CN109402221B - A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application - Google Patents
A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application Download PDFInfo
- Publication number
- CN109402221B CN109402221B CN201811140241.0A CN201811140241A CN109402221B CN 109402221 B CN109402221 B CN 109402221B CN 201811140241 A CN201811140241 A CN 201811140241A CN 109402221 B CN109402221 B CN 109402221B
- Authority
- CN
- China
- Prior art keywords
- reagent
- quick detection
- bacterial vaginosis
- phosphate buffer
- detection kit
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000001514 detection method Methods 0.000 title claims abstract description 77
- 208000004926 Bacterial Vaginosis Diseases 0.000 title claims abstract description 59
- 208000037009 Vaginitis bacterial Diseases 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 76
- 239000008363 phosphate buffer Substances 0.000 claims abstract description 52
- SQVRNKJHWKZAKO-UHFFFAOYSA-N beta-N-Acetyl-D-neuraminic acid Natural products CC(=O)NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO SQVRNKJHWKZAKO-UHFFFAOYSA-N 0.000 claims abstract description 22
- 150000003839 salts Chemical class 0.000 claims abstract description 18
- 229940113115 polyethylene glycol 200 Drugs 0.000 claims abstract description 10
- 239000002202 Polyethylene glycol Substances 0.000 claims description 9
- 229920001223 polyethylene glycol Polymers 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- 241000894006 Bacteria Species 0.000 claims description 8
- 239000000872 buffer Substances 0.000 claims description 5
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 claims 2
- 229910052698 phosphorus Inorganic materials 0.000 claims 2
- 239000011574 phosphorus Substances 0.000 claims 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims 2
- IGLKELDWPZFFKF-UHFFFAOYSA-N OC(C1=CC=CC=C1C(O)=O)=O.OC(C1=CC=CC=C1C(O)=O)=O.OC(C1=CC=CC=C1C(O)=O)=O.P.P Chemical compound OC(C1=CC=CC=C1C(O)=O)=O.OC(C1=CC=CC=C1C(O)=O)=O.OC(C1=CC=CC=C1C(O)=O)=O.P.P IGLKELDWPZFFKF-UHFFFAOYSA-N 0.000 claims 1
- 238000012360 testing method Methods 0.000 abstract description 39
- 230000035945 sensitivity Effects 0.000 abstract description 13
- 238000005259 measurement Methods 0.000 abstract description 3
- 230000000052 comparative effect Effects 0.000 description 56
- 102000005348 Neuraminidase Human genes 0.000 description 23
- 108010006232 Neuraminidase Proteins 0.000 description 23
- 239000000243 solution Substances 0.000 description 19
- 239000007788 liquid Substances 0.000 description 18
- 238000006243 chemical reaction Methods 0.000 description 17
- 239000003795 chemical substances by application Substances 0.000 description 13
- 238000000034 method Methods 0.000 description 8
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 201000010099 disease Diseases 0.000 description 5
- 210000001215 vagina Anatomy 0.000 description 5
- 208000015181 infectious disease Diseases 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000010998 test method Methods 0.000 description 4
- 102000004190 Enzymes Human genes 0.000 description 3
- 108090000790 Enzymes Proteins 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 3
- 241000287436 Turdus merula Species 0.000 description 3
- 230000003139 buffering effect Effects 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 230000007547 defect Effects 0.000 description 3
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- 229910052708 sodium Inorganic materials 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- 101710088194 Dehydrogenase Proteins 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- ROOXNKNUYICQNP-UHFFFAOYSA-N ammonium persulfate Chemical compound [NH4+].[NH4+].[O-]S(=O)(=O)OOS([O-])(=O)=O ROOXNKNUYICQNP-UHFFFAOYSA-N 0.000 description 2
- 238000003149 assay kit Methods 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 210000003756 cervix mucus Anatomy 0.000 description 2
- 239000007795 chemical reaction product Substances 0.000 description 2
- 238000003745 diagnosis Methods 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 230000035935 pregnancy Effects 0.000 description 2
- 238000004904 shortening Methods 0.000 description 2
- 239000012475 sodium chloride buffer Substances 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- 241001148471 unidentified anaerobic bacterium Species 0.000 description 2
- DWNBOPVKNPVNQG-LURJTMIESA-N (2s)-4-hydroxy-2-(propylamino)butanoic acid Chemical compound CCCN[C@H](C(O)=O)CCO DWNBOPVKNPVNQG-LURJTMIESA-N 0.000 description 1
- WZRJTRPJURQBRM-UHFFFAOYSA-N 4-amino-n-(5-methyl-1,2-oxazol-3-yl)benzenesulfonamide;5-[(3,4,5-trimethoxyphenyl)methyl]pyrimidine-2,4-diamine Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1.COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 WZRJTRPJURQBRM-UHFFFAOYSA-N 0.000 description 1
