CN1314593A - Test paper for detecting sterility and its test method - Google Patents
Test paper for detecting sterility and its test method Download PDFInfo
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- CN1314593A CN1314593A CN 00112779 CN00112779A CN1314593A CN 1314593 A CN1314593 A CN 1314593A CN 00112779 CN00112779 CN 00112779 CN 00112779 A CN00112779 A CN 00112779A CN 1314593 A CN1314593 A CN 1314593A
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- sample pad
- test paper
- urine
- nitrocellulose filter
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Abstract
When the sample pad end of the test paper for detecting sterility is socked in urine, the LH resisting monoantibody inside the sample pad and the LH antigen in the urine produce specific reaction. Under the action of capillary pipe, LH antigen shifts forwards in the cellulose nitrate film direction, and while shifting to the area of the cellulose nitrate film painted with an other LH resisting monoclone antibody, specific combination in sandwich mode takes place, the LH antigen is distinguished by LH resisting monoclone antibody in the detection line and the detection line becomes red with shade dependent on the LH hormone content in urine.
Description
The present invention relates to a kind ofly be used to detect the test paper of female infertility and use the infertile method of this detection paper, promptly a kind of infertility detects test paper and detection method thereof.
The women has only ovulation, just might become pregnant.Once ovulation only took place in every month in normal women of child-bearing age.Modern science confirms that the secretion of LH hormone can promote the discharging of human body mature egg and corpus luteum to form in the human body, has only normally and when reaching certain amount when the LH hormone secretion in the human body, and human body just can start ovulation.Before the ovulation, the obviously rising of LH value in human body blood and the urine, when reach a certain amount of after, ovum just can discharge.Medically define: matrimonial cohabitation, sexual life normally, do not adopt any contraceptives, that does not become pregnant in two years after marriage is called infertility.The person that never do not become pregnant after marriage is called primary infertility; Once conceived and contraception have 2 years and the person of not becoming pregnant is called secondary infertility.Tool statistics shows: because the women is former thereby take place infertile to account for 40%, male sex's reason takes place infertile to account for 30%, both sides' reason account for 30%.Because the influence of various factors faces fertility difficulty and sterile Mr. and Mrs' number and constantly rises, it is reported that now just there are 2,500 ten thousand pairs of infertile couples in China in recent years.The medical worker must accurately check at first that as carrying out infertility diagnosis, sterility treatment and observation of curative effect and carrying out the artificial impregnation assurance on opportunity the patient has rule and date, corpus luteum and the ovarian hormone secretion situation of anovulation, ovulation.In other words, accurately detect the amount of women LH hormone secretion, just can judge that the women has the correct time of anovulation and ovulation, this is the work that the medical worker at first will carry out when the diagnosis of carrying out infertility and treatment.But all using LH radioimmunological kit and LH enzyme to exempt from kit at present both at home and abroad measures, these medicine boxs are mainly used in hospital, need to detect the content of LH hormone in the urine, need long time and complicated process, can not be used for family and test oneself by professional, specialized equipment.
The objective of the invention is to overcome the shortcoming of above-mentioned prior art, invent a kind of whether the ovulation with regard to the detection women that can oneself finish and the infertility test paper of LH hormone secretion situation and the method for using this infertility detection test paper to detect at home.
The purpose of the present invention's invention is: the infertility detection test paper of invention design is overlapped mutually by base plate, nitrocellulose filter, water accepting layer and glass fiber sample layer and connects and composes, scribble the detection line of another anti-LH monoclonal antibody at the nitrocellulose filter middle part,, and the reacting value of detection line is greater than or equal to 5 mIU/ml; By shade and the standard color comparison card contrast that detection line after this infertile detection detection paper urine shows, confirm whether the LH hormone is normal in the tested human female.
The objective of the invention is to finish by following method and structure: a kind of infertility detects test paper and detection method thereof, it is characterized in that the base plate middle part is nitrocellulose filter, an anti-LH monoclonal antibody detection line is arranged on the nitrocellulose filter, end termination at base plate is an adsorptive pads, other end termination is a sample pad, accompany the anti-LH monoclonal antibody gold of one deck labeling antibody in the middle of sample pad, the reacting value of detection line is set at and is greater than or equal to 5 mIU/ml; The nitrocellulose filter two ends overlap mutually with sample pad with adsorptive pads respectively and are connected, and the part that overlaps mutually is in 2-5 millimeter scope; Test paper sample pad end is immersed in the urine, be clipped in anti-LH monoclonal antibody gold labeling antibody in the sample pad and the LH antigen generation idiosyncrasy in the urine, under capillarity, LH antigen moves forward along the direction of nitrocellulose filter, moved to when originally scribbling another anti-LH monoclonal antibody regional in the nitrocellulose filter, the specific bond of sandwich style takes place, anti-LH monoclonal antibody identification in the just tested survey line of LH antigen, detection line just shows redness, and the depth of its detection line color just is directly proportional with LH hormone-content in the urine.
