CN201583543U - Test tool and test case for quickly testing premature rupture of membranes - Google Patents
Test tool and test case for quickly testing premature rupture of membranes Download PDFInfo
- Publication number
- CN201583543U CN201583543U CN2010200376214U CN201020037621U CN201583543U CN 201583543 U CN201583543 U CN 201583543U CN 2010200376214 U CN2010200376214 U CN 2010200376214U CN 201020037621 U CN201020037621 U CN 201020037621U CN 201583543 U CN201583543 U CN 201583543U
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- testing tool
- pad
- premature rupture
- fetal membranes
- fast detecting
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Abstract
A test tool for quickly testing premature rupture of membranes comprises a liner, and a water absorbing pad, a nitrocellulose membrane, a conjugate pad and a sample pad which are sequentially adhered onto the liner from up to down, wherein a test line formed by rabbit-anti-human insulin-like growth factors binding a protein-1 polyclonal antibody coating and a control line formed by goat-anti-mouse insulin-like growth factors binding a protein-1 polyclonal antibody coating, the test line is positioned below the control line via a spacing, the conjugate pad is water absorbing fibers coated with a combination of conjugate rabbit-anti-human insulin-like growth factors binding protein-1 monoclonal antibodies, and the conjugated pad is partially coated by the sample pad. A test case for quickly testing premature rupture of membranes is formed by a case body and the test tool mounted inside the case body, inner cavity of the case body is matched with shape and size of the test tool, the top wall of the inner cavity is provided with an insertion hole for the test tool, and the lateral wall of the inner cavity is provided with a sample feeding hole and a view hole.
Description
Technical field
The utility model belongs to medical testing tool, particularly a kind of testing tool that detects the pregnancy women premature rupture of fetal membranes.
Background technology
Just before giving birth Qian rupture of membranes is called premature rupture of fetal membranes (Premature Rupture of Fetal Membrane is called for short PROM).Premature rupture of fetal membranes is to cause that the obstetrical patient is antenatal, the principal element of postpartum complication, is the main cause that causes the fetus premature labor and must move in neonatal intensive care unit (NICU), so, big to premature rupture of fetal membranes patient's handling cost height, difficulty.Therefore, it is most important accurately and timely to diagnose the pregnant woman whether premature rupture of fetal membranes to take place.
In the prior art, adopting goldstandard is a kind of accurate method of diagnosis premature rupture of fetal membranes, promptly in pregnant woman's amniotic cavity, inject dyestuff (as methylene blue), if have in the vagina by the outflow of the liquid of dye coloring and can be diagnosed as premature rupture of fetal membranes, but adopt goldstandard to detect clinical very difficult operation, and cause patient's misery, so clinical seldom use.Usually (normal vaginal secretion pH is 4.5～5.5 to adopt inquiry medical history, patient's private prosecution vagina to have amniotic fluid outflow, vaginal secretion pH value to become meta-alkalescence clinically, and amniotic fluid pH value is 7.0～7.5), microscopically looks into the methods such as occurring amniotic fluid crystal in the vaginal fluid smear of seeing, though these methods are simple to operate, accuracy, susceptibility are all lower.
Summary of the invention
The purpose of this utility model is to overcome the deficiencies in the prior art, provides a kind of and detects the testing tool of premature rupture of fetal membranes and detect box, uses described testing tool and detects box, can not only realize not having wound and detect, and can obtain testing result accurately fast.
The testing tool of fast detecting premature rupture of fetal membranes described in the utility model is with insulin-like growth factor binding protein 1 (Insulin-like growth factor-binding protein 1, be called for short IGFBP-1, hereinafter, with " IGFBP-1 " expression insulin-like growth factor binding protein 1) serve as to detect index, described IGFBP-1 is a kind of insulin and progesterone dependent protein, molecular weight is 25kDa, is responsible for the storage and the transhipment of IGF in the body.IGFBP-1 mainly by decidual cell, fetus and adult human liver, the synthetic justacrine of gonad granulocyte, can come across in gravid woman's the serum and amniotic fluid, and the mass concentration in the amniotic fluid in the mass concentration ratio serum of IGFBP-1 exceeds 100～1000 times.IGFBP-1 is that gestation comes across the topmost protein in the amniotic fluid after 3 months.To have amniotic fluid to spill during premature rupture of fetal membranes, the IGFBP-1 in the amniotic fluid then can appear in the cervical mucus, and the vaginal fluid with testing tool detection gravid woman described in the utility model can judge whether to take place premature rupture of fetal membranes.
