Assay and methods to determine body conditions

Abstract

Disclosed is an assay for measuring concentration / level of alpha subunit of Luteinizing Hormone (αLH) and / or beta subunit of Luteinizing Hormone (βLH) in a biological sample. Further, an assay for determining peak fertility in a user by analysing a biological sample of the user is disclosed. The assay further includes detecting one or more first reproductive hormones or their metabolites from a group including alpha subunit of Luteinizing Hormone (αLH), beta subunit of Luteinizing Hormone (βLH) and determining one or more second reproductive hormones such as Follicle- stimulating Hormone (FSH), Human chorionic gonadotropin (hCG) in free or bound form.

Description

[0001] ASSAY AND METHODS TO DETERMINE BODY CONDITIONS

[0002] TECHNICAL FIELD

[0003] The present aspect generally relates to a medical assay. More particularly, the present disclosure relates to a assay, and methods for determining a body condition.

[0004] BACKGROUND

[0005] Presently, continuous efforts are being made to understand a complex process of fertility in a female body. Fertility management is crucial for a female due to numerous reasons inter alia achieving / avoiding pregnancy, in vitro fertilization, detecting / mana ging / treating menopause, and other health conditions / disorders. In the process of monitoring / managing fertility levels in a female body, the very first step is to attain information on fertility status, fertile phase in the cycle (ovulation), etc.

[0006] Therefore, considering the criticality of fertility management, various methods / devices have been proposed in the art to predict / treat fertility level and to provide effective and reliable birth control solutions. Few of the existing / conventional techniques solely rely on variation in few parameters during ovulation cycle. One of the major drawbacks inherent in such techniques is inconsistency in parameter variations in luteinizing hormone detection from one female to another, and certainly from one cycle to another cycle in the same female body which in turn makes the observations / data unreliable and inaccurate for practical use.

[0007] Other conventional fertility testing methods involve measuring concentration / level of parameters / analytes such as Estradiol glucuronide (E3G) and Luteinizing hormone (LH) for assessment of fertility status since it is known that high levels of estradiol precede LH surge in the female body and LH surge triggers ovulation (follicle rupture). Therefore, high E3G levels and peak LH levels indicate high fertility and peak fertility respectively. Further, Pregnanediol glucuronide (PdG) is a urine metabolite of progesterone (secreted by the Corpus Luteum) and therefore indicates occurrence of ovulation. Furthermore, Progesterone supports the endometrium, thus allowing pregnancy to continue. In a particular ovulation cycle, if the female body does not conceive, progesterone levels fall. Alternatively, if the female conceives, the progesterone levels are maintained throughout the pregnancy period. In addition, a quick decline in PdG levels during pregnancy is an indicator of putative miscarriage. Once the PdG falls, follicle-stimulating hormone (FSH) increases enabling maturation of the follicles and a new cycle begins.

[0008] However, the existing technologies fail to effectively provide results / data for multiple scenarios / tests using a single test to predict, detect or establish fertility tests in the female. Moreover, the female / user is required to perform individual tests for monitoring each of the follicle maturation, follicle growth (fertility), follicle rupture (ovulation), and successful conception. Thus, the existing technologies significantly face performance issues, are not only time-consuming but are also frustrating for the user. Furthermore, existing systems and methods do not utilize alpha and beta subunits of LH to predict fertile phase of ovulation more accurately or on the cross-reactivity between alpha LH and hCG for monitoring healthy pregnancy.

[0009] Accordingly, in view of the aforementioned limitations inherent in the existing fertility testing methods, there exists a need to provide a single test to determine multiple parameters / analytes affecting the fertility test. More particularly, there exists a need of an assay and method for personal, home -based, and / or point-of-care determining fertility level in a female body and monitoring pregnancy based on a plurality of analytes present in a biological sample of a female.

[0010] SUMMARY OF THE INVENTION

[0011] In an aspect of the present disclosure, an assay for measuring measuring concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) in a biological sample is provided.

[0012] In some aspects, the assay is a lateral flow assay.

[0013] In some aspects, the biological sample for the assay is selected from a group including 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.

[0014] In some aspects, the assay measures the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) in the same biological sample.

[0015] In some aspects, the assay measures the concentration alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) is measured in free or bound form.

[0016] In some aspects, the assay is provided for predicting pregnancy.

[0017] In some aspects, the assay is provided for determining peak fertility in a user.

[0018] In some aspects, the assay measures the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and beta subunit of Luteinizing Hormone (PLH) is measured for predicting highest chances of conception.

[0019] In another aspect of the present disclosure, assay for determining peak fertility in a user is provided. The assay includes measuring concentration / levels of one or more first reproductive hormones including alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (PLH) or their metabolites and, determining concentration / levels one or more second reproductive hormones such as the Follicle Stimulating Hormone (FSH) and the Human chorionic gonadotropin (hCG).

[0020] In some aspects, the one or more first reproductive hormones and one or more second reproductive hormones are present in the same biological sample.

[0021] In some aspects, the the biological sample is selected from a group including 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. In some aspects, the measured alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (PLH) are cross reactive to FSH present in the biological sample.

[0022] In some aspects, the measured alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (PLH) are cross- reactive to hCG present in the sample.

[0023] In some aspects, the assay measures alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH), Follicle Stimulating Hormone (FSH), Human chorionic gonadotropin (hCG) and their metabolites in free or bound form and their metabolites in free or bound form.

[0024] In some aspects, the assay is provided for predicting pregnancy.

[0025] In some aspects, the assay identifies an ovarian reserve as a substitute for the Follicle Stimulating Hormone (FSH).

[0026] In another aspect of the present disclosure, a method for determining peak fertility in a user by analysing the biological sample is provided. The method includes determining concentration / level of one or more first reproductive hormones including alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) and their metabolites and determining concentration / level of one or more second reproductive hormones such as Follicle Stimulating Hormone (FSH) and / or Human chorionic gonadotropin (hCG) in free or bound form.

