GB2353357A - Amniotic fluid detection - Google Patents
Amniotic fluid detection Download PDFInfo
- Publication number
- GB2353357A GB2353357A GB0019670A GB0019670A GB2353357A GB 2353357 A GB2353357 A GB 2353357A GB 0019670 A GB0019670 A GB 0019670A GB 0019670 A GB0019670 A GB 0019670A GB 2353357 A GB2353357 A GB 2353357A
- Authority
- GB
- United Kingdom
- Prior art keywords
- reagent
- assay
- amniotic
- sample
- colour
- 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.)
- Withdrawn
Links
- 210000004381 amniotic fluid Anatomy 0.000 title claims abstract description 26
- 238000001514 detection method Methods 0.000 title description 2
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 40
- 238000003556 assay Methods 0.000 claims abstract description 27
- 238000012360 testing method Methods 0.000 claims abstract description 17
- NUHCTOLBWMJMLX-UHFFFAOYSA-N bromothymol blue Chemical compound BrC1=C(O)C(C(C)C)=CC(C2(C3=CC=CC=C3S(=O)(=O)O2)C=2C(=C(Br)C(O)=C(C(C)C)C=2)C)=C1C NUHCTOLBWMJMLX-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000007788 liquid Substances 0.000 claims abstract description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 23
- 239000011780 sodium chloride Substances 0.000 claims description 13
- 210000004369 blood Anatomy 0.000 claims description 11
- 239000008280 blood Substances 0.000 claims description 11
- 239000012530 fluid Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 4
- 210000001215 vagina Anatomy 0.000 claims description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 3
- 239000003085 diluting agent Substances 0.000 claims description 3
- 229920002994 synthetic fiber Polymers 0.000 claims description 2
- 210000001691 amnion Anatomy 0.000 abstract description 3
- 238000003745 diagnosis Methods 0.000 abstract 1
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 15
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 210000002700 urine Anatomy 0.000 description 9
- PXIPVTKHYLBLMZ-UHFFFAOYSA-N Sodium azide Chemical compound [Na+].[N-]=[N+]=[N-] PXIPVTKHYLBLMZ-UHFFFAOYSA-N 0.000 description 8
- 239000000975 dye Substances 0.000 description 5
- 210000003756 cervix mucus Anatomy 0.000 description 4
- 239000013642 negative control Substances 0.000 description 4
- 229920004934 Dacron® Polymers 0.000 description 3
- 238000011109 contamination Methods 0.000 description 3
- 210000004379 membrane Anatomy 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 239000013641 positive control Substances 0.000 description 3
- 238000003908 quality control method Methods 0.000 description 3
- XBLIFEQTVVSTIM-UHFFFAOYSA-L chembl2105392 Chemical compound [Na+].[Na+].[O-]S(=O)(=O)C1=CC2=CC(S([O-])(=O)=O)=CC=C2C(O)=C1N=NC1=CC=C([N+]([O-])=O)C=C1[N+]([O-])=O XBLIFEQTVVSTIM-UHFFFAOYSA-L 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 150000008053 sultones Chemical group 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 101100420946 Caenorhabditis elegans sea-2 gene Proteins 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- 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 1
- AFCARXCZXQIEQB-UHFFFAOYSA-N N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CCNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 AFCARXCZXQIEQB-UHFFFAOYSA-N 0.000 description 1
- 208000034713 Spontaneous Rupture Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000012790 confirmation Methods 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
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 0.000 description 1
- 210000004291 uterus Anatomy 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 239000001043 yellow dye Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
- A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/521—Single-layer analytical elements
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0048—Devices for taking samples of body liquids for taking amniotic fluid samples
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Physics & Mathematics (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Medical Informatics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Food Science & Technology (AREA)
- Optics & Photonics (AREA)
- Inorganic Chemistry (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
An assay to detect amniotic fluid in a test sample e.g. to assist diagnosis of amniotic membrane rupture and onset of labour in a pregnant woman, uses bromthymol blue as a colorimetric reagent. The reagent may be in liquid form and applied to a dressing or sanitary towel previously worn or can be applied to a swab carrying a test sample taken from a patient. Kits containing the reagent are also claimed.
