Strip adhered absorbent sanitary article for detecting analyte levels and its production thereof

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

FIELD OF THE INVENTION 5 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 10 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. 15 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 20 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 25 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 30 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 2022341637   22 Jun 2026 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 5 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 10 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 15 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 20 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 25 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 30 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 2022341637   22 Jun 2026 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 5 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 10 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 15 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 20 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 25 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 30 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. 2022341637   22 Jun 2026 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 5 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. 10   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. 15 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 20    intervention. Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended 25 claims. Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. 30 OBJECTIVES OF THE INVENTION: 2022341637   22 Jun 2026 Some embodiments of the present disclosure 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 5 using the naked eye with high sensitivity and selectivity. Some embodiments of the present disclosure provide a process for the production of the said device which facilitates early screening of biomolecules from the menstrual discharge / secretion 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 10 eye with high sensitivity and selectivity. Some embodiments of the present disclosure 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: 15 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 20 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

[011] , wherein the strip

[001] is adhered to the absorbent sanitary article

[013] by means of 25 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

[011] . Another aspect of the invention also discloses the application of said strip adhered absorbent 30 sanitary article for early screening of biomolecules which could predict / prognose disorders 2022341637   22 Jun 2026 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. 5 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. Some embodiments of the present disclosure relate to a strip adhered absorbent sanitary article for screening of biomolecules in a sample fluid, wherein the strip is adhered to the 10 absorbent sanitary article by means of an adhesive; wherein the strip is positioned proximal to a flow of the sample fluid; wherein the strip comprises at least one membrane-based sensor and embedded in a laminated envelope; wherein the membrane-based sensor comprises: a backing card as support; a sample-filtration pad for consistent intake of the sample fluid; a conjugate pad embedded with detection reagents and signal reagents; a 15 nitrocellulose membrane having a control zone and a test zone embedded with capture reagents for screening biomolecules; and an absorbent pad to maintain consistency of the flow, to prevent backflow and absorb excess sample fluid; wherein the membrane-based sensors are configured to be aligned in a specific configuration inside the laminated envelope, such that the sample-filtration pads of each of said membrane-based sensors 20 intersect in a mid spot of the laminated envelope; wherein the laminated envelope includes a peelable handle at its base to facilitate peeling of the laminated envelope; wherein the strip is enveloped between laminated liquid impermeable layers to render the strip impervious to the sample fluid except at the top and bottom sides of the mid spot and at the bottom sides of the absorbent pads of the membrane-based sensors where the strip remains unlaminated 25 and unenveloped; wherein the sample-filtration pad of the embedded membrane-based sensor contains an unlaminated, unenveloped window on its upper side to facilitate the flow of the sample fluid into the sample-filtration pad for filtration, allowing filtrate to flow into the nitrocellulose membrane; and the absorbent pad of the membrane-based sensor contains an unlaminated unenveloped window on its lower side to drain out the excess filtrated 30 sample fluid. Some embodiments of the present disclosure relate to method of production of the strip adhered absorbent sanitary article as disclosed herein, wherein said method comprises: 2022341637   22 Jun 2026 fabricating a membrane-based sensor comprising formation of a zoned nitrocellulose membrane, wherein the sample-filtration pad and the conjugate pad embedded with detection reagents and signal reagents, are laid on the proximal end of the zoned nitrocellulose membrane while the test zone and the control zone created by conjugation 5 with capture reagents and the absorbent pad are laid on the distal end of the zoned nitrocellulose membrane; affixing said zoned nitrocellulose membrane onto a backing card to form a zoned backed nitrocellulose membrane; laminating the 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 absorbent pad to form a laminated membrane- 10 based sensor; affixing said laminated membrane-based sensor onto an absorbent sanitary article in a specific peelable configuration to form the strip adhered absorbent sanitary article. Some embodiments of the present disclosure relate to a kit comprising the strip adhered absorbent sanitary article as disclosed herein and a reference colour index. 15 BRIEF DESCRIPTION OF THE FIGURES: FIGURE 1 / 1A: 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

