CN102321730A - Joint vaginitis detection kit - Google Patents
Joint vaginitis detection kit Download PDFInfo
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- CN102321730A CN102321730A CN201110172859A CN201110172859A CN102321730A CN 102321730 A CN102321730 A CN 102321730A CN 201110172859 A CN201110172859 A CN 201110172859A CN 201110172859 A CN201110172859 A CN 201110172859A CN 102321730 A CN102321730 A CN 102321730A
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- detection reagent
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- hydrogen peroxide
- detection kit
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Abstract
The invention aims to provide a joint vaginitis detection kit which is convenient, quick and sensitive to operate, does not need any high-end instrument and equipment, and has low price. The technical scheme of the invention is to provide the joint vaginitis detection kit comprising a clamp-shaped reaction device with four dry chemical reaction blind holes, diluent and chromogenic reagent; and the four blind holes are respectively provided with a hydrogen peroxide concentration determination test reagent pad, a sialic acid glucoside enzyme activity test reagent pad, a leukocyte esterase activity determination test reagent pad and a vaginal fluid pH test reagent pad. The joint vaginitis detection kit can simultaneously test four indexes, i.e. the pH value of vaginal secretion, hydrogen peroxide, sialic acid glucoside enzyme and leukocyte esterase. Through the four indexes, the micro-ecological environment of vagina is determined, and the joint vaginitis detection kit is for identifying bacterial vaginosis of normal vaginal flora and bacteria groups.
Description
Technical field
The present invention relates to a kind of colpitic combined detection kit, be used in particular for auxiliary diagnosis women bacterial vaginosis.
Background technology
Bacterial vaginosis (bacterial vaginosis; Be called for short BV) be meant that one type shows as reproductive tract normal microflora (producing the lactobacillus spp of hydrogen peroxide) quantity and reduces on bacteriology, and a kind of disease of the no obvious mucous membrane inflammation that causes by multiple pathogenic anaerobic infection (mainly being gardnerella vaginalis).Bacterial vaginosis and trichomonacide are closely related, and 80% trichomonad patient infects with BV simultaneously; Be the major cause that causes colpitis mycotica, be prone to cause salpingitis, pelvic inflammatory disease, urinary system infection, postoperative infection, relevant with Infertility, ectopic pregnancy, gynecological tumor.The Gestation period is prone to take place BV because of hormonal change, and average infection rate is 16-37%, and the Gestation period suffers from BV and is prone to take place the premature labor or the childbirth infant of low-birth weight, than the high 3-4 of normal women doubly.Vaginal pathogenic can go upward to amnion, and chorio-amnion or amniotic fluid cause the infection and the inflammation at these positions.
Clinical diagnosis BV recognised standard is the Amsel standard at present, and the Amsel method comprises: 1. secretory product increases (the evenly viscous secretion of white); 2. pH＞4.5; 3. vaginal secretion mixes the release fishy smell with equivalent 10%KOH; 4. clues cell surpasses 20% (epithelial cell becomes the ratio of clues cell), more than three kinds of positives in four kinds of signs diagnosable be BV.This method is simple; But this method is subject to artificial factor (like proofer's experience; The quality of microscopy apparatus, the collection of sample and operator are to recognition capability of smell etc.); Reach the influence of infecting the irrelevant many factors of factor (after recent sexual intercourse, vagina lavation, being in menstrual period or menopause) with BV, subjectivity is strong.And bacterial vaginosis is a process that progressively takes place, and the Case definition that is divided into two for the Amsel method has been limited to its detection to BV.
Bacterial vaginosis mainly is that patient's ability of Lactobacillus in human vagina reduces and other malignant bacteria breeds in a large number, causes the intravaginal concentration of hydrogen peroxide to reduce, the rising of pH value; Pathogenic bacterium (Gardnerella, various anerobes and human body mycoplasma etc.) produce a large amount of neuraminidases (the significant products of bacterial vaginosis pathogenic bacterium) on the other hand, exceed 100-1000 doubly than the normal people.When patient's intravaginal was inflamed reaction, multinuclear leucocyte discharged leukocyte esterase in a large number in the inflammatory lesions gathering.