The testing tool of fast detecting premature rupture of fetal membranes described in the utility model comprises liner, and adsorptive pads, nitrocellulose filter, the gold mark that sticks on the liner that from top to bottom join successively fills up and sample pad; Described nitrocellulose filter is provided with detection line that is formed by the anti-people IGFBP-1 of rabbit polyclonal antibody bag and the control line that is formed by sheep anti mouse IGFBP-1 polyclonal antibody bag, detection line is positioned under the control line and the spacing of being separated by, and described gold mark fills up for the water-absorption fiber that is coated with gold mark mouse-anti people IGFBP-1 monoclonal antibody bond and by sample pad and partly covers.
The detection box of fast detecting premature rupture of fetal membranes described in the utility model is made of the above-mentioned testing tool in the box body and the box body of packing into; The inner chamber of described box body and the shape and size of testing tool are complementary, the roof of described box body is provided with the testing tool patchhole, sidewall is provided with well and viewport, described well that position and the testing tool position of its sample pad of packing into behind the box body is set is corresponding, described viewport that position and the testing tool position of its detection line and control line of packing into behind the box body is set is corresponding.
In the above-mentioned testing tool, the preferred 0.8mm～1mm of the width of described detection line and control line; Preferred 10mm～the 12mm of spacing between described detection line and the control line.The shape of testing tool does not have strict demand, from saving cost, the convenient angle consideration of making, the preferred rectangular strip of its shape.Described adsorptive pads is the pad of being made by thieving paper, and sample pad is the pad of being made by water-absorption fiber, is the water-absorption fiber pad.
Testing tool described in the utility model and detection box have following beneficial effect:
1, use detection box described in the utility model to making a definite diagnosis the rupture of membranes group, making a definite diagnosis the broken group of fetal membrane and doubtful rupture of membranes group gravid woman carries out sample detecting, testing result shows, rate of accuracy reached 100%.
2, use detection box described in the utility model, detect a sample and only need 5-10 minute, compare with existing method, detection speed increases substantially.
3,, thereby be that a kind of nothing wound detects because test sample is gravid woman's a vaginal fluid.
4, use detection box described in the utility model to detect, simple to operate, no matter in gynemetrics clinic, hospital or family, all can obtain result equally accurately.
5, testing tool described in the utility model and detection box are simple in structure, are easy to processing and fabricating, and production cost is low, is convenient to suitability for industrialized production.
Testing tool described in the utility model and detection box are applicable to all pregnancy women, the pregnancy women that especially exists premature delivery risk, belly to sustain damage.
Description of drawings
Fig. 1 is a kind of structural representation of the testing tool of fast detecting premature rupture of fetal membranes described in the utility model;
Fig. 2 is the left view of Fig. 1;
Fig. 3 is a kind of structural representation of the detection box box body of fast detecting premature rupture of fetal membranes described in the utility model;
Fig. 4 is the vertical view of Fig. 3;
Fig. 5 is the A-A cut-open view of Fig. 3;
Fig. 6 is a kind of structural representation of the detection box of fast detecting premature rupture of fetal membranes described in the utility model.Among the figure, 1-liner, 2-adsorptive pads, 3-control line, 4-detection line, 5-nitrocellulose filter, 6-gold mark pad, 7-sample pad, 8-box body, 9-viewport, 10-well, 11-testing tool patchhole; IGFBP-1 in 12-testing tool, the 13-testing sample.
Embodiment
Be described further below in conjunction with structure, method for making and the using method of accompanying drawing testing tool described in the utility model and detection box.