- CERZMXAJYMMUDR-QBTAGHCHSA-N 5-amino-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid Chemical compound N[C@@H]1[C@@H](O)CC(O)(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO CERZMXAJYMMUDR-QBTAGHCHSA-N 0.000 description 1
- 241000193830 Bacillus <bacterium> Species 0.000 description 1
- 208000003322 Coinfection Diseases 0.000 description 1
- 208000004145 Endometritis Diseases 0.000 description 1
- 208000009849 Female Genital Neoplasms Diseases 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- SQVRNKJHWKZAKO-LUWBGTNYSA-N N-acetylneuraminic acid Chemical compound CC(=O)N[C@@H]1[C@@H](O)CC(O)(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO SQVRNKJHWKZAKO-LUWBGTNYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 208000029082 Pelvic Inflammatory Disease Diseases 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- 206010067268 Post procedural infection Diseases 0.000 description 1
- 208000007893 Salpingitis Diseases 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- 241000607598 Vibrio Species 0.000 description 1
- 206010047400 Vibrio infections Diseases 0.000 description 1
- FHKPLLOSJHHKNU-INIZCTEOSA-N [(3S)-3-[8-(1-ethyl-5-methylpyrazol-4-yl)-9-methylpurin-6-yl]oxypyrrolidin-1-yl]-(oxan-4-yl)methanone Chemical compound C(C)N1N=CC(=C1C)C=1N(C2=NC=NC(=C2N=1)O[C@@H]1CN(CC1)C(=O)C1CCOCC1)C FHKPLLOSJHHKNU-INIZCTEOSA-N 0.000 description 1
- RUZXGXFZSOFFKG-UHFFFAOYSA-L [Na+].[Cl+].CC([O-])=O.CC([O-])=O Chemical compound [Na+].[Cl+].CC([O-])=O.CC([O-])=O RUZXGXFZSOFFKG-UHFFFAOYSA-L 0.000 description 1
- 229910001870 ammonium persulfate Inorganic materials 0.000 description 1
- 210000004381 amniotic fluid Anatomy 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- AMAICRYCMCVAHT-UHFFFAOYSA-K calcium;sodium;trichloride Chemical compound [Na+].[Cl-].[Cl-].[Cl-].[Ca+2] AMAICRYCMCVAHT-UHFFFAOYSA-K 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 230000003197 catalytic effect Effects 0.000 description 1
- 210000001136 chorion Anatomy 0.000 description 1
- 238000003759 clinical diagnosis Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000014670 detection of bacterium Effects 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000000975 dye Substances 0.000 description 1
- 201000003511 ectopic pregnancy Diseases 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- YAGKRVSRTSUGEY-UHFFFAOYSA-N ferricyanide Chemical compound [Fe+3].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-].N#[C-] YAGKRVSRTSUGEY-UHFFFAOYSA-N 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 150000002475 indoles Chemical class 0.000 description 1
- 208000000509 infertility Diseases 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 231100000535 infertility Toxicity 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000002350 laparotomy Methods 0.000 description 1
- 108010000849 leukocyte esterase Proteins 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 244000005706 microflora Species 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- CERZMXAJYMMUDR-UHFFFAOYSA-N neuraminic acid Natural products NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO CERZMXAJYMMUDR-UHFFFAOYSA-N 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- -1 potassium ferricyanide Chemical compound 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 239000012429 reaction media Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000007974 sodium acetate buffer Substances 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- SRWFBFUYENBCGF-UHFFFAOYSA-M sodium;chloride;hydrochloride Chemical compound [Na+].Cl.[Cl-] SRWFBFUYENBCGF-UHFFFAOYSA-M 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 230000001550 time effect Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 208000013464 vaginal disease Diseases 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
- C12Q1/40—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving amylase
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Immunology (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Abstract
The invention belongs to technical field of medical examination, and in particular to a kind of quick detection kit of bacterial vaginosis BV and its preparation method and application.The kit includes that reagent R1 and reagent R2, the reagent R1 are made of the chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of the bromo- 4- of 5-, polyethylene glycol 200 and phosphate buffer；The reagent R2 is made of 4-AA and phosphate buffer.The quick detection kit of bacterial vaginosis BV provided by the invention has the advantages that measurement sensitivity is high, testing result accuracy is high, reproducible and stability is high, it is a kind of quick detection kit of ideal bacterial vaginosis BV, is conducive to the promotion and application of the kit.
Description
Technical field
The invention belongs to technical field of medical examination, and in particular to a kind of quick detection kit of bacterial vaginosis BV and
Preparation method and application.
