad 2325 containing the helicobacter pylori antigen monoclonal antibody and biotin-BSA (Bovine Serum Album, bovine serum albumin) conjugate.
  • BSA Bovine Serum Album, bovine serum albumin
  • the second water absorbing plate 2322 and the second sample liquid absorbing layer 2324 are respectively disposed on both ends of the second bottom plate 2321, and the two ends of the second nitrocellulose membrane 2323 are respectively connected with the second water absorbing plate 2322 and the second color particle storage pad Connected to 2325, one end of the second sample absorbent layer 2324 is connected to the second color particle storage pad 2325, and the second nitrocellulose membrane 2323 carries the separate Helicobacter pylori antigen monoclonal antibody detection line 23231 and goat anti-mouse polyclonal antibody , Streptavidin control line 23232.
  • the color particles may be colloidal gold particles. Accordingly, the first color particle storage pad 2315 and the second color particle storage pad 2325 may be gold label pads.
  • the sample to be tested for example, stool
  • the sample to be tested can be collected by the collection stick 11 in the sample collection holding portion 1, and then the collection stick 11 is inserted into the sample container 12, and the sample container is shaken. 12 Make the sample to be tested evenly diluted.
  • sample collection and containment portion 1 After shaking, insert the sample collection and containment portion 1 into the sample detection portion 2 along the axial direction of the sample detection portion 2 until the piercing mechanism 24 punctures the sealing element 14 at the bottom of the sample collection and containment portion 1, and the sample collection containment portion 1
  • the sample solution flows into the detection container 21 (at this time, the lower part of the sampling rod 11 is located in the through hole 242, and the lower side wall of the sample container 12 is located between the outer periphery of the piercing mechanism 24 and the inner wall surface of the detection container 21).
  • sample solution containing the sample to be tested will be in contact with the test strip assembly 23, so that the respective detection lines and/or control lines of the test strip assembly 23 are colored (for example, red).
  • the inspector can observe the inspection result through the transparent wall of the inspection container 21.
  • transferrin and hemoglobin combined detection test strip 2331 if only the goat anti-mouse polyclonal antibody control line 23133 develops color, it means that the content of transferrin and hemoglobin in the sample to be tested does not exceed the predetermined content.
  • the test results of transferrin and hemoglobin were negative.
  • transferrin monoclonal antibody detection line 23131 and the goat anti-mouse polyclonal antibody control line 23133 are colored, it means that the transferrin content in the sample to be tested exceeds the predetermined value, the transferrin test result is positive, and the hemoglobin is The test result was negative.
  • both the hemoglobin monoclonal antibody test line 23132 and the goat anti-mouse polyclonal antibody control line 23133 are colored, it means that the hemoglobin content in the sample to be tested exceeds the predetermined value, the hemoglobin test result is positive, and the transferrin test result is negative .
  • transferrin monoclonal antibody test line 23131, hemoglobin monoclonal antibody test line 23132, and goat anti-mouse polyclonal antibody control line 23133 all show color, it means that the contents of transferrin and hemoglobin in the sample to be tested exceed the predetermined value. The test results of transferrin and hemoglobin were both positive.
  • transferrin monoclonal antibody test line 23131, hemoglobin monoclonal antibody test line 23132, and goat anti-mouse polyclonal antibody control line 23133 show color, it means that the test failed (may be the combined test device is damaged or the test operation is incorrect. Wait).
  • Helicobacter pylori antigen detection test strip 232 if only goat anti-mouse polyclonal antibody and streptavidin control line 23232 develop color, it means that the content of Helicobacter pylori antigen in the sample to be tested does not exceed the predetermined value , The test results of Helicobacter pylori antigen were all negative.
  • both the Helicobacter pylori antigen monoclonal antibody detection line 23231 and the goat anti-mouse polyclonal antibody and streptavidin control line 23232 are both colored, it indicates that the content of Helicobacter pylori antigen in the sample to be tested exceeds the predetermined value, and the Helicobacter pylori The bacterial antigen test result is positive.
  • the structure of the sample collection accommodating part and the sample detection part in this embodiment is basically the same as in the first embodiment.
  • the main difference lies in that, as shown in FIG. 10, the number of installation slots 221 on the test strip installation frame 22 in this embodiment is three.