Description
2353357 1 1 ASSAY TO DETECT AMNIOTIC FLUID 2 3 The present invention
relates to an assay to determine 4 the presence of amniotic fluid, and in particular to 5 clearly distinguish between amniotic fluid and urine, 6 blood or vaginal secretions. 7 8 In obstetrics, rupture of the amniotic membranes is 9 generally a clear indication of the onset of labour. 10 Accurate knowledge of this event is of clinical value 11 to the obstetrician or midwife in assessing a patient's 12 condition. More importantly, however, there are 13 occasions when there is uncertainty on whether or not 14 rupture of the membranes has occurred and confirmation is of the state of the membranes will enable the 16 obstetrician to more ap propriately manage this stage of 17 the pregnancy. However, accurate detection of the 18 presence of amniotic fluid is not easily performed. in 19 addition to the usual vaginal secretions, pregnant 20 patients may pass blood and mucus. Additionally, as 21 the enlarged uterus presses onto the bladder, urine may 22 be squeezed out without the conscious knowledge of the 23 patient. 24 2 1 A commercially available kit, sold under the Trade Mark 2 AMNICATOR relies upon the pH difference between 3 amniotic fluid and that of urine, blood and vaginal 4 secretions as detected by a dye based on nitrazine yellow. The AMNICATOR kit is produced in the form of 6 cotton swabs impregnated with the nitrazine yellow dye
7 and the instructions direct introduction of the swab
8 into the vagina in an invasive procedure. The pH of 9 the amniotic fluid is stated to be in the range of 7. 0 to 7. 5 whereas normal vaginal pH is 4. 5 to 6. 0.
11 Additionally, invasive procedures are time-consuming to 12 conduct and unpleasant for the patient to undergo.
13 14 It is an object of the present invention to provide an is accurate assay to detect amniotic fluid. In a 16 preferred embodiment the procedure does not rely upon 17 in vasive examination of a patient.
18 19 Additionally, our research into the field has noted that amniotic fluid does not have a pH between 7. 0 to 21 7.5 as suggested by the literature accompanying the 22 AMNICATOR assay, but instead has a minimum pH of from 23 8.1 to 8.5.
24 The present invention thus provides an assay to detect 26 the presence of amniotic fluid in a test sample, said 27 assay comprising:
28 29 a) exposing the test sample to a reagent which contains the dye bromthymol blue as indicator; and 31 32 b) noting any colour change and determining therefrom 33 (for example by reference to a colour chart) 34 whether or not amniotic fluid is present in the sample.
36 3 1 In a preferred embodiment the reagent comprises 2 bromthymol blue extracted with an alcohol, for example, 3 methanol and optionally contains a quantity of water or 4 saline as diluent. 5 6 Desirably the reagent comprises bromthymol blue, 7 methanol, sodium chloride and water which may be 8 desirably admixed in the proportions indicated below: 9 11 12 13 14 is 16 17 For convenience, the reagent will usually be supplied 18 in liquid form and drops of the reagent may simply be 19 spotted onto a sanitary towel or dressing previously worn by the patient and which has absorbed a sufficient 21 quantity of the sample to be tested.
22 23 Alternatively, if necessary, a quantity of the reagent 24 may be dropped onto DACRONTm swab which has been used to obtain a sample of the fluid by invasive techniques.
26 This approach will usually only be adopted where 27 internal examination of the patient is required for 28 other purposes.
29 In a further aspect, the present invention provides a 31 kit to detect the presence of amniotic f luid in a test 32 sample, said kit comprising a reagent containing the 33 dye bromthymol blue as indicator and a colour chart to 34 aid interpretation of the results.
