WO2021002528A1 - 베타 코어 단편 hcg를 표지자로 포함하는 신규 임신 진단 장치 - Google Patents
베타 코어 단편 hcg를 표지자로 포함하는 신규 임신 진단 장치 Download PDFInfo
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- WO2021002528A1 WO2021002528A1 PCT/KR2019/009573 KR2019009573W WO2021002528A1 WO 2021002528 A1 WO2021002528 A1 WO 2021002528A1 KR 2019009573 W KR2019009573 W KR 2019009573W WO 2021002528 A1 WO2021002528 A1 WO 2021002528A1
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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
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0012—Ovulation-period determination
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
- A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
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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
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
-
- 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
Definitions
- the present invention relates to an immune device for pregnancy diagnosis, and a pregnancy diagnosis method using the same.
- Human chorionic gonadotropin is a glycoprotein hormone produced during pregnancy. hCG is produced in the trophoblast of the chorionic cells of the placenta and continues to produce progesterone in the early stages of pregnancy, thereby maintaining the implantation until the 10th week of pregnancy when the placenta function is completed.
- Intact hCG Intact hCG (Intact hCG; I-hCG), an active form in the body, has a molecular weight of about 37 kDa and is composed of 244 amino acids. I-hCG is largely composed of two subunits, alpha ( ⁇ ) and beta ( ⁇ ), and the alpha-sub unit contains 92 amino acids and the beta-sub unit contains 145 amino acids.
- I-hCG is generally present in various stages during pregnancy and is the main structure present in the body, and in the early stages of pregnancy, such active structures are present in the form of polysaccharide chain hCG (hyperglycosylated hCG; H-hCG) at a high rate.
- various dissociation and degradation products of hCG are found in blood and urine, which are fragmented hCG (nicked hCG; N-hCG), free beta hCG (free ⁇ -hCG), free alpha hCG (free ⁇ -hCG). , Free ⁇ -core fragment hCG (free ⁇ -core fragment hCG), etc.
- the beta core fragment hCG ( ⁇ cf hCG) is a fragment of free ⁇ -hCG, one distinct decomposition product of hCG, and has a molecular weight of about 14 kDa.
- ⁇ cf hCG begins to appear in urine at a concentration of about 0.01 pmol/mL, which is a small amount compared to I-hCG, in the urine from 2 weeks after pregnancy, and gradually increases as the number of weeks of pregnancy elapses. After 5 weeks, it appears as a dominant concentration than I-hCG.
- ⁇ cf hCG unlike other metabolites, exists only in urine (J ClinEndocrinolMetab, 76, 1993, 704-10).
- the concentration of I-hCG is highest between 9-12 weeks in serum and urine, and the urine concentration of pregnant women is 150,000mIU/mL at 10 weeks, and it may be detected as a high concentration of 900,000mIU/mL depending on individual differences. do.
- Pregnancy diagnostic kits currently used determine whether or not you are pregnant by qualitative diagnosis of I-hCG at the beginning of pregnancy (3-5 weeks based on the last menstrual day). However, for 11,760 people who were determined to be pregnant, 22 people, about 0.2%, were found to be false negative as a result of the test with the existing pregnancy diagnostic kit, and the I-hCG concentration for them was measured at a maximum of 268,022.5 IU/mL (J. Emergency Medicine 2013, 44:155), suggesting that the current pregnancy diagnosis kit has a false negative problem caused by the Hook Effect.
- False negatives in pregnancy diagnosis can have serious consequences in emergency department (ED) situations. For example, even though a female patient is pregnant, if a false-negative result is produced when measured with a general pregnancy test kit using urine, a medical accident may occur in which treatment is performed without considering the fetus in the treatment of the female patient. In other words, it causes problems such as failure to diagnose ectopic pregnancy, administration of prohibited drugs during pregnancy, radiation exposure of the fetus, and disputes.
- FDA's MAUDE Manufacturer and User Facility Device Experience Database
- Pregnancy diagnostic kits using urine generally detect I-hCG in a test line by using an antibody against I-hCG as a label, but false negative results in pregnancy diagnosis may occur in the following cases.
- a probe substance-label such as gold or fluorescence saturate the sandwich formation in the I-hCG detection line of the diagnostic kit.
