Apparatus and method for monitoring health conditions

Abstract

Disclosed an apparatus 100 for determining one or more analytes in a sample. The apparatus 100 includes one or more test strips 102 (A-N) that further includes one or more first zones 106 (A-N) configured to produce a first result by binding with a complex formed from a sample and detector reagents, one or more second zones 108 (A-N) disposed downstream of the one or more first zones, configured to produce a second result by reacting with the complex, and one or more third zones 110 (A-N) disposed downstream of the one or more second zones, configured to produce a third result by reacting with unreacted sample. The one or more analytes in the sample is quantified by comparing the first, second and third result. Further a method 200 for monitoring health conditions of an individual is disclosed.

Description

[0001] APPARATUS AND METHOD FOR MONITORING HEALTH CONDITIONS

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medical device. More particularly, the disclosure relates to an apparatus, system and a method for monitoring health conditions of an individual.

[0004] BACKGROUND

[0005] Gynecologists commonly rely on monitoring serum hCG (human chorionic gonadotropin) levels to track pregnancy progression in women. Typically, hCG levels are detectable at approximately 15 mIU / ml to 20 mIU / ml around 8 to 10 days after implantation, which is roughly 3 to 5 days before a missed period, serving as a reliable indicator of pregnancy. By 3 to 5 weeks into pregnancy, hCG levels are expected to rise to over 1000 mIU / ml, with a peak around week 8 at approximately lOOOOmlU / ml. Monitoring the doubling of hCG levels can also reveal potential irregularities, such as in cases of biochemical pregnancy where hCG levels rise initially, peaking at 100 mIU / ml within 7 days before dropping rapidly. Similarly, distinctive hCG patterns, like a slower doubling rate and plateauing at a constant value, can help diagnose conditions of pregnancy.

[0006] While serum hCG remains the gold standard for monitoring pregnancy, the reliance on urinary hCG levels for home -use lateral flow urine tests poses significant challenges in the current scenario. Despite being showing a high sensitivity and accuracy, recent studies have unveiled drawbacks when these tests are administered by individuals without medical practices. Further, the research shows a decrease in sensitivity by 17.5% when compared to tests administered by professionals.

[0007] Furthermore, the subjective nature of visual interpretation in most home pregnancy tests adds another layer of uncertainty. In controlled experiments, nearly half of the women failed to correctly identify positive results generated by standard solution tests. This subjectivity often leads to misinterpretation and potentially delayed medical interventions or unnecessary stress for expectant mothers. Additionally, analysis from numerous studies indicates women encounter difficulties in understanding and interpreting Lateral-b flow assay-based pregnancy tests. Overall, the disadvantages of relying on hCG levels for home -use lateral flow urine tests include reduced sensitivity when used by untrained individuals, subjective result interpretation leading to errors, and the complexity of LFA assays contributing to misinterpretations.

[0008] Thus, there is a need for a technical solution that overcomes the aforementioned problems.

[0009] SUMMARY

[0010] In an aspect of the present disclosure, an apparatus for determining one or more analytes in a sample. The apparatus includes one or more test strips, each strip of one or more test strips includes one or more first zones configured to produce a first result by binding with a complex formed from a sample and detector reagents, one or more second zones disposed downstream of the one or more first zones configured to produce a second result by reacting with the complex, and one or more third zones disposed downstream of the one or more second zones configured to produce a third result by reacting with unreacted sample. The one or more analytes in the sample is quantified by comparing the produced first, second and third result.

[0011] In some aspects of the present disclosure, the sample is selected from a group but not limited to, a sweat, urine, blood, blood serum, semen, breast milk, saliva, blood plasma, tears, mucus, cerebrospinal fluids, saliva, amniotic fluid, vaginal lubrication fluids, pus, lymph, bile, synovial fluid, aqueous humour, phlegm, gastric acid, pre-ejaculate, or colostrum.

[0012] In some aspects of the present disclosure, the one or more test strips are arranged in an exponential increasing order of concentration of one or more analytes to be measured. In some aspects of the present disclosure, the one or more analyte is selected from a group but not limited to, Estradiol glucuronide (E3G), Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), Human chorionic gonadotrophin (hCG), alpha -hCG, beta- hCG, antibody, metabolite, virus, bacteria, protein, or sperm.

[0013] In some aspects of the present disclosure, one or more sample receiving pads positioned at a first end or second end of each strip of the one or more test strips, configured to receive the sample.

[0014] In some aspects of the present disclosure, one or more conjugate pads positioned downstream of the sample receiving pads, configured to form the complex between the sample and the detector reagents.

[0015] In some aspects of the present disclosure, the one or more first zones, one or more second zones, and one or more third zones are positioned sequentially downstream of the one or more conjugate pads on each strip of the one or more test strips.

[0016] In some aspects of the present disclosure, the one or more health conditions is selected from a group includes, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease.

[0017] In an aspect of the present disclosure, a method for monitoring health conditions of an individual is disclosed. The method includes receiving a sample at a first end of an apparatus, followed by enabling the sample to flow across the one or more test strips from the first end to a second end. The method further includes binding a target analyte in the sample with detector reagents to form a complex, producing a first result at one or more first zones of each test strip by binding the complex with a first set of biochemical reagents. The method further includes producing a second result at one or more second zones of each test strip by reacting the complex with a second set of biochemical reagents and comparing the first and second results to predict one or more health conditions of the individual.

[0018] In some aspects of the present disclosure, enabling the sample to flow across the one or more test strips further includes allowing the sample to flow by capillary action. In an aspect of the present disclosure, a system is disclosed. The system includes an imaging unit configured to capture one or more images of the one or more first zones and one or more second zones, and a processing unit configured to analyze on or more health conditions.

[0019] BRIEF DESCRIPTION OF DRAWINGS

[0020] The above and still further features and advantages of aspects of the present disclosure become apparent upon consideration of the following detailed description of aspects thereof, especially when taken in conjunction with the accompanying drawings, and wherein:

[0021] FIG. 1 illustrates an apparatus for monitoring health conditions of an individual, in accordance with an aspect of the present disclosure; and

[0022] FIG. 2 illustrates a flowchart of a method for monitoring health conditions in the individual, in accordance with an aspect of the present disclosure.