  • the test strip assembly 25 includes a transferrin test strip 251, a hemoglobin test strip 252, and a Helicobacter pylori antigen test strip 253.
  • the transferrin detection test strip 251, the hemoglobin detection test strip 252, and the Helicobacter pylori antigen detection test strip 253 are respectively set in the respective installation grooves 221.
  • the transferrin detection test strip 251 and the hemoglobin detection test strip 252 are similar in structure to the transferrin and hemoglobin combined detection test strip 231 in the first embodiment. That is, the transferrin test strip 251 includes a third bottom plate, a third absorbent plate, a third nitrocellulose membrane, a third sample absorbent layer, and a third color particle storage pad, and the hemoglobin test strip 252 includes a fourth The bottom plate, the fourth water absorbing plate, the fourth nitrocellulose membrane, the fourth sample liquid absorbing layer and the fourth color particle storage pad, and the connection structure between each part is the same as in the first embodiment.
  • the third-color particle storage pad in the transferrin detection test strip 251 in this embodiment only contains transferrin monoclonal antibody, and does not contain hemoglobin monoclonal antibody.
  • the third nitrocellulose membrane in the transferrin detection test strip 251 is only provided with a separate transferrin monoclonal antibody detection line and a goat anti-mouse polyclonal antibody control line, and no hemoglobin monoclonal antibody detection line is provided.
  • the fourth color particle storage pad in the hemoglobin detection test strip 252 in this embodiment only contains hemoglobin monoclonal antibody, and does not contain transferrin monoclonal antibody.
  • the fourth nitrocellulose membrane in the hemoglobin detection test strip 252 is only provided with a separate hemoglobin monoclonal antibody detection line and a goat anti-mouse polyclonal antibody control line, and no transferrin monoclonal antibody detection line is provided.
  • the structure of the Helicobacter pylori antigen detection test strip 253 is the same as the structure of the Helicobacter pylori antigen detection test strip 232 in the first embodiment, and will not be repeated here.
  • the color particles may all be colloidal gold particles. Accordingly, the third color particle storage pad and the fourth color particle storage pad may both be gold label pads.
  • the working principle of the combined detection device for transferrin, hemoglobin and Helicobacter pylori antigen according to the present invention is basically the same as that of the first embodiment. That is, when only the control line develops color, the test result is negative, when the test line and the control line develop colors at the same time, the test result is positive, and when the test line and the control line do not develop color, the test fails.
  • the combined detection device of transferrin, hemoglobin and Helicobacter pylori antigen according to the present invention has at least the following advantages:
  • test strip assembly can be conveniently installed by setting the test strip mounting rack.
  • the detection container is divided into two parts in the thickness direction of the detection container, one part is used to hold the sample container, and the other part is used to hold the sample container.
  • the test strip mounting frame equipped with the test strip assembly makes the entire combined detection device compact in structure and small in size, and can effectively avoid damage to the test strip assembly when the sample collection container is inserted into the test container.
  • the detection result can be easily observed by making the wall of the detection container corresponding to the detection test strip assembly a transparent wall.
  • the sealing element is a sealing aluminum foil
  • the present invention is not limited to this.
  • the sealing element may also be a sealing plug, a sealing film or other forms of sealing sheet (for example, a thin plastic sheet).
  • test strip mounting rack is set to install the test strip assembly
  • the present invention is not limited to this, and the test strip mounting rack may not be provided, and the test strip assembly can also be directly installed. Installed on the inner wall of the detection container (for example, an installation groove can be provided on the inner wall of the detection container).
  • the cross section of the detection container is substantially rectangular, the present invention is not limited to this, and the cross section of the detection container may also be circular or other shapes.
  • the piercing mechanism is described as being provided at the bottom of the detection container in the above embodiment, the present invention is not limited to this, and the piercing mechanism may be provided at, for example, the middle part of the detection container.
  • color particles are described as colloidal gold particles in the above embodiments, the present invention is not limited to this.
  • the color particles may also be colloidal silver particles, colloidal iron particles, magnetic particles, dye particles, latex particles or fluorescent particles.