Bromthymol Blue (Sultone form 31,311- 2.Og Dibromothymolsulfonephthalein) Methanol 100.0M1 Sodium chloride (NaCl) 1.Og Water 900.0M1 4 In the colour chart, yellow indicates urine; yellow/sea 2 green indicates urine and/or vaginal secretions; green 3 or dark green indicates blood or amniotic fluid and 4 blue indicates amniotic fluid.
6 Advantageously the kit contains full instructions for 7 use and may optionally include swabs of synthetic 8 fibres, for example DACRON'.
9 Additionally, positive and negative controls may be 11 provided.
12 13 In a further aspect, the present invention provides a 14 method of determining the rupture of amniotic membranes, said method comprising:
16 17 1) obtaining a sample of test fluid; 18 19 2) exposing said test fluid to a reagent which includes bromthymol blue as indicator; and 21 22 3) noting any colour change.
23 24 The assay will now be described in more detail.
26 Introduction
27 28 The protocol set out here exemplifies the assay to 29 detect presence of amniotic fluid as an aid to clinical judgement when a patient presents with Query 31 Spontaneous Rupture of Membranes (denoted as 119SRM11) 32 The assay is rapid and simple involving a colour change 33 and the interpretation of that colour change. 34 35 The assay differentiates between urine, vaginal 36 secretions, blood and amniotic fluid.
Test procedure: Speculum in place 2 3 1. If a speculum has been inserted into the vagina, a 4 sample of any fluid should be taken with a sterile swab (supplied with the kit) Preferably a 6 DACRONT' swab is used.
7 2. Withdraw the swab and add a drop of the reagent to 8 the swab.
9 3. Observe the colour change. This will develop instantly.
11 12 Test procedure: Using the patient's sanitary towel 13 14 1. Using the dropper bottle, a drop of the reagent is should be spotted to 3 or 4 different points 16 across the towel.
17 2. Observe for colour change. This will develop 18 instantly.
19 3. If necessary press the surface of the site of the drop to fully appreciate the developed colour.
21 22 Interpretation of developed colours 23 24 26 27 28 29 It is assumed that the user will observe any blood contamination on the swab or the towel and will abandon 31 the assay if excess blood is present since this will 32 mask the colour change of the reagent.
33 1. Yellow Not Amniotic Probably urine Fluid 2. Yellow/ Sea Green Not Amniotic Probably Urine Fluid or vaginal secretions 3. Mid/Dark Green Amniotic Fluid or blood 4. Blue Amniotic Fluid 1 6 1 The reagent is a non-hazardous fluid. It can be safely 2 mopped up if accidentally spilled or f lushed to waste.
3 4 The kit should be stored at ambient temperature in the box.
6 7 The following points should be noted to aid proper use 8 of the assay:
9 1. Excessive urine on the towel or in the vagina may 11 render the test invalid.
12 2. This test should only be considered as an aid to 13 clinical judgement and any result obtained should 14 not be considered diagnostic.
is 3. A towel soiled with amniotic fluid which has dried 16 will still give a positive result.
17 4. Reagent which appears turbid should not be used.
18 5. Reagent which appears other than red/orange should 19 not be used. If it appears yellow, green or blue it should be discarded.
21 6. Only the swabs supplied with the kit should be 22 used. Certain swabs are unsuitable and may 23 provide an erroneous result.
24 7. Do not touch the swab or the patient's towel with the tip of the dropper.
26 8. Do not attempt to clean the tip of the dropper 27 bottle with tap water. Wipe with a clean cloth 28 and rinse using the reagent from the bottle.
29 9. A dry new towel will give a negative result (yellow).
31 10. Contamination of a swab with lAquaGell or any 32 other speculum lubricant may lead to a false 33 positive result being recorded and care should be 34 exercised by the user to avoid such contamination.
36 7 1 Desirably the kit of the present invention contains the 2 following: 3 4 1. Reagent; 5 2. Positive control; 6 3. Negative control; 7 4. Sterile swab sticks (for example 50 DACRON swabs); 8 5. Instructions for use; and 9 6. Colour guidance chart. 10 11 The box and bottles may carry a batch number and an 12 expiry date. 13 14 Manufacture of the reagent and of the positive and 15 negative controls is described in Example 1. 16 17 8 1 Example 1 2 3 The Reagent is prepared as follows: 4 6 7 8 9 10 11 1. Accurately weigh the Bromthymol Blue and add to 12 the methanol.