Summary of the invention
It is a kind of easy and simple to handle that the object of the invention is to provide; Fast; Sensitivity does not need high-end plant and instrument, cheap bacterial vaginopathy combined detection reagent box; Through detecting index associating primary dcreening operation bacterial vaginosiss such as hydrogen peroxide, neuraminidase, leukocyte esterase and pH value in the vaginal secretions, as the auxiliary diagnosis of bacterial vaginosis infection.
Technical scheme of the present invention is for providing a kind of vaginitis combined detection kit; Comprise cellular type card shape reaction unit and the diluent that is provided with four dry chemistry reaction blind holes, the liquid that develops the color, said four blind holes are provided with concentration of hydrogen peroxide and measure detection reagent pad, the active detection reagent pad of neuraminidase, leukocyte esterase determination of activity detection reagent pad, pH proofing unit.
Said diluent is the solution of the pH=6.5 of saline water and MES damping fluid composition, and the sodium-chlor mass percentage concentration in the said diluent is 0.9%, and the concentration of said MES damping fluid in diluent is 2mmol/L;
Said colour developing liquid is the solid purple B solution of mass percentage concentration 0.1-0.5%.
Preferably, described hydrogen peroxide detection reagent pad is will fill up carrier in the hydrogen peroxide detection reagent, to soak withering reagent pad afterwards, and described hydrogen peroxide detection reagent is made up of following material:
Chromogen: mass concentration is 8.0-25.0g/L, and said chromogen is N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3-monomethylaniline sodium salt or 3,5-two chloro-2-DHBSs;
The hydrogen peroxide developer: mass concentration is 0.02-0.68g/L; Said hydrogen peroxide developer is 1,3-methyl-2-[4-morpholinodithio quinoline ketone hydrazone hydrochloride hydrate;
Px: 200-1000KU/L.
Preferably, described leukocyte esterase detection reagent pad is will fill up carrier warp in by the leukocyte esterase detection reagent to soak withering reagent pad afterwards, and described leukocyte esterase detection reagent is made up of following material:
Enzyme substrates A: mass concentration is 0.5-3.5g/L, and described enzyme substrates A is 5-bromo-4 chloro-3 indolylacetic acid salt;
Carbohydrate: mass concentration is 35-55g/L, and said carbohydrate is sucrose or trehalose.
Preferably, described neuraminidase detection reagent pad is will fill up carrier warp in the active detection reagent of neuraminidase to soak withering reagent pad afterwards, and the active detection reagent of said neuraminidase is made up of following material:
Enzyme substrates B: mass concentration is 0.5-5g/L, and described enzyme substrates B is 5-bromo-4 chloro-3-indoles-N acetyl-α-sialyl glycosides, oil of mirbane-N-acetyl-α-sialyl glycosides, naphthols-N-acetyl-α-sialyl glycosides or 5-bromo-4 chloro-3-indyl n acetylneuraminic acid n salt;
Carbohydrate: mass concentration is 35-65g/L, and said carbohydrate is sucrose or trehalose.
Preferably, said pad carrier is filter paper glass fibre membrane or chromatographic paper.
Preferably, said pH proofing unit is the pH test paper.
Beneficial effect of the present invention is that bacterial vaginopathy combined detection reagent box of the present invention is united the intravaginal situation of judgement through the reaction result of four dry chemical reaction blind holes.Judge microecology in vaginas environment, the bacterial vaginopathy combined detection reagent box of vagina normal microflora and pathogenic flora situation through above four indexs.Its diagnosis to bacterial vaginosis has higher susceptibility and specificity, and comparing with traditional Amsel diagnosis and clinical microscopy has higher coincidence rate.And the present invention to the detection of vaginal secretions have easy and simple to handle, can repeat, objective, quick and inexpensive, and do not need characteristics such as specific apparatus, can be Clinical Laboratory and bring many facilities.The prevalence survey etc. that it can make a definite diagnosis vaginal infection like suspicious, in asymptomatic individuality, find to infect, investigation produces drug-fast case, helps choosing clinical therapeutic regimen, judges the healing back and carry out vaginal infection conventional treatment; Be one type of extremely promising gynecological diagnosis technology, should widely popularize application in the gynecological diagnosis field.