[0027] In another aspect of the present disclosure, a method for suspecting pregnancy in a user by analysing a biological sample. The method includes determining concentration / level of one or more first reproductive hormones or their metabolites including alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH) and determining concentration / level of one or more second reproductive hormones including Human chorionic gonadotropin (hCG) in free or bound form. In another aspect of the present disclosure, a method for determining ultrasound day of ovulation (USDO) in a user by analysing a biological sample, the method includes determining concentration / level of one or more first reproductive hormones such as a beta subunit of Luteinizing Hormone (0LH) in free or bound form or their metabolites is provided.

[0028] In another aspect of the present disclosure, a method for determining selection of dominant follicle in a user by analysing a biological sample. The method includes determining concentration / level of one or more first reproductive hormones or their metabolites including alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH) and further determining concentration / level of one or more second reproductive hormones including Follicle Stimulating Hormone (FSH), Estrogen, Human chorionic gonadotropin (hCG) in free or bound form.

[0029] BREIF DESCRIPTION OF DRAWINGS:

[0030] The drawings mentioned in this section disclose exemplary aspects of the claimed system and method. Detailed description of well-known components and processing techniques are omitted to not unnecessarily obscure the embodiments herein. Further, the components / modules / units and steps of a process are assigned reference numerals that are used throughout the description to indicate the respective components and steps. Other objects, features, and advantages of the present invention will be apparent from the following description when read with reference to the accompanying drawings.

[0031] FIG. 1 illustrates a schematic diagram of an assay, according to an aspect herein; and FIG. 2 illustrates a block diagram of a system to determine fertility level of a user, according to an aspect herein.

[0032] To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.

[0033] DETAILED DESCRIPTION: V arious aspect of the present disclosure provides an assay and methods for determining concentration / level of alpha-beta luteinizing hormone in a biological sample of a user. 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.

[0034] 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.

[0035] 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.

[0036] 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 human chorionic gonadotrophin (hCG).

[0037] 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’, and ‘subject’ may refer to similar meaning / interpr etation and may be interchangeably used throughout the specification.

[0038] The term “assay” may refer to a “lateral flow assay cartridge” and are interchangeably used across the context.

[0039] As mentioned, there remains a need for an assay and method that overcomes the limitations such as laborious and time-consuming fertility determination method. The present disclosure, therefore, provides an assay, system, and method to determine alpha-beta luteinizing hormone assay that enables a user to monitor / predict / manage fertility, ovulation, pregnancy, or any related conditions based on one or more analytes present in a biological sample fluid associated with the user. The present disclosure may also provide a test strip that enables the user to undertake a fertility test and determine fertility level. The present disclosure may also enable the user to check whether the user may be in the phase of fertility / ovulation. The present disclosure also encompasses monitoring the fertility level based on the determined analytes.

[0040] FIG. 1 illustrates a schematic diagram of an assay 100. The assay 100 may be provided for quantifying concentration / level of one or more hormones in a biological sample. In some aspects, the one or more hormones may be selected from a group, but not limited to, Estradiol glucuronide (E3G), alpha and beta subunits of Luteinizing Hormone (LH), Pregnanediol Glucuronide (PdG), Follicle-stimulating hormone (FSH), and human chorionic gonadotrophin (hCG) and the like. Aspects of the present disclosure are intended to include or otherwise cover any type of hormones, including known, related art, and / or later developed hormones.

[0041] In some aspects, the assay 100 may be provided for a lateral flow assay. Aspects of the present disclosure are intended to include and / or otherwise cover any type of the lateral flow assay, including known, related, and later developed lateral flow assays.

[0042] In some aspects, the assay 100 may be provided to measure the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) in the biological sample. In some aspects, the assay 100 may quantify the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) when present in the same biological sample. In some aspects, the assay 100 may quantify the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) when present in one or more biological sample.

[0043] In some aspects, alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) may be present in free form in the biological sample. In some aspects, the alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) may be present in bound form in the biological sample. In some aspects, the concentration of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) may be measured in free or bound form by the assay 100.

[0044] In some aspects, the assay 100 is provided for predicting pregnancy of a user by measuring the concentration of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) in the biological sample.

[0045] In some aspects, the assay 100 determines peak fertility level in a user.

[0046] In some aspects, the measured concentration of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (PLH) is mapped against once cycle. In some aspects, the assay 100 includes quantifying concentration / level of beta subunit of luteinizing hormone (0LH) and an alpha subunit of luteinizing hormone (aLH) in the biological sample during at least one menstrual cycle. The assay 100 further includes determining a maximum concentration / level of 0LH (PLHmax) and a maximum concentration / level of an aLH (aLHmax) during at least one menstrual cycle. The assay 100 further includes determining, simultaneously, for the same cycle, whether the aLH levels in the biological sample are more than a first threshold during a follicular phase of at least one mensural cycle and whether the 0LH levels are maintained same as the PLHmax for at least four days during luteal phase of at least one menstrual cycle.

[0047] In some aspects, the assay 100 may include one or more test strips 101A-101N (of which first through second 101A - 101B are shown). The one or more test strips 101A- 101N may include one or more sample receiving pads 102A-102N (of which first and second sample receiving pads 102A - 102B are shown), one or more conjugate pads 104A-104N (of which first through second conjugate pads 104A-104N are shown), each test strips of one or more test strips 101A-101N may include one or more detection pads 106A-106N (of which first through fourth 106A - 106D are shown), each test strips of one or more test strips 101A-101N may include one or more corresponding control lines 108A - 108N (of which first through second 108A - 108B are shown).

[0048] The one or more test strips 101A-101N may include a distal end 114 and a proximal end 112 (for purposes of this disclosure, “distal end 114” refers to the portion of the one or more test strips 101A-101N that is far from the user during normal use and “proximal end 112” refers to the portion of the one or more test strips 101A-101N that is closer to the user during normal use).

[0049] The distal end 114 may be adapted to dip into the biological sample and the proximal end 112 may be adapted to flow excess biological sample. In some aspects of the present disclosure, the proximal end 114 may be adapted to dip into the biological sample and the distal end 114 may be adapted to flow excess biological sample. The one or more sample receiving pads 102A-102N may be adapted to mount on both the distal end 114 and the proximal end 112 of the one or more test strips 101 A- 10 IN. In some aspects of the present disclosure, the one or more sample-receiving pads 102A- 102N may be adapted to receive biological samples.