13 2. Allow to mix for at least 30 minutes and at least 14 until the dye has completely dissolved.
is 3. Add this concentrate to the water.
16 4. Add the sodium chloride. 17 18 mix thoroughly and filter to remove any remaining 19 particles from the dye. 20 21 Adjust the pH using N110 Sodium Hydroxide (NaOH) to 22 4.20 23 24 Quality Control pH 4.15-4.25 26 Spec reading 0.41-0.43 at 58Onm 27 Conductivity 1.90-2.1OmS at 22C 28 29 Water used must be very pure.
Bottle in plastics bottles.
31 32 33 34 Bromthymol Blue (Sultone form 31,311- 2.Og Dibromothymolsulfonephthalein) Methanol 100.0M1 Sodium chloride (NaCl) 1.Og Water 900.0M1 9 1 The Positive Control is prepared as follows:
2 3 4 6 7 8 9 10 11 12 Adjust pH to 7.80 (lowest end of scale for a positive 13 result) using NaOH.
14 Quality Control 16 pH 7.75-7.85 17 Conductivity 14.00-17.0OmS at 22'C 18 19 Bottle in 5m1 glass dropper bottles.
21 The Negative Control is prepared as follows:
22 23 24 26 27 28 29 31 32 di-Sodium Hydrogen Orthophosphate 0. 625g (Na2HP04) Sodium di-Hydrogen Orthophosphate 0.338g (NaH2P042H20) Sodium Chloride (NaCl) 8.650g Sodium Azide (NaN3) 0.1g Water to 1 litre di-Sodium Hydrogen 0.625g Orthophosphate (Na21-IP04) Sodium di-Hydrogen 0.338g Orthophosphate (Na,121:)042H20) Sodium Chloride (NaCl) 8.650g Sodium Azide (NaN3) 0.1g Water to 1 litre 1 Adjust pH to 5. G5.(Highest end of scale for a negative 2 result) using HC1.
3 4 Quality Control pH 5.60-5.70 6 Conductivity 14.00-17.OOmS at 22C 7 8 Bottle in 5ml glass dropper bottles.
9 Swabs suitable for this assay are those made of 11 synthetic fibre, for example of pure DACRON, which have 12 been rendered sterile by irradiation or other means.
13 14 Example 2
16 The protocol outlined above was followed in 141 17 patients using the reagent of Example 1. The results 18 are as follows:
19 11 1 2 3 Table 1
Total Test Result Is the Is O_. 10_. k.
Results test patient correct Correct Correct to Date result ?SRM Swabs Towels correct or likely Swab Towel to be correct Sea Dark Yellow Green Green Blue Yes No Yes No 564 152 45 1 203 1164 363 201 541 23 440 12 95.92 94.5 98.5 1 1 4 12 1 The results of the assay were verified by further 2 examination of the patient to yield the accuracy figure 3 of 95.92%. 4 5 13
Claims (1)
1 Claims
2 3 1 An assay to detect the presence of amniotic f luid 4 in a test sample, said assay comprising:
6 a) exposing the test sample to a reagent which 7 contains the dye bromthymol blue as 8 indicator; and 9 b) noting any colour change and determining 11 therefrom whether or not amniotic fluid is 12 present in the sample.
13 14 2 The assay as claimed in Claim 1 wherein a colour is change of the reagent to blue indicates the 16 presence of amniotic f luid in the sample and a 17 colour change of the reagent to dark green 18 indicates the presence of blood or amniotic fluid 19 in the sample.
21 3 The assay as claimed in either one of Claims 1 and 22 2 wherein the reagent is used in liquid form.
23 24 4 The assay as claimed in any of Claims 1 to 3 wherein the reagent comprises bromthymol blue 26 extracted with an alcohol.