Background technique
Bacterial vaginosis BV (bacteral vaginosis, BV) is a kind of common vagina infection disease of the women of child-bearing age
Disease is since the ecological balance of vagina normal flora gets muddled, and dominant microflora Bacillus acidi lactici is reduced or disappeared, and vagina adds spy
The mixed infection that absence of vagina mucosal inflammatory caused by the microorganisms undue growths such as bacterium, anaerobic bacteria, bending vibrios of receiving changes.BV can be led
Endometritis and other pregnancy badness and complications of pregnancy after cause sense of organization chorion inflammation, amniotic fluid infection, laparotomy ventrotomy, and with
Gynaecology's common disease such as salpingitis, pelvic inflammatory disease, ectopic pregnancy, infertility, urinary system infection contamination, postoperative infection and gynecological tumor is close
Cut phase is closed.
BV is one of most common disease of gynemetrics, and infection rate is and easy to recur in 15%-50%.Amsel method is bacillary
The basic methods for clinical diagnosis of vaginopathy, this method is low in cost, but is influenced by many factors in practical application, Amsel method
As a result judgement vulnerable to subjective impact, may be failed to pinpoint a disease in diagnosis, mistaken diagnosis, not be able to satisfy clinical want there are objectivity, repeatability are bad
It asks.
R.WIGGINS etc. has delivered entitled " Use of5-Bromo-4-Chloro-3-Indoili-a-D-N-
Acetyin euraminic Acid in a Novel Spot Test To Identify Sialidase Activity in
The paper (" JOURALOF of Vaginal Swabs from Women withBacterial Vaginosis "
CLINICALMICROBIOLOGY "), the article disclose with the chloro- 3- indyl α-D-N- n acetylneuraminic acid n of the bromo- 4- of 5-
(BCIN) as the sialidase activity in substrate detection vaginal swab with diagnosing bacterial vagina disease, the buffer of reaction solution is
The sodium acetate of pH=5.5-calcium chloride-sodium chloride buffer, be by sample to be tested and BCIN pH=5.5 sodium acetate-chlorine
Change and hatch in calcium-sodium chloride buffer, the sialidase to react is displayed in blue, and the sialidase not reacted shows nothing
Color judges testing result according to color.But the reaction medium that uses of the detection method is filter paper, needed during detection by
Warm bath in agent transfer to filter paper containing de- vaginal secretion after washing, vulnerable to the influence of impurity components other in sample, such as in reality
It inevitably will appear the sample containing blood in clinical application, dark brown can be presented in filter paper in the short period, can cover aobvious
The reaction of color can not differentiate.
Patent document CN104988208A discloses a kind of kit for detection bacterium vaginosis and its preparation side
Method and detection method, the kit are made of reaction solution and color developing agent, and the reaction solution is by the chloro- 3- indyl α-of the bromo- 4- of 5-
D-N- n acetylneuraminic acid n salt, nipagin A sodium and composite buffering liquid composition, the color developing agent are replaced by 4- amino peace
It is formed than woods and buffer, the composite buffering liquid is by the phosphate buffer of pH=7.2 and the sodium acetate buffer of pH=5.0
Isometric mixing composition.The kit can be further improved the sensitivity and specificity of detection using composite buffering liquid, and can
The time required to shortening detection, prepare liquid, which need to only be placed in 10min in 37 ± 1 DEG C, can carry out chromogenic reaction, improve detection efficiency.But
It is that the stabilization of kit is poor, it is less reproducible, it is unfavorable for large-scale promotion and application.
Summary of the invention
In order to overcome defect existing for bacterial vaginosis assay kit in the prior art, it is an object of the invention to mention
For a kind of quick detection kit of bacterial vaginosis BV, which is that inventor is deep to the further research of existing procucts
Enter, to solve defect existing for existing product.
The present invention provides a kind of quick detection kit of bacterial vaginosis BV, the kit includes reagent R1 and examination
Agent R2, the reagent R1 are made of following components and its concentration:
0.2~0.3g/L of the chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of the bromo- 4- of 5-, polyethylene glycol 2000 .1~
0.2g/L, surplus are phosphate buffer；
The reagent R2 is made of following components and its concentration:
0.3~0.4mg/L of 4-AA, surplus are phosphate buffer.
Further, the kit includes reagent R1 and reagent R2, and the reagent R1 is by following components and its concentration group
At:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .15g/L, surplus
For phosphate buffer；
The reagent R2 is made of following components and its concentration:
4-AA 0.35mg/L, surplus are phosphate buffer.
Further, the pH value of the phosphate buffer of the reagent R1 is 6.5~7.0.
Further, the pH value of the phosphate buffer of the reagent R1 is 6.6.
Further, the pH value of the phosphate buffer of the reagent R2 is 7.5~8.0.
Further, the pH value of the phosphate buffer of the reagent R2 is 7.8.
Further, the volume ratio of the reagent R1 and reagent R2 is 10:3.