[0050] In some aspects of the present disclosure, the one or more sample receiving pads 102A- 102N may be a porous membrane that includes a binding reagent having capability to bind to each of the one or more analytes.

[0051] The one or more conjugate pads 104A - 104N may be integrated with the one or more sample receiving pads 102A-102N, while in another aspect, the one or more conjugate pads 104A - 104N may not be integrated with the one or more sample receiving pads 102A-102N and may be provided separately on the one or more test strips 101A-101N. In some aspects, the one or more conjugate pads 104A-104N may be configured to provide one or more detector antibodies to the biological sample. In some aspects, the one or more conjugate pads 104A - 104N may include at least one of glass fibre-based polymers, woven cellulose fibre polymers, and non-woven cellulose fibre polymers.

[0052] The one or more detection pads 106A-106N may be mounted on each test strip of the one or more test strips 101A-101N and may be adapted to receive one or more analytes of reacted biological sample (combination of the biological sample and the one or more detector antibodies). In some aspects of the present disclosure, each detection zone of the one or more detection pads 106A-106N may be configured for one analyte, and the one or more detection pads 106A-106N may include corresponding biochemical reagent / s. Pursuant to the reaction at the one or more conjugate pads 104A - 104N, each of the one or more analytes of the reacted biological sample may be adapted to react with the corresponding biochemical reagent at the corresponding detection pads 106A-106N.

[0053] In some aspects of the present disclosure, 106A may refer to detect FSH, 106B may refer to detect hCG, 106C may refer to detect alpha LH, and 106D may refer to detect beta LH i.e. reaction of FSH with the corresponding biochemical reagent occurs at detection pads 106A and the like.

[0054] In some aspects of the present disclosure, the one or more reactions may produce signals through either chemical or physical means, such signals may be optically detectable. In some aspects of the present disclosure, the one or more detection pads 106A-106N may include enzymes and substrates, chromogens, catalysts, fluorescent compounds, chemiluminescent compounds, electroactive species, dye molecules, radioactive labels, and particle labels. In another embodiment, the one or more detection pads 106A-106N may include magnetic or electronically charged labels, which can be detected by magnetic or electrochemical means. In some aspects of the present disclosure, the optically detectable labels may include colloidal metallic particle labels and dye-laden particles.

[0055] The one or more control lines 108A-108N may be integrated into the one or more test strips 101A- 10 IN.

[0056] The one or more control lines 108A-108N may be adapted to receive one or more analytes of reacted biological sample. In some aspects of the present disclosure, each detection zone of the one or more control lines 108A-108N may be configured for one analyte, and the one or more control lines 108A-108N may include corresponding biochemical reagent / s.

[0057] In some aspects of the present disclosure, antibodies in the one or more control lines 108A-108B may not be same as the antibodies in the one or more detection pads 106A- 106B.

[0058] In some aspects of the present disclosure, the one or more conjugate pads 104A-104N may include a first set of antibodies against the alpha subunit of LH and the one or more test lines 108A-108N may include a second set of antibodies against the alpha subunit of LH. In some aspects, the first set of antibodies for the alpha subunit of LH and the second set of antibodies for the alpha subunit of LH may be same or different. In some aspects of the present disclosure, the one or more conjugate pad 104A-104N may include a first set of antibodies against the beta subunit of LH and the one or more test lines 108A-108N may include a second set of antibodies against the beta subunit of LH. In some aspects, the first set of antibodies for the beta subunit of LH and the second set of antibodies for the beta subunit of LH may be same or different.

[0059] In some aspects of the present disclosure, antibodies in the one or more control lines 108A-108B may be same as the antibodies in the one or more detection pads 106A- 106B.

[0060] The one or more test strips 101A-101N may further include a holding portion 110A- 110B. The holding porting enables the user to hold the test strip.

[0061] In some aspects, the assay 100 may be provided for measuring one or more of first and second reproductive hormones. In some aspects, the one or more first reproductive hormones include alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (PLH) or their metabolites. In some aspects, the one or more second reproductive hormones include Follicle Stimulating Hormone (FSH) and the Human chorionic gonadotropin (hCG).

[0062] In some aspects, the assay 100 may measure one or more first reproductive hormones and one or more second reproductive hormones and their metabolites in free or bound form.

[0063] In some aspects, the one or more first reproductive hormones and one or more second reproductive hormones and their metabolites maybe present in the same biological sample. In some aspects, the one or more first reproductive hormones and one or more second reproductive hormones and their metabolites maybe present in one or more biological samples.

[0064] In some aspects, the assay 100 may include quantifying concentration / level of one or more first reproductive hormones or their metabolites that is beta subunit of luteinizing hormone (0LH) in the sample during at least one menstrual cycle, determining one or more secondary reproductive hormones such as Human chorionic gonadotropin (hCG) in the biological sample by correlating the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (0LH), or their metabolites for at least one mensural cycle, determining a maximum concentration / level of 0LH (PLHmax) and a maximum concentration / level of a Human chorionic gonadotropin (hCGmax) during at least one menstrual cycle and determining, simultaneously, for the same cycle, whether the hCGmax levels in the biological sample are more than a first threshold during the follicular phase of at least one mensural cycle and whether the 0LH levels in the biological sample are more than a second threshold of the PLHmax for at least four days during the follicular phase or luteal phase of at least one menstrual cycle. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0065] In some aspects of the present disclosure, the peak fertility is determined by cross - reacting the one or more first reproductive hormones with the one or more third second reproductive hormones such as FSH and HCG present in the biological sample.

[0066] FIG. 2 illustrates a block diagram of a system 200 that may determine a fertility level in a user. The system 200 may be adapted to determine fertility level in the user based on one or more analytes present in the biological sample collected from the user. The system 200 may be configured to monitor the fertility level in the user.

[0067] The system 200 may include an optical wave guide 204, a sensing device 206, a server 208, a communication network 210, and a user device 212.

[0068] The one or more reaction produced by chemical or physical means in the one or more test strips 101A-101N may be detected by way of the sensing device 206 through the optical waveguide 204.