Embodiment
The preparation of embodiment 1 combined detection kit of the present invention:
The whatman glass microfiber filter paper 23SL that aperture 4.5mm is housed respectively in four holes of cellular type card shape reaction unit does the concentration of hydrogen peroxide reagent pad of carrier; Leukocyte esterase is measured reagent pad; Neuraminidase is measured reagent pad, and Prolyl iminopeptidase is measured reagent pad.
The making of hydrogen peroxide agent pad: will fill up carrier and carry out drying treatment after in following soak solution (hydrogen peroxide detection reagent), soaking, said soak solution is N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3-monomethylaniline sodium salt (TOOS) of 8.0g/L.
The making of leukocyte esterase detection reagent pad: will fill up carrier and in following soak solution (leukocyte esterase detection reagent), soak, said soak solution is: 5-bromo-4-chloro-3-indolyl acetic acid salt 0.5g/L; Sucrose 35g/L.
The making of neuraminidase detection reagent pad: will fill up carrier and carry out drying treatment after in following soak solution, soaking, said soak solution is: withering afterwards reagent pad.The active detection reagent of said neuraminidase is made up of following material: oil of mirbane-N-acetyl-α-sialyl glycosides 0.5g/L; Sucrose: 35g/L; 0.1% solid purple B solution carries out drying treatment afterwards.
Market is buied pH and is detected test paper.
Diluent preparing: the solution of the pH=6.5 that forms by saline water and MES damping fluid, the mass percentage concentration of said saline water in diluent is 0.9%, the concentration of said MES damping fluid in diluent is 2mmol/L.
Colour developing liquid is the solid purple B solution of mass percentage concentration 0.1%.
Another embodiment of embodiment 2 combined detection kits of the present invention:
The making of hydrogen peroxide agent pad: will fill up carrier and carry out drying treatment after in following soak solution, soaking, said soak solution is 3 of 15g/L, and 5-two chloro-2-DHBSs (DHBS) carry out drying treatment afterwards.
The making of leukocyte esterase detection reagent pad: will fill up carrier and in following soak solution, soak, said soak solution is: 5-bromo-4-chloro-3-indolyl acetic acid salt 2g/L; Sucrose 40g/L.
The making of neuraminidase detection reagent pad: will fill up carrier and in the following soak solution of detection reagent (the active detection reagent of neuraminidase), carry out drying treatment after the immersion, said soak solution is: withering afterwards reagent pad.The active detection reagent of said neuraminidase is made up of following material: oil of mirbane-N-acetyl-α-sialyl glycosides 0.5-5g/L; Sucrose: 40g/L; The solid purple B solution of 0.1-1.0% carries out drying treatment afterwards.
Market is buied pH and is detected test paper.
Diluent preparing: the solution of the pH=6.5 that forms by saline water and MES damping fluid, the mass percentage concentration of said saline water in diluent is 0.9%, the concentration of said MES damping fluid in diluent is 2mmol/L,
Colour developing liquid is the solid purple B solution of mass percentage concentration 0.2%.
The another embodiment of embodiment 3 combined detection kits of the present invention:
The making of hydrogen peroxide agent pad: will fill up carrier and carry out drying treatment after in following soak solution, soaking, said soak solution is 3 of 25g/L, and 5-two chloro-2-DHBSs (DHBS) carry out drying treatment afterwards.
The making of leukocyte esterase detection reagent pad: will fill up carrier and in following soak solution, soak, said soak solution is: 5-bromo-4-chloro-3-indolyl acetic acid salt 2g/L; Sucrose 60g/L.