Test shows: the LH hormone secretion amount in the female body is during less than 5 mIU/ml, and the women can not produce ovulation, so infertility of the present invention detects the detection line (4) in the test paper, and its reacting value is set at and is greater than or equal to 5mIU/ml.
The present invention is owing to adopt immunochromatography single stage method principle, and detection line (4) reacting value that infertility is detected test paper is set at and is greater than or equal to 5 mIU/ml.Women oneself just can use the infertile detection test paper of the present invention at home, and LH hormone secretion situation in the detection bodies provides the means of a kind of convenience, practicality and fast detecting for detecting infertility, thereby reaches the purpose of auxiliary diagnosis infertility.
Fig. 1 detects the front view of test paper for infertility of the present invention.
Fig. 2 is that infertility shown in Figure 1 detects test paper A-A direction cut-open view.
When Fig. 3 detects the test paper actual detected for infertility of the present invention, show the synoptic diagram of positive findings.
When Fig. 4 detects the test paper actual detected for infertility of the present invention, show the synoptic diagram of negative findings.
Fig. 5 detects prepositioned standard color comparison card synoptic diagram in the test paper packing box for infertility of the present invention.
Embodiment: the reacting value that infertility of the present invention is detected fixing (being coated with) anti-LH monoclonal antibody formation detection line (4) on nitrocellulose filter (3) in the test paper is set at 5 mIU/ml.During use, open paper box, take out a test paper, test paper sample pad (6) one ends are immersed in the urine, when having LH antigen in the urine, the LH antigen generation specific bond that has in anti-LH monoclonal antibody gold labeling antibody (5) that accompanies in the sample pad (6) and the urine, under capillarity, LH antigen moves to adsorptive pads (1) direction along nitrocellulose membrane (3), when LH antigen moves to nitrocellulose filter (3) central region, specific bond with the anti-LH monoclonal antibody generation sandwich style that is fixed on (or being coated in) nitrocellulose filter (3) middle part in advance, cause detection line (4) to demonstrate redness, and the depth of the shown color of detection line (4) is directly proportional with LH concentration of hormone in the urine.The effect of adsorptive pads (1) has two, and one is to increase the suction of nitrocellulose filter (3) to urine, and another is to absorb unnecessary urine.
The LH hormone-content is lower than 5 mIU/ml in urine, the LH antigen that has on the test paper sample pad (6) just can not with the specific bond of anti-LH monoclonal antibody generation sandwich style on the detection line (4), just do not develop the color in detection line (4) position.
Using method and step: the 1. selected time that begins to test: according to length A days of PMP, and according to following table, after this menstruation is risen B days begin test.From the beginning test day, test with a test paper in the relatively-stationary time every day,
| 21 | ?22 | ?23 | ?24 | ?25 | ?26 | ?27 | ?28 | ?29 | ?30 | ?31 | ?32 | ?33 | ?34 | ?35 | ?36 | ?37 | ?38 | ?39 | ?40 | ?41 | ?42 |
| ?3 | ?3 | ?4 | ?5 | ?6 | ?7 | ?8 | ?9 | ?10 | ?11 | ?12 | ?13 | ?14 | ?15 | ?16 | ?17 | ?18 | ?19 | ?20 | ?21 | ?22 | ?23 |
2. METHOD FOR CONTINUOUS DETERMINATION 10 days was a mensuration cycle, observed every day and the record measurement result;
3. test strips and standard color card after will testing compare, and judge the sort of situation that belongs in the standard color card.
1). as a mensuration in the cycle, the color that test paper stage casing red ribbon is shown is the shallow or close of 1 color than sequence number in the standard color card all, illustrate that then the LH hormone concentration is less than or equal to 10 milli-international unit/milliliters in detected person's body, cause of infertility may be for due to the hypopituitarism.Please arrive hospital further makes a definite diagnosis.
2). as a mensuration in the cycle be near the mark sequence number in the colour atla of the color as shown in the red ribbon of test paper stage casing be 2 color, illustrate then in detected person's body that the LH hormone concentration is lower than or equals 20 milli-international unit/milliliters, cause of infertility may for anovulation or ovulate undesired due to.Advise that hospital does further diagnosis.
3). as the Changing Pattern of " not having-shallow-dark-shallow-do not have " is arranged significantly in the mensuration color that test paper stage casing red ribbon is shown in the cycle, and dark part sequence number in standard color card is 3,4 or 5 color, illustrate that then detected person's ovulation function is normal, due to the non-ovulation of cause of infertility, suggestion checks that other causes infertile reason.