[0023] FIG. 3 illustrates a block diagram of a system 300, in accordance with an aspect of the present disclosure.

[0024] To facilitate understanding, reference numerals have been used, where possible, to designate elements common to the figures.

[0025] DETAILED DESCRIPTION OF PREFERRED ASPECTS

[0026] This section is intended to provide an explanation and description of various possible aspects of the present disclosure. The aspects used herein, and the various features and advantageous details thereof are explained more fully with reference to non -limiting aspects illustrated in the accompanying drawing / s and detailed in the following description. The examples used herein are intended only to facilitate an understanding of ways in which the aspects may be practiced and to enable the person skilled in the art to practice the aspects used herein. Also, the examples / aspects described herein should not be construed as limiting the scope of the aspects herein. Various aspect of the present disclosure provides an apparatus and a method for monitoring health conditions in an individual. The following description provides specific details of certain aspects of the disclosure illustrated in the drawings to provide a thorough understanding of those aspects. It should be recognized, however, that the present disclosure can be reflected in additional aspects and the disclosure may be practiced without some of the details in the following description.

[0027] The various aspects including the example aspects are now described more fully with reference to the accompanying drawings, in which the various aspects of the disclosure are shown. The disclosure may, however, be embodied in different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects are provided so that this disclosure is thorough and complete, and fully conveys the scope of the disclosure to those skilled in the art. In the drawings, the sizes of components may be exaggerated for clarity.

[0028] It is understood that when an element or layer is referred to as being “on,” “connected to,” or “coupled to” another element or layer, it can be directly on, connected to, or coupled to the other element or layer or intervening elements or layers that may be present. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0029] The subject matter of example aspects, as disclosed herein, is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventor / inventors have contemplated that the claimed subject matter might also be embodied in other ways, to include different features or combinations of features similar to the ones described in this document, in conjunction with other technologies. Generally, the various aspects including the example aspects relate to an apparatus and a method for monitoring health conditions in an individual.

[0030] The terms ‘biological sample,’ ‘sample fluid,’ and ‘sample’ may refer to similar meaning / interpretation and may be interchangeably used throughout the specification. Such biological samples may be one of sweat, urine, blood, blood serum, semen, breast milk, saliva, blood plasma, tears, mucus, cerebrospinal fluids, saliva, amniotic fluid, vaginal lubrication fluids, pus, lymph, bile, synovial fluid, aqueous humour, phlegm, gastric acid, pre-ejaculate, colostrum, and other such fluids as may be obvious to a person skilled in the art. The biological sample may refer any bodily fluid or fluid-type substance from the user to determine the presence, absence, levels / concentration of any hormones, analytes, metabolites, minerals, etc. in the user’s body. Further, the biological sample may include the one or more analytes including, but not limiting to, Estradiol glucuronide (E3G), alpha and beta subunits of Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), and alpha and beta subunits of human chorionic gonadotrophin (hCG).

[0031] The terms ‘test strip’ and ‘strip’ may refer to similar meaning / interpretation and may be interchangeably used throughout the specification. Such test strip may be immunoassay strips or immunochromatographic strips. The test strip may refer to a capillary, an atomizer, medium or base, or any paper-based device on which a biochemical reagent and other antibodies are integrated / affixed / immobilized to react with the one or more analytes present in the biological sample associated with the user. The terms ‘user,’ ‘patient,’ ‘body,’ ‘individual’ and ‘subject’ may refer to similar meaning / interpretation and may be interchangeably used throughout the specification. As mentioned, there remains a need for the apparatus and the method for monitoring health conditions in an individual that overcomes the limitations associated with the currently available apparatus. The apparatus may include one or more test strips such that each strip of the one or more test strip may possess a first zone, second zone and third zone for quantifying one or more analytes present in a sample.

[0032] The terms “bodily fluid”, “biological sample”, and “sample” may be interchangeably used throughout the specification.

[0033] FIG. 1 illustrates an apparatus 100 for monitoring one or more health conditions in an individual in accordance with an aspect of the present disclosure. The apparatus 100 may be provided to monitor one or more health conditions of a user by detecting one or more target analytes in a sample received from the user. In some aspects, the one or more health conditions may be selected from a group including, but not limited to, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease. Aspects of the present disclosure are intended to include and / or otherwise cover any type of health conditions, including known, related, and later developed analytes.

[0034] In some aspects, the sample may be a biological sample. In some aspects, the biological samples may include, but are not limited to, a urine, semen, pre-ejaculate, saliva, blood, and the like. Aspects of the present disclosure are intended to include or otherwise cover any type of biological sample, without deviating from the scope of the present disclosure. In some aspects, one or more analytes include but are not limited to, Estradiol glucuronide (E3G), Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), Human chorionic gonadotrophin (hCG), alpha -hCG, beta- hCG, antibody, metabolite, virus, bacteria, protein, sperm or the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the analytes, including known, related, and later developed analytes.

[0035] In some aspects of the present disclosure, the apparatus 100 may include a first end (not shown) and a second end (not shown). The first end may be referred to as sample receiving end while the second end may be referred to as an excess flow end of the apparatus 100. In some aspects, the first end may be the dipping end and is towards the user, while the second end may be the excess flow end and is away from the user. In some aspects, the first end may be referred as the proximal end and the second end may be referred as the distal end of the apparatus 100. The one or more test strips 102(A-N) may include a distal end and a proximal end (for purposes of this disclosure, “distal end” refers to the portion of the one or more test strips 102 (A-N) that is far from the user during normal use and “proximal end” refers to the portion of the one or more test strips 102 (A-N) that is closer to the user during normal use). The distal end may be adapted to dip into the biological sample and the proximal end may be adapted to flow excess biological sample. In some aspects of the present disclosure, the proximal end may be adapted to dip into the biological sample and the distal end may be adapted to flow excess biological sample.

