WO2023037391A1 - Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof - Google Patents
Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof Download PDFInfo
- Publication number
- WO2023037391A1 WO2023037391A1 PCT/IN2022/050810 IN2022050810W WO2023037391A1 WO 2023037391 A1 WO2023037391 A1 WO 2023037391A1 IN 2022050810 W IN2022050810 W IN 2022050810W WO 2023037391 A1 WO2023037391 A1 WO 2023037391A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- strip
- sample
- membrane
- biomolecules
- pad
- Prior art date
Links
- 239000002250 absorbent Substances 0.000 title claims abstract description 67
- 230000002745 absorbent Effects 0.000 title claims abstract description 67
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 17
- 239000012491 analyte Substances 0.000 title description 2
- 239000012528 membrane Substances 0.000 claims abstract description 92
- 230000002175 menstrual effect Effects 0.000 claims abstract description 30
- 238000012216 screening Methods 0.000 claims abstract description 27
- 239000000020 Nitrocellulose Substances 0.000 claims description 34
- 229920001220 nitrocellulos Polymers 0.000 claims description 34
- 238000001914 filtration Methods 0.000 claims description 29
- 239000003153 chemical reaction reagent Substances 0.000 claims description 24
- 238000012360 testing method Methods 0.000 claims description 24
- 229940088597 hormone Drugs 0.000 claims description 19
- 239000005556 hormone Substances 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 17
- 210000004369 blood Anatomy 0.000 claims description 16
- 239000008280 blood Substances 0.000 claims description 16
- 108010005853 Anti-Mullerian Hormone Proteins 0.000 claims description 13
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 claims description 13
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 claims description 13
- 102100030173 Muellerian-inhibiting factor Human genes 0.000 claims description 13
- 239000000868 anti-mullerian hormone Substances 0.000 claims description 13
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 claims description 12
- 239000000706 filtrate Substances 0.000 claims description 11
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 claims description 10
- FMGSKLZLMKYGDP-UHFFFAOYSA-N Dehydroepiandrosterone Natural products C1C(O)CCC2(C)C3CCC(C)(C(CC4)=O)C4C3CC=C21 FMGSKLZLMKYGDP-UHFFFAOYSA-N 0.000 claims description 8
- 239000000427 antigen Substances 0.000 claims description 8
- 102000036639 antigens Human genes 0.000 claims description 8
- 108091007433 antigens Proteins 0.000 claims description 8
- FMGSKLZLMKYGDP-USOAJAOKSA-N dehydroepiandrosterone Chemical compound C1[C@@H](O)CC[C@]2(C)[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CC=C21 FMGSKLZLMKYGDP-USOAJAOKSA-N 0.000 claims description 8
- 238000001514 detection method Methods 0.000 claims description 8
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 claims description 8
- 238000011065 in-situ storage Methods 0.000 claims description 8
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims description 8
- 239000002105 nanoparticle Substances 0.000 claims description 8
- 229960002847 prasterone Drugs 0.000 claims description 8
- 102000003946 Prolactin Human genes 0.000 claims description 7
- 108010057464 Prolactin Proteins 0.000 claims description 7
- 102000034755 Sex Hormone-Binding Globulin Human genes 0.000 claims description 7
- 108010089417 Sex Hormone-Binding Globulin Proteins 0.000 claims description 7
- 239000000262 estrogen Substances 0.000 claims description 7
- 229940097325 prolactin Drugs 0.000 claims description 7
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 6
- 229910052737 gold Inorganic materials 0.000 claims description 6
- 239000010931 gold Substances 0.000 claims description 6
- 229960003604 testosterone Drugs 0.000 claims description 6
- 230000015572 biosynthetic process Effects 0.000 claims description 5
- 230000008859 change Effects 0.000 claims description 5
- 238000010030 laminating Methods 0.000 claims description 5
- 239000000186 progesterone Substances 0.000 claims description 5
- 229960003387 progesterone Drugs 0.000 claims description 5
- DBPWSSGDRRHUNT-UHFFFAOYSA-N 17alpha-hydroxy progesterone Natural products C1CC2=CC(=O)CCC2(C)C2C1C1CCC(C(=O)C)(O)C1(C)CC2 DBPWSSGDRRHUNT-UHFFFAOYSA-N 0.000 claims description 4
- DBPWSSGDRRHUNT-CEGNMAFCSA-N 17α-hydroxyprogesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)C)(O)[C@@]1(C)CC2 DBPWSSGDRRHUNT-CEGNMAFCSA-N 0.000 claims description 4
- 108091023037 Aptamer Proteins 0.000 claims description 4
- 108010074051 C-Reactive Protein Proteins 0.000 claims description 4
- 102400001329 Epiregulin Human genes 0.000 claims description 4
- 101800000155 Epiregulin Proteins 0.000 claims description 4
- 102000004877 Insulin Human genes 0.000 claims description 4
- 108090001061 Insulin Proteins 0.000 claims description 4
- 102000003816 Interleukin-13 Human genes 0.000 claims description 4
- 108090000176 Interleukin-13 Proteins 0.000 claims description 4
- 102000013691 Interleukin-17 Human genes 0.000 claims description 4
- 108050003558 Interleukin-17 Proteins 0.000 claims description 4
- 102000004889 Interleukin-6 Human genes 0.000 claims description 4
- 108090001005 Interleukin-6 Proteins 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 4
- 102000011923 Thyrotropin Human genes 0.000 claims description 4
- 108010061174 Thyrotropin Proteins 0.000 claims description 4
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims description 4
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims description 4
- 108010073929 Vascular Endothelial Growth Factor A Proteins 0.000 claims description 4
- 102000005789 Vascular Endothelial Growth Factors Human genes 0.000 claims description 4
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims description 4
- 239000000853 adhesive Substances 0.000 claims description 4
- 230000001070 adhesive effect Effects 0.000 claims description 4
- 210000003756 cervix mucus Anatomy 0.000 claims description 4
- 230000021615 conjugation Effects 0.000 claims description 4
- 229960000890 hydrocortisone Drugs 0.000 claims description 4
- 229940125396 insulin Drugs 0.000 claims description 4
- 229940100601 interleukin-6 Drugs 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 230000001592 luteinising effect Effects 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- 241000282414 Homo sapiens Species 0.000 claims description 3
- 102000003810 Interleukin-18 Human genes 0.000 claims description 3
- 108090000171 Interleukin-18 Proteins 0.000 claims description 3
- 102000016267 Leptin Human genes 0.000 claims description 3
- 108010092277 Leptin Proteins 0.000 claims description 3
- 239000003463 adsorbent Substances 0.000 claims description 3
- 238000003018 immunoassay Methods 0.000 claims description 3
- 229940039781 leptin Drugs 0.000 claims description 3
- NRYBAZVQPHGZNS-ZSOCWYAHSA-N leptin Chemical compound O=C([C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](N)CC(C)C)CCSC)N1CCC[C@H]1C(=O)NCC(=O)N[C@@H](CS)C(O)=O NRYBAZVQPHGZNS-ZSOCWYAHSA-N 0.000 claims description 3
- -1 polyethylene Polymers 0.000 claims description 3
- 241000894006 Bacteria Species 0.000 claims description 2
- 102000005600 Cathepsins Human genes 0.000 claims description 2
- 108010084457 Cathepsins Proteins 0.000 claims description 2
- 241000233866 Fungi Species 0.000 claims description 2
- 102000035195 Peptidases Human genes 0.000 claims description 2
- 108091005804 Peptidases Proteins 0.000 claims description 2
- 239000004365 Protease Substances 0.000 claims description 2
- 102000007156 Resistin Human genes 0.000 claims description 2
- 108010047909 Resistin Proteins 0.000 claims description 2
- 101710170513 Retinoic acid receptor responder protein 2 Proteins 0.000 claims description 2
- 102100033914 Retinoic acid receptor responder protein 2 Human genes 0.000 claims description 2
- FOIXSVOLVBLSDH-UHFFFAOYSA-N Silver ion Chemical compound [Ag+] FOIXSVOLVBLSDH-UHFFFAOYSA-N 0.000 claims description 2
- 241000700605 Viruses Species 0.000 claims description 2
- 238000002835 absorbance Methods 0.000 claims description 2
- 210000004381 amniotic fluid Anatomy 0.000 claims description 2
- 229920000249 biocompatible polymer Polymers 0.000 claims description 2
- 238000004737 colorimetric analysis Methods 0.000 claims description 2
- 239000000412 dendrimer Substances 0.000 claims description 2
- 229920000736 dendritic polymer Polymers 0.000 claims description 2
- 238000005516 engineering process Methods 0.000 claims description 2
- 239000003102 growth factor Substances 0.000 claims description 2
- 230000002757 inflammatory effect Effects 0.000 claims description 2
- 239000000893 inhibin Substances 0.000 claims description 2
- ZPNFWUPYTFPOJU-LPYSRVMUSA-N iniprol Chemical compound C([C@H]1C(=O)NCC(=O)NCC(=O)N[C@H]2CSSC[C@H]3C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@H](C(N[C@H](C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N[C@@H](CC=4C=CC=CC=4)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](CO)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC=4C=CC=CC=4)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC2=O)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H]2N(CCC2)C(=O)[C@@H](N)CCCNC(N)=N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N2[C@@H](CCC2)C(=O)N2[C@@H](CCC2)C(=O)N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N2[C@@H](CCC2)C(=O)N3)C(=O)NCC(=O)NCC(=O)N[C@@H](C)C(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@H](C(=O)N1)C(C)C)[C@@H](C)O)[C@@H](C)CC)=O)[C@@H](C)CC)C1=CC=C(O)C=C1 ZPNFWUPYTFPOJU-LPYSRVMUSA-N 0.000 claims description 2