[0069] The sensing device 206 may be further configured to communicate signals that represent one or more input parameters of the one or more reaction pads with the server 208. The sensing device 206 may be configured to communicate the signals with the server 208 by way of the communication network 210. In some aspects of the present disclosure, the sensing device 206 may include, but is not limited to, a camera, a spectrophotometer, a colorimeter, an optical sensor, and the like. In some aspects of the present disclosure, the one or more input parameters may include, but not limited to image, and values representing temperature, pH, color intensity, optical / light intens ity, and the like.

[0070] The server 208 may include processing circuitry 214 and a storage unit 216.

[0071] The server 208 may include an operating system that provides executable instructions for a basic management and operation of the server 208.

[0072] The processing circuitry 214 may be any or a combination of microprocessor, microcontroller, development board, or other similar processing units, and like.

[0073] In some aspects of the present disclosure, the processing circuitry 214 may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, logic circuitries, and / or any devices that manipulate data based on operational instructions stored in the storage unit 216. In some aspects of the present disclosure, the processing circuitry 214 may be implemented as a combination of hardware and instructions (for example, machine executable instructions) to implement one or more functionalities of the processing circuitry 214.

[0074] The processing circuitry 214 may include a data processing engine 218 and a triggering engine 220.

[0075] The data processing engine 218 in the processing circuitry 214 may be configured to receive the signals that represent the one or more input parameters of the one or more reaction pads. The data processing engine 218 may be configured to compare the one or more input parameters with a prestored threshold stored in the storage unit 216.

[0076] In some aspects of the present disclosure, the data processing engine 218 may include a quantification engine (not shown). The quantification engine may be configured to determine concentration values for each analyte of the one or more analytes. The data processing engine 218 may be further be configured to communicate the determined data representing one or more body parameters with the triggering engine 220. The triggering engine 220 may be configured to compare the determined one or more body parameters received from the data processing engine 218 with a predetermined one or more body parameters as stored in the storage unit 216.

[0077] The triggering engine 220 may be configured to generate first alert when the determined data may be greater than the predetermined body condition data. The triggering engine 220 may be configured to generate second alert when the determined data may be less than the predetermined body condition data. In some aspects of the present disclosure, the triggering engine 220 may be configured to generate a third alert when the biological sample in the one or more test strips may be non-detectable or low. The triggering engine 220 may further be configured to communicate the generated alerts (the first alert, the second alert, and the third alert) implication of each signal individually or in combination with the user by way of the user device 212.

[0078] In some aspects of the present disclosure, the triggering engine 220 may be configured to analyse the determined concentration values of each analyte by comparing a predefined threshold concentration in the storage unit 216. Based on the comparison, the triggering engine 220 determines a fertility level of the user.

[0079] In some aspects, the triggering engine 220 may also encompass to monitor the fertility level of the user. In some other aspects of the present disclosure, the monitoring may be periodic or non-periodic.

[0080] The storage unit 216 may be configured to store data that represents predetermined threshold values of the one or more reaction pads, the predetermined one or more body parameters, predetermined optical density values, predetermined images of the one or more test strips, and the like. Aspects of the present disclosure are intended to include and / or otherwise cover any type of data, including known, related, and later-developed data. The user device 212 may be capable of facilitating the user to input data, share one or more results, and / or transmit data within the system 200. Examples of the user device 212 may include, but are not limited to, a desktop, a notebook, a laptop, a handheld computer, a touch sensitive device, a computing device, a smart-phone, and / or a smart watch. In the illustrated aspect of FIG. 2, the user devices 212 may include an interface 222 and a processing unit 224. In some other aspects of the present disclosure, the user of the user device may be a patient, doctor and any such person as may be obvious to a person skilled in the art.

[0081] The interface 222 may include an input interface for receiving inputs from the user. In some aspects of the present disclosure, the input interface may include, but are not limited to, a touch interface, a mouse, a keyboard, a motion recognition unit, a gesture recognition unit, a voice recognition unit, or the like.

[0082] The interface 222 may further include an output interface for displaying (or presenting) an output to the user. In some aspects of the present disclosure, the output interface may include, but are not limited to, a display device, a printer, a projection device, and / or a speaker. In some other aspects of the present disclosure, the output interface may include, but are not limited to, a digital display, an analog display, a touch screen display, a graphical user interface, a website, a webpage, a keyboard, a mouse, a light pen, an appearance of a desktop, and / or illuminated characters.

[0083] The processing unit 224 may include suitable circuitry for executing various operations, to control one or more operations executed by the user device 212 in response to the input received at the user device 212 from the user.

[0084] The user device 212 may further include a memory 226 configured to store logic, instructions, circuitry, interfaces, and / or codes of the processing unit 224, data associated with the user device 212, and data associated with the system 200.

[0085] The user device 212 may further include a communication interface 230. The communication interface 230 may be configured to enable the user device 212 to communicate with the server 208 and other components of the system 200 over the communication network 210, according to an aspect of the present disclosure. In some aspects, the user device 212 and the receiver antenna (not shown) may further be configured to receive a radio wave containing modulated signal information transmitted from the data processing engine 218 and the triggering engine 220 by way of transceiver over a wireless network.

[0086] In an exemplary scenario, if the user wishes to determine fertility level, the user may require to put / flow / pass on a biological sample onto the one or more sample receiving pads 102A-102N of the one or more test strips 101 A- 10 IN. Therefore, when the biological sample may get introduced onto the one or more sample receiving pad 102A- 102N, the one or more analytes (E3G, alpha and beta LH, PdG, FSH, and hCG) present in the biological sample may be pre-treated in the one or more sample receiving pads 102A-102N. Subsequently, the pre-treated biological sample may flow to one or more conjugate pads 104A - 104N where a detector reagent that may include one or more detector antibodies may get reacted with the pre-treated sample (i.e., with the one or more analytes present in the sample).