4). as the mensuration color that test paper stage casing red ribbon is shown in the cycle all than the sequence number in the standard color card be 6 dark or close, illustrate that then the LH hormone concentration is more than or equal to 200 milli-international unit/milliliters in detected person's body, this result shows the hormone in vivo diacrisis, cause this unusual cause of disease a lot, examination in hospital is arrived in suggestion immediately.
Like this, detect the variation of test paper shade, then can judge tested women lutropin LH secretion situation in each menstrual cycle, thereby determine that it has anovulation and determines the corresponding ovulation date by infertility.The infertile detection detection paper of the present invention line (4) reacting value is set at more than or equal to 5 mIU/ml, and being placed with the LH value in the infertile detection test paper packing box is the standard color card of 10 mIU/ml, 20 mIU/ml, 25 mIU/ml, 50 mIU/ml, 100 mIU/ml and six kinds of different numerical value of 200 mIU/ml.Tested women only need use a female acyesis of the present invention to detect test paper every day, infertile detection test paper sample pad end is immersed in the urine 10 seconds the back took out traverse 10 minutes, change according to the depth that detects the test paper color, the color of reference standard colour atla, can judge whether whether the LH hormone secretion is normal in ovulation and the body, realize that the individual just can detect lutropin LH at home, help the doctor that the infertility reason is judged.
Product of the present invention is by accurately measuring the women of child-bearing age's content of LH and variation in the urine in the menstrual cycle, can be used for the ovulate detection of situation and LH hormonal readiness of infertile women, articles for use are detected on basis as a kind of infertility diagnosis, for infertility diagnosis provides a kind of up-to-date detection technique means, have fast and safely characteristics easily.
The 1-adsorptive pads; The 2-base plate; The 3-nitrocellulose filter; The 4-detection line; The anti-LH monoclonal antibody gold of 5-labeling antibody; The 6-sample pad;
Claims (3)
1. an infertility detects test paper and detection method thereof, it is characterized in that base plate (2) middle part is nitrocellulose filter (3), an anti-LH monoclonal antibody detection line (4) is arranged on the nitrocellulose filter (3), in base plate (2) one end terminations adsorptive pads (1) is arranged, there is sample pad (6) other end termination, nitrocellulose filter (3) two ends overlap mutually with sample pad (6) with adsorptive pads (1) respectively and are connected, accompany the anti-LH monoclonal antibody gold of one deck labeling antibody (5) in the middle of sample pad (6), the reacting value of detection line (4) is set at and is greater than or equal to 5 mIU/ml.
2. detect test paper and detection method thereof according to the described a kind of infertility of claim 1, it is characterized in that nitrocellulose filter (3) two ends are connected partly in 2-5 millimeter scope with mutual overlapping of adsorptive pads (1) and sample pad (6) respectively.
3. detect test paper and detection method thereof according to claim 1 or 2 described a kind of infertilities, it is characterized in that immersing in the urine detecting the low sample pad (6) of examination, be clipped in the LH antigen generation idiosyncrasy in anti-LH monoclonal antibody gold labeling antibody (5) and the urine in the sample pad (6), under capillarity, LH antigen moves forward along the direction of nitrocellulose filter (3), moved to when originally scribbling another anti-LH monoclonal antibody regional in the nitrocellulose filter (3), the specific bond of sandwich style takes place, anti-LH monoclonal antibody identification in the just tested survey line of LH antigen (4), detection line (4) just shows red, and the depth of its detection line (4) color just is directly proportional with the LH hormone-content in the urine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00112779 CN1116607C (en) | 2000-03-16 | 2000-03-16 | Test paper for detecting sterility and its test method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00112779 CN1116607C (en) | 2000-03-16 | 2000-03-16 | Test paper for detecting sterility and its test method |
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| CN1314593A true CN1314593A (en) | 2001-09-26 |