- 150000002632 lipids Chemical class 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 102000039446 nucleic acids Human genes 0.000 claims description 2
- 108020004707 nucleic acids Proteins 0.000 claims description 2
- 150000007523 nucleic acids Chemical class 0.000 claims description 2
- 239000000813 peptide hormone Substances 0.000 claims description 2
- 229920002635 polyurethane Polymers 0.000 claims description 2
- 239000004814 polyurethane Substances 0.000 claims description 2
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 2
- 230000000750 progressive effect Effects 0.000 claims description 2
- 230000000770 proinflammatory effect Effects 0.000 claims description 2
- 210000000278 spinal cord Anatomy 0.000 claims description 2
- 239000003270 steroid hormone Substances 0.000 claims description 2
- 206010046901 vaginal discharge Diseases 0.000 claims description 2
- 230000028327 secretion Effects 0.000 abstract description 8
- 230000001850 reproductive effect Effects 0.000 abstract description 3
- 230000009323 psychological health Effects 0.000 abstract description 2
- 210000004379 membrane Anatomy 0.000 description 40
- 201000010065 polycystic ovary syndrome Diseases 0.000 description 14
- 102000009151 Luteinizing Hormone Human genes 0.000 description 9
- 108010073521 Luteinizing Hormone Proteins 0.000 description 9
- 230000003054 hormonal effect Effects 0.000 description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 8
- 229940028334 follicle stimulating hormone Drugs 0.000 description 8
- 229940040129 luteinizing hormone Drugs 0.000 description 8
- 208000000509 infertility Diseases 0.000 description 6
- 230000035945 sensitivity Effects 0.000 description 6
- 206010036049 Polycystic ovaries Diseases 0.000 description 5
- 239000003098 androgen Substances 0.000 description 5
- 201000010099 disease Diseases 0.000 description 5
- 230000027758 ovulation cycle Effects 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 208000019802 Sexually transmitted disease Diseases 0.000 description 4
- 229940030486 androgens Drugs 0.000 description 4
- 238000003475 lamination Methods 0.000 description 4
- 230000005906 menstruation Effects 0.000 description 4
- 238000012545 processing Methods 0.000 description 4
- 230000009933 reproductive health Effects 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 3
- 239000000090 biomarker Substances 0.000 description 3
- 208000035475 disorder Diseases 0.000 description 3
- 210000004696 endometrium Anatomy 0.000 description 3
- 230000036512 infertility Effects 0.000 description 3
- 231100000535 infertility Toxicity 0.000 description 3
- 206010006187 Breast cancer Diseases 0.000 description 2
- 208000026310 Breast neoplasm Diseases 0.000 description 2
- 206010008342 Cervix carcinoma Diseases 0.000 description 2
- 201000009273 Endometriosis Diseases 0.000 description 2
- 208000008589 Obesity Diseases 0.000 description 2
- 208000029082 Pelvic Inflammatory Disease Diseases 0.000 description 2
- 208000002500 Primary Ovarian Insufficiency Diseases 0.000 description 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 description 2
- 208000002495 Uterine Neoplasms Diseases 0.000 description 2
- 230000005856 abnormality Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 201000010881 cervical cancer Diseases 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 230000035558 fertility Effects 0.000 description 2
- 230000002538 fungal effect Effects 0.000 description 2
- 230000002068 genetic effect Effects 0.000 description 2
- 230000004630 mental health Effects 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 235000020824 obesity Nutrition 0.000 description 2
- 230000002611 ovarian Effects 0.000 description 2
- 230000035790 physiological processes and functions Effects 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 208000016685 primary ovarian failure Diseases 0.000 description 2
- 206010046766 uterine cancer Diseases 0.000 description 2
- 210000001215 vagina Anatomy 0.000 description 2
- 230000003612 virological effect Effects 0.000 description 2
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 102000014654 Aromatase Human genes 0.000 description 1
- 108010078554 Aromatase Proteins 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- 101710088194 Dehydrogenase Proteins 0.000 description 1
- 238000009007 Diagnostic Kit Methods 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010060378 Hyperinsulinaemia Diseases 0.000 description 1
- 208000013016 Hypoglycemia Diseases 0.000 description 1
- 206010022489 Insulin Resistance Diseases 0.000 description 1
- 208000037093 Menstruation Disturbances Diseases 0.000 description 1
- 206010027339 Menstruation irregular Diseases 0.000 description 1
- 206010027940 Mood altered Diseases 0.000 description 1
- 206010027951 Mood swings Diseases 0.000 description 1
- 206010033128 Ovarian cancer Diseases 0.000 description 1
- 206010061535 Ovarian neoplasm Diseases 0.000 description 1
- CZWCKYRVOZZJNM-UHFFFAOYSA-N Prasterone sodium sulfate Natural products C1C(OS(O)(=O)=O)CCC2(C)C3CCC(C)(C(CC4)=O)C4C3CC=C21 CZWCKYRVOZZJNM-UHFFFAOYSA-N 0.000 description 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 description 1
- 208000021017 Weight Gain Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000002306 biochemical method Methods 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- CZWCKYRVOZZJNM-USOAJAOKSA-N dehydroepiandrosterone sulfate Chemical compound C1[C@@H](OS(O)(=O)=O)CC[C@]2(C)[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CC=C21 CZWCKYRVOZZJNM-USOAJAOKSA-N 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000002996 emotional effect Effects 0.000 description 1
- 230000002357 endometrial effect Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 235000021191 food habits Nutrition 0.000 description 1
- 239000003163 gonadal steroid hormone Substances 0.000 description 1
- 210000002503 granulosa cell Anatomy 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000003862 health status Effects 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000003451 hyperinsulinaemic effect Effects 0.000 description 1
- 201000008980 hyperinsulinism Diseases 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000003821 menstrual periods Effects 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000037323 metabolic rate Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000007510 mood change Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 206010029410 night sweats Diseases 0.000 description 1
- 230000036565 night sweats Effects 0.000 description 1
- 229940127234 oral contraceptive Drugs 0.000 description 1
- 239000003539 oral contraceptive agent Substances 0.000 description 1
- 210000001672 ovary Anatomy 0.000 description 1
- 230000016087 ovulation Effects 0.000 description 1
- 210000004681 ovum Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 230000036186 satiety Effects 0.000 description 1
- 235000019627 satiety Nutrition 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000004797 therapeutic response Effects 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
Classifications
-
- 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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
- G01N21/8483—Investigating reagent band
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/775—Indicator and selective membrane
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/7796—Special mountings, packaging of indicators
Definitions
- the present invention is related to the field of medical devices. Specifically, the invention discloses a strip for screening of biomolecules in a sample, comprising one or more membrane-based sensors embedded in a laminated envelope, wherein said membrane-based sensor further comprises means to collect, separate and screen the biomolecules from the sample such as menstrual secretion.
- the invention also discloses said strip adhered absorbent sanitary article and the method for production of said strip and strip adhered absorbent sanitary article.
- the invention also discloses the application of said strip and strip adhered absorbent sanitary article in tracking the reproductive, physical and psychological health status of menstruators by early screening of biomolecules.
- Menstruation is a physiological phenomenon, wherein the regular discharge of blood and mucosal tissue from the inner lining of the uterus or uterine endometrium occurs through the vagina at more or less regular time intervals.
- the menstrual cycle is characterized by the rise and fall of hormones. If the egg/ovum ovulated from the ovaries is not fertilized by sperm, it triggers the shedding of uterine endometrium with blood to the outside of the body through the vagina. Menstruation remains one of the major factors limiting the social life of menstruators. This physiological phenomenon is stimulated by an interplay of various hormones in the body.