Abstract

一种转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置。该联合检测装置包括样本采集容纳部(1)和样本检测部(2)，样本采集容纳部(1)的底部设置密封元件(14)，样本检测部(2)包括检测容器(21)、检测试纸条组件(23)和刺破机构(24)，检测试纸条组件(23)设置于检测容器(21)内，刺破机构(24)设置于检测容器(21)中，样本采集容纳部(1)能够沿检测容器(21)的轴向插设于检测容器(21)中，并且当样本采集容纳部(1)沿轴向朝向刺破机构(24)移动时，刺破机构(24)能够刺破密封元件(14)，使得样本采集容纳部(1)中的待检测样本进入检测容器(21)中，进而使得待检测样本能够接触检测试纸条组件(23)。该转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置能够同时对转铁蛋白、血红蛋白和幽门螺杆菌抗原进行检测。

Description

转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置
相关申请的引用
本发明要求2019年7月25日在中国提交的，名称为“转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置”、申请号为201910676651.5的发明专利申请的优先权，该申请的全部内容通过引用并入本文。
技术领域
本发明涉及体外诊断技术领域，尤其涉及一种转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置。
背景技术
便潜血的检测对于慢性消化道出血的诊断以及大肠恶性肿瘤的筛选有很重要的价值。目前常用免疫法检测便潜血的指标为血红蛋白和转铁蛋白，应用联合免疫检测法能够同时检测粪便中的血红蛋白和转铁蛋白，对消化道出血性疾病的阳性检出率有显著提高。
幽门螺杆菌是一种寄生在胃部和十二指肠的革兰氏阴性微量需氧细菌，其感染非常普遍，全球自然人群感染率超过50％，传播途径推测为经口感染。
幽门螺杆菌感染为一种传染性疾病，可导致慢性胃炎、消化性溃疡等，常见症状包括胃上部不适感以及疼痛、胀气、厌食、恶心、呕吐以及深色或焦油色粪便等，其中70％以上感染者无明显症状。幽门螺杆菌是胃炎、消化性溃疡的主要致病因素，并与功能性消化不良、胃黏膜相关性淋巴组织淋巴瘤和胃癌的发生密切相关，世界卫生组织国际癌症研究机构已将其列为Ⅰ类致癌因子。
根除幽门螺杆菌可显著减少胃和十二指肠疾病的发病率，并可在未来减 少幽门螺杆菌感染的新发病例。目前幽门螺杆菌检测的金标准为细菌分离培养技术，但因其实验条件和技术要求高，不易被推广。而粪便中幽门螺杆菌抗原检测无需昂贵设备、操作和结果判读方便、灵敏度和特异性好，越来越普及。
目前粪便类检测装置有转铁蛋白、血红蛋白的联合检测装置，但缺少一种能够同时检测转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置。
发明内容
基于现有技术中的上述缺陷，本发明的目的在于提供一种能够同时检测转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置。
为此，本发明提供如下技术方案。
本发明提供了一种转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置，所述联合检测装置包括样本采集容纳部和样本检测部，
所述样本采集容纳部用于采集和容纳待检测样本，所述样本采集容纳部的底部设置密封元件，
所述样本检测部包括检测容器、检测试纸条组件和刺破机构，
所述检测试纸条组件设置于所述检测容器内，用于同时检测所述转铁蛋白、所述血红蛋白和所述幽门螺杆菌抗原，
所述刺破机构设置于所述检测容器中，
所述样本采集容纳部能够沿所述检测容器的轴向插设于所述检测容器中，并且
当所述样本采集容纳部沿所述轴向朝向所述刺破机构移动时，所述刺破机构能够刺破所述密封元件，使得所述样本容纳采集部中的所述待检测样本进入所述检测容器中，进而使得所述待检测样本能够接触所述检测试纸条组件。