27 28 5 The assay as claimed in Claim 4 wherein water or 29 saline is used as a diluent in said reagent.
31 6 The assay as claimed in any one of Claims 1 to 5 32 wherein said reagent is applied to a portion of a 33 dressing or sanitary towel previously worn by the 34 patient and which has absorbed a sufficient quantity of the sample to be tested, and wherein 36 the colour change of the reagent on said towel or 14 dressing is used to determine whether or not 2 amniotic fluid is present.
3 4 7 The assay as claimed in any one of Claims 1 to 6 wherein a quantity of said reagent is applied to a 6 swab previously used to obtain a test sample from 7 the vagina of the patient, and wherein the colour 8 change of the reagent on said swab is used to 9 determine whether or not amniotic fluid is present.
11 12 8 A kit to detect the presence of amniotic f luid in 13 a test sample, said kit comprising a reagent 14 containing the dye bromthymol blue as indicator is and a colour chart to aid interpretation of the 16 results.
17 18 9 The kit as claimed in Claim 8 wherein the colour 19 chart includes the following:
21 blue - indicates amniotic fluid 22 present; and 23 green/dark green indicates blood or amniotic 24 fluid present 26 10 The kit as claimed in either one of Claims 8 and 9 27 wherein said reagent is in liquid form.
28 29 11 The kit as claimed in any one of the Claims 8 to 10 further comprising positive and negative 31 controls.
32 33 12 The kit as claimed in any one of Claims 8 to 10 34 further comprising swabs of synthetic fibres.
36 13 A method of determining the rupture of amniotic is membranes, said method comprising:
2 3 1) obtaining a sample of test fluid; 4 2) exposing said test fluid to a reagent which 6 includes bromthymol blue as indicator; and 7 8 3) noting any colour change.
9 14 The assay as claimed in Claim 13 wherein a colour 1 11 change of the reagent to blue indicates the 12 presence of amniotic fluid in the sample and a 13 colour change of the reagent to dark green 14 indicates the presence of blood or amniotic fluid is in the sample.
16 17 is The assay as claimed in either one of Claims 13 18 and 14 wherein the reagent is used in liquid form.
19 16 The assay as claimed in any one of Claims 13 to 15 21 wherein the reagent comprises bromthymol blue 22 extracted with an alcohol.
23 24 17 The assay as claimed in any one of Claims 13 to 16 wherein water or saline is used as a diluent in 26 said reagent.
27 28
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9919134.8A GB9919134D0 (en) | 1999-08-14 | 1999-08-14 | Assay |
Publications (2)
Publication Number | Publication Date |
---|---|
GB0019670D0 GB0019670D0 (en) | 2000-09-27 |
GB2353357A true GB2353357A (en) | 2001-02-21 |
Family
ID=10859096
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GBGB9919134.8A Ceased GB9919134D0 (en) | 1999-08-14 | 1999-08-14 | Assay |
GB0019670A Withdrawn GB2353357A (en) | 1999-08-14 | 2000-08-11 | Amniotic fluid detection |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GBGB9919134.8A Ceased GB9919134D0 (en) | 1999-08-14 | 1999-08-14 | Assay |
Country Status (2)
Country | Link |
---|---|
GB (2) | GB9919134D0 (en) |
IE (1) | IE20000630A1 (en) |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003007997A2 (en) * | 2001-07-19 | 2003-01-30 | Common Sense Ltd. | Secretion-monitoring article |
US6627394B2 (en) * | 2001-07-19 | 2003-09-30 | Common Sense Ltd. | Diagnostic pad |
EP1960762A2 (en) * | 2005-12-12 | 2008-08-27 | Common Sense Ltd. | Compositions and articles for detection of analytes exceeding a pre-set threshold |