[0036] In some aspects, the sample may flow from the first end to the second end of the apparatus 100 by way of a capillary force or a membrane. In some aspects, the membrane may be made of materials including, but not limited to, a cyclopore polycarbonate, nuclepore polycarbonate, polycarbonate, cellulose acetate, regenerated cellulose, nylon, cellulose nitrate, polyamide, aluminum oxide, polytetrafluoroethylene (PTFE), nitrocellulose, mixed cellulose ester, glass, or the like. Aspects of the present disclosure are intended to include or otherwise cover any type of material including known, related art, and / or without deviating from the scope of the present disclosure.

[0037] In some aspects of the present disclosure, the apparatus 100 may include one or more test strips 102 (A-N). The one or more test strips 102 (A-N) may further include one or more sample receiving pads 103 (A-N), one or more conjugate pads 104(A-N), one or more first zones 106 (A-N), one or more second zones 108 (A-N) and one or more third zones 110 (A-N).

[0038] In some aspects of the present disclosure, the one or more test strips 102 (A-N) may include one or more sample receiving pads 103 (A-N) adapted to receive a sample. In some aspects, the one or more sample receiving pads 103 (A-N) may be positioned at least one of the first end or the second end of the apparatus 100. In some aspects, at least one sample receiving pad of one or more sample receiving pads 103 (A-N) may be placed on each strip of the one or more test strips 102 (A-N) of the apparatus 100. In some aspects, one or more sample receiving pads 103 (A-N) may be positioned on both the first end and second end of the apparatus 100. In some aspects of the present disclosure, the sample may be received on the sample receiving pad. The apparatus 100 the sample may be introduced on the one or more sample receiving pads 103 (A-N) of the apparatus 100 by a method selected from a group, but are not limited to, a dropper, dipping, pouring, or the like. Aspects of the present disclosure are intended to include or otherwise cover any type of sample introduction method, without deviating from the scope of the present disclosure.

[0039] In some aspects of the present disclosure, the one or more test strips 102 (A-N) may include one or more conjugate pads 104(A-N). In some aspects, the one or more conjugate pads 104(A-N) may be positioned downstream of one or more sample receiving pads. In some aspects, the one or more conjugate pads 104 (A-N) may be positioned on at least one of, the first end or the second end of the apparatus 100. The one or more conjugate pads 104A - 104N may be integrated with the one or more sample receiving pads, while in another aspect, the one or more conjugate pads 104(A - N) may not be integrated with the one or more sample receiving pads 103 (A-N) and may be provided separately on each strip the one or more test strips 102(A-N).

[0040] The one or more conjugate pads 104 (A-N) may include one or more detector reagents having one or more detector antibodies that may react with one or more analytes present in the sample to form a conjugate (or a complex). Aspects of the present disclosure are intended to include or otherwise cover any type of detector reagents, without deviating from the scope of the present disclosure. In a preferred aspect of the present disclosure, the detector reagent may be colloidal gold. In some aspects of the present disclosure the complex may be a sandwich complex (detector reagent-target analyte-antibody).

[0041] In some aspects, the one or more detector reagents within the one or more conjugate pads 104(A-N) may be configured to bind specifically to target analytes such as beta- hCG, alpha-hCG, or other pregnancy -related hormones. In some aspects, the binding specificity may be achieved through the use of monoclonal or polyclonal antibodies that recognize specific epitopes on the target analytes. The antibody -colloidal gold conjugates may maintain both the binding specificity of the antibodies and the visual detection properties of the colloidal gold particles.

[0042] In some aspects, the one or more conjugate pad may include buffer systems or stabilizing agents that maintain detector reagent activity during storage and operation. These buffer systems may include phosphate buffers, tris buffers, or other buffering agents that maintain appropriate pH conditions for detector reagent stability and binding activity.

[0043] In some aspects, the one or more test strips 102 (A-N) may further include one or more first zones 104 (A-N) (for the purpose of this disclosure “one or more first zones” may be inferred to one or more test zones). In some aspects of the present disclosure, the one or more first zones 106 (A-N) may be disposed downstream of the one or more conjugate pads 104(A-N). In some aspects, the one or more first zones 106 (A-N) may be placed on each strip of the one or more test strips 102 (A-N). In some aspects, the one or more first zones 106 (A-N) may include one or more first set of biochemical reagents. The sample (detector reagent-target analyte-antibody complex) received from the one or more conjugate pads 104(A-N) binds with the one or more first set of biochemical reagents to form a first result. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the biochemical reagents, including known, related, and later developed biochemical reagents. In some aspects, the one or more biochemical reagents within the one or more first zones 106 (A-N) may include monoclonal antibodies, polyclonal antibodies, or recombinant binding proteins that recognize specific epitopes on target analytes such as beta-hCG, alpha- hCG, or other pregnancy-related hormones.

[0044] In some aspects, the first set of biochemical reagents may be applied to the first zone 104 (A-N) through various immobilization techniques including, but not limited to, physical adsorption, covalent attachment, or entrapment within polymer matrices. Aspects of the present disclosure are intended to include or otherwise cover any type of immobilization techniques, without deviating from the scope of the present disclosure.

[0045] In some aspects, the first result may include, but not limited to, a visual changes including color development, line formation, or intensity variations that can be observed through direct visual inspection or instrumental analysis. In some aspects, the first result may be visualized by naked eye. In some aspects, the first result may be visualized by a scanner or imaging sensor configured on a handheld system. The scanner or imaging sensor systems may capture digital images of the one or more first zones 106 (A-N) and process the image data to determine quantitative measurements of the second result for comparison with the first result. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the imaging devices, including known, related, and later developed imaging devices.

[0046] In some aspect, the one or more second zones 108 (A-N) (for the purpose of this disclosure the “one or more second zones” may be inferred as “one or more reference zones”) may be disposed downstream of one or more first zones 106(A-N). The one or more second zone 108 (A-N) may serve as a secondary detection region where complexes that have passed through the one or more first zones 106 (A-N) undergo additional processing to generate reference measurements. In some aspects, the one or more second zones 108 (A-N) may be placed on each strip of the one or more test strips 102 (A-N) of the apparatus 100. In some aspects, the one or more second zones 108 (A-N) may further include one or more second set of biochemical reagents. The sample received from the one or more first zones 106(A-N) may further react with the one or more second set of biochemical reagents to form a second result at the one or more second zones 108 (A-N). Aspects of the present disclosure are intended to include and / or otherwise cover any type of the biochemical reagents, including known, related, and later developed biochemical reagents.