In addition, the present invention also provides the preparation methods of the quick detection kit of the bacterial vaginosis BV, including
Following steps:
Polyethylene glycol 200 is added into phosphate buffer and stirs evenly by S1, stands 25~35min, it is bromo- to be subsequently added into 5-
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of 4-, stirs evenly, obtains reagent R1；
4-AA is added into phosphate buffer by S2, stirs evenly, obtain reagent R2 to get.
In addition, the present invention also provides the quick detection kits of the bacterial vaginosis BV in detection bacterium vagina
Application in sick reagent.
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of the bromo- 4- of the 5- that the present invention uses is the chloro- 3- indoles of the bromo- 4- of 5-
Base α-D-N- n acetylneuraminic acid n sodium salt, No. CAS is 160369-85-7；The phosphate buffer using sodium dihydrogen phosphate and
Disodium hydrogen phosphate configures.
The testing principle of the quick detection kit of bacterial vaginosis BV provided by the invention are as follows: by chloro- 3 indoles of 5- bromo- 4
Base-α-D-N- n acetylneuraminic acid n reacts with the sialidase in prepare liquid, the chloro- 3 indyl-α-D-N- acetyl of 5- bromo- 4
The glycosidic bond of neuraminic acid is broken, post-rift product be in acid medium it is colourless, when the pH value of dissolution becomes alkalinity,
Post-rift product in the presence of oxygen, shows color change, without the chloro- 3 indyl-α-D- of 5- bromo- 4 of decomposition
N-acetyl-neuraminate turns yellow, the chloro- 3 indyl-α-D-N- acetyl nerve of substrate 5- bromo- 4 after being decomposed by sialidase
Blue reaction is presented in propylhomoserin, and mixing yellow according to three primary color theory blue is green.So if the color of prepare liquid is yellow, inspection
Surveying result is BV negative；If the color of prepare liquid is green to blue, testing result is BV positive.
4-AA is often used as color developing agent, by reacting shape with the potassium ferricyanide, ferricyanide or ammonium persulfate
The dyestuff that reddish orange is formed at phenol and its derivative or homologue and 4-AA, can achieve the effect of colour developing.This
Inventor is found surprisingly that during groping test, on the basis of original kit, reduces 4-AA
Concentration, it is found that it can promote the reaction of sialidase and substrate, promote reaction product and OH-In conjunction with, accelerate developing time,
It can be used as the catalyst of the chloro- 3 indyl-α-D-N- n acetylneuraminic acid n chromogenic reaction of 5- bromo- 4.
Further, the polyethylene glycol 200 and 4-AA that the present invention adds are used in combination can be anti-for colour developing
One more suitably colour developing medium should be provided, reaction product and oxygen, OH can be significantly promoted-In conjunction with further shortening
Developing time can effectively improve detection efficiency.Be used in combination can be with for polyethylene glycol 200 and 4-AA simultaneously
The sensitivity for improving testing result is a kind of quick detection kit of ideal bacterial vaginosis BV.
In the prior art using the chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of the bromo- 4- of 5- after sialidase catalytic
The self color of product when being judged, be sodium hydroxide to be added to develop the color, and reagent system of the invention is containing
Under conditions of the 4-AA of 0.3-0.4mg/L and the polyethylene glycol 200 of 0.1~0.2g/L, using pH=7.5~
8.0 phosphate buffer can carry out chromogenic reaction, can there are corrosivity height, environment to avoid when using sodium hydroxide solution
Heavy-polluted defect is a kind of environmental protection, non-stimulated detection kit.
In addition, polyethylene glycol 200 provided by the invention is mixed partially weakly alkaline in reagent R1 of the present invention and reagent R2
The pollution that bacterium or fungi can be prevented in reagent system avoids detecting using the sialidase activity of anaerobic bacteria as the bacterium of principle
Premature failure when vaginosis can also reduce influence of the other impurities to testing result, the standard of testing result can be improved
True property and stability, greatly prolong the service life of the kit.
In short, compared with prior art, the quick detection kit of bacterial vaginosis BV provided by the invention has measurement
High sensitivity, the advantage that testing result accuracy is high, reproducible and high stability are a kind of ideal bacterial vaginosis
The quick detection kit of disease, is conducive to the promotion and application of the kit.
Specific embodiment
The present invention is further described below by way of specific embodiment, the present invention is not limited only to following embodiment.In this hair
In bright range or the contents of the present invention are not being departed from, in spirit and scope, the change that carries out to the present invention is combined or replaced
It changes, will be apparent to the person skilled in the art, and be included within the scope of the present invention.
A kind of quick detection of bacterial vaginosis BV described in embodiment 1, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.2g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .1g/L, surplus are
Phosphate buffer；The pH value of the phosphate buffer is 6.5.
The reagent R2 is made of following components and its concentration:
4-AA 0.3mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is 7.5.