The making of neuraminidase detection reagent pad: will fill up carrier and carry out drying treatment after in the following soak solution of detection reagent, soaking, said soak solution is: withering afterwards reagent pad.The active detection reagent of said neuraminidase is made up of following material: oil of mirbane-N-acetyl-α-sialyl glycosides 5g/L; Sucrose: 60g/L; 0.5% solid purple B solution carries out drying treatment afterwards.
Market is buied pH and is detected test paper.
Diluent preparing: the solution of the pH=6.5 that forms by saline water and MES damping fluid, the mass percentage concentration of said saline water in diluent is 0.9%, the concentration of said MES damping fluid in diluent is 2mmol/L,
Colour developing liquid is the solid purple B solution of mass percentage concentration 0.2%.
The use of embodiment 4 test kits of the present invention:
A. concentration of hydrogen peroxide detects: on the hydrogen peroxide pad 1,5-dimethyl--2-phenyl-4-amino-3-pyrazolone under the effect of hydrogen peroxide with the developer DHBS coloured product of generation that reacts.When containing a certain amount of hydrogen peroxide in the sample, reaction result shows redness or red-purple, and color depth is directly proportional with concentration of hydrogen peroxide, when concentration of hydrogen peroxide in the sample is lower than when a certain amount of the reacting pad nondiscoloration.
B. neuraminidase is active detects: after the interior neuraminidase hydrolysis of substrate on the neuraminidase pad--5-bromo-4-chloro-3-indyl n acetylneuraminic acid n sodium salt transvaginal; Exhibit red or red-violet colour after one of its product reacts with colored indicator are color depth and are directly proportional with the neuraminidase activity.
C. leukocyte esterase is active detects: white corpuscle esterase hydrolyzed in substrate on the leukocyte esterase pad--the 5-bromo-4-chloro-3-indoleacetic acid ester transvaginal; The oxygen effect in air of one of its product is blue-greenish colour or blueness after issuing and being conigenous my polymerization, is color depth and is directly proportional with the leukocyte esterase activity.
The D.pH value detects: pH value pad is gone up the indicator substrate at different pHs, shows that corresponding color changes.
The bacterial vaginopathy combined detection reagent box is operated as follows:
With aseptic cotton swab in posterior fornix or vagina depths rotation 2-10 week, stop 10-20 second, collection patient vaginal secretions as much as possible has secretory product to adhere to be as the criterion with clear seeing on the cotton swab.Sample after the sampling should in time be measured, otherwise should be kept at 2-8 ℃, accomplishes in 24 hours and measures.
2. get an aseptic application of sample test tube, drip diluent 12-15 and drip, examination of having taken a sample is placed this test tube, extruding examination fully disengages vaginal secretions repeatedly, obtains sample liquid.
3. draw sample liquid with suction pipe, in four holes of test card, respectively add 1 sample liquid (about 30 μ L), in the hole that is provided with neuraminidase detection reagent pad, add one of colour developing liquid then.
4. will detect 37 ℃ of incubations of holding 15 minutes, sentence read result.
The colorimetric card that provides according to test kit carries out sentence read result:
Bacterial vaginosis mainly is that patient's ability of Lactobacillus in human vagina reduces and other malignant bacteria breeds in a large number, causes the intravaginal concentration of hydrogen peroxide to reduce, the rising of pH value; Pathogenic bacterium (Gardnerella, various anerobes and human body mycoplasma etc.) produce a large amount of neuraminidases (the significant products of bacterial vaginosis pathogenic bacterium) on the other hand, exceed 100-1000 doubly than the normal people.When patient's intravaginal was inflamed reaction, multinuclear leucocyte discharged leukocyte esterase in a large number in the inflammatory lesions gathering.