[0047] In some aspects, the one or more second zones 108 (A-N) may be referred to as the reference zone. The reference zone designation may reflect the function of the one or more second zones 108 (A-N) as a comparative measurement region that provides standardized reference signals for quantitative analysis. The reference zone configuration may enable comparison between test measurements obtained in the one or more first zones 106 (A-N) and reference measurements obtained in the one or more second zones 108 (A-N). In some aspect, the second set of biochemical reagents may be configured to react with the complexes received from the one or more first zones 106(A-N) to produce a second result within the one or more second zone 108 (A-N). The reaction between the second set of biochemical reagents and the complexes may result in the formation of detectable signals that provide reference measurements for comparison with the first result obtained in the one or more first zones 106 (A-N). The second result may include, but not limited to, visual changes including color development, line formation, or intensity variations that can be observed through direct visual inspection or instrumental analysis.

[0048] In some aspects, the second result may be visualized by naked eye. In some aspects, the second result may be visualized by a scanner or imaging sensor configured on a handheld system. The scanner or imaging sensor systems may capture digital images of the one or more second zones 108 (A-N) and process the image data to determine quantitative measurements of the second result for comparison with the first result. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the imaging devices, including known, related, and later developed imaging devices.

[0049] In some aspects the one or second zones 108 (A-N) may function as part of a quantitative analysis system where the second set of biochemical reagents corresponds to fixed concentration thresholds for one or more target analytes. The reference zone configuration may enable semi-quantitative measurements by providing standardized comparison points against which the first result can be evaluated. The comparison between the first result and the second result may indicate whether analyte concentrations fall within specific concentration ranges or exceed predetermined thresholds.

[0050] In some aspects, the second set of biochemical reagents placed within the one or more second zone 108 (A-N) may include monoclonal antibodies, polyclonal antibodies, or recombinant binding proteins that recognize specific epitopes on one or more target analytes such as beta-hCG, alpha-hCG, or other pregnancy -related hormones.

[0051] In some aspects, the second set of biochemical reagents may be applied to the second zones 108 (A-N) through various immobilization techniques including but not limited to, physical adsorption, covalent attachment, or entrapment within polymer matrices. The immobilization method may be selected to maintain biochemical reagent activity while providing stable attachment to the membrane substrate. The reagent concentration and distribution within the one or more second zones 108 (A-N) may be controlled to achieve consistent reference signal generation across one or more test strips 102 (A-N). Aspects of the present disclosure are intended to include or otherwise cover any type of immobilization techniques, without deviating from the scope of the present disclosure.

[0052] In some aspects, the one or more third zones 110 (A-N) (for the purpose of this disclosure the “one or more third zones” may be inferred as “one or more control zones”) may be disposed downstream of the one or more second zones 108 (A-N). In some aspects, the one or more third zones 110 (A-N) may be placed on each strip of the one or more test strip 102 (A-N) of the apparatus 100. In some aspects, the one or more third zones 110 (A-N) may further include one or more third set of biochemical reagents. The unreacted sample or excess sample received from one or more second zones 108 (A-N) may further react with the one or more third set of biochemical reagents to form a third result at the one or more third zones 110 (A-N). Aspects of the present disclosure are intended to include and / or otherwise cover any type of the biochemical reagents, including known, related, and later developed biochemical reagents.

[0053] In some aspects, the one or more third zones 110 (A-N) may be referred to as the control zone. The control zone designation may reflect the function of the one or more third zones 110 (A-N) as a validation region that confirms proper sample flow, reagent functionality, and assay performance within each test strip. The control zone configuration may provide quality assurance measurements that indicate whether the lateral flow assay has operated correctly regardless of the presence or absence of target analytes in the biological sample.

[0054] In some aspects, the third set of biochemical reagents may be configured to react with the unreacted sample to produce a third result within the one or more third zones 110 (A-N). The reaction between the third set of biochemical reagents and the unreacted sample components may result in the formation of detectable signals that confirm proper assay function and sample processing. The third result may include, but not limited to, a visual changes including color development, line formation, or intensity variations that can be observed through direct visual inspection or instrumental analysis.

[0055] In some aspects, the third result may be visualized by naked eye. In some aspects, the second result may be visualized by a scanner or imaging sensor configured on a handheld system. The scanner or imaging sensor systems may capture digital images of the one or more third zones 110 (A-N) and process the image data to determine quantitative measurements of the third result for quality control purposes. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the imaging devices, including known, related, and later developed imaging devices.

[0056] In some aspects, the one or more third zones 110 (A-N) may function as part of a quality assurance system where the third set of biochemical reagents responds to sample components or detector reagents that remain unreacted after passing through the one or more first zones 106 (A-N) and second zone 108 (A-N). The control zone configuration may enable validation of proper sample flow and reagent functionality by capturing residual detector reagents or sample components that have not been bound in the upstream detection zones.

[0057] In some aspects, the control function of the one or more third zones 110 (A-N) may enable users to distinguish between valid negative results and invalid test results caused by assay malfunction or improper sample application. The presence of a third result in the one or more third zones 110 (A-N) may indicate that the sample has flowed properly through the apparatus 100 and that the detector reagents have been released and are functional. The absence of a third result may indicate assay failure, insufficient sample volume, or other technical problems that invalidate the test results obtained from the one or more first zones 106 (A-N) and second zone 108 (A-N).

[0058] In some aspects, the apparatus 100 may be provided to quantify one or more analytes present in the sample. In some aspects, the apparatus 100 may be provided to measure levels of hCG in the sample. In an aspect, the apparatus 100 may be provided for measuring alpha and beta form of hCG present in the sample. In a preferred aspect of the present disclosure, the apparatus may be provided to quantify the level of beta hCG present in the sample.

