CN202159067U - Test strip for rapidly and quantitatively detecting HCG - Google Patents
Test strip for rapidly and quantitatively detecting HCG Download PDFInfo
- Publication number
- CN202159067U CN202159067U CN2011202564852U CN201120256485U CN202159067U CN 202159067 U CN202159067 U CN 202159067U CN 2011202564852 U CN2011202564852 U CN 2011202564852U CN 201120256485 U CN201120256485 U CN 201120256485U CN 202159067 U CN202159067 U CN 202159067U
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- 238000012360 testing method Methods 0.000 title claims abstract description 32
- 101001038874 Homo sapiens Glycoprotein hormones alpha chain Proteins 0.000 claims abstract description 47
- 238000001514 detection method Methods 0.000 claims abstract description 30
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 9
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims abstract description 8
- 102000015872 Human beta Subunit Chorionic Gonadotropin Human genes 0.000 claims abstract description 6
- 108010010590 Human beta Subunit Chorionic Gonadotropin Proteins 0.000 claims abstract description 6
- 241001494479 Pecora Species 0.000 claims abstract description 6
- 102000045729 human CGA Human genes 0.000 claims abstract description 6
- 238000002372 labelling Methods 0.000 claims description 17
- 238000011002 quantification Methods 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 9
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- 239000008280 blood Substances 0.000 abstract description 7
- 210000004369 blood Anatomy 0.000 abstract description 7
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- 238000004587 chromatography analysis Methods 0.000 abstract 1
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- 238000003317 immunochromatography Methods 0.000 description 9
- 239000000427 antigen Substances 0.000 description 8
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- FJWGYAHXMCUOOM-QHOUIDNNSA-N [(2s,3r,4s,5r,6r)-2-[(2r,3r,4s,5r,6s)-4,5-dinitrooxy-2-(nitrooxymethyl)-6-[(2r,3r,4s,5r,6s)-4,5,6-trinitrooxy-2-(nitrooxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-3,5-dinitrooxy-6-(nitrooxymethyl)oxan-4-yl] nitrate Chemical compound O([C@@H]1O[C@@H]([C@H]([C@H](O[N+]([O-])=O)[C@H]1O[N+]([O-])=O)O[C@H]1[C@@H]([C@@H](O[N+]([O-])=O)[C@H](O[N+]([O-])=O)[C@@H](CO[N+]([O-])=O)O1)O[N+]([O-])=O)CO[N+](=O)[O-])[C@@H]1[C@@H](CO[N+]([O-])=O)O[C@@H](O[N+]([O-])=O)[C@H](O[N+]([O-])=O)[C@H]1O[N+]([O-])=O FJWGYAHXMCUOOM-QHOUIDNNSA-N 0.000 description 3
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Images
Abstract
The utility model discloses a test strip for rapidly and quantitatively detecting HCG. The test strip comprises a sample feeding pad, a label pad, an NC film, a sample sucking pad and a plastic plate, wherein the sample feeding pad, the label pad, the NC film and the sample sucking pad are adhered on the plastic plate in sequence; mouse-anti HCG-Beta monoclonal antibodies labeled by colloidal gold is coated on the label pad; a detection line T line comprising mouse-anti HCG-Alpha antibodies and a quality control line C line comprising sheep anti-mouse IgG antibodies are respectively coated on the NC film; and simultaneously a sample adding indicating line used for indicating a sample adding position is marked on the detection line T line on the NC film close to one side of the label pad. The test strip can not only overcome the hook effect of the existing detection reagent caused by overhigh HCG content through a way of adding samples on the film, but also perform quantitative detection on HCG in blood or urine through a matched immunity-chromatography interpretoscope.
Description
Technical field
The utility model relates to the biologic applications technical field, and particularly a kind of fast quantification detects the test strips of HCG.
Background technology
After embryonated egg is implanted the uterus, will secrete a kind of new hormone in pregnant woman's body, be called human chorionic gonadotrophin (Human Chorionic Gonadotrophin is called for short HCG).HCG is found in pregnant woman's urine by Aschheim and zondek in nineteen twenty-seven first.HCG is a kind of hormone of cytotrophoblast and plamoditrophoblast secretion, and it at first is present in the placenta, is excreted in the urine through blood circulation.In placenta, blood and urine, all there are HCG and metabolic product thereof.Becoming pregnant back about 10 days, just can in pregnant woman's urina sanguinis, detect HCG.In the normal pregnant women serum, HCG concentration after corpus luteum reaches peak value 7～10 days or embryonated egg are implanted and are begun after postuterine 4～7 days to increase, and increase with exponential form, and average per 1.5～2 days concentration is just double, also varies with each individual but advance the speed.Gestation 7～10 week back HCG concentration just can reach 20,000～100,000IU/L, gestation during 13～15 weeks concentration decrease, beginning again afterwards slowly increases until 30～33 weeks of gestation, and slowly reduction finishes until gestation.Ectopic pregnancy HCG rises then slower, or 3～6 conceived weeks, and HCG can not continue double increase, the possibility of considered ectopic pregnancy or threatened abortion.