- Hormonal changes are natural processes of physiological function that change with age, food habits, mental health, climate, and environmental factors. Imbalance in hormones leads to reproductive health issues like infertility, polycystic ovary syndrome (PCOS), polycystic ovarian disease (PCOD), primary ovarian insufficiency (POI), Ovarian, Endometrial, Cervical Cancer, Breast Cancer, Uterine cancer, perimenopause, subfertility and infertility conditions and other conditions such as obesity, depression, hyper/hypo glycemia, etc.
- PCOS polycystic ovary syndrome
- PCOD polycystic ovarian disease
- POI primary ovarian insufficiency
- Ovarian Endometrial
- Cervical Cancer Cervical Cancer
- Breast Cancer Uterine cancer
- perimenopause subfertility and infertility conditions and other conditions such as obesity, depression, hyper/hypo glycemia, etc.
- PCOS is assessed by a combination of tests to determine various aspects of a woman's hormone levels. Blood samples are taken to measure levels of LH (luteinizing hormone) and FSH (follicle stimulating hormone). These hormones help regulate ovulation and the menstrual cycle. Thyroid functioning is tested as well as oestrogens, progesterone, DHEA sulphate, prolactin, and testosterone. All these tests are used to analyse different parts of the body. Additionally, urine is tested to look for evidence of polycystic ovarian syndrome. Some women with polycystic ovarian syndrome (PCOS) have an abnormal FSH to LH ratio. This condition occurs when the two hormones are not present at the same levels during the menstrual cycle.
- LH leukinizing hormone
- FSH follicle stimulating hormone
- both FSH and LH need to be present at certain times and at certain levels.
- the FSH and LH ratio is around 1:1.
- the FSH to LH ratio is typically higher than in other women. It is important to note that the normal FSH and LH levels in women with the said condition are not always the same. Monitoring these two hormones can be very helpful in diagnosing the condition, but it is not always necessary.
- the presence of AMH in the blood can be considered a potential marker for the development of PCOS. It does not affect the menstrual cycle or the use of oral contraceptives.
- AMH is produced after the deployment of a follicle, and it continues to affect the growth of the follicle through the antral phase. It also prevents the production of FSH and prevents the expression of the aromatase-dependent receptor. Compared to healthy women, the granulosa cells produce more AMH.
- PCOS polycystic ovarian syndrome
- Most women with this condition have elevated levels of androgens, such as testosterone and pro-androgens. They also have an enzyme required to convert these to androgens, 3-hydroxysteroid dehydrogenase (3-HSD). High androgen levels can be caused by hyperinsulinemia and insulin resistance. This condition can reduce the levels of sex hormone binding globulin. This can then lead to an increase in free androgens and an unfavourable metabolic profile.
- a patent application discloses a sanitary pad for medical examination comprising, an absorbent core for absorbing menstrual blood; a liquid-permeable first cover located on one side of the absorbent core; a liquid-impermeable second cover located on the other side of the absorbent core; and a transparent window formed on the center side of the second cover and configured to allow the menstrual blood absorbed in the absorbent core to be viewed from the outside.
- a plurality of hues formed so as to be in contrast to the color of the menstrual blood is displayed on one side of the transparent window on an outer surface of the second cover, and the medical examination identification information classified by color is displayed on one side of the displayed plurality of hues.
- absorbent and non-absorbent sanitary hygiene products comprising an impermeable outer layer, adhesive tabs, permeable top sheet, and padded absorbent layers attached to the top sheet with a padded layer of absorbent polymer material sandwiched between.
- the polymer material comprises an integrated screening and diagnostic means for detecting the presence or precursors of anatomical abnormalities, diseases, infections, or conditions as well as enabling genetic and molecular profiling from the integral analysis of the biological contents absorbed, collected, retained, or contained by the product. This includes an area for visible and/or electronic alert means to translate and transmit any resulting detected information, abnormality, and genetic or molecular profiles to external devices.
- the product may also comprise a therapeutic response to specific conditions detected and may also be suited as a non-disposable reusable hygiene product.
- the products disclosed above comprise complicated diagnostic kits and/or electronic readers with economic disadvantages.
- devices which facilitates early in- situ screening of one or more biomolecules from a sample such as menstrual discharge in a rapid, cost-effective, automatic, non-invasive, convenient manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity.
- biomolecules present in venous blood are also present in the menstrual blood, although in lesser quantities. It is difficult to measure the biomolecules (hormones and biomarkers) by biochemical methods when they are present in low quantities.
- the present invention addresses the aforesaid problems in the prior art by providing a strip for screening one or more biomolecules simultaneously, in a sample preferably menstrual discharge/secretion, comprising one or more membrane-based sensor(s) embedded in a laminated envelope, wherein said membrane-based sensor further comprises means to collect, separate and screen the biomolecules from the sample such as menstrual secretion.
- the invention also discloses said strip adhered absorbent sanitary article. Said strip and strip adhered absorbent sanitary article facilitate automatic self-monitoring of the levels of various biomolecules from one’s own sample (menstrual discharge/secretion) in-situ without employing additional kits and/or electronic readers using the naked eye. Said device is helpful in the early screening of biomolecules thereby effectively facilitating early intervention.
- the objective of the present invention is to provide a device which facilitates early in-situ screening of one or more biomolecules simultaneously from the menstrual discharge/secretion in a rapid, cost-effective, automatic, non-invasive, convenient manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity.
- the present invention pertains to a strip [001] for screening of biomolecules in a sample comprising at least one membrane -based sensor [012] embedded in a laminated envelope [003]; wherein the membrane -based sensors [012] are configured to be aligned in a specific configuration inside the laminated envelope [003], such that the sample-filtration pads [4] of each of said membrane -based sensor [012] intersect in the mid spot [004] of the laminated envelope [003]; wherein the strip [001] is configured to be in proximity to the flow of sample; wherein the laminated envelope [003] is provided with a peelable handle [002] at its base to facilitate ease of peeling off the laminated envelope [003].
- Another aspect of the invention pertains to a strip adhered absorbent sanitary article [Oi l], wherein the strip [001] is adhered to the absorbent sanitary article [013] by means of adhesive; wherein the strip [001]is configured to be proximal to the flow of sample.
- Yet another aspect of the invention pertains to a method of production of strip [001].
- Yet another aspect of the invention pertains to a method of production of strip adhered adsorbent sanitary article [Oi l].
- Another aspect of the invention also discloses the application of said strip adhered absorbent sanitary article for early screening of biomolecules which could predict/prognose disorders and diseases such as polycystic ovarian syndrome, polycystic ovarian disease, breast cancer, ovarian cancer, uterine cancer, perimenopause, subfertility and infertility condition, sexually transmitted diseases (STDs) of fungal, bacterial and viral origin, pelvic inflammatory diseases, endometriosis, cervical cancer, ovarian reserve, etc.
- STDs sexually transmitted diseases
- the present invention also discloses the application of said strip adhered absorbent sanitary article for early screening of biomolecules preferably hormones during the menstrual period of menstruators which could predict/prognose early identification of hormonal imbalances.
- FIGURE 1/1 A Top view/side view of a strip [001] with a peelable handle [002] at its base, wherein four membrane-based sensors [012] are aligned in a cross configuration.
- FIGURE 2 Schematic representation of components of membrane -based sensor [012].
- FIGURE 3 Schematic representation of strip adhered absorbent sanitary article [Oi l].
- Absorbent sanitary article refers to a sanitary napkin or disposable diaper which comprises an absorbing region capable of absorbing body fluids. This includes menstrual pads, biodegradable pads, panty liners, diapers.
- the present invention discloses a strip [001] for screening of biomolecules in a sample comprising at least one membrane -based sensor [012] embedded in a laminated envelope [003]; wherein the membrane -based sensors [012] are configured to be alligned in a specific configuration inside the laminated envelope [003], such that the sample-filtration pads [4] of each of said membrane -based sensor [012] intersect in the mid spot [004] of the laminated envelope [003]; wherein the strip [001] is configured to be in proximity to the flow of sample; wherein the laminated envelope [003] is provided with a peelable handle [002] at its base to facilitate ease of peeling off the laminated envelope [003].
- the membrane -based sensors [012] are configured to be aligned in a configuration selected from cross or cruciform, ‘T’-shape, peace signshape, ‘Y’- shape, or circular spinal cord progressive shape, dendrimer shape, multi- spoke wheel shape , Y- spoke wheel shape configuration inside the laminated envelope [003].
- the membrane-based sensor [012] comprises a backing card [10] as support, a sample-filtration pad [4] for consistent intake of the sample, a conjugate pad [5] embedded with detection reagents and signal reagents, nitrocellulose membrane [9] having a control zone [7] and a test zone [6] embedded with capture reagents for screening biomolecules, an absorbent pad [8] to maintain consistency of the flow, to prevent backflow and for excess sample absorbance.