在至少一个实施方式中，所述样本采集容纳部包括采集棒和样本容器，所述采集棒插设于所述样本容器中，所述密封元件设置于所述样本容器的底部。
在至少一个实施方式中，所述样本检测部还包括试纸条安装架，所述试纸条安装架插设于所述检测容器中，所述检测试纸条组件设置于所述试纸条安装架上。
在至少一个实施方式中，所述试纸条安装架上开设有安装槽，所述安装槽沿所述轴向延伸，所述检测试纸条组件设置于所述安装槽中。
在至少一个实施方式中，所述刺破机构设置于所述检测容器的底部。
在至少一个实施方式中，所述检测容器的至少对应所述检测试纸条组件的壁部为透明的壁部。
在至少一个实施方式中，所述检测试纸条组件包括转铁蛋白和血红蛋白联合检测试纸条和幽门螺杆菌抗原检测试纸条，所述转铁蛋白和血红蛋白联合检测试纸条用于检测所述转铁蛋白和所述血红蛋白，所述幽门螺杆菌抗原检测试纸条用于检测所述幽门螺杆菌抗原。
在至少一个实施方式中，所述转铁蛋白和血红蛋白联合检测试纸条包括第一底板、第一吸水板、第一硝酸纤维素膜、第一样品吸液层及含有转铁蛋白单抗和血红蛋白单抗的第一颜色颗粒储藏垫，
所述第一硝酸纤维素膜上载有相互分离的转铁蛋白单抗检测线、血红蛋白单抗检测线和羊抗鼠多克隆抗体控制线。
在至少一个实施方式中，所述检测试纸条组件包括转铁蛋白检测试纸条、血红蛋白检测试纸条和幽门螺杆菌抗原检测试纸条，
所述转铁蛋白检测试纸条用于检测所述转铁蛋白，
所述血红蛋白检测试纸条用于检测所述血红蛋白，
所述幽门螺杆菌抗原检测试纸条用于检测所述幽门螺杆菌抗原。
在至少一个实施方式中，所述幽门螺杆菌抗原检测试纸条包括第二底板、第二吸水板、第二硝酸纤维素膜、第二样品吸液层及含有幽门螺杆菌抗原单抗和生物素-牛血清白蛋白结合物的第二颜色颗粒储藏垫，
所述第二硝酸纤维素膜上载有相互分离的幽门螺杆菌抗原单抗检测线和羊抗鼠多克隆抗体、链霉亲和素控制线。
通过采用上述的技术方案，本发明提供了一种转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置，通过设置能够同时检测转铁蛋白、血红蛋白和幽门螺杆菌抗原的检测试纸条组件，能够对转铁蛋白、血红蛋白和幽门螺杆菌抗原同时进行检测。
附图说明
图1示出了根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的第一实施方式的结构示意图。
图2示出了图1中的样本采集容纳部的爆炸图。
图3示出了图1中的样本采集容纳部的剖视图。
图4示出了图1中的样本检测部的爆炸图。
图5示出了图4中的检测容器的剖视图。
图6示出了图4中的转铁蛋白和血红蛋白联合检测试纸条的结构示意图。
图7示出了图6的剖视图。
图8示出了图4中的幽门螺杆菌抗原检测试纸条的结构示意图。
图9示出了图8的剖视图。
图10示出了根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的第二实施方式中的检测试纸条组件和试纸条安装架的结构示意图。
附图标记说明
1 样本采集容纳部；11 采集棒；12 样本容器；121 腔室；13 密封圈；14 密封元件；
2 样本检测部；21 检测容器；22 试纸条安装架；221 安装槽；23 检测试纸条组件；
231 转铁蛋白和血红蛋白联合检测试纸条；2311 第一底板；2312 第一吸水板；2313 第一硝酸纤维素膜；23131 转铁蛋白单抗检测线；23132 血红蛋白单抗检测线；23133 羊抗鼠多克隆抗体控制线；2314 第一样品吸液层；2315 第一颜色颗粒储藏垫；
232 幽门螺杆菌抗原检测试纸条；2321 第二底板；2322 第二吸水板；2323 第二硝酸纤维素膜；23231 幽门螺杆菌抗原单抗检测线；23232 羊抗鼠多克隆抗体、链霉亲和素控制线；2324 第二样品吸液层；2325 第二颜色颗粒储藏垫；
24 刺破机构；241 尖锐部；242 通孔；
25 检测试纸条组件；251 转铁蛋白检测试纸条；252 血红蛋白检测试纸条；253 幽门螺杆菌抗原检测试纸条。