HCG is the main signal in the early pregnancy, and specificity marker has become the common counter of diagnosing early pregnancy clinically.Quantitatively dynamic monitoring HCG amount is also as the monitor control index of ectopic pregnancy.
The method of early detection gestation mainly contains three kinds: ultrasound detection, examination of basal body temperature and immunochromatography detect.Ultrasound detection be owing to can only detect the situation in uterus, gestation 6 week back, and is normally used for the monitoring of fetus clinically.But though examination of basal body temperature is simple more loaded down with trivial details.Immunochromatography detect since it easy and simple to handle, have directly perceived, fast, advantages such as detection efficiency is high, method is easy, pollution-free, cost, highly sensitive, high specificity, be widely used in clinical diagnosis, field condition and the oneself of family and detect.
Immunochromatography detects the reagent utilization double antibody sandwich method of HCG.After test fluid is soaked or is splashed into the sample pad of test strips, through the capillary action of water-absorption fiber, the drenched rapidly gold-marking binding pad of test fluid, the collaurum bond on the gold-marking binding pad is dissolved, and moves forward along chromatographic material with test fluid.If have determined antigen Ag in the test fluid, then it will with the antibody generation specific immune response in the collaurum bond, form the immune complex of collaurum bond-determined antigen.Flow through with test fluid then and be fixed on the capture agent of T line on the Nc film.The capture agent of T line is caught collaurum bond-determined antigen immune complex; Promptly with this immune complex generation specific immune response; Form the immune complex of collaurum bond-determined antigen-capture agent, thereby make collaurum bond-determined antigen immune complex be trapped in T line place.Test fluid continues reach, when on the Nc film of flowing through, being fixed with the C line of sheep anti-mouse igg antibody, and sheep anti-mouse antibody generation immune response on the collaurum bond that does not react with determined antigen Ag and the C line, thus make the collaurum bond that dissociates be trapped in C line place.This moment, T line and C line place all had the collaurum bond to be detained, and promptly T line and C line place all can observe color (redness or purple), then represent the positive result of testing result, promptly in the test fluid determined antigen are arranged; If only C line place observes color, and T line place does not observe color, then representes the negative result of testing result, does not promptly have determined antigen in the test fluid; HCG content is different in the liquid to be measured, and the T line color depth that is produced is also inequality, and along with the increase of HCG content, the T line color will be dark more.Yet; Then can cause high-caliber " hook effect (hook effect) " at some sample middle and high concentration HCG; Be HCG concentration when being far longer than the upper limit of detection of colloidal gold strip, HCG records the result and descends with the increase of concentration on the contrary, and the T line color shoals on the contrary; In clinical diagnosis, cause the low-level illusion of HCG, make diagnostic result false problem occur.
Summary of the invention
In view of the deficiency of prior art, the purpose of the utility model is to provide a kind of fast quantification to detect the test strips of HCG, especially provides a kind of ability fast quantification to detect the test strips of HCG in urine or the blood.This test strips not only can overcome the hook effect that existing detectable produces because of the HCG too high levels, and can be to the HCG Quantitative Monitoring in blood or the urine, and quantitatively scope is 10～15000mIU/ml, has avoided sample dilution institute's trouble caused and error.Easy, accurate, fast quantification, sensitivity and specificity is high, economical and practical and do not have with other hormone and to intersect can better meet clinical requirement.
In order to realize the purpose of the utility model, the inventor has obtained following technical scheme through a large amount of experimental studies:
A kind of fast quantification detects the test strips of HCG; Comprise appearance pad, labeling pad, NC film, inhale appearance pad and plastic plate; It is characterized in that: described appearance pad, labeling pad, NC film and the suction appearance pad gone up adheres to plastic plate successively; Be coated with the mouse-anti HCG-β monoclonal antibody of colloid gold label on the labeling pad; Be coated with the detection line T line of mouse-anti HCG-Alpha antibodies formation and the nature controlling line C line that sheep anti-mouse igg antibody constitutes on the NC film respectively, detection line T line is drawn near labeling pad one side and is useful on the application of sample index line that indicates the application of sample position on the NC film simultaneously.