- a hook phenomenon can result in false negative results, and the presence of ⁇ cf hCG in high concentrations in the urine prevents the binding of I-hCG by binding probe material-labeled free floating I-hCG antibodies with ⁇ cf hCG.
- I-hCG binds to the detection antibody immobilized on the detection line of the diagnostic kit
- the free-floating I-hCG antibody bound to ⁇ cf hCG fails to bind to the antigen I-hCG, thereby preventing sandwich formation. Occurs (Griffey et al., The journal of Emergency Medicine, 44, 2013, 155-160).
- the urine pregnancy diagnosis kit can lead to false negative results in pregnancy diagnosis due to hook phenomenon when high concentrations of I-hCG are present, and false negative results even when high concentrations of ⁇ cf hCG are reported.
- LMP menstrual period
- C&D's pregnancy diagnostic kit contains antibodies that detect ⁇ cf hCG and other types of mutated hCG in addition to I-hCG in one detection line, but sensitivity in the detection line decreases due to mutual interference effects. There is a problem that a false negative result comes out.
- the present inventors continued research to solve the problems of the prior art related to the pregnancy diagnosis kit, in addition to the detection line for detecting I-hCG, a detection line for detecting ⁇ cf hCG was separately added, and mutual interference phenomenon did not occur.
- a pregnancy diagnostic kit that minimizes false negative results by accurately diagnosing pregnancy or not through the color development of the ⁇ cf hCG detection line even if hooking phenomenon occurs due to high concentrations of I-hCG by arranging each of the undesired I-hCG antibodies and ⁇ cf hCG antibodies. .
- the present inventors have added a second detection line for detecting ⁇ cf hCG in addition to the first detection line for detecting I-hCG that minimizes false negative results due to hook phenomenon, which is a problem of the prior art related to pregnancy diagnosis kit.
- the present invention provides a pregnancy diagnostic kit comprising an antibody that specifically recognizes ⁇ cf hCG.
- a signal detection region linked to the conjugate region including a first detection line to which an anti-I-hCG antibody is immobilized, a second detection line to which an anti- ⁇ cf hCG antibody is immobilized, and a control line connected to the specimen region ;
- a pregnancy diagnosis immunity device including a moisture absorption region located downstream of the signal detection region for absorbing the test sample for which the signal detection reaction has ended.
- the probe material of 2) is gold nanoparticles, silver nanoparticles, quantum dot nanoparticles, carbon nanoparticles, latex beads/fluorescent nanoparticles, cellulose nanoparticles, magnetic nanoparticles. particle. It is characterized in that one or more selected from the group consisting of silica nanoparticles, polymer beads, fluorescent substances, Luminescent substances, dyes, and proteins.
- the signal detection region of 3) is a first detection line to which an anti-I-hCG antibody is fixed, and a second detection line to which an anti- ⁇ cf hCG antibody is fixed downstream of the first detection line. And a control line downstream of the second detection line.
- the signal detection region of 3) is a second detection line in which an anti- ⁇ cf hCG antibody is fixed, and a first detection line in which an anti-I-hCG antibody is fixed downstream of the second detection line. And a control line downstream of the first detection line.
- the signal detection region of 3) is any one selected from the group consisting of nitrocellulose, cellulose, polyethylene, polyethersulfone, and nylon.
- the moisture absorption region of 4) is characterized in that it includes a porous support and an absorbent dispersed in the pores of the porous support or adsorbed or coated on the fiber yarn of the porous support.
- the immune device is used to determine pregnancy when 1) control line and first detection line, 2) control line and second detection line, or 3) control line, first detection line and second detection line. It features.
- I-hCG and ⁇ cf hCG are signals generated by the presence of the sandwich complex in each detection line. Detected by;
- the immunochromatographic strip according to an embodiment of the present invention further includes a detection line for detecting ⁇ cf hCG in addition to a detection line for detecting I-hCG, and hooking phenomenon and/or interference of ⁇ cf hCG by a high concentration of I-hCG.
- FIG. 1 is a schematic diagram showing an embodiment of an immunochromatographic strip prepared according to the present invention.
- FIG. 2 is a schematic diagram showing a specific example of applying the immunochromatography strip according to the present invention to a kit.