具体实施方式
下面参照附图描述本发明的示例性实施方式。应当理解，这些具体的说明仅用于示教本领域技术人员如何实施本发明，而不用于穷举本发明的所有可行的方式，也不用于限制本发明的保护范围。
(第一实施方式)
下面根据图1至图9详细说明根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的第一实施方式。
在本实施方式中，如图1所示，根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置包括样本采集容纳部1和样本检测部2。其中， 样本采集容纳部1能够沿样本检测部2的轴向(长度方向)插设于样本检测部2中，用于采集和容纳待检测样本(例如，粪便)。
在本实施方式中，如图1和图2所示，样本采集容纳部1包括采集棒11、样本容器12、密封圈13和密封元件14。其中，采集棒11用于采集待检测样本。
在本实施方式中，如图3所示，采集棒11插设于样本容器12中，样本容器12具有用于盛放稀释溶液的腔室121，采集棒11与样本容器12之间设置密封圈13。这样，密封圈13能够密封样本容器12的腔室121，避免腔室121中的稀释溶液在运输时进入腔室121上方的腔室中，进而保证稀释溶液的量足够。
在本实施方式中，密封元件14设置于样本容器12的底部，用于密封腔室121。其中，密封元件14可以为密封铝箔，密封铝箔可以烫封到样本容器12的底部。
在本实施方式中，如图1、图4和图5所示，样本检测部2包括检测容器21、试纸条安装架22、检测试纸条组件23和刺破机构24。
在本实施方式中，如图4所示，检测容器21呈筒状，检测容器21的横截面大致呈矩形形状。
在本实施方式中，如图4所示，试纸条安装架22上开设有两个安装槽221，两个安装槽221沿检测容器21的轴向(长度方向)平行并列地延伸。试纸条安装架22插设于检测容器21中。
在本实施方式中，如图4所示，检测试纸条组件23包括转铁蛋白和血红蛋白联合检测试纸条231和幽门螺杆菌抗原检测试纸条232。其中，转铁蛋白和血红蛋白联合检测试纸条231和幽门螺杆菌抗原检测试纸条232分别设置于各自相应的安装槽221中。
在本实施方式中，检测容器21的与检测试纸条组件23相对应的壁部为透明的壁部。当然，本发明不限于此，检测容器21的整个侧壁部均可以是透明的。
在本实施方式中，检测试纸条组件23的一端(具有吸液层的一端)延伸到检测容器21的底部。这样，检测试纸条组件23可以容易地接触到样本溶液，从而减少对样本溶液的量的要求。
在本实施方式中，如图5所示，刺破机构24设置于检测容器21的底部。
刺破机构24具有尖锐部241(刃部)和通孔242。其中，尖锐部241用于刺破密封元件14，通孔242用于容置采集棒11的下部，刺破机构24的外周与检测容器21的内壁面之间具有用于容置样本容器12的侧壁的空间。这样，能够减少样本采集容纳部的轴向尺寸，进而减小整个联合检测装置的轴向尺寸。
在本实施方式中，如图6和图7所示，转铁蛋白和血红蛋白联合检测试纸条231包括第一底板2311、第一吸水板2312、第一硝酸纤维素膜2313、第一样品吸液层2314及含有转铁蛋白单抗和血红蛋白单抗的第一颜色颗粒储藏垫2315。
其中，第一吸水板2312和第一样品吸液层2314分别设置于第一底板2311的两端，第一硝酸纤维素膜2313的两端分别与第一吸水板2312和第一颜色颗粒储藏垫2315连接，第一样品吸液层2314的一端与第一颜色颗粒储藏垫2315连接，第一硝酸纤维素膜2313上载有相互分离的转铁蛋白单抗检测线23131、血红蛋白单抗检测线23132和羊抗鼠多克隆抗体控制线23133。
在本实施方式中，如图8和图9所示，幽门螺杆菌抗原检测试纸条232包括第二底板2321、第二吸水板2322、第二硝酸纤维素膜2323、第二样品吸液层2324及含有幽门螺杆菌抗原单抗和生物素-BSA(Bovine Serum Albumin，牛血清白蛋白)结合物的第二颜色颗粒储藏垫2325。