- the strip is enveloped in between laminated liquid impermeable layers to render it impervious to sample except for the top and bottom side of mid spot [004] and the bottom sides of absorbent pads [8] of the embedded membrane-based sensors [012], wherein it is unlaminated and unenveloped.
- the sample-filtration pad [4] of the embedded membrane-based sensor[012] contains an unlaminated, unenveloped window on its upper side to facilitate the flow of sample into the sample-filtration pad [4] for filtration, allowing the filtrate to flow into the nitrocellulose membrane [9]; and the absorbent pad [8] of the membrane-based sensor [012] contains an unlaminated unenveloped window on its lower side to drain out the excess filtrated sample.
- the filtrate from the sample-filtration pad [4] travels towards the conjugate pad [5], test zone [6] wherein the biomolecules are detected and the excess filtrate drains out through the absorbent pad [8].
- the strip [001] comprises at least four membrane-based sensors [012] .
- the strip [001] comprises 4-10 membrane-based sensors[012].
- the strip is laminated with liquid impermeable layers made of biocompatible polymers such as polyethylene, polyurethane.
- the detection reagents comprise antibodies, aptamers, nucleic acids, protein receptors.
- the captive reagents comprise antibodies, aptamers.
- the signal reagents comprise metallic nanoparticles such as Gold nanoparticles, Silver Nanoparticles.
- the sample can be menstrual discharge, menstrual blood, vaginal secretions, vaginal effluents, amniotic fluid, and other vaginal discharges, preferably menstrual discharge, menstrual blood.
- the biomolecules are screened in situ on the test zone [6] in a semiquantitative manner using the techniques such as colorimetry, Immunoassays, DNA/RNA aptameric technology
- the biomolecules are screened in situ by colour coding in a semiquantitative manner which is observable by the naked eye by comparison of the change in the colour of the test zone [6] in comparison with the reference chart.
- the colour of the test zone[6] of membrane-based sensors [012] changes depending on the concentration of biomolecules in the sample which is either higher or lower than the reference values.
- the biomolecules comprise DNA, RNA, proteins, lipids from single and multi-cellular organisms such as bacteria, fungi, viruses and human; Steroid hormones comprising LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17-hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol; wherein the proteins comprises antigens, peptides, peptide hormones comprising Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin; pro-inflammatory markers comprising Interleukin- IBeta ( IL- Ip), Interleukin -6 (IL-6), Interleukin- 13 (IL-13), Interleukin- 17 (IL-17), Interleukin- 18 (IL- 18), Tumor Necrosis Factor-alpha (TNF-a), high-
- the biomolecules screened comprise hormones such as LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17- hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol, Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin or a combination thereof.
- hormones such as LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17- hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol, Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin or a combination thereof.
- the biomolecules screened comprise hormones such as FSH, AMH, Oestrogen, Prolactin.
- the biomolecules are screened with high specificity and sensitivity.
- the strip [001] enables screening of FSH, AMH, Oestrogen, Prolactin from menstrual blood with high sensivity and specificity towards menstrual secreted samples.
- Another aspect of the invention pertains to a strip adhered absorbent sanitary article [Oi l], wherein the strip [001] is adhered to the absorbent sanitary article [013] by means of adhesive; wherein the strip [001 ]is configured to be proximal to the flow of sample.
- the absorbent sanitary article [013] comprises menstrual pads, biodegradable pads, panty liners, diapers.
- the membrane -based sensors [012] screen the same or different biomolecule from the sample.
- the membrane -based sensors [012] screen the presence of two or more biomolecules simultaneously.
- the membrane-based sensors [012] of the strip[001] screen the presence of biomolecules within 30 minutes of adequate sample entry.
- Another aspect of the invention pertains to a method of production of strip [001] comprising:
- membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9] while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
- Yet another aspect of the invention pertains to a method of production of strip adhered absorbent sanitary article[011] comprising:
- membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9] while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
- the strip adhered absorbent sanitary article [011] can be applied to screen the hormonal changes, especially imbalance during the menstrual cycle which might impair normal physiological function as well as fertility and reproductive health.
- the strip adhered absorbent sanitary article [Oi l] can be applied to analyse the biomarkers and/or hormones relating to irregular menstruation, perimenopause, premenopausal syndrome, mood swings, headaches, memory problems, night sweats, weight gain, subfertility and other diseases caused by an imbalance in hormones.
- the membrane-based sensor is fabricated using the following components Nitrocellulose membrane FF120HP of Cytiva with the capillary rise of 120 s/4cm, Sample-filtration pad 1662 blood separator of Ahlstrom which filter out the RBC for ease flow of total serum or plasma to the testing zone, Conjugate pad of 6613 polyester fibre along with gold nanoparticles as labelling material with size of 40nm particles conjugated with antibodies, Absorbent pad made of cotton with grade 222 chromatography paper.
- the process involves formation of zoned nitrocellulose membrane, wherein said sample-filtration pad, the conjugate pad, are laid on the proximal end of the nitrocellulose membrane while the test zone and the control zone coated with antibodies comprising but not limited to LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), AMH (Anti -Mullerian Hormone), Prolactin, Oestrogen, 17-hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), SHBG (sex hormone binding globulin), HbAlc (glycosylated haemoglobin), Insulin, Cortisol, TSH (thyroid stimulating hormone) and the conjugate pad are laid on the distal end of the nitrocellulose membrane; affixing said zoned nitrocellulose membrane onto a backing card; Laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of sample -filtration pad and the lower side of
- the membrane-based sensor works on the principle of immunoassay, which uses a strip of nitrocellulose membrane to separate the components of an antigen- antibody reaction.
- the sample menstrual discharge
- enters the sample-filtration pad where it gets filtered and only the filtrate enters the conjugate pad and then to the nitrocellulose membrane.
- the conjugate pad contains a gold nanoparticle conjugated antibody that binds to a specific antigen if present in the sample.
- the test line contains a second antibody that binds to the first antibody, which in turn binds to the antigen. If there are any antigens present in the sample, they will bind to both antibodies and show up as a line on the test line.
- the menstrual secretion mainly the menstrual blood is collected on the sample-filtration pad region of the embedded membrane-based sensors.
- the sample is then filtered by the sample-filtration pad which has the blood separator and filters out the RBC and the remaining filtrate travels laterally towards the nitrocellulose membrane by chromatographic principle.
- the filtrate touches the conjugate pad where the gold nanoparticle conjugated primary antibodies are present. If the filtrate contains the (biomolecule) antigen then antigen- antibody (primary antibodies conjugated with gold nanoparticles) complex forms.
- the filtrate with said antigen-antibody complex moves towards the test and control zones, where the antigen-antibody complex interacts with secondary antibodies present in said zones and shows colour changes in both test and control zones depending on the presence of antigen(biomolecule) in a particular concentration.
- concentration-based colour appearance is controlled by the input concentration of antigen (biomolecules) in the test and control region and through other optimisation techniques.
- the key advantage of the presently claimed strip adhered absorbent sanitary article is that it facilitates early in-situ screening of one or more biomolecules simultaneously from the menstrual discharge in a rapid, cost-effective, automatic, non-invasive manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity.
- the claimed strip adhered absorbent sanitary article is capable of screening the biomolecules even when these are present in very limited concentration in the menstrual discharge with high sensitivity and selectivity.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Plasma & Fusion (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The present invention discloses a strip [001] for screening of biomolecules in a sample comprising one or more membrane-based sensors [012] embedded in a laminated envelope [003], wherein said membrane-based sensors further comprise means to collect, separate, and screen the biomolecules from the sample such as menstrual secretion. The invention also discloses said strip adhered absorbent sanitary article [011] and the method for production of said strip and strip adhered absorbent sanitary article. The invention also discloses the application of said strip and strip adhered absorbent sanitary article in tracking the reproductive, physical, and psychological health status of menstruators by early screening of biomolecules.
Description
STRIP ADHERED ABSORBENT SANITARY ARTICLE FOR DETECTING ANALYTE LEVELS AND ITS PRODUCTION THEREOF
FIELD OF THE INVENTION
The present invention is related to the field of medical devices. Specifically, the invention discloses a strip for screening of biomolecules in a sample, comprising one or more membrane-based sensors embedded in a laminated envelope, wherein said membrane-based sensor further comprises means to collect, separate and screen the biomolecules from the sample such as menstrual secretion. The invention also discloses said strip adhered absorbent sanitary article and the method for production of said strip and strip adhered absorbent sanitary article. The invention also discloses the application of said strip and strip adhered absorbent sanitary article in tracking the reproductive, physical and psychological health status of menstruators by early screening of biomolecules.