The utility model adopts the immunity principle of double antibody sandwich method to the easy fast method that lacks at present fast quantification HCG clinically, and nitrocellulose membrane detection zone (T line) is coated with mouse-anti HCG-α; Be fixed with the colloid gold particle of the mouse-anti HCG-β labeling of monoclonal antibody of pairing at an end of test card application of sample.On NC film sign line, add 3～5ul test sample (blood or urine) during detection; On the application of sample pad, add an amount of sample dilution again; When having HCG antigen in the sample; Then caught, and combine, form coated antibody-antigen-Jin labeling antibody compound with the antibody of mouse-anti HCG-β monoclonal antibody-collaurum on being diffused into the NC film by the mouse-anti HCG-Alpha antibodies on the NC film; When captive colloidal gold composite reaches some, then on detection zone, form a macroscopic red ribbon.The appearance situation of naked eyes Direct observation C, T line can be judged the qualitative detection result in 5 minutes.Red ribbon intensity can be used supporting immunochromatography interpretoscope quantitative test, and quantitatively scope is 10～15000mIU/ml.
Compared with prior art, the fast quantification that relates to of the utility model test strips that detects HCG has following advantage and obvious improvement:
(1) multifunctionality: the utility model both can be qualitative, but detection by quantitative goes out the content of HCG in urine or the blood again;
(2) fast quantification: supporting immunochromatography interpretation registering instrument quantizes the shade degree that the people is observed visually the detection zone reaction solution; According to instrument memory standard curve; In certain scope; The depth of reaction line color and the concentration of measured object can demonstrate certain relation, can accurately carry out quantitatively HCG concentration in the sample;
(3) overcome hook effect: the utility model not only can overcome the hook effect that existing detectable produces because of the HCG too high levels, and can be to the HCG Quantitative Monitoring in blood or the urine.Be specially; Add sample loading mode during detection on the NC film, adding earlier the seized sample of 3～5ul; Upwards the appearance pad is gone up an amount of dilution of adding then, has both overcome existing detectable because of the hook effect that the HCG too high levels produces, and has avoided consequent erroneous judgement, false negative result; Improved the detection sensitivity of reagent again, sensitivity can reach 10mIU/ml;
Description of drawings
Fig. 1 is the colloidal gold strip structural representation of fast detecting HCG;
1, goes up the appearance pad; 2, labeling pad; 3, cellulose nitrate (NC) film; 4, inhale the appearance pad; 5, application of sample index line; 6, detection line T line; 7, nature controlling line C line; 8, plastic plate.
Embodiment
Below be the specific embodiment that the fast quantification that relates to of the utility model detects the method for septicemia article, the technical scheme of the utility model is done further the description, but the protection domain of the utility model be not limited to these embodiment.Every do not deviate from the change of the utility model design or be equal to substitute include within the protection domain of the utility model.
The preparation of embodiment 1 HCG test strip and detection are used
(1) assembling of test strips
20～25 ℃ of dry indoor temperatures, humidity is got plastic support board less than 30%, and paste at the middle part that the NC film that has encapsulated is placed on plastic support board, in NC film T line one side overlap joint labeling pad, pastes the appearance pad at labeling pad opposite side overlap joint; Inhale the appearance pad in NC film C line one side apart from overlapping edges.With cutter the plastic plate that posts is cut into the test strips of proper width then.The test strips that cuts also can be packed in the plastic clip, forms the detectable card.
Test strips after the assembling comprises appearance pad 1, labeling pad 2, NC film 3, inhales appearance pad 4 and plastic plate 8; Wherein go up appearance pad 1, labeling pad 2, NC film 3 and inhale appearance pad 4 and adhere to plastic plate 8 successively; Be coated with the mouse-anti HCG-β monoclonal antibody of colloid gold label on the labeling pad 2; Be coated with the detection line T line 6 of mouse-anti HCG-Alpha antibodies formation and the nature controlling line C line 7 of sheep anti-mouse igg antibody formation on the NC film 3 respectively, detection line T line 6 is drawn near labeling pad 2 one sides and is useful on the application of sample index line 5 that indicates the application of sample position on NC film 3 simultaneously.Specifically referring to accompanying drawing 1.
(2) clinical sample detects
Elder generation application of sample index line position on the NC film adds 3～5ul test sample during detection, and upwards the appearance pad upward adds an amount of dilution again, but leaves standstill the outlet situation of naked eyes Direct observation detection line T line, nature controlling line C line in 5 minutes, can judge the qualitative detection result; Can pass through supporting immunochromatography interpretoscope quantitative test in 10～15 minutes, quantitatively scope is 10～15000mIU/ml.