[0059] In an exemplary aspect of the present disclosure, the apparatus 100 may be provided to determine concentration of beta- hCG in the sample taken from the user. The one or more test strips 102 (A-N) may be arranged in exponential increasing order of concentration of beta hCG. The one or more first zones 106 (A-N) may represent minimum concentration (varying concentration) of beta hCG whereas the one or more second zones 108 (A-N) may represent the maximum concentration (fixed cut-off concentration) of beta-hCG to be measured such that the one or more first zones 106 (A-N) and one or more second zones 108 (A-N) may together form the limit of quantification.

[0060] In some aspects, the comparative analysis methodology may involve visual assessment of relative color intensities between the first result and the second result to determine analyte concentration ranges. In cases where the first result appears lighter in color intensity compared to the second result, the analyte concentration may be determined to fall within the limit of quantification established by the apparatus 100. The lighter color intensity of the first result may indicate that the target analyte concentration lies between the minimum detection threshold and the fixed cut-off concentration represented by the second result. In an exemplary scenario, the first result produced at the one or more first zones 106 (A-N) is lighter in color in comparison to the second result produced at one or more second zone 108 (A-N). The result may predict that the concentration of beta-HCG lies within the limit of quantification such that the concentration of one or more analytes is fixed at the one or more second zones 108(A-N).

[0061] In another exemplary scenario, the first result produced at the one or more first zones 106 (A-N) is darker in color in comparison to the second result produced at one or more second zone 108 (A-N). The result may predict that the concentration of beta-HCG is higher than the limit of quantification.

[0062] In some aspects, the comparative analysis may incorporate assessment of the third result to validate the reliability of comparative measurements between the first result and the second result. The presence of a visible third result may confirm that the apparatus 100 has functioned properly and that the comparative analysis between the first result and the second result represents valid measurements. The absence of a visible third result may indicate assay failure or technical problems that invalidate the comparative measurements.

[0063] In some aspects, the apparatus 100 may be configured with the one or more test strips 102 (A-N) arranged in exponential increasing order of concentration to enable quantitative measurement of target analytes across multiple concentration ranges. The exponential arrangement may provide systematic coverage of clinically relevant concentration spans while enabling semi-quantitative determination of analyte levels through comparative analysis between detection zones within each test strip.

[0064] The exponential increasing order arrangement may position one or more test strips 102(A-N) with progressively higher concentration thresholds in sequence within the apparatus 100. The systematic arrangement may enable users to identify appropriate concentration ranges by evaluating multiple test strips that span different portions of the overall measurement range. The exponential progression may provide efficient coverage of wide concentration ranges while maintaining adequate resolution for clinical applications.

[0065] In some aspects, the one or more first zones 106 (A-N) may represent minimum concentration thresholds for beta-hCG detection within each test strip of the apparatus 100. The minimum concentration representation may establish the lower detection limit for each test strip, enabling determination of whether analyte concentrations exceed the baseline threshold for that particular concentration range. The one or more first zones 106 (A-N) may be configured with biochemical reagents that respond to varying concentration levels corresponding to the minimum detection requirements for each test strip.

[0066] In some aspects, the one or more second zones 108 (A-N) may represent maximum concentration thresholds for beta-hCG detection within each test strip of the apparatus 100. The maximum concentration representation may establish the upper detection limit for each test strip, enabling determination of whether analyte concentrations fall within or exceed the quantification range for that particular test strip. The one or more second zones 108 (A-N) may be configured with biochemical reagents that respond to fixed cut-off concentrations corresponding to the maximum detection capabilities for each test strip.

[0067] In some aspects, the combination of the one or more first zones 106 (A-N) and the one or more second zones 108 (A-N) may establish limits of quantification for each test strip within the apparatus 100. The limits of quantification may define concentration ranges within which semi-quantitative measurements can be obtained through comparative analysis of visual signals generated in the one or more first zones 106 (A- N) and the one or more second zones 108 (A-N). The quantification limits may enable determination of whether analyte concentrations fall within measurable ranges or exceed the detection capabilities of individual test strips.

[0068] In some aspects, the apparatus 100 may be configured for beta-hCG monitoring with specific cut-off concentrations including 25, 60, 100, 300, 500, 1200, 2000, 5000, 10000, and 30000 mIU / ml. The cut-off concentrations may correspond to clinically relevant thresholds for pregnancy monitoring and may enable tracking of hCG doubling patterns that indicate normal pregnancy progression or potential complications. The concentration thresholds may be distributed across multiple test strips to provide comprehensive coverage of the beta-hCG measurement range.

[0069] In some exemplary aspect of the present disclosure, the apparatus 100 may include 5 test strips configured to cover concentration ranges of 25-60 mIU / ml, 100-300 mIU / ml, 500-1200 mIU / ml, 2000-5000 mIU / ml, and 10000-30000 mIU / ml. The 5-test strip configuration may provide efficient coverage of the beta-hCG measurement range while maintaining a compact apparatus design. Each test strip within the 5-test strip arrangement may correspond to specific concentration ranges that enable semi- quantitative determination of beta-hCG levels through comparative analysis between the one or more first zones 106 (A-N) and one or more second zones 108 (A-N).

[0070] In some exemplary aspects of the present disclosure, the apparatus 100 may include 7 test strips that incorporate intermediate concentration ranges between the primary concentration ranges covered by the 5-test strip configuration. The 7 -test strip arrangement may provide enhanced resolution for beta-hCG measurement by including additional concentration ranges that enable more precise determination of analyte levels. The intermediate ranges may correspond to concentration thresholds that fall between the primary cut-off concentrations, enabling finer discrimination of analyte concentration levels.

[0071] In an exemplary aspect of the present disclosure, the apparatus 100 may include 9 test strips that provide enhanced resolution across all concentration ranges for beta-hCG measurement. The 9-test strip configuration may enable more precise semi-quantitative determination of analyte levels by incorporating additional concentration ranges that provide finer discrimination capabilities. The enhanced resolution may enable users to identify narrower concentration ranges that correspond more closely to the actual analyte levels present in biological samples. In an exemplary aspect of the present disclosure, the apparatus 100 may include 10 test strips that cover all individual cut-off concentrations for comprehensive beta-hCG measurement. The 10-test strip arrangement may provide maximum resolution for semi-quantitative analysis by dedicating individual test strips to each of the primary cut-off concentrations including 25, 60, 100, 300, 500, 1200, 2000, 5000, 10000, and 30000 mIU / ml. The comprehensive coverage may enable precise identification of concentration ranges through systematic evaluation of multiple test strips.