BACKGROUND ART
Menstruation is a physiological phenomenon, wherein the regular discharge of blood and mucosal tissue from the inner lining of the uterus or uterine endometrium occurs through the vagina at more or less regular time intervals. The menstrual cycle is characterized by the rise and fall of hormones. If the egg/ovum ovulated from the ovaries is not fertilized by sperm, it triggers the shedding of uterine endometrium with blood to the outside of the body through the vagina. Menstruation remains one of the major factors limiting the social life of menstruators. This physiological phenomenon is stimulated by an interplay of various hormones in the body. When there is a change in the optimal levels of said hormones, the menstruation process itself gets affected leading to various reproductive health issues and many more. Although the changes associated due to modification in the levels of hormones are not noticeable in the short run, it apparently paves the way to culminate in higher degrees of disease/ disorders in the long run.
The physical, mental and emotional health of menstruators keeps changing on a daily basis according to the dynamic changes in their hormonal levels. Assessment and comprehension of the health status of menstruators remain a challenging aspect in view of said dynamic changes in hormonal levels. Even an individual can't understand his/her own body and mind
unless much information is provided. Changes in hormonal levels play an essential influential role in controlling the physical and mental health of human beings and such changes govern various stages of reproductive health and metabolism. Hormonal imbalances are essential biomarkers for various ailments, disorders, and diseases. For instance, the difference in certain hormonal levels plays a major role in causing mood changes, increase/decrease in the body weight, satiety levels, metabolic rate, libido, etc.
Hormonal changes are natural processes of physiological function that change with age, food habits, mental health, climate, and environmental factors. Imbalance in hormones leads to reproductive health issues like infertility, polycystic ovary syndrome (PCOS), polycystic ovarian disease (PCOD), primary ovarian insufficiency (POI), Ovarian, Endometrial, Cervical Cancer, Breast Cancer, Uterine cancer, perimenopause, subfertility and infertility conditions and other conditions such as obesity, depression, hyper/hypo glycemia, etc.
Generally, PCOS is assessed by a combination of tests to determine various aspects of a woman's hormone levels. Blood samples are taken to measure levels of LH (luteinizing hormone) and FSH (follicle stimulating hormone). These hormones help regulate ovulation and the menstrual cycle. Thyroid functioning is tested as well as oestrogens, progesterone, DHEA sulphate, prolactin, and testosterone. All these tests are used to analyse different parts of the body. Additionally, urine is tested to look for evidence of polycystic ovarian syndrome. Some women with polycystic ovarian syndrome (PCOS) have an abnormal FSH to LH ratio. This condition occurs when the two hormones are not present at the same levels during the menstrual cycle. In order to develop proper egg and follicle development, both FSH and LH need to be present at certain times and at certain levels. Usually, the FSH and LH ratio is around 1:1. In women with polycystic ovaries, the FSH to LH ratio is typically higher than in other women. It is important to note that the normal FSH and LH levels in women with the said condition are not always the same. Monitoring these two hormones can be very helpful in diagnosing the condition, but it is not always necessary. The presence of AMH in the blood can be considered a potential marker for the development of PCOS. It does not affect the menstrual cycle or the use of oral contraceptives. AMH is produced after the deployment of a follicle, and it continues to affect the growth of the follicle through the antral phase. It also prevents the production of FSH and prevents the expression of the aromatase-dependent receptor. Compared to healthy women, the granulosa cells produce more AMH. The prevalence of androgenism is a chief characteristic of the polycystic ovarian syndrome (PCOS). Most women with this condition have elevated levels of
androgens, such as testosterone and pro-androgens. They also have an enzyme required to convert these to androgens, 3-hydroxysteroid dehydrogenase (3-HSD). High androgen levels can be caused by hyperinsulinemia and insulin resistance. This condition can reduce the levels of sex hormone binding globulin. This can then lead to an increase in free androgens and an unfavourable metabolic profile.
Thus it is evident that it's essential to focus on early screening of said hormonal imbalances which may aid in the prognosis or prediction of these various above-cited ailments which facilitates devising early treatment intervention which will bring much easier recovery rate and all over wellness. Similarly, an assay of biomolecules from the menstrual discharge/secretion also facilitates early screening of Sexually Transmitted Diseases (STDs) of fungal, bacterial, and viral origin, pelvic inflammatory diseases, and Endometriosis.
A patent application discloses a sanitary pad for medical examination comprising, an absorbent core for absorbing menstrual blood; a liquid-permeable first cover located on one side of the absorbent core; a liquid-impermeable second cover located on the other side of the absorbent core; and a transparent window formed on the center side of the second cover and configured to allow the menstrual blood absorbed in the absorbent core to be viewed from the outside. A plurality of hues formed so as to be in contrast to the color of the menstrual blood is displayed on one side of the transparent window on an outer surface of the second cover, and the medical examination identification information classified by color is displayed on one side of the displayed plurality of hues.
Yet another patent application discloses absorbent and non-absorbent sanitary hygiene products comprising an impermeable outer layer, adhesive tabs, permeable top sheet, and padded absorbent layers attached to the top sheet with a padded layer of absorbent polymer material sandwiched between. The polymer material comprises an integrated screening and diagnostic means for detecting the presence or precursors of anatomical abnormalities, diseases, infections, or conditions as well as enabling genetic and molecular profiling from the integral analysis of the biological contents absorbed, collected, retained, or contained by the product. This includes an area for visible and/or electronic alert means to translate and transmit any resulting detected information, abnormality, and genetic or molecular profiles to external devices. The product may also comprise a therapeutic response to specific conditions detected and may also be suited as a non-disposable reusable hygiene product.
However, the products disclosed above comprise complicated diagnostic kits and/or electronic readers with economic disadvantages. Thus, there is a need for devices which facilitates early in- situ screening of one or more biomolecules from a sample such as menstrual discharge in a rapid, cost-effective, automatic, non-invasive, convenient manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity. One study suggests that the biomolecules present in venous blood are also present in the menstrual blood, although in lesser quantities. It is difficult to measure the biomolecules (hormones and biomarkers) by biochemical methods when they are present in low quantities.
The present invention addresses the aforesaid problems in the prior art by providing a strip for screening one or more biomolecules simultaneously, in a sample preferably menstrual discharge/secretion, comprising one or more membrane-based sensor(s) embedded in a laminated envelope, wherein said membrane-based sensor further comprises means to collect, separate and screen the biomolecules from the sample such as menstrual secretion. The invention also discloses said strip adhered absorbent sanitary article. Said strip and strip adhered absorbent sanitary article facilitate automatic self-monitoring of the levels of various biomolecules from one’s own sample (menstrual discharge/secretion) in-situ without employing additional kits and/or electronic readers using the naked eye. Said device is helpful in the early screening of biomolecules thereby effectively facilitating early intervention.
OBJECTIVES OF THE INVENTION:
The objective of the present invention is to provide a device which facilitates early in-situ screening of one or more biomolecules simultaneously from the menstrual discharge/secretion in a rapid, cost-effective, automatic, non-invasive, convenient manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity.
Yet another objective of the present invention is to provide a process for the production of the said device which facilitates early screening of biomolecules from the menstrual discharge/secertion in a rapid, cost-effective, automatic, non-invasive manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity.
Yet another objective of the present invention is to provide a method for analyzing one or more biomolecules simultaneously from the menstrual discharge in a rapid and cost- effective manner.
SUMMARY OF THE INVENTION:
The present invention pertains to a strip [001] for screening of biomolecules in a sample comprising at least one membrane -based sensor [012] embedded in a laminated envelope [003]; wherein the membrane -based sensors [012] are configured to be aligned in a specific configuration inside the laminated envelope [003], such that the sample-filtration pads [4] of each of said membrane -based sensor [012] intersect in the mid spot [004] of the laminated envelope [003]; wherein the strip [001] is configured to be in proximity to the flow of sample; wherein the laminated envelope [003] is provided with a peelable handle [002] at its base to facilitate ease of peeling off the laminated envelope [003].
Another aspect of the invention pertains to a strip adhered absorbent sanitary article [Oi l], wherein the strip [001] is adhered to the absorbent sanitary article [013] by means of adhesive; wherein the strip [001]is configured to be proximal to the flow of sample.
Yet another aspect of the invention pertains to a method of production of strip [001].
Yet another aspect of the invention pertains to a method of production of strip adhered adsorbent sanitary article [Oi l].
Another aspect of the invention also discloses the application of said strip adhered absorbent sanitary article for early screening of biomolecules which could predict/prognose disorders and diseases such as polycystic ovarian syndrome, polycystic ovarian disease, breast cancer, ovarian cancer, uterine cancer, perimenopause, subfertility and infertility condition, sexually transmitted diseases (STDs) of fungal, bacterial and viral origin, pelvic inflammatory diseases, endometriosis, cervical cancer, ovarian reserve, etc.