The principle and the method for immunochromatography interpretoscope integrated application machinery, electronics, optics, microcomputer and psychophysics; Reach intelligent human eye identification interpretation function; Visual signal to immunochromatography reagent response line is located automatically, and background is rejected, color identifying; Quantification treatment, the GOD value through a quantification shows.Promptly in certain scope, the depth of line color and the concentration of measured object can demonstrate certain relation, are stored in instrument and carry in the IC-card as long as in the test reaction process, do a typical curve, just can carry out quantitative test to immunochromatography reagent bar.
Detecting 30 parts of clinical samples according to above-mentioned detection method, is contrast with the general HCG quantitative reagent of Austria, and the result shows that the sensitivity of this product reaches 10mIU/ml, and specificity 100% and general HCG quantitative reagent difficult to understand coincidence rate as a result are 98.1%.
Claims (3)
1. a fast quantification detects the test strips of HCG; Comprise appearance pad (1), labeling pad (2), NC film (3), inhale appearance pad (4) and plastic plate (8); It is characterized in that; Described appearance pad (1), labeling pad (2), NC film (3) and the suction appearance pad (4) gone up adheres to plastic plate (8) successively; Be coated with the mouse-anti HCG-β monoclonal antibody of colloid gold label on the labeling pad (2), be respectively arranged with detection line T line (6) and nature controlling line C line (7) on the NC film (3), go up detection line T line (6) at NC film (3) simultaneously and draw the application of sample index line (5) that is useful on sign application of sample position near labeling pad (2) one sides.
2. reagent strip according to claim 1 is characterized in that, described detection line T line (6) is to be encapsulated by mouse-anti HCG-Alpha antibodies to process.
3. reagent strip according to claim 1 is characterized in that, described nature controlling line C line (7) is to be encapsulated by sheep anti-mouse igg antibody to process.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202564852U CN202159067U (en) | 2011-07-20 | 2011-07-20 | Test strip for rapidly and quantitatively detecting HCG |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202564852U CN202159067U (en) | 2011-07-20 | 2011-07-20 | Test strip for rapidly and quantitatively detecting HCG |
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| Publication Number | Publication Date |
|---|---|
| CN202159067U true CN202159067U (en) | 2012-03-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2011202564852U Expired - Lifetime CN202159067U (en) | 2011-07-20 | 2011-07-20 | Test strip for rapidly and quantitatively detecting HCG |
Country Status (1)
| Country | Link |
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| CN (1) | CN202159067U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102879576A (en) * | 2012-10-23 | 2013-01-16 | 广州万孚生物技术股份有限公司 | Early pregnancy detection test strip and detection method thereof |
| CN104062427A (en) * | 2014-07-07 | 2014-09-24 | 广州万孚生物技术股份有限公司 | Novel immunochromatographic strip and preparation method thereof |
-
2011
- 2011-07-20 CN CN2011202564852U patent/CN202159067U/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102879576A (en) * | 2012-10-23 | 2013-01-16 | 广州万孚生物技术股份有限公司 | Early pregnancy detection test strip and detection method thereof |
| CN104062427A (en) * | 2014-07-07 | 2014-09-24 | 广州万孚生物技术股份有限公司 | Novel immunochromatographic strip and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of utility model: Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG) Effective date of registration: 20121210 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2012990000773 |
|
| PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of utility model: Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG) Effective date of registration: 20140212 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2014120000005 |
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| PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20131224 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2012990000773 |
|
| PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20141231 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2014120000005 |
|
| PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of utility model: Test strip and method for fast quantitative detection of human chorionic gonadotropin (HCG) Effective date of registration: 20150204 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2015120000009 |
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| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20160307 Granted publication date: 20120307 Pledgee: Tianjin TEDA Small Enterprise Credit Guarantee Center Pledgor: Newscen Coast Bio-Pharmaceutical Co., Ltd. Registration number: 2015120000009 |
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| PLDC | Enforcement, change and cancellation of contracts on pledge of patent right or utility model | ||
| CP01 | Change in the name or title of a patent holder | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 300457 Tianjin Development Zone, Sixth Street, No. 65 Patentee after: Tianjin new torch bio pharmaceutical Limited by Share Ltd Address before: 300457 Tianjin Development Zone, Sixth Street, No. 65 Patentee before: Newscen Coast Bio-Pharmaceutical Co., Ltd. |
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| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20120307 |