[0072] In an exemplary aspect of the present disclosure, the apparatus 100 may be configured with 12 test strips arranged to provide maximum resolution and redundancy for beta- hCG measurement applications. The 12-test strip configuration may include duplicate test strips for selected concentration ranges while incorporating additional intermediate ranges to achieve comprehensive coverage of the measurement spectrum. The arrangement may include primary concentration ranges with duplicate configurations for critical measurement thresholds such as 25-60 mIU / ml and 100-300 mIU / ml, which correspond to early pregnancy detection phases where measurement accuracy may be particularly important. The 12-test strip configuration may provide both enhanced resolution and built-in redundancy for improved measurement reliability.

[0073] In an exemplary aspect of the present disclosure, the apparatus 100 may be configured with 15 test strips that incorporate comprehensive intermediate ranges and selective redundancy to provide optimal measurement capabilities across the entire beta-hCG concentration spectrum. The 15 -test strip arrangement may include intermediate concentration ranges positioned at regular intervals throughout the measurement range, such as 25-40 mIU / ml, 40-60 mIU / ml, 60-100 mIU / ml, 100-200 mIU / ml, 200-300 mIU / ml, and similar subdivisions across higher concentration ranges. The comprehensive coverage provided by the 15-test strip configuration may enable precise tracking of hCG concentration changes and detailed monitoring of doubling patterns that may be clinically significant for pregnancy assessment and complication detection. In an exemplary aspect of the present disclosure, the apparatus 100 may be configured to determine that the concentration of beta-hCG lies within the limit of quantification when the first result obtained from the one or more first zones 106 (A-N) appears lighter in color compared to the second result obtained from the one or more second zones 108 (A-N). The color comparison methodology may enable semi-quantitative determination of analyte levels through visual assessment of relative color intensities between the detection zones. The lighter color intensity of the first result may indicate that the beta-hCG concentration falls between the minimum detection threshold represented by the one or more first zones 104 (A-N) and the maximum detection threshold represented by the one or more second zones 108 (A-N).

[0074] In some aspects, the quantification methodology may enable monitoring of beta-hCG doubling patterns through repeated testing and comparative analysis across multiple time points. The semi-quantitative measurements may provide information about concentration trends that may indicate normal pregnancy progression or potential complications such as biochemical pregnancy or ectopic pregnancy conditions. The concentration range determination may enable healthcare providers and users to track beta-hCG level changes over time through systematic evaluation of test results.

[0075] In an exemplary aspect, the concentration ranges covered by each strip of the one or more test strips 102 (A-N) may be distributed to provide comprehensive coverage of beta-hCG levels encountered during early pregnancy monitoring. The first test strip may cover concentration ranges from 25 mIU / ml to 60 mIU / ml, corresponding to the initial detection threshold for pregnancy confirmation approximately 8 to 10 days after implantation. The second test strip may cover concentration ranges from 100 mIU / ml to 300 mIU / ml, corresponding to beta-hCG levels typically observed during the first few weeks of pregnancy progression. The third test strip may cover concentration ranges from 500 mIU / ml to 1,200 mIU / ml, corresponding to beta-hCG levels observed during weeks 3 to 5 of pregnancy when hormone concentrations begin to increase substantially. The fourth test strip may cover concentration ranges from 2,000 mIU / ml to 5,000 mIU / ml, corresponding to intermediate beta-hCG levels observed during continued pregnancy progression. The fifth test strip may cover concentration ranges from 10,000 mIU / ml to 30,000 mIU / ml, corresponding to peak beta-hCG levels typically observed around week 8 of pregnancy.

[0076] In some aspects, the quantitative measurement capability may enable monitoring of hCG doubling patterns that provide clinical information about pregnancy progression and potential complications. Normal pregnancy progression may be characterized by hCG doubling approximately every 24 to 48 hours during early pregnancy stages. The apparatus 100 may enable tracking of these doubling patterns through repeated testing and comparative analysis of concentration ranges over time.

[0077] In some aspects, abnormal hCG doubling patterns may indicate potential pregnancy complications including biochemical pregnancy or ectopic pregnancy conditions. Biochemical pregnancy may be characterized by initial hCG level increases that peak at approximately 100 mIU / ml within 7 days of initial detection, followed by rapid concentration decreases. The apparatus 100 may enable detection of these patterns through monitoring of concentration changes across the 25 mIU / ml to 300 mIU / ml ranges covered by the first and second test strips.

[0078] In some aspects, ectopic pregnancy conditions may be characterized by slower hCG doubling rates and plateauing of hormone concentrations at constant values rather than continued exponential increases. The apparatus 100 may enable detection of these abnormal patterns through monitoring of concentration progression across multiple test strips over time. The semi-quantitative measurement capability may provide information about whether hCG levels are increasing, decreasing, or remaining constant within specific concentration ranges.

[0079] In some aspects, the apparatus 100 may be configured with fluorescence -based detection capabilities through the incorporation of fluorophore compounds within the one or more first zones 106 (A-N), one or more second zones 108(A-N), one or more third zones HO(A-N) of each strip of the one or more test strips 102(A-N). The fluorophore compounds may be attached to, impregnated within, or added to the biochemical reagents present in the detection zones to enable fluorescent signal generation upon binding with target analyte complexes. The fluorophore selection may include compounds such as fluorescein, rhodamine, cyanine dyes, quantum dots, or other fluorescent molecules that provide distinct emission wavelengths and intensity characteristics when excited by appropriate light sources. The fluorescence -based detection approach may enhance measurement sensitivity and reduce interference from ambient lighting conditions or background coloration that may affect visual interpretation methods.