其中，第二吸水板2322和第二样品吸液层2324分别设置于第二底板2321的两端，第二硝酸纤维素膜2323的两端分别与第二吸水板2322和第二颜色颗粒储藏垫2325连接，第二样品吸液层2324的一端与第二颜色颗粒储藏垫2325 连接，第二硝酸纤维素膜2323上载有相互分离的幽门螺杆菌抗原单抗检测线23231和羊抗鼠多克隆抗体、链霉亲和素控制线23232。
在本实施方式中，颜色颗粒可以为胶体金颗粒，相应地，第一颜色颗粒储藏垫2315和第二颜色颗粒储藏垫2325可以为金标垫。
下面说明根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的工作原理。
在本实施方式中，当需要检测待检测样本(例如，粪便)时，可以使用样本采集容纳部1中的采集棒11采集待检测样本，然后将采集棒11插入样本容器12中，摇晃样本容器12使得待检测样本被稀释均匀。
摇晃完毕后，将样本采集容纳部1沿样本检测部2的轴向插入样本检测部2中，直至刺破机构24将样本采集容纳部1底部的密封元件14刺破，样本采集容纳部1中的样本溶液流入到检测容器21中(此时，采集棒11的下部位于通孔242中，样本容器12的下部侧壁位于刺破机构24的外周和检测容器21的内壁面之间)。
进一步地，含有待检测样本的样本溶液将与检测试纸条组件23接触，使得检测试纸条组件23的各个检测线和/或控制线显色(例如，红色)。检验人员可以通过检测容器21的透明的壁部观察检测结果。
具体地，对于转铁蛋白和血红蛋白联合检测试纸条231来说，如果仅有羊抗鼠多克隆抗体控制线23133显色，说明待检测样本中的转铁蛋白和血红蛋白的含量均未超过预定值，转铁蛋白和血红蛋白的检测结果均为阴性。
如果转铁蛋白单抗检测线23131和羊抗鼠多克隆抗体控制线23133两者显色，说明待检测样本中的转铁蛋白的含量超过预定值，转铁蛋白的检测结果为阳性，血红蛋白的检测结果为阴性。
如果血红蛋白单抗检测线23132和羊抗鼠多克隆抗体控制线23133两者显色，说明待检测样本中的血红蛋白的含量超过预定值，血红蛋白的检测结 果为阳性，转铁蛋白的检测结果为阴性。
如果转铁蛋白单抗检测线23131、血红蛋白单抗检测线23132和羊抗鼠多克隆抗体控制线23133三者均显色，说明待检测样本中的转铁蛋白和血红蛋白的含量均超过预定值，转铁蛋白和血红蛋白的检测结果均为阳性。
如果转铁蛋白单抗检测线23131、血红蛋白单抗检测线23132和羊抗鼠多克隆抗体控制线23133三者均不显色，说明此次检测失败(可能是联合检测装置损坏或检测操作有误等)。
应当理解，转铁蛋白和血红蛋白中的任一者的检测结果为阳性，都说明消化道有出血。
对于幽门螺杆菌抗原检测试纸条232来说，如果仅有羊抗鼠多克隆抗体、链霉亲和素控制线23232显色，说明待检测样本中的幽门螺杆菌抗原的含量未超过预定值，幽门螺杆菌抗原的检测结果均为阴性。
如果幽门螺杆菌抗原单抗检测线23231和羊抗鼠多克隆抗体、链霉亲和素控制线23232两者均显色，说明待检测样本中的幽门螺杆菌抗原的含量超过预定值，幽门螺杆菌抗原的检测结果为阳性。
如果幽门螺杆菌抗原单抗检测线23231和羊抗鼠多克隆抗体、链霉亲和素控制线23232两者均不显色，说明此次检测失败(可能是联合检测装置损坏或检测操作有误等)。
(第二实施方式)
下面根据图10详细说明根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的第二实施方式。
本实施方式中的样本采集容纳部和样本检测部的结构与第一实施方式中基本相同。区别主要在于，如图10所示，本实施方式中的试纸条安装架22上的安装槽221的数量为三个。
相应地，在本实施方式中，如图10所示，检测试纸条组件25包括转铁蛋 白检测试纸条251、血红蛋白检测试纸条252和幽门螺杆菌抗原检测试纸条253。其中，转铁蛋白检测试纸条251、血红蛋白检测试纸条252和幽门螺杆菌抗原检测试纸条253分别设置于各自相应的安装槽221中。
在本实施方式中，转铁蛋白检测试纸条251和血红蛋白检测试纸条252和第一实施方式中的转铁蛋白和血红蛋白联合检测试纸条231的结构相似。即，转铁蛋白检测试纸条251包括第三底板、第三吸水板、第三硝酸纤维素膜、第三样品吸液层及第三颜色颗粒储藏垫，血红蛋白检测试纸条252包括第四底板、第四吸水板、第四硝酸纤维素膜、第四样品吸液层及第四颜色颗粒储藏垫，且各个部分之间的连接结构与第一实施方式中相同。