[011] . 20 Figure Legend: 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. 25 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, 30 it is to be understood that this invention is not limited to particularly exemplified systems or process parameters that may, of course, vary. 2022341637   22 Jun 2026 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 5 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 10 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 15 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 20 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 25 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] . 30 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 sign- 2022341637   22 Jun 2026 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] . 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 5 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 10 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 15 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 20 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 25 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. 2022341637   22 Jun 2026 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, 5 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 10 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. 15 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, 20 peptide hormones comprising Prolactin, AMH (Anti-Mullerian Hormone), Insulin, TSH (thyroid stimulating hormone), leptin; pro-inflammatory markers comprising Interleukin-IBeta (IL-1P), 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 25 growth factor (VEGF), Soluble VEGF-R1 (sVEGF-R1), Epiregulin (EREG), inhibin PA; inflammatory proteases comprising Matrix metalloprotease-9 (MMP-9), Cathepsin; SHBG (sex hormone binding globulin), HbA1c (glycosylated haemoglobin) or a combination thereof. In a preferable embodiment of the strip

[001] , the biomolecules screened comprise hormones 30 such as LH (Luteinising Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17- 2022341637   22 Jun 2026 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 5 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. 10 Another aspect of the invention pertains to a strip adhered absorbent sanitary article

[011] , 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

[011] , the absorbent sanitary article

[013] comprises menstrual pads, biodegradable pads, panty liners, diapers. 15 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

[011] , the 20 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 25                 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 2022341637   22 Jun 2026 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 5                 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

[011] and reference colour index. Another aspect of the invention pertains to a method of screening the biomolecules in the 10 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 15                  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 20                  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; 25              • affixing said laminated membrane-based sensor onto absorbent sanitary article

[013] in a specific peelable configuration. 2022341637   22 Jun 2026 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

[011] , can be applied to 5 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 10 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 15   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 20 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), HbA1c 25 (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, 30 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 ); Sample- 2022341637   22 Jun 2026 filtration 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 5 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 10 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, 15 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 20 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 25 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 30 (biomolecules) in the test and control region and through other optimisation techniques. 2022341637   22 Jun 2026 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 1a, all the membrane-based sensors receive the sample and show a change of colour bands according to the presence and concentration of the 5 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 10 of Care Devices. 2022341637   22 Jun 2026 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 5 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. 10 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 / s12958-018-0336-z 15       • 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 20

Claims

2022341637   04 Aug 2026The Claim:

1. A strip adhered absorbent sanitary article for screening of biomolecules in asample fluid, wherein the strip is adhered to the absorbent sanitary article by means of an adhesive; wherein the strip is positioned proximal to a flow of the sample fluid; wherein the 5 strip comprises at least one membrane-based sensor embedded in a laminated envelope;wherein the at least one membrane-based sensor comprises:a backing card as support;a sample-filtration pad for consistent intake of the sample fluid;a conjugate pad embedded with detection reagents and signal reagents;10                a nitrocellulose membrane having a control zone and a test zone embeddedwith capture reagents for screening biomolecules; andan absorbent pad to maintain consistency of the flow of the sample fluid, to prevent backflow and absorb excess sample fluid;wherein the at least one membrane-based sensor is configured to be aligned in a specific 15 configuration inside the laminated envelope, such that the sample-filtration pad of each of said at least one membrane-based sensor intersect in a mid spot of the laminated envelope;wherein the laminated envelope includes a peelable handle at its base to facilitate peeling of the laminated envelope;wherein the strip is enveloped between laminated liquid impermeable layers to render 20 the strip impervious to the sample fluid except at the top and bottom sides of the mid spot and at the bottom sides of the absorbent pads of the at least one membrane-based sensor where the strip remains unlaminated and unenveloped;wherein the sample-filtration pad of the at least one membrane-based sensor contains an unlaminated, unenveloped window on its upper side to facilitate the flow of the sample fluid 25 into the sample-filtration pad for filtration, allowing filtrate to flow into the nitrocellulose membrane; and the absorbent pad of the at least one membrane-based sensor contains an unlaminated unenveloped window on its lower side to drain out the excess filtrated sample fluid.2022341637   04 Aug 20262.       The strip adhered absorbent sanitary article as claimed in claim 1, whereinthe at least one membrane-based sensor is configured to be aligned in a configuration inside the laminated envelope, the configuration comprising cross or cruciform, ‘T’-shape, peace sign-shape, ‘Y’-shape, circular spiral progressive shape, dendrimer shape, multi-spoke5 wheel shape, or Y-spoke wheel shape configuration.

3. The strip adhered absorbent sanitary article as claimed in claim 1 or claim 2,wherein the filtrate from the sample-filtration pad travels towards the conjugate pad, to the test zone where the biomolecules are detected, and the excess filtrate drains out through the absorbent pad.10         4.       The strip adhered absorbent sanitary article as claimed in any one of claims1 to 3, comprising at least four membrane-based sensors.

5. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 4, wherein the strip is laminated with liquid impermeable layers made of biocompatible polymers comprising polyethylene polyurethane, or a combination thereof.15         6.       The strip adhered absorbent sanitary article as claimed in any one of claims1 to 5, wherein the detection reagents comprise antibodies, aptamers, nucleic acids, and / or protein receptors;wherein the capture reagents comprise antibodies and / or aptamers;wherein the signal reagents comprise metallic nanoparticles comprising Gold 20          nanoparticles, Silver Nanoparticles or a combination thereof.

7. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 6, wherein the sample fluid comprises menstrual discharge, menstrual blood, vaginal secretions, vaginal effluents, amniotic fluid, other vaginal discharges or a combination thereof.25         8.       The strip adhered absorbent sanitary article as claimed in any one of claims1 to 7, wherein the biomolecules are screened in situ on the test zone in a semiquantitative manner using immunoassays and / or DNA / RNA aptameric technology.2022341637   04 Aug 20269.       The strip adhered absorbent sanitary article as claimed in claim 8, whereinthe semiquantitative screening is performed using colorimetry.

10. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 9, wherein the biomolecules are screened in situ by colour coding in a semiquantitative 5 manner, which is observable by naked eye by comparison of the change in the colour of the test zone in comparison with a reference chart.

11. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 10, wherein the colour of the test zone of the at least one membrane-based sensor changes depending on a concentration of biomolecules in the sample fluid, which is either 10 higher or lower than reference values.

12. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 11, wherein the biomolecules comprise one or more of DNA, RNA, proteins, or lipids from single and multi-cellular organisms comprising bacteria, fungi, viruses or human;wherein the lipids comprise one or more steroid hormones comprising LH (Luteinising 15 Hormone), FSH (Follicle Stimulating Hormone), Oestrogen, 17-hydroxyprogesterone, Progesterone, Testosterone, DHEA (Dehydroepiandrosterone), or Cortisol;wherein the proteins comprise:one or more antigens, peptides, and / or peptide hormones, wherein the one or more peptide hormones comprise Prolactin, AMH (Anti-Mullerian Hormone), 20          Insulin, TSH (thyroid stimulating hormone), or leptin; and / orone or more pro-inflammatory markers comprising Interleukin-1Beta (IL-1P), 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 25         endothelial growth factor (VEGF), Soluble VEGF-R1 (sVEGF-R1), Epiregulin(EREG), inhibin PA; inflammatory proteases comprising Matrix metalloprotease-9 (MMP-9), Cathepsin; SHBG (sex hormone binding globulin), or HbA1c (glycosylated haemoglobin); orany combination thereof.2022341637   04 Aug 202613.     The strip adhered absorbent sanitary article as claimed in any one of claims1 to 12, wherein the absorbent sanitary article comprises a menstrual pad, biodegradable pad, panty liner, or diaper.

14. The strip adhered absorbent sanitary article as claimed in any one of claims5   1 to 13, wherein the at least one membrane-based sensor screens the same or differentbiomolecules from the sample fluid.

15. The strip adhered absorbent sanitary article as claimed in any one of claims1 to 14, wherein the at least one membrane-based sensor screens the presence of two or more biomolecules simultaneously.10         16.     The strip adhered absorbent sanitary article as claimed in any one of claims1 to 15, wherein the at least one membrane-based sensor screens the presence of biomolecules within 30 minutes of adequate sample fluid entry.

17. A method of production of the strip adhered absorbent sanitary article asclaimed in any one of claims 1 to 16, wherein said method comprises:15          fabricating a membrane-based sensor comprising formation of a zoned nitrocellulosemembrane, wherein the sample-filtration pad and the conjugate pad embedded with detection reagents and signal reagents, are laid on the proximal end of the zoned nitrocellulose membrane while the test zone and the control zone created by conjugation with capture reagents and the absorbent pad are laid on the distal end of the zoned20 nitrocellulose membrane;affixing said zoned nitrocellulose membrane onto a backing card to form a zoned backed nitrocellulose membrane;laminating the 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 absorbent pad25 to form a laminated membrane-based sensor;affixing said laminated membrane-based sensor onto an absorbent sanitary article in a specific peelable configuration to form the strip adhered absorbent sanitary article.2022341637   04 Aug 202618.      A kit comprising the strip adhered absorbent sanitary article as claimed inany one of claims 1 to 16 and a reference colour index.

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