Preparation method:
Polyethylene glycol 200 is added into phosphate buffer and stirs evenly by S1, stands 25min, is subsequently added into the bromo- 4- of 5-
Chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt, stirs evenly, obtains reagent R1；
4-AA is added into phosphate buffer by S2, stirs evenly, obtain reagent R2 to get.
A kind of quick detection of bacterial vaginosis BV described in embodiment 2, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .15g/L, surplus
For phosphate buffer；The pH value of the phosphate buffer is 6.6.
The reagent R2 is made of following components and its concentration:
4-AA 0.35mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is
7.8。
Preparation method is similar to Example 1.
A kind of quick detection of bacterial vaginosis BV described in embodiment 3, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.3g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .2g/L, surplus are
Phosphate buffer；The pH value of the phosphate buffer is 6.8.
The reagent R2 is made of following components and its concentration:
4-AA 0.4mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is 8.0.
Preparation method is similar to Example 1.
A kind of quick detection of bacterial vaginosis BV described in comparative example 1, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, nipagin A sodium
0.15g/L, surplus are phosphate buffer；The pH value of the phosphate buffer is 6.6.
The reagent R2 is made of following components and its concentration:
4-AA 0.35mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is
7.8。
Preparation method is similar to Example 1.
The difference from example 2 is that: polyethylene glycol 200 is replaced with into nipagin A sodium.
A kind of quick detection of bacterial vaginosis BV described in comparative example 2, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, lauryl glucosyl 0.15g/
L, surplus are phosphate buffer；The pH value of the phosphate buffer is 6.6.
The reagent R2 is made of following components and its concentration:
4-AA 0.35mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is
7.8。
Preparation method is similar to Example 1.
The difference from example 2 is that: polyethylene glycol 200 is replaced with into lauryl glucosyl.
A kind of quick detection of bacterial vaginosis BV described in comparative example 3, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .15g/L, surplus
For phosphate buffer；The pH value of the phosphate buffer is 6.6.
The reagent R2 is made of following components and its concentration:
4-AA 0.45mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is
7.8。
Preparation method is similar to Example 1.
The difference from example 2 is that: increase the content of 4-AA.
A kind of quick detection of bacterial vaginosis BV described in comparative example 4, quick detection kit of bacterial vaginosis BV tries
Agent box is made of the reagent R1 and reagent R2 that volume ratio is 10:3:
The reagent R1 is made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .15g/L, surplus
For phosphate buffer；The pH value of the phosphate buffer is 6.6.
The reagent R2 is made of following components and its concentration:
4-AA 0.25mg/L, surplus are phosphate buffer；The pH value of the phosphate buffer is
7.8。
Preparation method is similar to Example 1.
The difference from example 2 is that: reduce the content of 4-AA.
The developing time measurement test of test example one, the quick detection kit of bacterial vaginosis BV
1, test material:
It is bacillary made from embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
The quick detection kit of vaginopathy.
2, test method:
In the reagent R1 of the neuraminidase solution sample elution of 10U/mL to 500 μ L and sample to be tested will be made in reaction solution
Middle dispersion, obtains prepare liquid；Prepare liquid is placed in 37 ± 1 DEG C and stands 10min；Then the reagent of 150 μ L is added into prepare liquid
R2 records developing time.
3, test result:
Test result is as shown in table 1.
The developing time of the quick detection kit of 1 bacterial vaginosis BV of table
| To the developing time (s) of the neuraminidase solution of 10U/mL | |
| Embodiment 1 | 10 |
| Embodiment 2 | 12 |
| Embodiment 3 | 11 |
| Comparative example 1 | 135 |
| Comparative example 2 | 110 |
| Comparative example 3 | 145 |
| Comparative example 4 | 120 |
As shown in Table 1, the developing time of the quick detection kit of bacterial vaginosis BV provided by the invention is less than 12s,
It can quickly and effectively detect as a result, improving detection efficiency, and can effectively improve the accuracy of testing result, and compare
The developing time of the quick detection kit for the bacterial vaginosis BV that example 1~4 provides is greater than 2min, illustrates provided by the invention thin
Each ingredient of the quick detection kit of bacterium vaginosis interact its shorten developing time effect, improve detection efficiency.
The sensitivity test of test example two, the quick detection kit of bacterial vaginosis BV
1, test material:
It is bacillary made from embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
The quick detection kit of vaginopathy.
2, test method:
Using thin made from embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
The quick detection kit of bacterium vaginosis detects the spirit of the neuraminidase solution sample kits for evaluation of various concentration respectively
Sensitivity.
2.1, sample to be tested configuration:
Neuraminidase dried frozen aquatic products (sigma) is taken, is buffered with -50% glycerol -5%BSA of 0.02mol/L pH7.3 phosphate
Liquid dilutes neuraminidase dried frozen aquatic products, and being prepared into concentration is respectively 0U/20uL, 5U/20uL, 6U/20uL, 7U/20uL, 8U/
The neuraminidase stoste of 20uL, 9U/20uL.