区别主要在于，本实施方式中的转铁蛋白检测试纸条251中的第三颜色颗粒储藏垫只含有转铁蛋白单抗，不含有血红蛋白单抗。转铁蛋白检测试纸条251中的第三硝酸纤维素膜上仅设置有相互分离的转铁蛋白单抗检测线和羊抗鼠多克隆抗体控制线，不设置血红蛋白单抗检测线。
本实施方式中的血红蛋白检测试纸条252中的第四颜色颗粒储藏垫只含有血红蛋白单抗，不含有转铁蛋白单抗。血红蛋白检测试纸条252中的第四硝酸纤维素膜上仅设置有相互分离的血红蛋白单抗检测线和羊抗鼠多克隆抗体控制线，不设置转铁蛋白单抗检测线。
在本实施方式中，幽门螺杆菌抗原检测试纸条253的结构与第一实施方式中的幽门螺杆菌抗原检测试纸条232的结构相同，此处不再赘述。
在本实施方式中，与第一实施方式相似地，颜色颗粒均可以为胶体金颗粒，相应地，第三颜色颗粒储藏垫和第四颜色颗粒储藏垫均可以为金标垫。
在本实施方式中，根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置的工作原理与第一实施方式基本相同。即，当只有控制线显色时，检测结果为阴性，当检测线和控制线同时显色时，检测结果为阳性，当检测线和控制线均不显色时，说明检测失败。
通过采用上述技术方案，根据本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置至少具有如下优点：
(1)在本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置中，通过设置能够同时检测转铁蛋白、血红蛋白和幽门螺杆菌抗原的检测试纸条组件，能够对转铁蛋白、血红蛋白和幽门螺杆菌抗原同时进行检测。
(2)在本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置中，通过设置试纸条安装架，能够方便地安装检测试纸条组件。
(3)在本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置中，在检测容器的厚度方向上将检测容器分成了两部分，一部分用于容纳样本容器，另一部分用于容纳装设了检测试纸条组件的试纸条安装架，使得整个联合检测装置的结构紧凑，尺寸小，且能够有效地避免样本采集容纳部插入检测容器中时损坏检测试纸条组件。
(4)在本发明的转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置中，通过使检测容器的对应检测试纸条组件的壁部为透明的壁部，能够方便地观察检测结果。
以上的具体实施方式对本发明的技术方案进行了详细阐述，但是还需要补充说明的是：
(1)虽然在上述实施方式中说明了密封元件为密封铝箔，但是本发明不限于此，密封元件也可以为密封塞、密封薄膜或其它形式的密封片(例如，薄塑料片)。
(2)虽然在上述实施方式中说明了设置试纸条安装架以安装检测试纸条组件，但是本发明不限于此，也可以不设置试纸条安装架，检测试纸条组件也可以直接安装于检测容器的内壁(例如，可以在检测容器的内壁开设安装槽)。
(3)虽然在上述实施方式中说明了检测容器的横截面大致呈矩形形状，但是本发明不限于此，检测容器的横截面也可以为圆形或其它形状。
(4)虽然在上述实施方式中说明了刺破机构设置于检测容器的底部，但是本发明不限于此，刺破机构也可以设置于检测容器的例如中间部分。
(5)虽然在上述实施方式中说明了颜色颗粒为胶体金颗粒，但是本发明不限于此，颜色颗粒也可以为胶体银颗粒、胶体铁颗粒、磁性颗粒、染料颗粒、乳胶颗粒或荧光颗粒。

Claims (10)

  1. 一种转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置，其特征在于，所述联合检测装置包括样本采集容纳部(1)和样本检测部(2)，
    所述样本采集容纳部(1)用于采集和容纳待检测样本，所述样本采集容纳部(1)的底部设置密封元件(14)，