- 1 indicates the reading window of the diagnostic kit
- 2 is the control line indicating the end of the test.
- 3 and 4 denote detection lines
- 5 denotes a sample area into which a test sample is inserted.
- FIG 3 shows the first and second detection lines and control lines of the kit including the immunochromatographic strip prepared according to the present invention according to the concentration of I-hCG and ⁇ cf hCG.
- FIG. 4 shows the results of evaluating the ⁇ cf hCG response of a kit including the immunochromatographic strip of the present invention compared to other pregnancy diagnostic kits.
- FIG. 5 shows a comparison that even when a false negative is determined in a general pregnancy diagnosis immunochromatography strip, a pregnancy positive determination is possible in an immunochromatography strip equipped with a heterogeneous detection line of the present invention.
- the immune device for pregnancy diagnosis according to an embodiment of the present invention
- a signal detection region linked to the conjugate region including a first detection line to which an anti-I-hCG antibody is immobilized, a second detection line to which an anti- ⁇ cf hCG antibody is immobilized, and a control line connected to the specimen region ;
- It includes a moisture absorption region located downstream of the signal detection region for absorbing the specimen to be tested after the signal detection reaction has ended.
- the sample area preferably accommodates a liquid sample such as blood or urine of a woman of childbearing age, but any sample expected to contain I-hCG and/or ⁇ cf hCG may be used.
- the sample region may additionally have a filtering function in order to further improve selectivity for an analyte or to minimize an influence by an interfering substance that may be included in the sample.
- an auxiliary region containing a substance capable of increasing the reaction between the analyte and the conjugate or excluding an effect by an interfering substance may be further provided upstream of the specimen region.
- the control line of the conjugate region refers to a portion of the test sample that emits a constant signal regardless of the concentration of I-hCG or ⁇ cf hCG.
- the control line may be formed by immobilizing a ligand that binds to a third conjugate that moves along the detection region by a mobile phase together with a test sample without binding to I-hCG or ⁇ cf hCG. Regardless of the presence or absence of I-hCG and ⁇ cf hCG in the sample, a ligand capable of emitting a constant signal is immobilized.
- the third conjugate may be combined with the sample and captured on the control line.
- the target sample does not exist in the sample
- color or the like is expressed in the control line even if the color or the like is not expressed in the detection line.
- the response at the control line means that the liquid sample is properly passing through the sensor.
- mouse IgG or chicken IgY may be used.
- anti-rabbit IgG, anti-chicken IgY, streptavidin, bovine serum albumin, goat anti-mouse IgG or goat-anti-chicken IgY may be used.
- the probe material of the conjugate region is gold nanoparticles, silver nanoparticles, quantum dot nanoparticles, carbon nanoparticles, latex beads/fluorescent nanoparticles, cellulose nanoparticles, magnetic nanoparticles, silica nanoparticles, polymer beads
- One or more probe materials selected from the group consisting of (polymer bead), fluorescent material (fluorescein), luminescent material, dye, and protein may be used.
- the probe material is colloidal gold nanoparticles, but is not limited thereto.
- the signal detection region of 3) is a first detection line to which an anti-I-hCG antibody is fixed, and a second detection line to which an anti- ⁇ cf hCG antibody is fixed downstream of the first detection line. And a control line downstream of the second detection line.
- the signal detection region of 3) is a second detection line in which an anti- ⁇ cf hCG antibody is fixed, and a first detection line in which an anti-I-hCG antibody is fixed downstream of the second detection line. And a control line downstream of the first detection line.
- the signal detection region is a medium in which the mobile phase and the sample are developed, and the mobile phase and the test sample may be moved by a capillary phenomenon of the porous membrane in the signal detection region.
- the signal detection region may be selected from the group consisting of a well plate synthesized of nitrocellulose, PVDF, polyvinyl resin or polystyrene resin, and a slide glass made of glass. .
- nitrocellulose is used as the signal detection region, but is not limited thereto.
- a nitrocellulose membrane having pores of 5 to 15 ⁇ m may be used, but is not limited thereto.
- the moisture absorption region may include a porous support and an absorbent dispersed in the cavity of the porous support or adsorbed or coated on the fiber yarn of the porous support, and may further include a porous film layer on the upper surface of the porous support. It is not limited to this.