[0087] In some aspects of the present disclosure, the system 200 may be configured to receive a sequence of inputs consecutively over time and may further be configured to generate a relative threshold for each user based on each input of the sequence of inputs. The system 200 may further utilize the generated relative threshold from each input of the sequence of inputs to generate a relationship function between each input of the sequence of inputs. In some aspects of the present disclosure, the system 200 may be configured to generate a state vector corresponding to each input of the sequence of inputs based on which the system 200 may be configured to generate a relationship function between each input of the sequence of inputs. Based on the relationship function, the system 200 may be configured to generate one or more outputs. In some aspects of the present disclosure, the value of each state and the relative threshold generated from each input of the sequence of inputs, and the relationship function between each input of the sequence of inputs may be stored in a storage unit. In an exemplary scenario, the sensing device 206 may be configured to capture one or more images of the one or more detection zone 106A-106N of the one or more test strips 101 A- 10 IN. The data processing engine 218 may be configured to detect the color changes in each image of the one or more images of the one or more reaction pads in the one or more test strips 101A-101N. The data processing engine 218 may further be configured to compare signals representing one or more images of the one or more reaction pads with a prestored image stored in the storage unit 216. In some aspects of the present disclosure, the data processing engine 218 may further be configured to determine one or more body parameters based on the compared image data.

[0088] In some aspects of the present disclosure, the data processing engine 218 may be configured to integrate data representing reaction in the one or more control lines 108A-108B with the data representing reaction in the one or more detection pads 106A- 106B.

[0089] In an exemplary scenario, the data processing engine 218 may be configured to determine pregnancy by cross-reacting by determining reaction in an alpha LH by detecting chemical reaction in corresponding detection zone of alpha LH in the one or more detection pads 106A-106N along with reaction in detecting hCG by detecting chemical reaction in corresponding detection zone of hCG in the one or more detection pads 106A-106N.

[0090] In another exemplary scenario, the data processing engine 218 may be configured to identify peak fertility based on the low beta LH content in the biological sample by detecting an intensity of the chemical reaction in corresponding detection zone of beta LH in the one or more detection pads 106A-106N.

[0091] In another exemplary scenario, the data processing engine 218 may be configured to estimate ultrasound day of ovulation based on the chemical reaction in corresponding detection zone of alpha LH in the one or more detection pads 106A-106N and the chemical reaction in corresponding detection zone of beta LH in the one or more detection pads 106A-106N.

[0092] In another exemplary scenario, the data processing engine 218 may be configured to monitor healthy pregnancy by calculating a double rate of hCG. The double rate of hCG may be calculated by detecting an intensity of the chemical reaction in corresponding detection zone of hCG in the one or more detection pads 106A-106N.

[0093] In another exemplary scenario, the data processing engine 218 may be configured to monitor the LH level, when the LH level may raise rapidly than the normal state of the human, the data processing engine 218 may be configured to communicate with the triggering engine 220 regarding a sign of ovulation. The triggering engine 220 may also be configured to determine a period of ovulation based on the raised LH levels and may further be configured to recommends the user for intercourse.

[0094] In an exemplary scenario, the data processing engine 218 may be configured to quantify the alpha subunit of the LH in the biological sample when beta LH content in the biological sample is low. The data processing engine 218 determines peak fertility based on the alpha LH content by detecting an intensity of chemical reaction in corresponding detection zone of alpha LH in the one or more detection pads 106A- 106N.

[0095] In another exemplary scenario, the data processing engine 218 may be configured to monitor a true LH peak based on detecting an intensity of chemical reaction in corresponding detection zone of beta LH in the one or more detection pads 106A-106N. The data processing engine 218 may be configured to differentiate the true LH peak and false LH peak from the actual peak.

[0096] In an aspect of the present disclosure, a method for determining peak fertility in a user by analyzing a biological sample of the user. The method may include detecting one or more first reproductive hormones or their metabolites from a group that may include alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH) and determining one or more second reproductive hormones such as Follicle- stimulating Hormone (FSH), Human chorionic gonadotropin (hCG) in free or bound form. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0097] In some aspects of the present disclosure, the peak fertility may be determined by crossreacting the one or more first reproductive hormones with the one or more third reproductive hormones such as Oestrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG). In some aspects of the present disclosure, the peak fertility may be determined by determining a phase of the cycle.

[0098] In an exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The peak fertility in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include FSH. In another exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The peak fertility in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include hCG.

[0099] The method may further include measuring levels of the one or more first reproductive hormones and one or more second reproductive hormones or their metabolites during at least one mensural cycle, determining a maximum concentration of the one or more first reproductive hormones and one or more second reproductive hormones or their metabolites during at least one mensural cycle, and determining, simultaneously, for at least one mensural cycle, for one or more first reproductive hormones and the one or more second reproductive hormones whether the concentration of one or more first reproductive hormones and one or more second reproductive hormones is greater than or lesser than a first threshold value during follicular phase respectively, of at least one mensural cycle. The method may further include placing the biological sample over a sample receiving zone 102A-102N of one or more test strips 101A-101N pre-treating, at one or more test strips 101 A- 10 IN, the biological sample includes one or more analytes such as Oestrone-3 -glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH), and Pregnanediol Glucuronide (PdG).

[0100] The method may further include reacting the pre-treated biological sample with a first detector reagent that includes one or more first detector antibodies, wherein the first detector reagent is present in one or more conjugate pads 104A-104N. Each of the one or more analytes of the reacted biological sample is further adapted to flow to corresponding detection pads of one or more detection pads 106A-106N.

[0101] The method may further include reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of one or more detection zone 106A-106N and adapted to produce a characteristic color on one or more detection zones 106A-106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines one or more control lines 108A-108N and adapted to produce another characteristic colors on one or more control lines 108A-108N, quantifying of the one or more first reproductive hormones or their metabolites in the biological sample by comparing the produced characteristic colors against a control, and determining the one or more second reproductive hormones or their metabolites in the biological sample by way of quantifying the one or more first reproductive hormones.

[0102] The method may further include capturing image of the one or more detection zones 106A-106N of the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of the one or more first reproductive hormones in the biological sample by comparing the color on the corresponding detection zone 106A- 106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values. In some aspects of the present disclosure, the user device 212 may be a handheld user device.