Hydrogen peroxide index: normally show redness or purple, undesired colourless or blush;
The neuraminidase index: normally do not develop the color, it is positive to show redness or purple;
Leukocyte esterase index: normally do not develop the color, show blue or green positive;
The pH value detects: pH value pad is gone up the indicator substrate at different pHs, shows that corresponding color changes.
The above is merely embodiments of the invention; Be not so limit claim of the present invention; Every utilize specification sheets of the present invention and in equivalent structure or the equivalent flow process conversion done; Or directly or indirectly be used in other relevant technical fields, all in like manner be included in the scope of patent protection of the present invention.
Claims (6)
1. vaginitis combined detection kit; It is characterized in that; Comprise be provided with four dry chemistry reaction blind holes cellular type card shape reaction unit with diluent, liquid develops the color; Said four blind holes are provided with concentration of hydrogen peroxide and measure detection reagent pad, the active detection reagent pad of neuraminidase, leukocyte esterase determination of activity detection reagent pad, pH proofing unit
Said diluent is the solution of the pH=6.5 of saline water and MES damping fluid composition, and the sodium-chlor mass percentage concentration in the said diluent is 0.9%, and the concentration of said MES damping fluid in diluent is 2mmol/L;
Said colour developing liquid is the solid purple B solution of mass percentage concentration 0.1-0.5%.
2. by the described vaginitis combined detection kit of claim 1; It is characterized in that; Described hydrogen peroxide detection reagent pad is will fill up carrier in the hydrogen peroxide detection reagent, to soak withering reagent pad afterwards, and described hydrogen peroxide detection reagent is made up of following material:
Chromogen: mass concentration is 8.0-25.0g/L, and said chromogen is N-ethyl-N-(2-hydroxyl-3-sulfopropyl)-3-monomethylaniline sodium salt or 3,5-two chloro-2-DHBSs;
The hydrogen peroxide developer: mass concentration is 0.02-0.68g/L; Said hydrogen peroxide developer is 1,3-methyl-2-[4-morpholinodithio quinoline ketone hydrazone hydrochloride hydrate;
Px: 200-1000KU/L.
3. by the described vaginitis combined detection kit of claim 1; It is characterized in that; Described leukocyte esterase detection reagent pad is will fill up carrier warp in by the leukocyte esterase detection reagent to soak withering reagent pad afterwards, and described leukocyte esterase detection reagent is made up of following material:
Enzyme substrates A: mass concentration is 0.5-3.5g/L, and described enzyme substrates A is 5-bromo-4 chloro-3 indolylacetic acid salt;
Carbohydrate: mass concentration is 35-55g/L, and said carbohydrate is sucrose or trehalose.
4. by the described vaginitis combined detection kit of claim 1; It is characterized in that; Described neuraminidase detection reagent pad is will fill up carrier warp in the active detection reagent of neuraminidase to soak withering reagent pad afterwards, and the active detection reagent of said neuraminidase is made up of following material:
Enzyme substrates B: mass concentration is 0.5-5g/L, and described enzyme substrates B is 5-bromo-4 chloro-3-indoles-N acetyl-α-sialyl glycosides, oil of mirbane-N-acetyl-α-sialyl glycosides, naphthols-N-acetyl-α-sialyl glycosides or 5-bromo-4 chloro-3-indyl n acetylneuraminic acid n salt;
Carbohydrate: mass concentration is 35-65g/L, and said carbohydrate is sucrose or trehalose.
5. by the described vaginitis combined detection kit of claim 1, it is characterized in that said pad carrier is filter paper glass fibre membrane or chromatographic paper.
6. by the described vaginitis combined detection kit of claim 1, it is characterized in that said pH proofing unit is the pH test paper.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110172859A CN102321730A (en) | 2011-06-23 | 2011-06-23 | Joint vaginitis detection kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110172859A CN102321730A (en) | 2011-06-23 | 2011-06-23 | Joint vaginitis detection kit |
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| Publication Number | Publication Date |
|---|---|
| CN102321730A true CN102321730A (en) | 2012-01-18 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110172859A Pending CN102321730A (en) | 2011-06-23 | 2011-06-23 | Joint vaginitis detection kit |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102998440A (en) * | 2012-12-28 | 2013-03-27 | 闫志文 | Dry chemical multinomial detecting device |
| CN104792986A (en) * | 2015-02-14 | 2015-07-22 | 江苏宜偌维盛生物技术有限公司 | Multi-indexes joint detection kit for vaginitis |
| CN106226301A (en) * | 2016-08-22 | 2016-12-14 | 长沙励思生物技术有限公司 | Vaginitis multi-joint detection card |
| CN106442989A (en) * | 2016-09-30 | 2017-02-22 | 广州鸿琪光学仪器科技有限公司 | Proline aminopeptidase detection reagent, reaction pad, preparation method of reaction pad, and kit |
| WO2018001215A1 (en) * | 2016-06-27 | 2018-01-04 | 广州瑞博奥生物科技有限公司 | Kit for detecting bacterial vaginosis |
| CN109490519A (en) * | 2018-10-16 | 2019-03-19 | 迪瑞医疗科技股份有限公司 | A kind of leukocyte esterase Test paper and preparation method thereof |
| CN114317678A (en) * | 2021-12-31 | 2022-04-12 | 港龙生物技术（深圳）有限公司 | Biological paper chip, high-flux multi-connection detection microporous plate device, preparation method and kit for multi-connection detection of vaginitis |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1850985A (en) * | 2006-03-07 | 2006-10-25 | 北京中生金域诊断技术有限公司 | Combined test kit for bacterial vagina disease |
| CN101487041A (en) * | 2009-02-26 | 2009-07-22 | 广州鸿琪光学仪器科技有限公司 | Bacterial vaginopathy combined detection reagent |
-
2011
- 2011-06-23 CN CN201110172859A patent/CN102321730A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1850985A (en) * | 2006-03-07 | 2006-10-25 | 北京中生金域诊断技术有限公司 | Combined test kit for bacterial vagina disease |
| CN101487041A (en) * | 2009-02-26 | 2009-07-22 | 广州鸿琪光学仪器科技有限公司 | Bacterial vaginopathy combined detection reagent |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102998440A (en) * | 2012-12-28 | 2013-03-27 | 闫志文 | Dry chemical multinomial detecting device |
| CN104792986A (en) * | 2015-02-14 | 2015-07-22 | 江苏宜偌维盛生物技术有限公司 | Multi-indexes joint detection kit for vaginitis |
| WO2018001215A1 (en) * | 2016-06-27 | 2018-01-04 | 广州瑞博奥生物科技有限公司 | Kit for detecting bacterial vaginosis |
| CN107541543A (en) * | 2016-06-27 | 2018-01-05 | 广州瑞博奥生物科技有限公司 | The kit of detection bacterium vaginosis |
| CN106226301A (en) * | 2016-08-22 | 2016-12-14 | 长沙励思生物技术有限公司 | Vaginitis multi-joint detection card |
| CN106442989A (en) * | 2016-09-30 | 2017-02-22 | 广州鸿琪光学仪器科技有限公司 | Proline aminopeptidase detection reagent, reaction pad, preparation method of reaction pad, and kit |
| CN109490519A (en) * | 2018-10-16 | 2019-03-19 | 迪瑞医疗科技股份有限公司 | A kind of leukocyte esterase Test paper and preparation method thereof |
| CN114317678A (en) * | 2021-12-31 | 2022-04-12 | 港龙生物技术（深圳）有限公司 | Biological paper chip, high-flux multi-connection detection microporous plate device, preparation method and kit for multi-connection detection of vaginitis |
| CN114317678B (en) * | 2021-12-31 | 2023-11-10 | 港龙生物技术（深圳）有限公司 | Biological paper chip, high-throughput multi-detection microplate device, preparation method and kit for vaginal inflammation multi-detection |
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Application publication date: 20120118 |