Embodiment 1
In the present embodiment, the testing tool of fast detecting premature rupture of fetal membranes as shown in Figure 1 and Figure 2, it is shaped as rectangular strip, its structure comprises liner 1, from top to bottom joining successively sticks on adsorptive pads 2 on the liner, nitrocellulose filter 5, gold mark pad 6 and sample pad 7, and described gold mark pad 6 is partly covered by sample pad.Liner 1 is made by the high whiteness PVC sheet material of medical plastic, above pressure-sensitive adhesive coating, bioactive molecule is had inertia; Adsorptive pads 2 is a thieving paper, nitrocellulose filter 5 be provided with the detection line 4 that is formed by the anti-people IGFBP-1 of rabbit polyclonal antibody (Santz Cruz company) bag and the control line 3 that is formed by sheep anti mouse IGFBP-1 polyclonal antibody (going up the female bioengineering of Shanghai's style company limited) bag (rabbit anti-people IGFBP-1 polyclonal antibody and the method for coating of sheep anti mouse IGFBP-1 polyclonal antibody on nitrocellulose filter are seen paper " development of AFP immune chromatograph testing strip ", Hou Huiren, Wu Feng Bo, Chen Jian, Liu Yibing, He Youfeng, " isotope ", 2000,13 (3): 124-126), detection line 4 is positioned under the control line 3, their width is 1mm (or 0.8mm or 0.9mm), spacing between them is 10mm (or 11mm or 12mm), gold mark pad 6 is for being coated with the glass fibre membrane or the dacron film of gold mark mouse-anti people IGFBP-1 monoclonal antibody bond, and sample pad 7 is glass fibre membrane or dacron film.The preparation method of gold mark pad 6 is as follows:
(1) preparation of collaurum
Get the 0.01g gold chloride and be dissolved in the 100ml tri-distilled water, form aqueous solution of chloraurate; The 100ml aqueous solution of chloraurate is heated to boiling, and under agitation adding concentration is the trisodium citrate aqueous solution 1.5ml of 10g/100ml, boils to presenting transparent orange red (about 7～10 minutes) again, and being cooled to after the room temperature with concentration is the K of 0.2mol/L
2CO
3Solution is regulated its pH to 7.0-7.2, obtains collaurum;
(2) preparation of gold mark mouse-anti people IGFBP-1 monoclonal antibody bond
In the 100ml collaurum of step (1) preparation, add 200 μ g mouse-anti people IGFBP-1 monoclonal antibodies (Thermoscientific company), mix the back and add 250mg bovine serum albumin(BSA) (BSA, Roche company), mixing the back again, to add concentration be the NaCl solution of 10g/100ml, and the addition of NaCl solution reaches 1g/100ml with the concentration of NaCl in the colloidal gold solution and exceeds.Continue after respectively with 2,000 rev/min, 4,000 rev/min, 10,000 rev/min condition each centrifugal 10 minutes, the separated product that obtains is gold mark mouse-anti people IGFBP-1 monoclonal antibody bond, described bond is dissolved in the phosphate buffer (PBS contains 0.09% Sodium azide) of pH 7.2,4 ℃ of storages are standby;
(3) preparation of gold mark pad
With concentration is the bovine serum albumin(BSA) (BSA of 0.5g/100ml, Roche company) solution soaks glass fibre membranes or dacron film after 1 hour at 22 ℃～25 ℃, the gold of step (2) preparation is marked mouse-anti people IGFBP-1 monoclonal antibody binding substance coated label, and (method for coating is seen paper " development of AFP immune chromatograph testing strip " on glass fibre membrane or dacron film, Hou Huiren, Wu Fengbo, Chen Jian, Liu Yibing, He Youfeng, " isotope ", 2000,13 (3): 124-126), promptly obtain gold mark pad.
The preparation of described testing tool can be bonded at sheet adsorptive pads 2, nitrocellulose filter 5, gold mark pad 6 and sample pad 7 on the sheet liner, is cut into rectangular strip then.
In the present embodiment, the shape of the detection box of fast detecting premature rupture of fetal membranes and structure are made of the testing tool 12 in the box body 8 and the box body of packing into as shown in Figure 6.Described testing tool 12 is the testing tool of embodiment 1 described shape and structure.Described box body 8 usefulness medical plastics are made, as Fig. 3, Fig. 4, shown in Figure 5, profile is a rectangular parallelepiped, the shape and size of inner chamber and testing tool are complementary, its roof is provided with testing tool patchhole 11, its sidewall is provided with well 10 and viewport 9, described well 10 that position and the testing tool position of its sample pad 7 of packing into behind the box body is set is corresponding, described viewport 9 that position and the testing tool position of its detection line 4 and control line 3 of packing into behind the box body is set is corresponding.The detection box of made is standby with the aluminium foil bag sealed package that is placed with drying agent.