US7947467B2 (en) | 2001-07-19 | 2011-05-24 | Common Sense Ltd. | Methods for monitoring pathological conditions in a female subject |
WO2013008239A1 (en) * | 2011-07-14 | 2013-01-17 | Mor Gideon | Noninvasive detection of meconium in amniotic fluid |
US9486368B2 (en) | 2013-12-05 | 2016-11-08 | Medline Industries, Inc. | Disposable hygienic article with means for diagnostic testing |
US11135338B2 (en) | 2014-07-01 | 2021-10-05 | Common Sense Ltd. | Diagnostic composition for identifying amniotic fluid |
US11471335B2 (en) | 2018-09-05 | 2022-10-18 | University Of South Carolina | Gel-within-gel wound dressing |
US11698344B2 (en) | 2018-09-05 | 2023-07-11 | University Of South Carolina | PH indicator swabs for biomonitoring and diagnostics |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4357945A (en) * | 1981-06-01 | 1982-11-09 | Janko Albert B | Device for testing and rupturing amniotic membrane |
JPH05123324A (en) * | 1991-11-05 | 1993-05-21 | Hakujiyuuji Kk | Pad for judging amniorrhexis of amniotic fluid |
US5425377A (en) * | 1994-08-25 | 1995-06-20 | Caillouette; James C. | pH measurement of body fluid |
US5738634A (en) * | 1994-08-25 | 1998-04-14 | Caillouette; James C. | pH measurement of body fluid |
WO1999002985A1 (en) * | 1997-07-11 | 1999-01-21 | Rosengreen Lea T | Wearable amniotic fluid detection device |
WO2000004822A1 (en) * | 1998-07-22 | 2000-02-03 | Smith Ramada S | System for identifying premature rupture of membrane during pregnancy |
-
1999
- 1999-08-14 GB GBGB9919134.8A patent/GB9919134D0/en not_active Ceased
-
2000
- 2000-08-09 IE IE20000630A patent/IE20000630A1/en unknown
- 2000-08-11 GB GB0019670A patent/GB2353357A/en not_active Withdrawn
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4357945A (en) * | 1981-06-01 | 1982-11-09 | Janko Albert B | Device for testing and rupturing amniotic membrane |
JPH05123324A (en) * | 1991-11-05 | 1993-05-21 | Hakujiyuuji Kk | Pad for judging amniorrhexis of amniotic fluid |
US5425377A (en) * | 1994-08-25 | 1995-06-20 | Caillouette; James C. | pH measurement of body fluid |
US5738634A (en) * | 1994-08-25 | 1998-04-14 | Caillouette; James C. | pH measurement of body fluid |
WO1999002985A1 (en) * | 1997-07-11 | 1999-01-21 | Rosengreen Lea T | Wearable amniotic fluid detection device |
WO2000004822A1 (en) * | 1998-07-22 | 2000-02-03 | Smith Ramada S | System for identifying premature rupture of membrane during pregnancy |
Non-Patent Citations (1)
Title |
---|
WPI Accession No: 1993-199764 & JP 05 123 324 A * |
Cited By (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003007997A2 (en) * | 2001-07-19 | 2003-01-30 | Common Sense Ltd. | Secretion-monitoring article |
US6627394B2 (en) * | 2001-07-19 | 2003-09-30 | Common Sense Ltd. | Diagnostic pad |
WO2003007997A3 (en) * | 2001-07-19 | 2004-03-18 | Common Sense Ltd | Secretion-monitoring article |
AU2002354890B2 (en) * | 2001-07-19 | 2007-05-31 | Common Sense Ltd. | Diagnostic pad |
US7947467B2 (en) | 2001-07-19 | 2011-05-24 | Common Sense Ltd. | Methods for monitoring pathological conditions in a female subject |
EP1960762A2 (en) * | 2005-12-12 | 2008-08-27 | Common Sense Ltd. | Compositions and articles for detection of analytes exceeding a pre-set threshold |
EP1960762A4 (en) * | 2005-12-12 | 2009-05-13 | Common Sense Ltd | Compositions and articles for detection of analytes exceeding a pre-set threshold |
US9144520B2 (en) | 2011-07-14 | 2015-09-29 | Gideon Mor | Noninvasive detection of meconium in amniotic fluid |
WO2013008239A1 (en) * | 2011-07-14 | 2013-01-17 | Mor Gideon | Noninvasive detection of meconium in amniotic fluid |