It takes 6 by-reaction pipes (every by-reaction Guan Zhonghan reaction solution 490uL), opens reaction lid, it is corresponding into 6 by-reaction pipes
It is former that the neuraminidase that 10uL concentration is 0U/20uL, 5U/20uL, 6U/20uL, 7U/20uL, 8U/20uL, 9U/20uL is added
Liquid, the concentration of neuraminidase is that 0U/mL, 5U/mL, 6U/mL, 7U/mL, 8U/mL, 9U/mL are examined respectively in 6 by-reaction pipes
It surveys.
2.2, detection method:
Sample to be tested is eluted in the reagent R1 of 500 μ L and disperses sample to be tested in reaction solution, obtains prepare liquid；It will
Prepare liquid is placed in 37 ± 1 DEG C and stands 10min；Then the reagent R2 of 150 μ L is added into prepare liquid；If the color of prepare liquid is
Yellow indicates that testing result is BV negative；If the color of prepare liquid is green to blue, indicate that testing result is BV positive.Note
Evaluation index of the minimum concentration of the neuraminidase solution of the record display BV positive as sensitivity, above-mentioned steps are repeated 3 times, take
Average value is as final result.
3, test result:
Test result is as shown in table 2.
The sensitivity test of the quick detection kit of 2 bacterial vaginosis BV of table
| Show the neuraminidase solution (U/mL) of the BV positive | |
| Embodiment 1 | 5 |
| Embodiment 2 | 5 |
| Embodiment 3 | 5 |
| Comparative example 1 | 7 |
| Comparative example 2 | 8 |
| Comparative example 3 | 7 |
| Comparative example 4 | 9 |
As shown in Table 2, the quick detection kit of bacterial vaginosis BV provided by the invention is for neuraminidase activity
The neuraminidase solution of >=5U/mL, the testing result of kit are the BV positive；For neuraminidase activity < 5U/mL
Neuraminidase solution, the testing result of kit are BV feminine gender, illustrate the quick of bacterial vaginosis BV provided by the invention
Detection kit sensitivity with higher.
The accuracy test of test example three, the quick detection kit of bacterial vaginosis BV
1, test material:
Embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4 are prepared bacillary
The quick detection kit of vaginopathy.
2, test method:
Measure the thin of embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and the preparation of comparative example 4
The specificity and and accuracy of the quick detection kit detection of bacterium vaginosis.
2.1, embodiment 1, embodiment 2, embodiment 3, comparative example 1, comparative example 2,3 and of comparative example specific assay: are used
The quick detection kit of bacterial vaginosis BV prepared by comparative example 4 detects leukocyte esterase solution (the leucocyte ester respectively
The concentration of enzyme solutions is 9U/mL), lactic dehydrogenase enzyme solutions (concentration of the lactic dehydrogenase enzyme solutions is 9U/mL) and urase it is molten
Liquid (concentration of the urase solution is 9U/mL), to calculate specificity, above-mentioned steps are repeated 20 times record colour developing result, are taken
Average value is as final result.
2.2, accuracy rate measures: 700 medical Patients with Bacterial Vaginosis of Out-patient Clinic of Department of Gynecology is randomly selected, according to clinical yin
Sample is randomly divided into 7 groups by the acquisition Vaginal secretion sample of road secretion, every group of 100 sample samples, will using embodiment 1,
The quick detection of bacterial vaginosis BV prepared by embodiment 2, embodiment 3, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
The testing result of kit is compared with using same a sample of Amsel method detection, to calculate accuracy rate.
3, test result
Test result is as shown in table 3.
The accuracy test of the quick detection kit of 3 bacterial vaginosis BV of table
| Specific (%) | Accuracy (%) | |
| Embodiment 1 | 100.00 | 99.00 |
| Embodiment 2 | 100.00 | 100.00 |
| Embodiment 3 | 100.00 | 99.00 |
| Comparative example 1 | 96.66 | 98.00 |
| Comparative example 2 | 95.00 | 97.00 |
| Comparative example 3 | 93.33 | 95.00 |
| Comparative example 4 | 98.33 | 98.00 |
As shown in Table 3, the specificity of the quick detection kit of bacterial vaginosis BV provided by the invention is 100% and standard
True property is greater than 99%, is a kind of quick detection kit of ideal bacterial vaginosis BV.
The stability test of test example four, the quick detection kit of bacterial vaginosis BV
1, test material:
The quick detection of bacterial vaginosis BV made from embodiment 2, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
Kit.
2, test method:
The quick inspection of bacterial vaginosis BV prepared by embodiment 2, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
Test agent box after 20 DEG C are placed 18 months respectively, according to the method assay kit of test example two the 0th, 1,2,3,6,12,
Sensitivity in 18 months.