The using method of described detection box and detection principle are as follows:
The sample pad 7 that testing sample is added testing tool from the well 10 of box body 8, because chromatographic theory, testing sample moves up along the strip testing tool from sample pad 7, when moving to gold mark pad 6, gold is marked the dissolving of mouse-anti people IGFBP-1 monoclonal antibody bond, and be with gold mark mouse-anti people IGFBP-1 monoclonal antibody to continue to move up, when the detection line 4 that moves on the nitrocellulose filter, if there is IGFBP-1 antigen to exist in the sample, IGFBP-1 antigen in the anti-people IGFBP-1 of rabbit on the detection line 4 polyclonal antibody and gold mark mouse-anti people's IGFBP-1 monoclonal antibody and the sample will form a mauve sandwich immunoassay compound on detection line, a visible purplish red clearly colo(u)r streak on the detection line, this result is judged to the positive; IGFBP-1 antigenic content in the sample is high more, and the colo(u)r streak color is dark more.If there is not IGFBP-1 antigen in the sample, gold mark mouse-anti people IGFBP-1 monoclonal antibody then can not form compound with the anti-people IGFBP-1 of the rabbit on detection line polyclonal antibody, does not have colo(u)r streak to occur on the detection line, and this result is judged to be feminine gender.When testing sample continues to be moved upward to control line 3 with gold mark mouse-anti people IGFBP-1 monoclonal antibody, sheep anti mouse IGFBP-1 polyclonal antibody on the control line will be marked mouse-anti people IGFBP-1 monoclonal antibody with gold and combine, on control line, form a redness or purplish red colo(u)r streak, prove that testing tool is effective.Testing result is observed by the viewport on the box body 9 and is obtained.
Claims (10)
1. the testing tool of a fast detecting premature rupture of fetal membranes, it is characterized in that comprising liner (1), from top to bottom join successively and stick on adsorptive pads (2) on the liner, nitrocellulose filter (5), gold mark pad (6) and sample pad (7), described nitrocellulose filter (5) is provided with detection line (4) that is formed by the white 1 polyclonal antibody bag of the anti-human insulin-like growth factor binding protein of rabbit and the control line (3) that is formed by sheep anti mouse insulin-like growth factor binding protein 1 polyclonal antibody bag, detection line is positioned under the control line and the spacing of being separated by, and described gold mark pad (6) partly covers for the water-absorption fiber that is coated with the white 1 monoclonal antibody bond of gold mark mouse-anti human insulin-like growth factor binding protein and by sample pad.
2. the testing tool of fast detecting premature rupture of fetal membranes according to claim 1 is characterized in that the width of described detection line (4) and control line (3) is 0.8mm～1mm.
3. the testing tool of fast detecting premature rupture of fetal membranes according to claim 1 and 2 is characterized in that the spacing between described detection line (4) and the control line (3) is 10mm～12mm.
4. the testing tool of fast detecting premature rupture of fetal membranes according to claim 1 and 2 is characterized in that its rectangular strip that is shaped as.
5. the testing tool of fast detecting premature rupture of fetal membranes according to claim 3 is characterized in that its rectangular strip that is shaped as.
6. the testing tool of fast detecting premature rupture of fetal membranes according to claim 1 and 2 is characterized in that described adsorptive pads (2) is a thieving paper, and sample pad (7) is the water-absorption fiber pad.
7. the testing tool of fast detecting premature rupture of fetal membranes according to claim 3 is characterized in that described adsorptive pads (2) is a thieving paper, and sample pad (7) is the water-absorption fiber pad.
8. the testing tool of fast detecting premature rupture of fetal membranes according to claim 4 is characterized in that described adsorptive pads (2) is a thieving paper, and sample pad (7) is the water-absorption fiber pad.