[0080] In some aspects, the fluorescence detection system may incorporate excitation light sources and emission detection components that enable quantitative measurement of fluorescent signals generated within the detection zones. The excitation sources may include light-emitting diodes (LEDs), laser diodes, or filtered light sources that provide specific wavelengths optimized for the selected fluorophore compounds. The emission detection may be accomplished through photodetectors, charge-coupled devices (CCDs), or complementary metal-oxide-semiconductor (CMOS) sensors that capture fluorescent emissions and convert them to quantitative measurements. The fluorescence -based approach may enable automated analysis of test results through digital signal processing algorithms that correlate fluorescent intensity measurements with analyte concentrations, providing objective and reproducible measurements that may be less susceptible to user interpretation variability compared to colorimetric detection methods.

[0081] In an exemplary aspect of the present invention, the apparatus 100 may be configured with modular test strip arrangements that enable users to select specific combinations of test strips based on their individual monitoring needs or clinical recommendations. The modular configuration may include interchangeable test strip modules that may be combined to create customized measurement systems with varying numbers of test strips ranging from 3 to 20 or more. The modular approach may enable healthcare providers to recommend specific test strip combinations for different patients based on their pregnancy stage, risk factors, or monitoring requirements, providing personalized measurement capabilities while maintaining the core functionality of the apparatus 100.

[0082] FIG. 2 illustrates a method 200 for monitoring health conditions of an individual. The method 200 may include following steps: at step 204, receiving a sample at a first end of an apparatus 100 by one or more sample receiving pads 103 (A-N); at step 206, enabling the sample to flow across the one or more test strips 102 (A-N) from the first end to a second end; at step 208, binding one or more analytes in the sample with one or more detector reagents placed on the one or more conjugate pads 104 (A-N) to form a complex; at step 210, producing a first result at one or more first zones 106(A-N) of each strip of the one or more test strips 102 (A-N) by binding the complex with a first set of biochemical reagents; at step 212, producing a second result at one or more second zones 108 (A-N) of each strip of the one or more test strips 102 (A-N) by reacting the complex with a second set of biochemical reagents at step 214, producing a third result at one or more third zones 110 (A-N) of each strip of the one or more test strips 102(A-N) by reacting unreacted sample with a third set of biochemical reagents; and at step 216, comparing the first, second and third results to predict one or more health conditions of the individual.

[0083] In some aspects, the one or more health conditions may be selected from a group including, but not limited to, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease. FIG. 3 illustrates a block diagram of a system 300 by an aspect of the present disclosure. The system 300 may include one or more imaging units 302 and processing unit 304.

[0084] In some aspects of the present disclosure, the one or more imaging units 302 may be configured to capture one or more images of the one or more first zones 106 (A-N) and one or more second zones 108(A-N). The one or more imaging units 302 may include a feature detector module, a feature matching module, a homography matrix calculator, a canvas generator, a stitching module, and a blending module. The feature detecting module may be configured to detect features of the biological sample. Examples of the feature detector module may include, but are not limited to, SIFT, ORB, SuperPoint, Optical Flow based Method like Flownet or EiteFlowNet, and the like. Aspects of the present disclosure are intended to include or otherwise cover any type of feature detection module including known, related art, and / or later developed feature detection module. The feature matching module may be configured to compare the features of the biological sample with the pre-trained data of the biological sample. Examples of the feature matching module may include, but are not limited to, Brute Force Matcher, FEANN Based Matcher, and the like. Aspects of the present disclosure are intended to include or otherwise cover any type of feature matching module including known, related art, and / or later developed feature detection module.

[0085] In some aspects, the processing unit 304 may be configured to to analyze on or more health conditions. In some aspects, the one or more health conditions may be selected from a group including, but not limited to, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease.

[0086] In some aspects, the processing unit 304 may be configured to analyze color intensities and contrast ratios. In some aspects, the processing unit 304 may be configured to determine concentration ranges based on comparative measurements between the one or more first zones 106(A-N) and one or more second zones 108 (A-N). The processing unit 304 may be a network of computers, a server, a framework, or a combination thereof, that may provide a generalized approach to create a server implementation. In some aspects of the present disclosure, the processing unit 304 may be a server. Examples of the information processing unit 304 may include but are not limited to, personal computers, laptops, mini-computers, mainframe computers, any non-transient and tangible machine that can execute a machine -readable code, cloud-based servers, distributed server networks, or a network of computer systems. The processing unit 304 may be realized through various web-based technologies such as, but not limited to, a Java web framework, a NET framework, a Hypertext Preprocessor (PHP) framework, JavaScript, React, Python, PyQt, Qt, and C / C++ or any other web application framework. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the web-based technologies, without deviating from the scope of the present disclosure.

[0087] In some aspects, the communication network (not shown) may include suitable logic, circuitry, and interfaces that may be configured to provide a plurality of network ports and a plurality of communication channels for the transmission and reception of data related to operations of various entities of the system 300. Each network port may correspond to a virtual address (or a physical machine address) for transmission and reception of the communication data. For example, the virtual address may be an Internet Protocol Version 4 (IPV4) (or an IPV6 address) and the physical address may be a Media Access Control (MAC) address. The communication network may be associated with an application layer for the implementation of communication protocols based on one or more communication requests from the one or more imaging units 302 and the processing unit 304. The communication data may be transmitted or received via the communication protocols. Examples of the communication protocols may include, but are not limited to, Hypertext Transfer Protocol (HTTP), File Transfer Protocol (FTP), Simple Mail Transfer Protocol (SMTP), Domain Network System (DNS) protocol, Common Management Interface Protocol (CMIP), Transmission Control Protocol and Internet Protocol (TCP / IP), User Datagram Protocol (UDP), Long Term Evolution (LTE) communication protocols, or any combination thereof. Aspects of the present disclosure are intended to include or otherwise cover any type of communication protocols including known, related art, and / or later developed communication protocols.

[0088] Advantages of the present disclosure

[0089] • The apparatus may eliminate subjective visual interpretation challenges by providing comparative analysis between multiple detection zones within each test strip.

[0090] • The apparatus may reduce sensitivity loss associated with untrained user administration through standardized reference measurements and objective result interpretation.

[0091] • The apparatus may enable semi -quantitative measurement of beta-hCG concentrations across multiple concentration ranges from 25 mIU / ml to 30,000 mIU / ml using a single testing device.

[0092] • The apparatus may provide enhanced measurement reliability through duplicate test strip configurations that enable validation of results across identical detection systems.