- the absorbent may be selected from the group consisting of calcium chloride, magnesium chloride, diatomaceous earth, bentonite, dolomite, gypsum, silica gel, and mixtures thereof, but is not limited thereto.
- the concentration measurement range of the target substance in the sample through the signal strength of the first detection line and the second detection line is 25mIU/mL or more for I-hCG, and 1 pmol/mL or more for ⁇ cf hCG.
- the immune device consisting of two detection lines of the present invention can diagnose pregnancy by a detection line that detects ⁇ cf hCG regardless of the hook phenomenon caused by the increase in I-hCG concentration even if the concentration of I-hCG in the sample increases, In order to minimize false negatives caused by interference caused by an increase in the concentration of ⁇ cf hCG in the sample, an anti ⁇ cf hCG antibody is included in the detection line.
- the anti-I-hCG antibody first conjugate present in the conjugate region binds to I-hCG in the sample when it moves toward the membrane and a liquid sample such as blood or urine of a woman of childbearing age (I- hCG)-conjugate to form a first complex.
- a liquid sample such as blood or urine of a woman of childbearing age (I- hCG)-conjugate
- the anti- ⁇ cf hCG antibody second conjugate present in the conjugate region moves to the liquid sample and the signal detection region, it binds with the ⁇ cf hCG in the sample to form a second ⁇ cf hCG-conjugate complex.
- the first complex reacts with the anti-I-hCG antibody immobilized on the first detection line during deployment
- the second complex reacts with the anti- ⁇ cf hCG antibody immobilized on the second detection line during deployment.
- the signal intensity of the I-hCG detection line increases as the concentration of I-hCG in the sample increases, but when the concentration exceeds a certain level, the signal intensity decreases due to the hook phenomenon.
- ⁇ cf hCG is sensitively detected by the second detection line, so that it is not affected by the hook phenomenon, so that it can be determined as positive.
- the results of the first detection line and the second detection line according to an increase in the concentration of I-hCG of the present invention are shown in FIG. 3.
- the second detection line detected ⁇ cf hCG and confirmed that pregnancy was diagnosed.
- the immune device of the present invention may include a solid support underneath.
- the solid support may be formed of a material selected from the group consisting of nitrocellulose, nylon, PVDF, glass, and plastic. Since it is manufactured by attaching the strip on the solid support, the durability of the strip can be increased, and handling and storage can be facilitated. In addition, it is possible to facilitate mounting of additional external devices.
- plastic material that can be used as the solid support a polypropylene film, a polyester film, a polycarbonate film, an acrylic film, etc. may be used, but is not limited thereto.
- the present invention is a kit wherein the immunity device is additionally fixed in the device, wherein the lower device is provided with a guide and a strip support, and the upper device is provided with a specimen inlet; And a kit including a result confirmation window at positions corresponding to the first detection line, the second detection line, and the control line.
- the upper and lower devices may be manufactured using conventional plastic materials, and materials such as polycarbonate and acrylonitrile butadiene styrene (ABS) may be used, but are not limited thereto.
- ABS acrylonitrile butadiene styrene
- the immune device for pregnancy diagnosis of the present invention is
- I-hCG and ⁇ cf hCG in the sample by applying a test sample to the immune device is a probe material-labeled anti-I-hCG antibody and a probe material-labeled anti- ⁇ cf reacting with the hCG antibody, respectively;
- I-hCG and ⁇ cf hCG are signals generated by the presence of the sandwich complex in each detection line.
- a method of diagnosing pregnancy using the immunochromatographic strip is provided.
- I-hCG and ⁇ cf hCG are signals generated by the presence of the sandwich complex in each detection line.
- Anti-I-hCG monoclonal antibody (Monoclonal anti-hCG) was used as the I-hCG antibody of the first detection line, and anti- ⁇ cf hCG monoclonal antibody (Monoclonal anti- ⁇ cf hCG) was used as the ⁇ cf hCG antibody of the second detection line.
- As a ligand goat anti-mouse immunoglobulin (Goat anti-mouse IgG) was dispensed and dried.