    所述样本检测部(2)包括检测容器(21)、检测试纸条组件(23，25)和刺破机构(24)，
    所述检测试纸条组件(23，25)设置于所述检测容器(21)内，用于同时检测所述转铁蛋白、所述血红蛋白和所述幽门螺杆菌抗原，
    所述刺破机构(24)设置于所述检测容器(21)中，
    所述样本采集容纳部(1)能够沿所述检测容器(21)的轴向插设于所述检测容器(21)中，并且
    当所述样本采集容纳部(1)沿所述轴向朝向所述刺破机构(24)移动时，所述刺破机构(24)能够刺破所述密封元件(14)，使得所述样本容纳采集部(1)中的所述待检测样本进入所述检测容器(21)中，进而使得所述待检测样本能够接触所述检测试纸条组件。
  2. 根据权利要求1所述的联合检测装置，其特征在于，所述样本采集容纳部(1)包括采集棒(11)和样本容器(12)，
    所述采集棒(11)插设于所述样本容器(12)中，
    所述密封元件(14)设置于所述样本容器(12)的底部。
  3. 根据权利要求1所述的联合检测装置，其特征在于，所述样本检测部(2)还包括试纸条安装架(22)，
    所述试纸条安装架(22)插设于所述检测容器(21)中，所述检测试纸条组件(23，25)设置于所述试纸条安装架(22)上。
  4. 根据权利要求3所述的联合检测装置，其特征在于，所述试纸条安装架(22)上开设有安装槽(221)，所述安装槽(221)沿所述轴向延伸，
    所述检测试纸条组件(23，25)设置于所述安装槽(221)中。
  5. 根据权利要求1所述的联合检测装置，其特征在于，所述刺破机构(24)设置于所述检测容器(21)的底部。
  6. 根据权利要求1所述的联合检测装置，其特征在于，所述检测容器(21)的至少对应所述检测试纸条组件(23，25)的壁部为透明的壁部。
  7. 根据权利要求1所述的联合检测装置，其特征在于，所述检测试纸条组件(23)包括转铁蛋白和血红蛋白联合检测试纸条(231)和幽门螺杆菌抗原检测试纸条(232)，
    所述转铁蛋白和血红蛋白联合检测试纸条(231)用于检测所述转铁蛋白和所述血红蛋白，
    所述幽门螺杆菌抗原检测试纸条(232)用于检测所述幽门螺杆菌抗原。
  8. 根据权利要求1所述的联合检测装置，其特征在于，所述转铁蛋白和血红蛋白联合检测试纸条(231)包括第一底板(2311)、第一吸水板(2312)、第一硝酸纤维素膜(2313)、第一样品吸液层(2314)及含有转铁蛋白单抗和血红蛋白单抗的第一颜色颗粒储藏垫(2315)，
    所述第一硝酸纤维素膜(2313)上载有相互分离的转铁蛋白单抗检测线(23131)、血红蛋白单抗检测线(23132)和羊抗鼠多克隆抗体控制线(23133)。
  9. 根据权利要求1所述的联合检测装置，其特征在于，所述检测试纸条组件(25)包括转铁蛋白检测试纸条(251)、血红蛋白检测试纸条(252)和幽门螺杆菌抗原检测试纸条(253)，
    所述转铁蛋白检测试纸条(251)用于检测所述转铁蛋白，
    所述血红蛋白检测试纸条(252)用于检测所述血红蛋白，
    所述幽门螺杆菌抗原检测试纸条(253)用于检测所述幽门螺杆菌抗原。
  10. 根据权利要求7或9所述的联合检测装置，其特征在于，所述幽门螺 杆菌抗原检测试纸条(232)包括第二底板(2321)、第二吸水板(2322)、第二硝酸纤维素膜(2323)、第二样品吸液层(2324)及含有幽门螺杆菌抗原单抗和生物素-牛血清白蛋白结合物的第二颜色颗粒储藏垫(2325)，
    所述第二硝酸纤维素膜(2323)上载有相互分离的幽门螺杆菌抗原单抗检测线(23231)和羊抗鼠多克隆抗体、链霉亲和素控制线(23232)。
PCT/CN2019/116161 2019-07-25 2019-11-07 转铁蛋白、血红蛋白和幽门螺杆菌抗原的联合检测装置 WO2021012469A1 (zh)

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