3, test result:
Test result is as shown in table 4.
The stability test of the quick detection kit of 4 bacterial vaginosis BV of table
| Embodiment 2 | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 | |
| 0th month (U/mL) | 5 | 7 | 8 | 7 | 9 |
| 1st month (U/mL) | 5 | 7 | 8 | 7 | 9 |
| 2nd month (U/mL) | 5 | 8 | 8 | 7 | 9 |
| 3rd month (U/mL) | 5 | 8 | 9 | 8 | 10 |
| 6th month (U/mL) | 6 | 9 | 9 | 9 | 12 |
| 12nd month (U/mL) | 7 | 15 | 12 | 12 | 16 |
| 18th month (U/mL) | 8 | 20 | 15 | 14 | 18 |
As shown in Table 4, the quick detection kit of bacterial vaginosis BV provided by the invention places 18 at 20 DEG C respectively
Sensitivity is substantially unchanged after month, illustrates that the quick detection kit of bacterial vaginosis BV provided by the invention is with higher steady
Qualitative and preferable sensitivity.
In addition, after the quick detection kit of bacterial vaginosis BV provided by the invention saves 36 months at 4 DEG C, reagent
Box sensitivity is good, with the kit that just prepares without significant difference.
Claims (7)
1. a kind of quick detection kit of bacterial vaginosis BV, which is characterized in that the kit includes reagent R1 and reagent
R2, the reagent R1 are made of following components and its concentration:
0.2~0.3g/L of the chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt of the bromo- 4- of 5-, polyethylene glycol 2000 .1~0.2g/L,
Surplus is phosphate buffer；
The reagent R2 is made of following components and its concentration:
0.3~0.4mg/L of 4-AA, surplus are phosphate buffer；
The pH value of the phosphate buffer of the reagent R1 is 6.5~7.0；
The pH value of the phosphate buffer of the reagent R2 is 7.5~8.0.
2. the quick detection kit of bacterial vaginosis BV as described in claim 1, which is characterized in that the kit includes
Reagent R1 and reagent R2, the reagent R1 are made of following components and its concentration:
The chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt 0.25g/L of the bromo- 4- of 5-, polyethylene glycol 2000 .15g/L, surplus is phosphorus
Phthalate buffer；
The reagent R2 is made of following components and its concentration:
4-AA 0.35mg/L, surplus are phosphate buffer.
3. the quick detection kit of bacterial vaginosis BV as described in claim 1, which is characterized in that the phosphorus of the reagent R1
The pH value of phthalate buffer is 6.6.
4. the quick detection kit of bacterial vaginosis BV as described in claim 1, which is characterized in that the phosphorus of the reagent R2
The pH value of phthalate buffer is 7.8.
5. the quick detection kit of bacterial vaginosis BV as claimed in claim 1 or 2, which is characterized in that the reagent R1
Volume ratio with reagent R2 is 10:3.
6. the preparation method of the quick detection kit of the bacterial vaginosis BV as described in Claims 1 to 5 is any, feature exist
In, comprising the following steps:
Polyethylene glycol 200 is added into phosphate buffer and stirs evenly by S1, stands 25~35min, is subsequently added into the bromo- 4- of 5-
Chloro- 3- indyl α-D-N- n acetylneuraminic acid n salt, stirs evenly, obtains reagent R1；
4-AA is added into phosphate buffer by S2, stirs evenly, obtain reagent R2 to get.