[0103] In another aspect of the present disclosure, a method for determining peak fertility in a user by analyzing the biological sample obtained from the user is provided. The method includes quantifying concentration / level of the beta subunit of luteinizing hormone (PLH) and the alpha subunit of luteinizing hormone (aLH) in the sample during at least one menstrual cycle, determining a maximum concentration / level of 0LH (PLHmax) and a maximum concentration / level of the aLH (aLHmax) during at least one menstrual cycle, and determining, simultaneously, for the same cycle, whether the aLHmax in the biological sample is more than a first threshold during the follicular phase of at least one mensural cycle and whether the PLH levels are maintained same as the PLHmax for at least four days during luteal phase of at least one menstrual cycle. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0104] The method may further include placing the biological sample over the sample receiving zone (102A-102B) of the one or more test strips 101A-101N, pre-treating, at the one or more test strips 101A-101N, the biological sample may include the one or more analytes such as are Oestrone-3-glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH), and Pregnanediol Glucuronide (PdG), reacting the pre-treated biological sample with a first detector reagent that include one or more first detector antibodies, wherein the first detector reagent is present in the one or more conjugate pads 104A-104B, each of the one or more analytes of the reacted biological sample is further adapted to flow to corresponding detection pads of the one or more detection pads 106A-106N, reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of the one or more detection zone 106A-106N and adapted to produce a characteristic color on the one or more detection zones 106A-106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines one or more control lines 108A-108N and adapted to produce another characteristic colors on one or more control lines 108A-108N, and quantifying, the one or more first reproductive hormones or their metabolites in the biological sample by comparing the produced characteristic colors against a control.

[0105] The method may further include capturing image of the one or more detection zones 106A-106N the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of one or more first reproductive hormones such as the beta subunit of luteinizing hormone (PLH) and the estrogen metabolite in the biological sample by comparing the color on the corresponding detection zone 106A-106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values. In some aspects of the present disclosure, the user device 212 may be a handheld user device.

[0106] In an aspect of the present disclosure, a method for determining the one or more second reproductive hormones such as Follicle-stimulating Hormone (FSH) and Human chorionic gonadotropin (hCG) in a user by analyzing a biological sample may be provided.

[0107] The method may include detecting the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH), and the beta subunit of Luteinizing Hormone (PLH) in free or bound form or their metabolites and determining one or more second reproductive hormones such as Follicle-stimulating Hormone (FSH) and Human chorionic gonadotropin (hCG) by cross-reacting the detected one or more first reproductive hormones.

[0108] The method may further include measuring levels of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH) or their metabolites during at least one mensural cycle and determining, for at least one mensural cycle, one or more second reproductive hormones such as the Follicle-stimulating Hormone (FSH) and the Human chorionic gonadotropin (hCG) by correlating the measured levels of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH) or their metabolites.

[0109] In an aspect of the present disclosure, a method for determining the ultrasound day of ovulation (USDO) in the user by analysing the biological sample may be provided.

[0110] The method may include detecting one or more first reproductive hormones from a group including an alpha subunit of Luteinizing Hormone (aLH), a beta subunit of Luteinizing Hormone (PLH) in free or bound form or their metabolites, determining, for at least one mensural cycle, one or more second reproductive hormones such as the Follicle-stimulating Hormone (FSH) by cross-reacting the detected one or more first reproductive hormones, determining whether the FSH levels in the biological sample are more than a first threshold during the follicular phase of at least on mensural cycle, and aLH levels in the biological sample are more than a second threshold during the follicular phase of at least on mensural cycle, determining USDO by correlating the FSH raise and LH stability in a raised state. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0111] In some aspects of the present disclosure, the USDO may be determined by crossreacting the one or more first reproductive hormones with the one or more third reproductive hormones such as Oestrone-3-glucuronide (E3G), and Pregnanediol Glucuronide (PdG).

[0112] In an exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The USDO in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include FSH.

[0113] The method may further include placing the biological sample over the sample receiving zone 102A-102B of one or more test strips 101 A- 10 IN, pre-treating, at one or more test strips 101 A- 10 IN, the biological sample includes one or more analytes such as Oestrone-3-glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH), and Pregnanediol Glucuronide (PdG), reacting the pre-treated biological sample with a first detector reagent including one or more first detector antibodies, wherein the first detector reagent is present in the one or more conjugate pads 104A-104B, each of the one or more analytes of the reacted biological sample is further adapted to flow to corresponding detection pads of the one or more detection pads 106A-106N, reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of the one or more detection zone 106A-106N and adapted to produce a characteristic color on the one or more detection zones 106A- 106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines on the one or more control lines 108A-108N and adapted to produce another characteristic colors on the one or more control lines 108A-108N, and quantifying, the beta subunit of Luteinizing Hormone (0LH) or their metabolites in the biological sample by comparing the produced characteristic colors against a control.

[0114] The method may further include capturing image of the one or more detection zones 106A-106N of the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of the beta subunit of Luteinizing Hormone (0LH) in the biological sample by comparing the color on the corresponding detection zone 106A-106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values. In some aspects of the present disclosure, the user device 212 may be a handheld user device.

[0115] In an aspect of the present disclosure, a method for determining pregnancy in the user by analysing a biological sample may be provided.

[0116] The method may include quantifying concentration / level of one or more first reproductive hormones or their metabolites that is beta subunit of luteinizing hormone (PLH) in the sample during at least one menstrual cycle, determining one or more secondary reproductive hormones such as Human chorionic gonadotropin (hCG) in the biological sample by correlating the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH), or their metabolites for at least one mensural cycle, determining a maximum concentration / level of 0LH (PLHmax) and a maximum concentration / level of a Human chorionic gonadotropin (hCGmax) during at least one menstrual cycle and determining, simultaneously, for the same cycle, whether the hCGmax levels in the biological sample are more than a first threshold during the follicular phase of at least one mensural cycle and whether the PLH levels in the biological sample are more than a second threshold of the PLHmax for at least four days during the follicular phase or luteal phase of at least one menstrual cycle. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0117] In an exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The pregnancy in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include hCG.