- a first conjugate solution was prepared in which colloidal gold nanoparticles and an anti-I-hCG antibody (Monoclonal anti-hCG) were conjugated, and colloidal gold nanoparticles and an anti- ⁇ cf hCG antibody (Monoclonal anti- ⁇ cf) were prepared.
- hCG conjugated a second conjugate solution was prepared.
- a third conjugate solution in which colloidal gold nanoparticles and mouse immunoglobulin (Mouse IgG) were bound was prepared.
- the first conjugate solution, the second conjugate solution, and the third conjugate solution were dispensed onto a pretreated conjugate pad, dried completely, and cut into appropriate sizes to prepare.
- sample pad was sufficiently wetted in the sample pad pretreatment solution containing a buffer and a preservative, dried completely, and cut into appropriate sizes to prepare.
- the moisture absorption pad in the dried state was prepared by cutting it into an appropriate size.
- the membrane, conjugate pad, specimen pad, and moisture absorption pad prepared through each of the above processes are assembled according to the structure shown in FIG. 1.
- a sample pad is attached to overlap one end of the conjugate pad, one end of the detection pad is attached to overlap the other end of the conjugate pad, and the other end of the detection pad and one end of the moisture absorption pad are attached. Attached to overlap each other.
- Example 2 Analysis of immunochromatographic strips according to the concentration of I-hCG and ⁇ cf hCG
- I-hCG and ⁇ cf hCG standards were spiked into non-pregnant urine to prepare a mixed standard sample and tested.
- the prepared standard sample solution was dispensed at a time of 100 ⁇ l into the device sample inlet and developed, and the results were confirmed between 3 minutes and up to 10 minutes.
- concentrations of I-hCG and ⁇ cf hCG in the prepared standard sample solution are as follows (Table 1).
- the detection area of a commonly used pregnancy diagnosis test device consists of one detection line and a control line, and when two lines appear, a pregnancy is diagnosed. Therefore, false negatives may occur due to the hook phenomenon caused by high concentration of I-hCG, or false negatives may be diagnosed due to the interference effect of ⁇ cf hCG in early pregnancy.
- the immune strip of the present invention has a line that detects ⁇ cf hCG, so even if there is a hook phenomenon caused by a high concentration of I-hCG or an interference phenomenon caused by ⁇ cf hCG increasing from the beginning of pregnancy (after 2 weeks of LMP), ⁇ cf hCG is separated separately. Since it can be detected by the detection line of and determined as pregnancy, the false negative problem occurring in early and late pregnancy was solved (FIG. 5).
- Comparative Example 1 the pregnancy diagnosis apparatus according to the present invention and the pregnancy diagnosis kit (Comparative Example 1) of C&D were compared.
- Comparative Example 1 when treated with high concentration of ⁇ cf hCG, one detection line showed a positive reaction. This proves that Comparative Example 1 does not show a hook effect due to ⁇ cf hCG interference, but when a high concentration of I-hCG (about 3,000 IU/mL) was treated with ⁇ cf hCG, a mutual interference phenomenon was shown on one detection line. A false negative occurred.
- the ⁇ cf hCG detection line was colored without being subjected to mutual interference from the high concentration of I-hCG, and thus it was possible to determine positive (Table 2 and Fig. 6). ).