The present invention also discloses the application of said strip adhered absorbent sanitary article for early screening of biomolecules preferably hormones during the menstrual period of menstruators which could predict/prognose early identification of hormonal imbalances.
BRIEF DESCRIPTION OF THE FIGURES:
FIGURE 1/1 A: Top view/side view of a strip [001] with a peelable handle [002] at its base, wherein four membrane-based sensors [012] are aligned in a cross configuration.
FIGURE 2: Schematic representation of components of membrane -based sensor [012].
FIGURE 3: Schematic representation of strip adhered absorbent sanitary article [Oi l].
Figure Eegend:
001 Strip; 002 Peelable handle; 003 Laminated envelope; 004 Mid spot of the Strip; 4 Sample-filtration pad; 5 Conjugate pad; 6 Test zone; 7 Control zone; 8 Absorbent pad; 9 Nitrocellulose membrane; 10 Backing card; 011 strip adhered absorbent sanitary article; 012 Membrane-based sensor; 013 absorbent sanitary article.
DETAILED DESCRIPTION OF THE INVENTION:
For the purposes of the following detailed description, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. Thus, before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified systems or process parameters that may, of course, vary.
It is also to be understood that the terminology used herein is for the purpose of describing embodiments of the invention only and is not intended to limit the scope of the invention in any manner. The use of examples anywhere in this specification, including examples of any terms discussed herein, is illustrative only and in no way limits the scope and meaning of the invention or any exemplified term. Likewise, the invention is not limited to various embodiments given in this specification.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In the case of conflict, the present document, including definitions, will control. It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. The terms “preferred” and “preferably” refer to embodiments of the invention that may afford certain benefits under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the recitation of one or more
preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the invention.
As used herein, the terms “comprising” “including” “having” “containing” “involving” and the like are to be understood to be open-ended, i.e., to mean including but not limited to.
The term “Absorbent sanitary article” refers to a sanitary napkin or disposable diaper which comprises an absorbing region capable of absorbing body fluids. This includes menstrual pads, biodegradable pads, panty liners, diapers.
The present invention discloses a strip [001] for screening of biomolecules in a sample comprising at least one membrane -based sensor [012] embedded in a laminated envelope [003]; wherein the membrane -based sensors [012] are configured to be alligned in a specific configuration inside the laminated envelope [003], such that the sample-filtration pads [4] of each of said membrane -based sensor [012] intersect in the mid spot [004] of the laminated envelope [003]; wherein the strip [001] is configured to be in proximity to the flow of sample; wherein the laminated envelope [003] is provided with a peelable handle [002] at its base to facilitate ease of peeling off the laminated envelope [003].
In various embodiments of the strip[001], the membrane -based sensors [012] are configured to be aligned in a configuration selected from cross or cruciform, ‘T’-shape, peace signshape, ‘Y’- shape, or circular spinal cord progressive shape, dendrimer shape, multi- spoke wheel shape , Y- spoke wheel shape configuration inside the laminated envelope [003].
In an embodiment of the strip [001], the membrane-based sensor [012] comprises a backing card [10] as support, a sample-filtration pad [4] for consistent intake of the sample, a conjugate pad [5] embedded with detection reagents and signal reagents, nitrocellulose membrane [9] having a control zone [7] and a test zone [6] embedded with capture reagents for screening biomolecules, an absorbent pad [8] to maintain consistency of the flow, to prevent backflow and for excess sample absorbance.
In yet another embodiment of the strip [001], the strip is enveloped in between laminated liquid impermeable layers to render it impervious to sample except for the top and bottom side of mid spot [004] and the bottom sides of absorbent pads [8] of the embedded membrane-based sensors [012], wherein it is unlaminated and unenveloped.
In an embodiment of the strip [001], the sample-filtration pad [4] of the embedded membrane-based sensor[012] contains an unlaminated, unenveloped window on its upper side to facilitate the flow of sample into the sample-filtration pad [4] for filtration, allowing the filtrate to flow into the nitrocellulose membrane [9]; and the absorbent pad [8] of the membrane-based sensor [012] contains an unlaminated unenveloped window on its lower side to drain out the excess filtrated sample.
In an embodiment of the strip [001], the filtrate from the sample-filtration pad [4] travels towards the conjugate pad [5], test zone [6] wherein the biomolecules are detected and the excess filtrate drains out through the absorbent pad [8].
In an embodiment of the strip [001], it comprises at least four membrane-based sensors [012] .
In various embodiments of the strip [001], it comprises 4-10 membrane-based sensors[012].
In an embodiment of the strip[001], the strip is laminated with liquid impermeable layers made of biocompatible polymers such as polyethylene, polyurethane.
In various embodiments of the strip[001], the detection reagents comprise antibodies, aptamers, nucleic acids, protein receptors.
In various embodiments of the strip[001], the captive reagents comprise antibodies, aptamers.
In various embodiments of the strip[001], the signal reagents comprise metallic nanoparticles such as Gold nanoparticles, Silver Nanoparticles.
In various embodiments of the strip[001], the sample can be menstrual discharge, menstrual blood, vaginal secretions, vaginal effluents, amniotic fluid, and other vaginal discharges, preferably menstrual discharge, menstrual blood.
In various embodiments of the strip[001], the biomolecules are screened in situ on the test zone [6] in a semiquantitative manner using the techniques such as colorimetry, Immunoassays, DNA/RNA aptameric technology
In various embodiments of the strip[001], the biomolecules are screened in situ by colour coding in a semiquantitative manner which is observable by the naked eye by comparison of the change in the colour of the test zone [6] in comparison with the reference chart.
In various embodiments of the strip[001], the colour of the test zone[6] of membrane-based sensors [012] changes depending on the concentration of biomolecules in the sample which is either higher or lower than the reference values.
In various embodiments of the strip[001], the biomolecules comprise DNA, RNA, proteins, lipids from single and multi-cellular organisms such as bacteria, fungi, viruses and human; Steroid hormones comprising LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17-hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol; wherein the proteins comprises antigens, peptides, peptide hormones comprising Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin; pro-inflammatory markers comprising Interleukin- IBeta ( IL- Ip), Interleukin -6 (IL-6), Interleukin- 13 (IL-13), Interleukin- 17 (IL-17), Interleukin- 18 (IL- 18), Tumor Necrosis Factor-alpha (TNF-a), high-sensitivity C-reactive protein (hs-CRP), chemerin, resistin; growth factors comprising Vascular endothelial growth factor (VEGF), Soluble VEGF-R1 (sVEGF-Rl), Epiregulin (EREG), inhibin pA; inflammatory proteases comprising Matrix metalloprotease-9 (MMP-9), Cathepsin; SHBG (sex hormone binding globulin), HbAlc (glycosylated haemoglobin) or a combination thereof.
In a preferable embodiment of the strip[001], the biomolecules screened comprise hormones such as LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17- hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol, Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin or a combination thereof.
In a preferable embodiment of the strip [001], the biomolecules screened comprise hormones such as FSH, AMH, Oestrogen, Prolactin.
In a specific embodiment of the strip [001], the biomolecules are screened with high specificity and sensitivity. Particularly, the strip [001] enables screening of FSH, AMH, Oestrogen, Prolactin from menstrual blood with high sensivity and specificity towards menstrual secreted samples.
Another aspect of the invention pertains to a strip adhered absorbent sanitary article [Oi l], wherein the strip [001] is adhered to the absorbent sanitary article [013] by means of adhesive; wherein the strip [001 ]is configured to be proximal to the flow of sample.
In an embodiment of the strip adhered absorbent sanitary article [Oi l], the absorbent sanitary article [013] comprises menstrual pads, biodegradable pads, panty liners, diapers.
In various embodiments of the strip [001], the membrane -based sensors [012] screen the same or different biomolecule from the sample.
In various embodiments of the strip [001], the membrane -based sensors [012] screen the presence of two or more biomolecules simultaneously.
In an embodiment of the strip [001] adhered to the absorbent sanitary article [Oi l], the membrane-based sensors [012] of the strip[001] screen the presence of biomolecules within 30 minutes of adequate sample entry.
Another aspect of the invention pertains to a method of production of strip [001] comprising:
• fabrication of membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9] while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
• affixing said zoned nitrocellulose membrane onto a backing card [10];
• Laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of sample-filtration pad [4] and the lower side of conjugate pad [8]to form laminated strip[001];
Yet another aspect of the invention pertains to a kit comprising strip adhered adsorbent sanitary article [Oi l] and reference colour index.
Another aspect of the invention pertains to a method of screening the biomolecules in the sample comprising collecting the sample in the strip adhered absorbent sanitary article and screening the biomolecules.