[0118] The method may further include placing the biological sample over the sample receiving zone (102A-102B) of the one or more test strips 101A-101N, pre-treating, at one or more test strips 101A-101N, wherein the biological sample includes one or more analytes such as are Oestrone-3-glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH), and Pregnanediol Glucuronide (PdG), reacting the pre-treated biological sample with a first detector reagent including one or more first detector antibodies, wherein the first detector reagent is present in the one or more conjugate pads 104A-104B, each of the one or more analytes of the reacted biological sample is further adapted to flow to corresponding detection pads of the one or more detection pads 106A-106N, reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of the one or more detection zone 106A-106N and adapted to produce a characteristic color on the one or more detection zones 106A-106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines on the one or more control lines 108A-108N and adapted to produce another characteristic colors on the one or more control lines 108A-108N, quantifying, the one or more first reproductivity hormones such as the alpha subunit of Luteinizing Hormone (aLH) and the beta subunit of Luteinizing Hormone (PLH) or their metabolites in the biological sample by comparing the produced characteristic colors against a control, and determining the level of one or more second reproductive hormones such as the Human chorionic gonadotropin (hCG) in the biological sample by corelating the level of alpha subunit of Luteinizing Hormone (aLH) and the beta subunit of Luteinizing Hormone (PLH), or their metabolites in the biological sample.

[0119] The method may further include capturing image of the one or more detection zones 106A-106N of the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of the one or more first reproductive hormones in the biological sample by comparing the color on the corresponding detection zone 106A- 106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values. In some aspects of the present disclosure, the user device 212 may be a handheld user device.

[0120] In an aspect of the present disclosure, a method for determining selection of dominant follicle in the user by analysing the biological sample may be provided.

[0121] The method may include detecting the one or more first reproductive hormones or their metabolites from the group that may include alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH). In some aspects of the present disclosure, the method may include detecting, simultaneously, Estrogen or the metabolite in another test strip. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones.

[0122] The method may further include determining the one or more second reproductive hormones such as Follicle-stimulating Hormone (FSH), in free or bound form based on the one or more first reproductive hormones and Estrogen metabolite.

[0123] In some aspects of the present disclosure, the selection of dominant follicle may be determined by cross-reacting the one or more first reproductive hormones with the one or more third reproductive hormones such as Oestrone-3 -glucuronide (E3G), and Pregnanediol Glucuronide (PdG).

[0124] In an exemplary scenario, when the biological sample of the user may be detected with the one or more first reproductive hormones that include 70% of 0LH and 30% of aLH. The selection of dominant follicle in the user may be determined by cross-reacting the 70% of 0LH and 30% of aLH of the user with one or more second reproductive hormones that include FSH. In another exemplary scenario, when the biological sample of the user may be detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The selection of dominant follicle in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include hCG.

[0125] The method may further include measuring levels of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH), or their metabolites during at least one mensural cycle, determining a maximum and minimum concentration of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH) or their metabolites during at least one mensural cycle, determining the one or more second reproductive hormones such as estrogen and FSH levels in the biological sample by correlating the one or more first reproductive first hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (0LH) or their metabolites during at least one mensural cycle, determining, simultaneously, for at least one mensural cycle, for the one or more first reproductive hormones whether the concentration of the one or more first reproductive hormones of the group that may include the alpha subunit of Luteinizing Hormone (aLH), the beta subunit of Luteinizing Hormone (PLH), or their metabolites may be greater than or lesser than a first threshold value during the follicular phase of at least one mensural cycle, and determining, simultaneously, for at least one mensural cycle, for the one or more second reproductive hormones whether the concentration of the one or more second reproductive hormones of the group that may include hCG, estrogen or their metabolites may be greater than or lesser than a first threshold value during the follicular phase of at least one mensural cycle.

[0126] The method may further include placing the biological sample over the sample receiving zone 102A-102B of one or more test strips 101A-101N; pre-treating, at the one or more test strips 101A-101B, the biological sample includes one or more analytes such as are Oestrone-3-glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH), and Pregnanediol Glucuronide (PdG), reacting the pre-treated biological sample with a first detector reagent that includes the one or more first detector antibodies, wherein the first detector reagent may present in one or more conjugate pads 104A-104B, each of the one or more analytes of the reacted biological sample may further be adapted to flow to corresponding detection pads of one or more detection pads 106A-106N, reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of the one or more detection zone 106A-106N and adapted to produce a characteristic color on one or more detection zones 106A-106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines on one or more control lines 108A-108N and adapted to produce another characteristic colors on the one or more control lines 108A-108N, and quantification of the one or more first reproductive hormones or their metabolites in the biological sample by comparing the produced characteristic colors against a control.

[0127] The method may further include capturing image of the one or more detection zones 106A-106N of the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of the one or more first reproductive hormones in the biological sample by comparing the color on the corresponding detection zone 106A- 106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values.

[0128] In some aspects of the present disclosure, the system 200 may be configured to determine the dominant follicle selection may be positive when the FSH level increases periodically with decrease in estrogen level.

[0129] In some aspects of the present disclosure, the system 200 may be configured to determine the dominant follicle selection may be negative when the FSH level is maintained same as the level in the follicular phase with increase in the estrogen level. In an aspect of the present disclosure, a method for determining chemical or ectopic selection in the user by analysing the biological sample may be provided.

[0130] The method includes detecting the one or more first reproductive hormones or their metabolites from the group that may include the alpha subunit of Luteinizing Hormone (aLH), the beta subunit of Luteinizing Hormone (PLH), and determining the one or more second reproductive hormones or their metabolites such as the Human chorionic gonadotropin (hCG) in free or bound form. In some aspects of the present disclosure, the one or more second reproductive hormones may be determined by cross-reacting with the detected one or more first reproductive hormones. In some aspects of the present disclosure, the peak fertility may be determined by determining a phase of the cycle. In some aspects of the present disclosure, the peak fertility may be determined by determining a follicular phase of the cycle. In some aspects of the present disclosure, the peak fertility may be determined by determining a luteal phase of the cycle. In some aspects of the present disclosure, the chemical or ectopic selection may be determined by cross-reacting the one or more first reproductive hormones with the one or more third reproductive hormones such as Oestrone-3 -glucuronide (E3G), and Pregnanediol Glucuronide (PdG).

[0131] In an exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of 0LH and 30% of aLH. The chemical or ectopic selection in the user may be determined by cross-reacting the 70% of 0LH and 30% of aLH of the user with one or more second reproductive hormones that include FSH. In another exemplary scenario, when the biological sample of the user may detected with the one or more first reproductive hormones that include 70% of PLH and 30% of aLH. The chemical or ectopic selection in the user may be determined by cross-reacting the 70% of PLH and 30% of aLH of the user with one or more second reproductive hormones that include hCG.