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Abstract
Description
Cut-off Value | 실험군 1 | 실험군 2 | 실험군 3 | 후크현상 | ||
실험군 4 | 실험군 5 | |||||
I-hCG (mIU/mL) | ≥25 | 25 | 100 | 1,000 | 212,000 | 800,000 |
βcf hCG (pmol/mL) | ≥1 | 1 | 10 | 100 | 10 | 500 |
결과 | ||
본 발명 면역 장치 | 비교예 1 | |
βcf hCG 500 pmol/mL | 양성 | 양성 |
Intact hCG 100 mIU/mL + βcf hCG 500 pmol/mL | 양성 | 양성 |
Intact hCG 0.5 mg/mL (3,000 IU/mL) + βcf hCG 500 pmol/mL | 양성 | 음성(Hook effect) |
Claims (6)
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JP2019563176A JP7144448B2 (ja) | 2019-07-04 | 2019-07-31 | ベータコア断片hCGをマーカーとして含む新規な妊娠診断装置 |
US16/572,364 US20210003568A1 (en) | 2019-07-04 | 2019-09-16 | Novel pregnancy diagnosis device including beta-core fragment hcg as marker |
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KR1020190080618A KR102079738B1 (ko) | 2019-07-04 | 2019-07-04 | 베타 코어 단편 hCG를 표지자로 포함하는 신규 임신 진단 장치 |
KR10-2019-0080618 | 2019-07-04 |
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US16/572,364 Continuation US20210003568A1 (en) | 2019-07-04 | 2019-09-16 | Novel pregnancy diagnosis device including beta-core fragment hcg as marker |
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WO2021002528A1 true WO2021002528A1 (ko) | 2021-01-07 |
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KR102473036B1 (ko) * | 2020-02-14 | 2022-12-01 | 에이디텍 주식회사 | 베타 코어 단편 hCG를 표지자로 하는 자궁 외 임신 진단 장치 |
KR102631747B1 (ko) * | 2023-08-17 | 2024-01-31 | 에이디텍 주식회사 | 베타 코어 단편 hCG 분포비를 측정하여 정상 및 비정상임신을 판별하는 신규 면역 진단 장치 |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110256554A1 (en) * | 1998-02-03 | 2011-10-20 | The Trustees Of Columbia University In The City Of New York | Methods for predicting pregnancy outcome in a subject by hcg assay |
US20130164858A1 (en) * | 2011-12-21 | 2013-06-27 | Church & Dwight Co., Inc. | Diagnostic detection device |
CN103777002A (zh) * | 2014-01-15 | 2014-05-07 | 南通市伊士生物技术有限责任公司 | 一种早孕多功能检测试纸的制备方法 |
KR20160108695A (ko) * | 2015-03-05 | 2016-09-20 | (주)프로테옴텍 | 이종 검사선을 구비한 임신진단용 면역크로마토그래피 스트립 및 이를 구비한 임신 진단 키트 |
CN108931654A (zh) * | 2018-07-05 | 2018-12-04 | 重庆早柒天生物科技股份有限公司 | 以尿液为检测样本的早孕检测试剂盒、其生产方法及用途 |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8821507D0 (en) | 1988-09-14 | 1988-10-12 | Cancer Res Campaign Tech | Improvements relating to peptides |
KR100403871B1 (ko) | 2000-08-12 | 2003-11-01 | 휴마시스 주식회사 | 정상 임신과 자궁외 임신을 진단하는 장치 및 이의제조방법 |
EP3221444B1 (en) | 2014-11-18 | 2022-03-02 | Siemens Healthcare Diagnostics Inc. | Lateral flow assay ratio test |
-
2019
- 2019-07-04 KR KR1020190080618A patent/KR102079738B1/ko active IP Right Grant
- 2019-07-31 WO PCT/KR2019/009573 patent/WO2021002528A1/ko active Application Filing
- 2019-07-31 JP JP2019563176A patent/JP7144448B2/ja active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110256554A1 (en) * | 1998-02-03 | 2011-10-20 | The Trustees Of Columbia University In The City Of New York | Methods for predicting pregnancy outcome in a subject by hcg assay |
US20130164858A1 (en) * | 2011-12-21 | 2013-06-27 | Church & Dwight Co., Inc. | Diagnostic detection device |
CN103777002A (zh) * | 2014-01-15 | 2014-05-07 | 南通市伊士生物技术有限责任公司 | 一种早孕多功能检测试纸的制备方法 |
KR20160108695A (ko) * | 2015-03-05 | 2016-09-20 | (주)프로테옴텍 | 이종 검사선을 구비한 임신진단용 면역크로마토그래피 스트립 및 이를 구비한 임신 진단 키트 |
CN108931654A (zh) * | 2018-07-05 | 2018-12-04 | 重庆早柒天生物科技股份有限公司 | 以尿液为检测样本的早孕检测试剂盒、其生产方法及用途 |
Non-Patent Citations (2)
Title |
---|
"ADTECH International Conference", ICEM 2019, 12 June 2019 (2019-06-12) * |
CHANG, JINDONG, ADTECH CO., LTD. DONGYANG DAILY NEWSPAPER, 9 June 2019 (2019-06-09), Retrieved from the Internet <URL:http://www.dynews.co.kr/news/articleView.html?idxno-458300> * |
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