Yet another aspect of the invention pertains to a method of production of strip adhered absorbent sanitary article[011] comprising:
• fabrication of membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9] while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
• affixing said zoned nitrocellulose membrane onto a backing card [10];
• laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of the sample-filtration pad and the lower side of the conjugate pad to form a laminated membrane-based sensor;
• affixing said laminated membrane -based sensor onto absorbent sanitary article [013] in a specific peelable configuration.
In various embodiments, the strip adhered absorbent sanitary article [011], can be applied to screen the hormonal changes, especially imbalance during the menstrual cycle which might impair normal physiological function as well as fertility and reproductive health.
In various embodiments, the strip adhered absorbent sanitary article [Oi l], can be applied to analyse the biomarkers and/or hormones relating to irregular menstruation, perimenopause, premenopausal syndrome, mood swings, headaches, memory problems, night sweats, weight gain, subfertility and other diseases caused by an imbalance in hormones.
EXAMPLES:
Without limiting the scope of the present invention as described above in any way, the present invention has been further explained through the examples provided below.
Fabrication of Membrane-based sensor adhered absorbent sanitary article:
The membrane-based sensor is fabricated using the following components Nitrocellulose membrane FF120HP of Cytiva with the capillary rise of 120 s/4cm, Sample-filtration pad 1662 blood separator of Ahlstrom which filter out the RBC for ease flow of total serum or plasma to the testing zone, Conjugate pad of 6613 polyester fibre along with gold nanoparticles as labelling material with size of 40nm particles conjugated with antibodies, Absorbent pad made of cotton with grade 222 chromatography paper. The process involves formation of zoned nitrocellulose membrane, wherein said sample-filtration pad, the conjugate pad, are laid on the proximal end of the nitrocellulose membrane while the test zone and the control zone coated with antibodies comprising but not limited to LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), AMH (Anti -Mullerian Hormone), Prolactin, Oestrogen, 17-hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), SHBG (sex hormone binding globulin), HbAlc (glycosylated haemoglobin), Insulin, Cortisol, TSH (thyroid stimulating hormone) and the conjugate pad are laid on the distal end of the nitrocellulose membrane; affixing said zoned nitrocellulose membrane onto a backing card; Laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of sample -filtration pad and the lower side of conjugate pad to form laminated membrane-based sensor; Particularly, sample-filtration pad and absorbent pad has the windows cut of lamination (30gsm/1.5Mil thickness lamination with skin friendly breathable Poly ethylene (PE) film ); Samplefiltration pad has the cut from lamination at the upper side and absorbent pad has the cut from lamination at the lower side to allow excess flow of sample into the sanitary absorbent article; Affixing said laminated membrane -based sensors (one or many) onto absorbent sanitary article in a specific peelable configuration. Alternatively, multiple laminated membrane-based sensors can be attached to the base component called as backing card that may be made of PVC with a thickness of 0.01cm to 0.03cm along with pressure-sensitive adhesive coating which in turn can be adhered to absorbent sanitary articles.
Working of membrane-based sensor adhered absorbent sanitary article
The membrane-based sensor works on the principle of immunoassay, which uses a strip of nitrocellulose membrane to separate the components of an antigen- antibody reaction. The sample (menstrual discharge) enters the sample-filtration pad where it gets filtered and only the filtrate enters the conjugate pad and then to the nitrocellulose membrane. The conjugate
pad contains a gold nanoparticle conjugated antibody that binds to a specific antigen if present in the sample. The test line contains a second antibody that binds to the first antibody, which in turn binds to the antigen. If there are any antigens present in the sample, they will bind to both antibodies and show up as a line on the test line.
When the users wear the strip adhered absorbent sanitary article on their second day of the menstruation cycle, the menstrual secretion mainly the menstrual blood is collected on the sample-filtration pad region of the embedded membrane-based sensors. The sample is then filtered by the sample-filtration pad which has the blood separator and filters out the RBC and the remaining filtrate travels laterally towards the nitrocellulose membrane by chromatographic principle. The filtrate touches the conjugate pad where the gold nanoparticle conjugated primary antibodies are present. If the filtrate contains the (biomolecule) antigen then antigen- antibody (primary antibodies conjugated with gold nanoparticles) complex forms. The filtrate with said antigen-antibody complex moves towards the test and control zones, where the antigen-antibody complex interacts with secondary antibodies present in said zones and shows colour changes in both test and control zones depending on the presence of antigen(biomolecule) in a particular concentration. The concentration-based colour appearance is controlled by the input concentration of antigen (biomolecules) in the test and control region and through other optimisation techniques.
Similarly, when the strip containing many membrane-based sensors, each capable of screening either the same or different biomolecules, is adhered to the absorbent sanitary article as shown in figure 1 and la, all the membrane-based sensors receive the sample and show a change of colour bands according to the presence and concentration of the biomolecules in the sample. The colour coding is then referred by peeling off the strip with the membrane-based sensors from the soiled absorbent sanitary article and comparing them against the reference range provided in the form of a pamphlet. These whole reactions happen within half an hour of adequate sample receipt by the membrane-based sensors adhered to absorbent sanitary article and hence the same can be considered as Rapid Point of Care Devices.
ADVANTAGES:
The key advantage of the presently claimed strip adhered absorbent sanitary article is that it facilitates early in-situ screening of one or more biomolecules simultaneously from the menstrual discharge in a rapid, cost-effective, automatic, non-invasive manner without the need for any further processing, wherein the results could be self-interpreted using the naked eye with high sensitivity and selectivity. The claimed strip adhered absorbent sanitary article is capable of screening the biomolecules even when these are present in very limited concentration in the menstrual discharge with high sensitivity and selectivity.
REFERENCES:
• Silvestris, E., de Pergola, G., Rosania, R., & Loverro, G. (2018). Obesity as disruptor of the female fertility. Reproductive Biology And Endocrinology, 16(1). https://doi.org/10.1186/sl2958-018-0336-z
• Stanikova, D., Luck, T., Pabst, A., Bae, Y., Hinz, A., & Glaesmer, H. et al. (2019). Associations Between Anxiety, Body Mass Index, and Sex Hormones in Women. Frontiers In Psychiatry, 10. https://doi.org/10.3389/fpsyt.2019.00479
• KR101890908B1
• GB 2578901A
Claims
The Claim:
1. Strip [001] for screening of biomolecules in a sample comprising at least one membrane-based sensor [012] embedded in a laminated envelope[003]; wherein the membrane-based sensors [012] are configured to be alligned in a specific configuration inside the laminated envelope [003], such that the sample-filtration pads [4] of each of said membrane -based sensor [012] intersect in the mid spot [004] of the laminated envelope [003]; wherein the strip [001] is configured to be in proximity to the flow of sample; wherein the laminated envelope [003] is provided with a peelable handle [002] at its base to facilitate ease of peeling off the laminated envelope [003].
2. The strip [001] as claimed in claim 1, wherein the membrane-based sensors [012] are configured to be aligned in a configuration selected from cross or cruciform, ‘T’- shape, peace sign- shape, ‘Y’- shape, or circular spinal cord progressive shape, dendrimer shape, multi-spoke wheel shape, Y-spoke wheel shape configuration inside the laminated envelope [003].
3. The strip [001] as claimed in claim 1, wherein the membrane-based sensor [012] comprises a backing card [10] as support, a sample-filtration pad [4] for consistent intake of the sample, a conjugate pad [5] embedded with detection reagents and signal reagents, nitrocellulose membrane [9] having a control zone [7] and a test zone [6] embedded with capture reagents for screening biomolecules, an absorbent pad [8] to maintain consistency of the flow, to prevent backflow and for excess sample absorbance.