[0093] • The apparatus may enable monitoring of hCG doubling patterns for pregnancy progression tracking and early detection of potential complications such as biochemical pregnancy or ectopic pregnancy.

[0094] • The apparatus 100 may offer modular design flexibility allowing customization of test strip numbers and concentration ranges based on specific clinical requirements or user needs.

[0095] • The apparatus 100 may support both visual interpretation and digital image analysis through scanner or imaging sensor systems for enhanced objectivity and precision. • The apparatus 100 may provide immediate feedback regarding analyte concentration ranges without requiring laboratory analysis or professional interpretation.

[0096] • The apparatus 100 may enable home -based quantitative health monitoring while maintaining clinical relevance through correlation with serum hCG measurements.

[0097] • The apparatus 100 may reduce interpretation errors by providing clear visual references through comparative analysis between one or more first zones and one or more second zones.

[0098] The foregoing discussion of the present disclosure has been presented for purposes of illustration and description. It is not intended to limit the present disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the present disclosure are grouped together in one or more aspects, configurations, or aspects for the purpose of streamlining the disclosure. The features of the aspects, configurations, or aspects may be combined in alternate aspects, configurations, or aspects other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention, the present disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspects, configuration, or aspect. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate aspect of the present disclosure.

[0099] Moreover, though the description of the present disclosure has included description of one or more aspects, configurations, or aspects and certain variations and modifications, other variations, combinations, and modifications are within the scope of the present disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, configurations, or aspects to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges, or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges, or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

We Claim1. An apparatus 100 for determining one or more analytes in a sample, comprising: one or more test strips 102 (A-N), each strip of one or more test strips 102(A-N) comprising: one or more first zones 106(A-N) configured to produce a first result by binding with a complex formed from a sample and detector reagents; one or more second zones 108 (A-N), disposed downstream of the one or more first zones 106(A-N), configured to produce a second result by reacting with the complex; and one or more third zones 110 (A-N), disposed downstream of the one or more second zones 108 (A-N), configured to produce a third result by reacting with unreacted sample; wherein the one or more analytes in the sample is quantified by comparing the produced first, second and third result.

2. The apparatus 100 as claimed in claim 1, wherein the sample is selected from a group comprising, a sweat, urine, blood, blood serum, semen, breast milk, saliva, blood plasma, tears, mucus, cerebrospinal fluids, saliva, amniotic fluid, vaginal lubrication fluids, pus, lymph, bile, synovial fluid, aqueous humour, phlegm, gastric acid, pre-ejaculate, or colostrum.

3. The apparatus 100 as claimed in claim 1, wherein the one or more test strips 102 (A-N) are arranged in an exponential increasing order of concentration of one or more analytes to be measured.

4. The apparatus 100 as claimed in claim 1, wherein the one or more analyte is selected from a group comprising, a Estradiol glucuronide (E3G), Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH),Human chorionic gonadotrophin (hCG), alpha -hCG, beta- hCG, antibody, metabolite, virus, bacteria, protein, or sperm.

5. The apparatus 100 as claimed in claim 1, further comprising one or more sample receiving pads 103 (A-N) positioned at a first end or second end of each strip of the one or more test strips 102(A-N), configured to receive the sample.

6. The apparatus 100 as claimed in claim 1, further comprising one or more conjugate pads 104(A-N) positioned downstream of the sample receiving pads 103(A-N), configured to form the complex between the sample and the detector reagents.

7. The apparatus 100 as claimed in claim 1, wherein the one or more first zones 106(A- N), one or more second zones 108 (A-N), and one or more third zones 110 (A-N) are positioned sequentially downstream of the one or more conjugate pads 104 (A- N) on each strip of the one or more test strips 102 (A-N).

8. The apparatus 100 as claimed in claim 1, wherein the one or more health conditions is selected from a group comprising, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease.

9. A method 200 for monitoring health conditions of an individual, comprising: receiving 202 a sample at a first end of an apparatus 100 by one or more sample receiving pads 103 (A-N); enabling 204 the sample to flow across the one or more test strips 102 (A-N) from the first end to a second end; binding 206 one or more analytes in the sample with one or more detector reagents placed on the one or more conjugate pads 104 (A-N) to form a complex; producing 208 a first result at one or more first zones 106(A-N) of each strip of the one or more test strips 102 (A-N) by binding the complex with a first set of biochemical reagents;producing 210 a second result at one or more second zones 108 (A-N) of each strip of the one or more test strips 102 (A-N) by reacting the complex with a second set of biochemical reagents producing 212 a third result at one or more third zones 110 (A-N) of each strip of the one or more test strips 102(A-N) by reacting unreacted sample with a third set of biochemical reagents; and comparing 214 the first, second and third results to predict one or more health conditions of the individual.

10. The method 200 as claimed in claim 9, wherein at step 202, the sample is selected from a group comprising, a sweat, urine, blood, blood serum, semen, breast milk, saliva, blood plasma, tears, mucus, cerebrospinal fluids, saliva, amniotic fluid, vaginal lubrication fluids, pus, lymph, bile, synovial fluid, aqueous humour, phlegm, gastric acid, or pre-ejaculate, colostrum.

11. The method 200 as claimed in claim 9, wherein at steps 208 the one or more analyte is selected from a group comprising, a Estradiol glucuronide (E3G), Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), Human chorionic gonadotrophin (hCG), alpha -hCG, beta- hCG, antibody, metabolite, virus, bacteria, protein, or sperm.

12. The method as claimed in claim 9, wherein at step 204 enabling the sample to flow across the one or more test strips 102 (A-N) further comprises allowing the sample to flow by capillary action.

13. The method as claimed in claim 9, wherein step 214 one or more health conditions is selected from a group comprising, a pregnancy, ectopic pregnancy, menopause, polycystic ovary syndrome (PCOS), ovarian cancer, or trophoblastic disease.

14. A system 300 comprising:a. an imaging unit 302 configured to capture one or more images of the one or more first zones 106 (A-N) and one or more second zones 108(A-N); b. a processing unit 304 configured to analyze on or more health conditions.

Images