7. a kind of quick detection kit of the bacterial vaginosis BV as described in Claims 1 to 5 is any is in preparation detection bacterium
Application in vaginosis reagent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811140241.0A CN109402221B (en) | 2018-09-28 | 2018-09-28 | A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811140241.0A CN109402221B (en) | 2018-09-28 | 2018-09-28 | A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109402221A CN109402221A (en) | 2019-03-01 |
| CN109402221B true CN109402221B (en) | 2019-08-23 |
Family
ID=65465579
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811140241.0A Active CN109402221B (en) | 2018-09-28 | 2018-09-28 | A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109402221B (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104988208A (en) * | 2015-07-14 | 2015-10-21 | 广州江元医疗科技有限公司 | Kit for detecting bacterial vaginosis, and preparation method and detection method thereof |
| CN105039497A (en) * | 2015-05-25 | 2015-11-11 | 陕西阳光生物工程股份有限公司 | Bacterial vaginosis combined detection reagent and method for using bacterial vaginosis combined detection reagent |
| 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 |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7591978B2 (en) * | 2006-08-10 | 2009-09-22 | Inverness Medical Switzerland Gmbh | Solid phase test device for sialidase assay |
-
2018
- 2018-09-28 CN CN201811140241.0A patent/CN109402221B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105039497A (en) * | 2015-05-25 | 2015-11-11 | 陕西阳光生物工程股份有限公司 | Bacterial vaginosis combined detection reagent and method for using bacterial vaginosis combined detection reagent |
| CN104988208A (en) * | 2015-07-14 | 2015-10-21 | 广州江元医疗科技有限公司 | Kit for detecting bacterial vaginosis, and preparation method and detection method thereof |
| 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 |
Non-Patent Citations (3)
| Title |
|---|
| BV 三联法与Amsel 法对检查结果的比较和分析;孙建方;《中国微生态学杂志》;20101130;1054-1055 |
| Poly(ethylene glycol) (PEG)-lactic acid nanocarrier-based degradable hydrogels for restoring the vaginal microenvironment;Sujata Sundara Rajan等;《NIH-PA Author Manuscript》;20141128;301-309 |
| Use of 5-Bromo-4-Chloro-3-Indolyl-a-D-N-Acetylneuraminic Acid in a Novel Spot Test To Identify Sialidase Activity in Vaginal Swabs from Women with Bacterial Vaginosis;R. WIGGINS等;《JOURNAL OF CLINICAL MICROBIOLOGY》;20000831;3096–3097 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109402221A (en) | 2019-03-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US5124254A (en) | Detection of diamines in biological fluids | |
| Thomason et al. | Proline aminopeptidase activity as a rapid diagnostic test to confirm bacterial vaginosis | |
| AU708541B2 (en) | Test media and quantitative method for identification and differentiation of biological materials in a test sample | |
| WO1989007152A2 (en) | Detection of diamines in biological fluids | |
| CN104792986B (en) | A kind of vaginitiss many index combined detection kit | |
| US3875013A (en) | Article for detecting the fertile period and method for using same | |
| CN105334211B (en) | It is a kind of while detect the kit of sodium and creatinine in urine | |
| CN113030076B (en) | Vaginal secretion multi-connected detection test paper, preparation method and test method thereof | |
| EP0775215B1 (en) | Chemiluminescence assays based on indoxyl substrates or thioindoxyl substrates | |
| EP2407549B1 (en) | Detection of trichomonas and candida | |
| CN102864206A (en) | Anti-heparin interference leucine aminopeptidase measuring reagent | |
| Sheiness et al. | High levels of Gardnerella vaginalis detected with an oligonucleotide probe combined with elevated pH as a diagnostic indicator of bacterial vaginosis | |
| US2999052A (en) | Composition for colorimetric test for serum enzymes | |
| US3002893A (en) | Method for the determination of serum acid phosphatase and diagnostic preparation therefor | |
| CN109402221B (en) | A kind of quick detection kit of bacterial vaginosis BV and its preparation method and application | |
| US20160177370A1 (en) | Method for detecting streptococcus agalactiae using esterase activity | |
| US5702911A (en) | Diagnostic test composition | |
| US20040219617A1 (en) | Enzymatic test for the determination of the risk of pathologies related to the presence of sialidase or prolidase activity in women body fluid samples | |
| Egley et al. | Leukocyte esterase: a simple bedside test for the detection of bacterial colonization of amniotic fluid | |
| EP2107121B1 (en) | A diagnostic test for bacterial vaginosis | |
| CN113655006B (en) | Urinary system knot Dan Chengdan risk factor detection and test system | |
| JP2001161396A (en) | Discrimination of microorganism in specimens | |
| WO1998005970A1 (en) | Method for examining chronic rejection reactions following organ transplantation and method for determining urine components | |
| JPS61172063A (en) | Method of detecting peritonitis or peritoneal infection | |
| JP2681635B2 (en) | Method to improve analysis sensitivity and accuracy |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A rapid detection kit for bacterial vaginosis and its preparation method and Application Effective date of registration: 20201013 Granted publication date: 20190823 Pledgee: Shanghai Pudong Development Bank Limited by Share Ltd. Guangzhou branch Pledgor: GUANGZHOU JIANGYUAN MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. Registration number: Y2020440000307 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20211022 Granted publication date: 20190823 Pledgee: Shanghai Pudong Development Bank Limited by Share Ltd. Guangzhou branch Pledgor: GUANGZHOU JIANGYUAN MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. Registration number: Y2020440000307 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: The invention relates to a rapid detection kit for bacterial vaginosis and a preparation method and application thereof Effective date of registration: 20211118 Granted publication date: 20190823 Pledgee: Shanghai Pudong Development Bank Limited by Share Ltd. Guangzhou branch Pledgor: GUANGZHOU JIANGYUAN MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. Registration number: Y2021440000346 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20230116 Granted publication date: 20190823 Pledgee: Shanghai Pudong Development Bank Limited by Share Ltd. Guangzhou branch Pledgor: GUANGZHOU JIANGYUAN MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. Registration number: Y2021440000346 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right |