US9486368B2 (en) | 2013-12-05 | 2016-11-08 | Medline Industries, Inc. | Disposable hygienic article with means for diagnostic testing |
US10583047B2 (en) | 2013-12-05 | 2020-03-10 | Medline Industries, Inc. | Disposable hygienic article with means for diagnostic testing |
US11376166B2 (en) | 2013-12-05 | 2022-07-05 | Medline Industries, Lp | Disposable hygienic article with means for diagnostic testing |
US12023228B2 (en) | 2013-12-05 | 2024-07-02 | Medline Industries, Lp | Disposable hygienic article with means for diagnostic testing |
US11135338B2 (en) | 2014-07-01 | 2021-10-05 | Common Sense Ltd. | Diagnostic composition for identifying amniotic fluid |
US11471335B2 (en) | 2018-09-05 | 2022-10-18 | University Of South Carolina | Gel-within-gel wound dressing |
US11698344B2 (en) | 2018-09-05 | 2023-07-11 | University Of South Carolina | PH indicator swabs for biomonitoring and diagnostics |
US12196684B2 (en) | 2018-09-05 | 2025-01-14 | University Of South Carolina | pH indicator swabs for biomonitoring and diagnostics |
Also Published As
Publication number | Publication date |
---|---|
GB0019670D0 (en) | 2000-09-27 |
IE20000630A1 (en) | 2001-04-04 |
GB9919134D0 (en) | 1999-10-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
Thomason et al. | Statistical evaluation of diagnostic criteria for bacterial vaginosis | |
Esim et al. | Diagnosis of premature rupture of membranes by identification of β-HCG in vaginal washing fluid | |
US5837197A (en) | Positive fertility testing and reproductive health system | |
Vermesh et al. | Reevaluation of the role of culdocentesis in the management of ectopic pregnancy | |
GB2353357A (en) | Amniotic fluid detection | |
WO2013008239A1 (en) | Noninvasive detection of meconium in amniotic fluid | |
CN102321730A (en) | Joint vaginitis detection kit | |
US20170252020A1 (en) | Fluid Sample Collection and Testing Method | |
Li et al. | The techniques and complications of out-patient uterine washing in the assessment of endometrial function | |
CN204909509U (en) | Disposable vagina PH test paper detects stick | |
Das et al. | Comparison of hysteroscopy and histopathology in diagnosing abnormal uterine bleeding: an experience from a tertiary care center of eastern India | |
RU18143U1 (en) | DEVICE FOR DIAGNOSTIC OF THE STATE OF THE GENITAL ORGANS IN COWS | |
JP2951127B2 (en) | Bacterial vaginosis test | |
RU2807923C1 (en) | Method of female fertility diagnostics | |
Emery | The tryptic activity and presence of cornified squames in meconium as a diagnostic aid in congenital intestinal obstruction | |
Said et al. | The study of vaginal fluid urea, creatinine, B-HCG and placental alpha-1 microglobulin in diagnosis of premature rupture of membranes | |
CN221845265U (en) | Amniotic fluid early leakage detection protection pad | |
FARAG et al. | Assessment of urea and creatinine in vaginal washing fluid as a method for diagnosis of premature rupture of membranes | |
Liston | Trichomonas vaginalis infestation | |
RU184214U1 (en) | Probe for ionometry | |
Pascoe et al. | Comparison between vaginal swab and endocervical swab during pelvic examination | |
Thomason et al. | Is pH test paper as accurate as the electronic measurement of thepH of vaginal secretions? | |
RU2545889C1 (en) | Device for vaginal sphincter contraction strength test | |
Qian et al. | Analysis of the influence of vaginal secretions on the results of routine urine clinical tests and countermeasures | |
Adler | Vaginal Discharge: Diagnosis |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
WAP | Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1) |