[0132] The method may further include measuring levels of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH), or their metabolites during at least one mensural cycle, determining a maximum concentration of the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH) or their metabolites during at least one mensural cycle, determining hCG levels in the biological sample by correlating the one or more first reproductive hormones such as the alpha subunit of Luteinizing Hormone (aLH) or the beta subunit of Luteinizing Hormone (PLH) or their metabolites during at least one mensural cycle, and calculating, doubling rate of the hCG in the biological sample with respect to time period for at least one mensural cycle.

[0133] The method may further include placing the biological sample over the sample receiving zone 102A-102B of the one or more test strips 101 A- 10 IN, pre-treating, at one or more test strips 101 A- 10 IN, the biological sample includes one or more analytes such as are Oestrone-3-glucuronide (E3G), alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH), and Pregnanediol Glucuronide (PdG), reacting the biological sample pre-treated at step a with a first detector reagent including one or more first detector antibodies, wherein the first detector reagent is present in one or more conjugate pads 104A-104B, each of the one or more analytes of the reacted biological sample is further adapted to flow to corresponding detection pads of one or more detection pads 106A-106N, reacting, each of the one or more analytes of the reacted biological sample, with corresponding biochemical reagent at the corresponding detection zone of one or more detection zone 106A-106N and adapted to produce a characteristic color on the one or more detection zones 106A-106N, reacting, simultaneously, each of the one or more analytes of the biological sample with corresponding second biochemical reagents at the corresponding control lines on one or more control lines 108A-108N and adapted to produce another characteristic colors on the one or more control lines 108A-108N, and quantification of the one or more first reproductive hormones or their metabolites in the biological sample by comparing the produced characteristic colors against a control.

[0134] The method may further include capturing image of the one or more detection zones 106A-106N of the one or more test strips WlA-lOlN by the user device 212 having the system 200 for quantification of the one or more first reproductive hormones in the biological sample by comparing the color on the corresponding detection zone 106A- 106N of the one or more test strips 101A-101N against a standard, a control or a prestored threshold values.

[0135] In some aspects of the present disclosure, when the doubling rate of hCG is maybe 2 times in 24-48 hours than the hCG in the follicular phase of at least one menstrual cycle, the system 200 may be configured to determine a healthy pregnancy. In some aspects of the present disclosure, when the doubling rate of hCG maybe 2 times in more than 36 hours than the hCG in the follicular phase of at least one menstrual cycle, the system 200 may be configured to determine a chemical or ectopic pregnancy. 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 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 aspect, 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.

[0136] 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 subject matter.

Claims

We Claim1. An assay for measuring concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (0LH) in a biological sample.

2. The assay as claimed in claim 1, wherein the assay is a lateral flow assay.

3. The assay as claimed in claim 1, wherein the biological sample is selected from a group comprising 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.

4. The assay as claimed in claim 1, wherein the assay measures the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (0LH) in the same biological sample.

5. The assay as claimed in claim 1, wherein the assay measures the concentration alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (0LH) is measured in free or bound form.

6. The assay as claimed in claim 1, wherein the assay is provided for predicting pregnancy.

7. The assay as claimed in claim 1, wherein the assay is provided for determining peak fertility in a user.

8. The assay as claimed in claim 1, wherein the concentration / level of alpha subunit of Luteinizing Hormone (aLH) and beta subunit of Luteinizing Hormone (0LH) is measured for predicting highest chances of conception.

9. An assay for determining peak fertility in a user, comprising: a. measuring concentration / levels of one or more first reproductive hormones comprising alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (0LH) or their metabolites; and b. determining concentration / levels one or more second reproductive hormones such as the Follicle Stimulating Hormone (FSH) and the Human chorionic gonadotropin (hCG).

10. The assay as claimed in claim 9, wherein the one or more first reproductive hormones and one or more second reproductive hormones are present in the same biological sample.

11. The assay as claimed in claim 9, wherein the biological sample is selected from a group comprising 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.

12. The assay as claimed in claim 9, wherein the measured alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (0LH) are cross reactive to FSH present in the biological sample.

13. The assay as claimed in claim 9, wherein the measured alpha subunit of Luteinizing Hormone (aLH) and / or the beta subunit of Luteinizing Hormone (0LH) are cross- reactive to HCG present in the sample.

14. The assay as claimed in claim 9, wherein the assay measures alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (PLH), Follicle Stimulating Hormone (FSH), Human chorionic gonadotropin (hCG) and their metabolites in free or bound form.

15. The assay as claimed in claim 9, wherein the assay is provided for predicting pregnancy.

16. The assay as claimed in claim 9, wherein the assay identifies an ovarian reserve as a substitute for the FSH.

17. A method for determining peak fertility in a user by analysing the biological sample, the method comprising: a. determining concentration / level of one or more first reproductive hormones comprising alpha subunit of Luteinizing Hormone (aLH) and / or beta subunit of Luteinizing Hormone (0LH) and their metabolites; and b. determining concentration / level of one or more second reproductive hormones comprising Follicle Stimulating Hormone (FSH) and / or Human chorionic gonadotropin (hCG) in free or bound form.

18. A method for determining ultrasound day of ovulation (USDO) in a user by analysing a biological sample, the method comprising determining concentration / level of one or more first reproductive hormones such as a beta subunit of Luteinizing Hormone (PLH) in free or bound form or their metabolites.

19. A method for suspecting pregnancy in a user by analysing a biological sample, the method comprising: a. determining concentration / level of one or more first reproductive hormones or their metabolites comprising alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH); and b. determining concentration / level of one or more second reproductive hormones comprising Human chorionic gonadotropin (hCG) in free or bound form.

20. A method for determining selection of dominant follicle in a user by analysing a biological sample, the method comprising: a. determining concentration / level of one or more first reproductive hormones or their metabolites comprising alpha subunit of Luteinizing Hormone (aLH), beta subunit of Luteinizing Hormone (0LH); and b. determining concentration / level of one or more second reproductive hormones comprising Follicle Stimulating Hormone (FSH), Estrogen, Human chorionic gonadotropin (hCG) in free or bound form.

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