9. the detection box of a fast detecting premature rupture of fetal membranes is made of the testing tool in the box body (8) and the box body of packing into; Described testing tool comprises liner (1), from top to bottom join successively and stick on adsorptive pads (2) on the liner, nitrocellulose filter (5), gold mark pad (6) and sample pad (7), described nitrocellulose filter (5) is provided with detection line (4) that is formed by the white 1 polyclonal antibody bag of the anti-human insulin-like growth factor binding protein of rabbit and the control line (3) that is formed by sheep anti mouse insulin-like growth factor binding protein 1 polyclonal antibody bag, described detection line is positioned under the control line and the spacing of being separated by, and described gold mark pad (6) partly covers for the water-absorption fiber that is coated with the white 1 monoclonal antibody bond of gold mark mouse-anti human insulin-like growth factor binding protein and by sample pad; The inner chamber of described box body and the shape and size of testing tool are complementary, the roof of described box body is provided with testing tool patchhole (11), sidewall is provided with well (10) and viewport (9), described well (10) that position and the testing tool position of its sample pad (7) of packing into behind the box body is set is corresponding, described viewport (9) that position and the testing tool position of its detection line (4) and control line (3) of packing into behind the box body is set is corresponding.
10. the detection box of fast detecting premature rupture of fetal membranes according to claim 9 is characterized in that the rectangular strip that is shaped as of described testing tool.
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| CN2010200376214U CN201583543U (en) | 2010-01-11 | 2010-01-11 | Test tool and test case for quickly testing premature rupture of membranes |
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| CN2010200376214U CN201583543U (en) | 2010-01-11 | 2010-01-11 | Test tool and test case for quickly testing premature rupture of membranes |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101871943A (en) * | 2010-06-02 | 2010-10-27 | 成都创宜生物科技有限公司 | Premature rupture of membrane fast examination tool using ICAM-1 as examination index and examination kit |
| CN101949925A (en) * | 2010-10-22 | 2011-01-19 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatographic test strip for rapidly testing prednisone acetate and derivative thereof and preparation method |
| CN101957376A (en) * | 2010-10-22 | 2011-01-26 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatography test paper for rapidly detecting guanidineacetic acid and derivatives thereof and preparation method thereof |
| CN101980021A (en) * | 2010-10-22 | 2011-02-23 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatography test strip for quickly detecting sibutramine and derivative thereof and preparation method |
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| CN102445534A (en) * | 2010-10-15 | 2012-05-09 | 无锡市凯奥善生物医药科技有限公司 | Combined assay kit for premature birth of pregnant woman and fetal membrane premature rupture |
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2010
- 2010-01-11 CN CN2010200376214U patent/CN201583543U/en not_active Expired - Fee Related
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101871943A (en) * | 2010-06-02 | 2010-10-27 | 成都创宜生物科技有限公司 | Premature rupture of membrane fast examination tool using ICAM-1 as examination index and examination kit |
| CN101871943B (en) * | 2010-06-02 | 2015-01-07 | 成都创宜生物科技有限公司 | Premature rupture of membrane fast examination tool using ICAM-1 as examination index and examination kit |
| CN102445534A (en) * | 2010-10-15 | 2012-05-09 | 无锡市凯奥善生物医药科技有限公司 | Combined assay kit for premature birth of pregnant woman and fetal membrane premature rupture |
| CN101949925A (en) * | 2010-10-22 | 2011-01-19 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatographic test strip for rapidly testing prednisone acetate and derivative thereof and preparation method |
| CN101957376A (en) * | 2010-10-22 | 2011-01-26 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatography test paper for rapidly detecting guanidineacetic acid and derivatives thereof and preparation method thereof |
| CN101980021A (en) * | 2010-10-22 | 2011-02-23 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatography test strip for quickly detecting sibutramine and derivative thereof and preparation method |
| CN101986156A (en) * | 2010-10-22 | 2011-03-16 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatography test paper for detecting glibenclamide and derivatives of glibenclamide quickly and preparation method thereof |
| CN101949925B (en) * | 2010-10-22 | 2013-07-31 | 南通市伊士生物技术有限责任公司 | Colloidal gold chromatographic test strip for rapidly testing prednisone acetate and derivative thereof and preparation method |
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| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20100915 Termination date: 20130111 |