4. The strip [001] as claimed in claim 1, wherein it is enveloped in between laminated liquid impermeable layers to render it impervious to sample except for the top and bottom side of mid spot [004] and the bottom sides of absorbent pads [8] of the embedded membrane-based sensors [012], wherein it is unlaminated and unenveloped;
5. The strip [001] as claimed in claim 1, wherein the sample-filtration pad [4] of the embedded membrane -based sensor[012] contains an unlaminated, unenveloped window on its upper side to facilitate the flow of sample into the sample-filtration pad [4] for filtration, allowing the filtrate to flow into the nitrocellulose membrane
[9]; and the absorbent pad [8] of the membrane -based sensor [012] contains an unlaminated unenveloped window on its lower side to drain out the excess filtrated sample. The strip [001] as claimed in claim 1, wherein the filtrate from the sample-filtration pad [4] travels towards the conjugate pad [5], test zone [6] wherein the biomolecules are detected and the excess filtrate drains out through the absorbent pad [8]. The strip [001] as claimed in claim 1, comprising at least four membrane-based sensors[012]. The strip [001] as claimed in claim 1, wherein the strip is laminated with liquid impermeable layers made of biocompatible polymers such as polyethylene, polyurethane. The strip [001] as claimed in claim 1, wherein the detection reagents comprises antibodies, aptamers, nucleic acids, protein receptors; wherein the captive reagents comprises antibodies, aptamers; wherein the signal reagents comprises metallic nanoparticles such as Gold nanoparticles, Silver Nanoparticles. The strip [001] as claimed in claim 1, wherein the sample can be menstrual discharge, menstrual blood, vaginal secretions, vaginal effluents, amniotic fluid, and other vaginal discharges. The strip [001] as claimed in claim 1, wherein the biomolecules are screened in situ on the test zone [6] in a semiquantitative manner using the techniques such as colorimetry, Immunoassays, DNA/RNA aptameric technology. The strip [001] as claimed in claim 1, wherein the biomolecules are screened in situ by colour coding in a semiquantitative manner which is observable by naked eye by comparison of the change in the colour of the test zone [6] in comparison with the reference chart. The strip [001] as claimed in claim 1, wherein colour of test zone[6] of membrane - based sensors [012] changes depending on the concentration of biomolecules in the sample which is either higher or lower than the reference values. The strip [001] as claimed in claim 1, wherein the biomolecules comprise DNA,
RNA, proteins, lipids from single and multi-cellular organisms such as bacteria,
17 fungi, viruses and human; Steroid hormones comprising LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17 -hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), Cortisol; wherein the proteins comprises antigens, peptides, peptide hormones comprising Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin; pro- inflammatory markers comprising Interleukin- IB eta (IL-ip), Interleukin-6 (IL-6), Interleukin- 13 (IL-13), Interleukin- 17 (IL-17), Interleukin- 18 (IL-18), Tumor Necrosis Factor-alpha (TNF-a), high-sensitivity C-reactive protein (hs-CRP), chemerin, resistin; growth factors comprising Vascular endothelial growth factor (VEGF), Soluble VEGF-R1 (sVEGF-Rl), Epiregulin (EREG), inhibin pA; inflammatory proteases comprising Matrix metalloprotease-9 (MMP-9), Cathepsin; SHBG (sex hormone binding globulin), HbAlc (glycosylated haemoglobin) or a combination thereof.
15. A strip adhered absorbent sanitary article [Oi l], wherein the strip [001] is adhered to the absorbent sanitary article [013] by means of adhesive; wherein the strip [001]is configured to be proximal to the flow of the sample.
16. The strip adhered absorbent sanitary article [Oi l] as claimed in claim 15, wherein the absorbent sanitary article [013] comprises menstrual pads, biodegradable pads, panty liners, diapers.
17. The strip [001] as claimed in claim 1 or 15, wherein each of the membrane-based sensors [012] screens the same or different biomolecule from the sample.
18. The strip [001] as claimed in claim 1 or 15, wherein the membrane-based sensors [012] screen the presence of two or more biomolecules simultaneously.
19. The strip [001] adhered absorbent sanitary article [Oi l] as claimed in claim 15, screens the presence of biomolecules within 30 minutes of adequate sample entry. 0. A method of production of strip [001] as claimed in claim 1 comprising:
• fabrication of membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9]
18 while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
• affixing said zoned nitrocellulose membrane onto a backing card [10];
• Laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of sample-filtration pad [4]and the lower side of conjugate pad [8]to form laminated strip[001]; A kit comprising strip adhered adsorbent sanitary article [Oi l] and reference colour index. A method of screening the biomolecules in sample comprising collecting the sample in the strip adhered absorbent sanitary article and screening the biomolecules. A method of production of strip adhered absorbent sanitary article[011] comprising:
• fabrication of membrane-based sensor [012] comprising formation of zoned nitrocellulose membrane [9] wherein the pre-fabricated sample-filtration pad[4], the conjugate pad[5] embedded with detection reagents and signal reagents, are laid on the proximal end of the nitrocellulose membrane [9] while the test zone[6] and the control zone[7] created by conjugation with capture reagents and the conjugate pad [5] are laid on the distal end of the nitrocellulose membrane[9];
• affixing said zoned nitrocellulose membrane onto a backing card [10];
• laminating said zoned backed nitrocellulose membrane on both upper and lower sides except for the upper side of sample-filtration pad and the lower side of conjugate pad to form laminated membrane-based sensor;
• affixing said laminated membrane -based sensor onto absorbent sanitary article [013] in a specific peelable configuration.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2022341637A AU2022341637A1 (en) | 2021-09-12 | 2022-09-12 | Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN202141010412 | 2021-09-12 | ||
| IN202141010412 | 2021-09-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2023037391A1 true WO2023037391A1 (en) | 2023-03-16 |
Family
ID=85507233
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IN2022/050810 WO2023037391A1 (en) | 2021-09-12 | 2022-09-12 | Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof |
Country Status (2)
| Country | Link |
|---|---|
| AU (1) | AU2022341637A1 (en) |
| WO (1) | WO2023037391A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170234817A1 (en) * | 2012-01-31 | 2017-08-17 | Regents Of The University Of Minnesota | Lateral flow assays with thermal contrast readers |
| JP2019187741A (en) * | 2018-04-24 | 2019-10-31 | 花王株式会社 | Absorbent article with sensor and production method thereof |
| US20210264604A1 (en) * | 2018-06-22 | 2021-08-26 | Oova, Inc. | Methods, devices, and systems for detecting analyte levels |
-
2022
- 2022-09-12 WO PCT/IN2022/050810 patent/WO2023037391A1/en active Application Filing
- 2022-09-12 AU AU2022341637A patent/AU2022341637A1/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170234817A1 (en) * | 2012-01-31 | 2017-08-17 | Regents Of The University Of Minnesota | Lateral flow assays with thermal contrast readers |
| JP2019187741A (en) * | 2018-04-24 | 2019-10-31 | 花王株式会社 | Absorbent article with sensor and production method thereof |
| US20210264604A1 (en) * | 2018-06-22 | 2021-08-26 | Oova, Inc. | Methods, devices, and systems for detecting analyte levels |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2022341637A1 (en) | 2024-03-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP3129738B2 (en) | Test patch and test method | |
| AU2011308615B2 (en) | Immunoassay test strip for use in a diagnostic system | |
| JP5630936B2 (en) | A method for detecting diseases at high speed by identifying targets in human body fluids | |
| US8911988B2 (en) | Menstrual fluid analysis | |
| JP5345677B2 (en) | Apparatus and method for separating and analyzing blood | |
| JP2002542846A (en) | Panty liner with menstruation prediction sensor | |
| US8105794B2 (en) | Rapid nasal assay kit | |
| CA2143292C (en) | Method for prediction of premature labor | |
| CA2121680C (en) | Screening method for identifying women at increased risk for preterm delivery | |
| WO2004071427A2 (en) | Screening and treatment methods for prevention of preterm delivery | |
| KR20150023721A (en) | Methods and compositions for personalized medicine by point-of-care devices for fsh, lh, hcg and bnp | |
| CN102830234A (en) | Rapid diagnostic kit for detecting novel marker ST2 of human heart failure | |
| WO2008141318A1 (en) | Device for determining risk of developing breast cancer and method thereof | |
| CN105785028A (en) | Rapid diagnosis kit for detecting novel human cardiac failure marker ST2 | |
| KR102473036B1 (en) | Novel ectopic pregnancy test devices by using beta core fragment hCG as diagnostic marker | |
| WO2023037391A1 (en) | Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof | |
| JP2021532332A (en) | A novel pregnancy diagnostic device containing the beta core fragment hCG as a marker | |
| KR20090097528A (en) | Method and apparatus for determining human chorionic gonadotropin levels | |
| US20020098532A1 (en) | One step test for abortion safety based on detection of 2 IU/ml or more of gonadtropin in a urine sample | |
| WO2012015327A1 (en) | Test system for determining a heart-type fatty acid-binding protein and troponin i (variants) | |
| TWI535426B (en) | Hygiene product with detection function and manufacturing method thereof | |
| US8778606B2 (en) | At-home cancer test | |
| CA3175417A1 (en) | Method for predicting the return to functional autonomy in a subject suffering from an acute event | |
| WO2020089612A1 (en) | Personal home health testing | |
| TWM488637U (en) | Hygiene supplies with detection function |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 22866904 Country of ref document: EP Kind code of ref document: A1 |
|
| WWE | Wipo information: entry into national phase |
Ref document number: 2022341637 Country of ref document: AU Ref document number: AU2022341637 Country of ref document: AU |
|
| ENP | Entry into the national phase |
Ref document number: 2022341637 Country of ref document: AU Date of ref document: 20220912 Kind code of ref document: A |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |