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CN107300615A - A kind of antenatal detection reagent and its detection articles for use - Google Patents

A kind of antenatal detection reagent and its detection articles for use Download PDF

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Publication number
CN107300615A
CN107300615A CN201710667898.1A CN201710667898A CN107300615A CN 107300615 A CN107300615 A CN 107300615A CN 201710667898 A CN201710667898 A CN 201710667898A CN 107300615 A CN107300615 A CN 107300615A
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China
Prior art keywords
detection reagent
detection
antenatal
articles
peg20000
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Pending
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CN201710667898.1A
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Chinese (zh)
Inventor
汤永平
潘秀华
陈静仪
张晓丽
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GUANGZHOU MICRON BIOTECHNOLOGY Co Ltd
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GUANGZHOU MICRON BIOTECHNOLOGY Co Ltd
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Priority to CN201710667898.1A priority Critical patent/CN107300615A/en
Publication of CN107300615A publication Critical patent/CN107300615A/en
Pending legal-status Critical Current

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14539Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/43Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343Pregnancy and labour monitoring, e.g. for labour onset detection
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/528Atypical element structures, e.g. gloves, rods, tampons, toilet paper
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/36Gynecology or obstetrics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Optics & Photonics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention discloses a kind of antenatal detection reagent and its detection articles for use, aim to provide a kind of discoloration accurate detection reagent of sensitive, testing result, the present invention also provides the detection articles for use containing the detection reagent, and the detection articles for use are using simple, detection time is short, testing result is accurate;It is such that its first skill, which states scheme,:The antenatal detection reagent, mainly includes the component of following mass percents, 0.8 1.2% nitro-nitrogen yellow, and 1.5 2.5%PEG20000, surplus is solvent;It is that will be supported on the cotton swab of aseptic cotton stick swab that detection reagent rod is made in the antenatal detection reagent that its second skill, which states scheme,;Or on be supported on conventional hygienic protection pad detection reagent panty liner be made.

Description

A kind of antenatal detection reagent and its detection articles for use
Skill states field
The invention discloses a kind of detection reagent and its detection articles for use, specifically, be a kind of antenatal detection reagent and its Detect articles for use.
Background skill is stated
For common woman, whether detection vaginal fluid has normally generally detected whether vaginitis;For just before giving birth Pregnant woman for, whether detection vaginal fluid normal more to detect whether leakage of amniotic fluid.
Vaginitis is the inflammation of connective tissue under vagina mucosa and mucous membrane, is the common disease of Out-patient Clinic of Department of Gynecology, common the moon Road inflammation has bacterial vaginitis, monilial vaginitis, trichomonas vaginitis, gonococcus property vaginitis etc..Vaginitis is clinically Changed using the character of leukorrhea and pruritus vulvue cusalgia is major clinical feature.Research discovery, vaginitis and premature labor, inflammation The obstetrical and gynecological diseases such as disease, infertility, tumour are closely related.Therefore, carried out before gynaecology, obstetrics and implementation surgery miscarriage are stated white Band routine inspection tool is of great significance.
Leakage of amniotic fluid:Refer to after premature rupture of fetal membranes, leakage of amniotic fluid is into vagina., can if leakage of amniotic fluid is detected not in time It can trigger the complication such as fetus premature labor, fetal distress in uterus, fetus bradytoia anoxic and mother and baby's infection.
For common woman, the detection whether normal method of vaginal fluid mainly has Microscope examination, such a Although method result is more accurate, it is higher that skill cumbersome, to user states requirement.
For pregnant woman just before giving birth, whether detection vaginal fluid is normally more to detect whether premature rupture of fetal membranes, if having Leakage of amniotic fluid has pH test paper methods to vagina, the at present method of detection leakage of amniotic fluid, and such a method is easily influenceed by urine, knot It is really inaccurate, easily there is false negative result, clinical judgment causes certain interference.
The content of the invention
For the above method, it is an object of the invention to provide one kind discoloration accurate detection reagent of sensitive, result, the present invention The detection articles for use containing the detection reagent are also provided, detection articles for use use is simple, detection time is short, testing result is accurate.
Therefore, it is such that first skill that the present invention is provided, which states scheme,:
A kind of antenatal detection reagent, mainly includes the component of following mass percents, 0.8-1.2% nitro-nitrogen yellows, 1.5- 2.5%PEG20000, surplus is solvent.
It is preferred that, a kind of above-mentioned antenatal detection reagent, in addition to 1.5-2.5% fructose.
It is preferred that, a kind of above-mentioned antenatal detection reagent, described solvent is purified water.
It is preferred that, a kind of above-mentioned antenatal detection reagent, described solvent is by ethanol and purified water according to volume ratio 3-5:1 Composition.
A kind of detection articles for use of antenatal detection reagent, including reagent rod and panty liner.
It is preferred that, above-mentioned detection articles for use, described detection reagent rod includes test bar body, described test bar body Upper end, which is wound, loads antenatal detection reagent layer in sterile cotton fresh idea, described sterile cotton fresh idea.
It is furthermore preferred that above-mentioned one kind is used for antenatal detection reagent rod, described detection reagent rod by following step according to It is secondary to be made:
1) each component is weighed;
2) nitro-nitrogen yellow, PEG20000, fructose are added in purified water, stirring and dissolving obtains solution;
3) cotton swab of aseptic cotton stick swab is soaked in 3-5min in above-mentioned solution;
4) take out, 30min is toasted in 50 DEG C of baking ovens;
5) load sleeve, sealed with bag film;
6) it is sterilized with gamma-radiation.
It is furthermore preferred that above-mentioned one kind is used for antenatal detection reagent rod, in addition to 80% ethanol is added to step 2) In solution, stirring and dissolving.
It is preferred that, above-mentioned detection articles for use, described detection panty liner is by antenatal detection reagent described in claim 1 On be supported on conventional sanitary towels inner surface.
It is preferred that, above-mentioned detection articles for use, described detection panty liner passes sequentially through following step and is made successively:
1) each component is weighed;
2) nitro-nitrogen yellow, PEG20000, fructose are added in purified water, stirring and dissolving obtains solution;
3) according to each panty liner 0.6mL-1.0mL amount, above-mentioned solution is uniformly added in pad surface;
4) protection pad is less than in 30% drying room in humidity and dried naturally;
5) sealed with packaging bag;
6) it is sterilized with gamma-radiation.
Compared with prior art, the present invention can be examined quickly with the cotton swab for containing nitro-nitrogen yellow as detection reagent rod Whether normal survey vagina secretion.Nitro-nitrogen yellow is a kind of pH indicator, and its color change interval is 6.0~7.0, and color change is Yellow-Blue, during 50 DEG C dry, if nitro-nitrogen yellow for a long time and air contact, can be oxidized to green, therefore in formula In with the addition of PEG20000, form layer protecting film, prevent it to be oxidized;Added in formula 80% ethanol, make its fast Rapid-curing cutback is dry, can be dried completely in 30min.
The technical scheme that the present invention is provided is particularly suitable for puerpera, and detection reagent rod is inserted at 1/3 under its vagina, rotates 3- 5 circles, take out, and observe the color change of detection reagent rod, if its color is yellow, show that its is normal;If its color is Green, then show there is slight leakage of amniotic fluid;If its color is blueness, show that its leakage of amniotic fluid is more serious.With pH test paper Method is compared, and its result is more accurate, is not easily susceptible to the influence of urine, can preferably be applied to clinic.
The technical scheme that the present invention is provided equally is practically applicable to common woman, and detection reagent rod is inserted at 1/3 under its vagina, 3-5 circles are rotated, are taken out, the color change of detection reagent rod is observed, if its color is yellow, show that its is normal;If its Color is green, then shows that it has vaginitis, vagina mild infection;If its color is blueness, show that its vagina infection is tight Weight.Compared with microscopic techniques, it is low to personnel requirement using simple, result is may occur in which in 1min;Need not be micro- The instrument and equipments such as mirror, are adapted to basic unit's application;
It will be supported in the technical scheme that the present invention is provided in detection reagent on panty liner, client need not go to hospital, only Need the protection pad note that provides of the present invention on underpants, the problems such as just can detecting whether vagina infection or leakage of amniotic fluid In the presence of, it is greatly convenient for users to use, the individual privacy of user is also protected well.
Brief description of the drawings
Fig. 1 is the detection reagent rod structural representation that the present invention is provided;
Fig. 2 is the panty liner structural representation that the present invention is provided.
Embodiment
With reference to embodiment, the claim to the present invention is described in further detail.
Embodiment 1
One kind that the present invention is provided is used for antenatal detection reagent, is made up of the component of following weight percentage:1% nitrate nitrogen Yellow, 2%PEG20000,70% ethanol, remaining be purified water.
Embodiment 2
One kind that the present invention is provided is used for antenatal detection reagent, is made up of the component of following weight percentage:0.8% nitrate nitrogen Huang, 80% ethanol, 1.5%PEG20000,1.5% fructose, remaining be purified water.
Embodiment 3
One kind that the present invention is provided is used for antenatal detection reagent, is made up of the component of following weight percentage:1.2% nitrate nitrogen Huang, 60% ethanol, 2.5%PEG20000,2.5% fructose, remaining be purified water.
Embodiment 4
A kind of antenatal detection reagent rod that the present invention is provided, refering to Fig. 1, including test bar body 1, described test bar sheet In the upper end of body 1 winding sterile cotton fresh idea 2, described sterile cotton fresh idea 2 load embodiment 1 to 3 it is any it is described be used for it is antenatal Detection reagent forms antenatal detection reagent layer 3, and the bottom of described test bar body 1 is additionally provided with flexible handle 4, and described is soft Property handle 4 is socketed in the bottom of test bar body 1.
Specific preparation method is as follows:
1) each component is weighed according to any one group of percetage by weight in embodiment 1 to 3;
2) nitro-nitrogen yellow, PEG20000, fructose (if without fructose in embodiment component, without adding) are added to purifying In water, stirring and dissolving;
3) ethanol is added in above-mentioned solution, stirring and dissolving;
4) cotton swab of aseptic cotton stick swab is soaked in 3-5min in above-mentioned solution;
5) take out, 30min is toasted in 50 DEG C of baking ovens;
6) load sleeve, sealed with bag film;
7) it is sterilized with gamma-radiation.
Embodiment 5
A kind of vaginal fluid quick detection panty liner that the present invention is provided, it is described refering to Fig. 2, including conventional protection pad 5 Conventional protection pad inner surface on be loaded with embodiment 1 to 3 it is any described be used for antenatal detection reagent formation detection layers 6.
Specific preparation method is as follows:
1) each component is weighed according to any one group of percetage by weight in embodiment 1 to 3;
2) nitro-nitrogen yellow, PEG20000, fructose (if without fructose in embodiment component, without adding) are added to purifying In water, stirring and dissolving;
3) ethanol is added in above-mentioned solution, stirring and dissolving;
4) according to each panty liner 0.6mL-1.0mL amount, above-mentioned solution is uniformly added in pad surface;
5) protection pad is less than in 30% drying room in humidity and dried naturally;
6) sealed with packaging bag;
7) it is sterilized with gamma-radiation.
Embodiment 6
One kind that the present invention is provided is used for antenatal detection reagent, is made up of following weight percentage component:1% nitro-nitrogen yellow, 2%PEG20000, remaining be purified water.
Embodiment 7
One kind that the present invention is provided is used for antenatal detection reagent, is made up of following weight percentage component:0.8% nitrate nitrogen Huang, 1.5%PEG20000,2% fructose, remaining be purified water.
Embodiment 8
A kind of antenatal detection reagent rod that the present invention is provided, its structure and the detection reagent rod structure provided in embodiment 4 Identical, difference is, what load embodiment 5 to 6 was any described in described sterile cotton fresh idea 2 is used for antenatal detection reagent Form antenatal detection reagent layer.
Specific preparation method is as follows:
1) each component is weighed according to any one group of percetage by weight in embodiment 6 to 7;
2) nitro-nitrogen yellow, PEG20000 (PEG 20000), fructose are added in purified water, stirring and dissolving;
3) cotton swab of aseptic cotton stick swab is soaked in 3-5min in above-mentioned solution;
4) take out, 30min is toasted in 50 DEG C of baking ovens;
5) load sleeve, sealed with bag film;
6) it is sterilized with gamma-radiation.
Embodiment 9
A kind of vaginal fluid quick detection panty liner that the present invention is provided, its structure and the inspection provided in embodiment 5 Survey panty liner structure identical, including conventional protection pad is loaded with embodiment 6 to 7 on the inner surface of described conventional protection pad any Described is used for antenatal detection reagent.
Specific preparation method is as follows:
1) each component is weighed according to any one group of percetage by weight in embodiment 6 to 7;
2) nitro-nitrogen yellow, PEG20000, fructose (if without fructose, without adding) are added in purified water, stirred molten Solution;
3) ethanol is added in above-mentioned solution, stirring and dissolving;
4) according to each panty liner 0.6mL-1.0mL amount, above-mentioned solution is uniformly added in pad surface;
5) protection pad is less than in 30% drying room in humidity and dried naturally;
6) sealed with packaging bag;
7) it is sterilized with gamma-radiation.
The specifically used method of test bar is as follows:
For common woman, test bar is inserted at 1/3 under its vagina, rotation 3-5 circles take out, observe test bar Color change, if its color be yellow, show that its is normal;If its color is green, show that it has vaginitis, it is cloudy Road mild infection;If its color is blueness, show that its vagina infection is serious.
For pregnant woman just before giving birth, test bar is inserted at 1/3 under its vagina, rotation 3-5 circles take out, observation detection The color change of rod, if its color is yellow, shows that its is normal;If its color is green, show there is slight sheep Water seepage;If its color is blueness, show that its leakage of amniotic fluid is more serious.
Detect that panty liner application method is as follows:
For common woman, panty liner is pasted on underpants, the color change of protection pad is observed, if its color is Yellow, then show that its is normal;If its color is green, show that it has vaginitis, vagina mild infection;If its color is Blueness, then show that its vagina infection is serious.
For pregnant woman just before giving birth, panty liner is pasted on underpants, the color change of protection pad is observed, if its color For yellow, then show that its is normal;If its color is green, show there is slight leakage of amniotic fluid;If its color is blueness, Then show that its leakage of amniotic fluid is more serious.
Above-described embodiment is preferably embodiment, but embodiments of the present invention are not by above-described embodiment of the invention Limitation, other any Spirit Essences without departing from the present invention and the change made under principle, modification, replacement, combine, simplification, Equivalent substitute mode is should be, protection scope of the present invention is included in.

Claims (10)

1. a kind of antenatal detection reagent, it is characterised in that mainly include the component of following mass percents, 0.8-1.2% nitrate nitrogens Huang, 1.5-2.5%PEG20000, surplus is solvent.
2. a kind of antenatal detection reagent according to claim 1, it is characterised in that also including 1.5-2.5% fructose.
3. a kind of antenatal detection reagent according to claim 1, it is characterised in that described solvent is purified water.
4. a kind of antenatal detection reagent according to claim 1, it is characterised in that described solvent is by ethanol and purified water According to volume ratio 3-5:1 composition.
5. a kind of detection articles for use of the antenatal detection reagent containing described in claim 1, it is characterised in that including reagent rod and health Protection pad.
6. detection articles for use according to claim 5, it is characterised in that described detection reagent rod includes test bar body (1) the antenatal detection examination in upper end winding sterile cotton fresh idea (2), described sterile cotton fresh idea (2) described in load claim 1 Oxidant layer (3).
7. it is according to claim 6 a kind of for antenatal detection reagent rod, it is characterised in that described detection reagent rod leads to Following step is crossed to be made successively:
1) each component is weighed according to claim 1 percetage by weight;
2) nitro-nitrogen yellow, PEG20000, fructose are added in purified water, stirring and dissolving obtains solution;
3) cotton swab of aseptic cotton stick swab is soaked in 3-5min in above-mentioned solution;
4) take out, 30min is toasted in 50 DEG C of baking ovens;
5) load sleeve, sealed with bag film;
6) it is sterilized with gamma-radiation.
8. it is according to claim 7 a kind of for antenatal detection reagent rod, it is characterised in that also including 80% ethanol is added Enter to step 2) solution in, stirring and dissolving.
9. detection articles for use according to claim 5, it is characterised in that described detection panty liner is by claim 1 Conventional sanitary towels inner surface is supported in described antenatal detection reagent.
10. detection articles for use according to claim 9, it is characterised in that described detection panty liner passes sequentially through following Step is made successively:
1) each component is weighed according to claim 1 percetage by weight;
2) nitro-nitrogen yellow, PEG20000, fructose are added in purified water, stirring and dissolving obtains solution;
3) according to each panty liner 0.6mL-1.0mL amount, above-mentioned solution is uniformly added in pad surface;
4) protection pad is less than in 30% drying room in humidity and dried naturally;
5) sealed with packaging bag;
(6) it is sterilized with gamma-radiation.
CN201710667898.1A 2017-08-07 2017-08-07 A kind of antenatal detection reagent and its detection articles for use Pending CN107300615A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710667898.1A CN107300615A (en) 2017-08-07 2017-08-07 A kind of antenatal detection reagent and its detection articles for use

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201710667898.1A CN107300615A (en) 2017-08-07 2017-08-07 A kind of antenatal detection reagent and its detection articles for use

Publications (1)

Publication Number Publication Date
CN107300615A true CN107300615A (en) 2017-10-27

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US20070003993A1 (en) * 2001-07-19 2007-01-04 Amnon Kritzman Secretion-monitoring article
CN101512009A (en) * 2006-08-31 2009-08-19 金伯利-克拉克环球有限公司 Array for rapid detection of a microorganism
US20100136707A1 (en) * 2001-07-19 2010-06-03 Amnon Kritzman Methods for monitoring pathological conditions in a female subject
CN201752403U (en) * 2010-04-01 2011-03-02 苏州市玮琪生物科技有限公司 Diagnostic tool for continuously monitoring premature rupture of membrane
CN203089556U (en) * 2013-01-31 2013-07-31 陈维京 Female hygienic product with inflammation-detecting function
CN204814434U (en) * 2015-07-13 2015-12-02 上海翔翊医疗器械有限公司 A protection pad for detecting amniotic fluid
CN205458804U (en) * 2016-02-04 2016-08-17 广州市微米生物科技有限公司 Swab stick with short -term test function

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070003993A1 (en) * 2001-07-19 2007-01-04 Amnon Kritzman Secretion-monitoring article
US20100136707A1 (en) * 2001-07-19 2010-06-03 Amnon Kritzman Methods for monitoring pathological conditions in a female subject
WO2004022115A1 (en) * 2002-09-09 2004-03-18 Kimberly-Clark Worldwide, Inc. Absorbent product moisturizing and lubricating composition
CN101512009A (en) * 2006-08-31 2009-08-19 金伯利-克拉克环球有限公司 Array for rapid detection of a microorganism
CN201752403U (en) * 2010-04-01 2011-03-02 苏州市玮琪生物科技有限公司 Diagnostic tool for continuously monitoring premature rupture of membrane
CN203089556U (en) * 2013-01-31 2013-07-31 陈维京 Female hygienic product with inflammation-detecting function
CN204814434U (en) * 2015-07-13 2015-12-02 上海翔翊医疗器械有限公司 A protection pad for detecting amniotic fluid
CN205458804U (en) * 2016-02-04 2016-08-17 广州市微米生物科技有限公司 Swab stick with short -term test function

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程裴丽: "应用硝嗪黄拭子试验诊断胎膜破裂", 《国外医学.妇产科学分册》 *

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Application publication date: 20171027

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