| CN1116607C CN1116607C (en) | 2003-07-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 00112779 Expired - Lifetime CN1116607C (en) | 2000-03-16 | 2000-03-16 | Test paper for detecting sterility and its test method |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008014709A1 (en) * | 2006-07-26 | 2008-02-07 | Abon Biopharm (Hangzhou) Co., Ltd. | Analysis device for biologicla sample |
| US7837939B2 (en) | 2003-11-14 | 2010-11-23 | Alere Switzerland Gmbh | Rapid sample collection and analysis device and methods of use |
| CN102183663A (en) * | 2011-03-24 | 2011-09-14 | 武汉璟泓万方堂医药科技有限公司 | Qualitative semi-quantitative dual-purpose female ovulation hormone detection test paper and colorimetric card |
| CN102207507A (en) * | 2011-03-24 | 2011-10-05 | 武汉璟泓万方堂医药科技有限公司 | Semi-quantitative detecting test paper of cardiac troponin and preparation method thereof |
| CN102565426A (en) * | 2011-12-22 | 2012-07-11 | 正元盛邦(天津)生物科技有限公司 | Method for diagnosing luteinizing hormone (LH) in semi-quantitative mode by employing double-indicatrix immunochromatography |
| CN103185804A (en) * | 2011-12-28 | 2013-07-03 | 丁鑫 | Method for semiquantitatively measuring LH concentration by combination of ovulation test strips of different sensitivities |
| US8871155B2 (en) | 2005-11-30 | 2014-10-28 | Alere Switzerland Gmbh | Devices for detecting analytes in fluid sample |
| CN104569441A (en) * | 2015-01-19 | 2015-04-29 | 成都大熊猫繁育研究基地 | Enzyme linked assay method for luteinizing hormone in panda urine and application of enzyme linked assay method |
| CN106146651A (en) * | 2015-04-17 | 2016-11-23 | 南京济朗生物科技有限公司 | Women luteal function quick non-invasive monitoring technology |
| CN106443022A (en) * | 2016-07-12 | 2017-02-22 | 昆明云大生物技术有限公司 | Luteinizing hormone semi-quantitative ovulation determination test paper and making method thereof |
| CN111537753A (en) * | 2020-04-03 | 2020-08-14 | 昆明云大生物技术有限公司 | Follicle-stimulating hormone detection test paper and use method thereof |
-
2000
- 2000-03-16 CN CN 00112779 patent/CN1116607C/en not_active Expired - Lifetime
Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7837939B2 (en) | 2003-11-14 | 2010-11-23 | Alere Switzerland Gmbh | Rapid sample collection and analysis device and methods of use |
| US8871155B2 (en) | 2005-11-30 | 2014-10-28 | Alere Switzerland Gmbh | Devices for detecting analytes in fluid sample |
| US8071394B2 (en) | 2006-07-26 | 2011-12-06 | Alere Switzerland Gmbh | Test device for detecting an analyte in a liquid sample |
| WO2008014709A1 (en) * | 2006-07-26 | 2008-02-07 | Abon Biopharm (Hangzhou) Co., Ltd. | Analysis device for biologicla sample |
| CN101893626B (en) * | 2006-07-26 | 2014-04-09 | 因韦尔尼斯医药瑞士股份有限公司 | Test device for detecting analyte in liquid sample |
| CN102183663A (en) * | 2011-03-24 | 2011-09-14 | 武汉璟泓万方堂医药科技有限公司 | Qualitative semi-quantitative dual-purpose female ovulation hormone detection test paper and colorimetric card |
| CN102207507A (en) * | 2011-03-24 | 2011-10-05 | 武汉璟泓万方堂医药科技有限公司 | Semi-quantitative detecting test paper of cardiac troponin and preparation method thereof |
| CN102565426A (en) * | 2011-12-22 | 2012-07-11 | 正元盛邦(天津)生物科技有限公司 | Method for diagnosing luteinizing hormone (LH) in semi-quantitative mode by employing double-indicatrix immunochromatography |
| CN103185804A (en) * | 2011-12-28 | 2013-07-03 | 丁鑫 | Method for semiquantitatively measuring LH concentration by combination of ovulation test strips of different sensitivities |
| CN104569441A (en) * | 2015-01-19 | 2015-04-29 | 成都大熊猫繁育研究基地 | Enzyme linked assay method for luteinizing hormone in panda urine and application of enzyme linked assay method |
| CN104569441B (en) * | 2015-01-19 | 2016-02-03 | 成都大熊猫繁育研究基地 | The enzyme connection detection method of giant panda urine luteotropin and application thereof |
| CN106146651A (en) * | 2015-04-17 | 2016-11-23 | 南京济朗生物科技有限公司 | Women luteal function quick non-invasive monitoring technology |
| CN110526964A (en) * | 2015-04-17 | 2019-12-03 | 南京济朗生物科技有限公司 | The quick non-invasive monitoring technology of women luteal function |
| CN106443022A (en) * | 2016-07-12 | 2017-02-22 | 昆明云大生物技术有限公司 | Luteinizing hormone semi-quantitative ovulation determination test paper and making method thereof |
| CN111537753A (en) * | 2020-04-03 | 2020-08-14 | 昆明云大生物技术有限公司 | Follicle-stimulating hormone detection test paper and use method thereof |
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| Publication number | Publication date |
|---|---|
| CN1116607C (en) | 2003-07-30 |
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Granted publication date: 20030730 |