WO2020222046A1

WO2020222046A1 - A biosensing device for separating blood plasma and testing thereon

Info

Publication number: WO2020222046A1
Application number: PCT/IB2020/050976
Authority: WO
Inventors: Vijaywanth MATHUR; Amardeep Singh SAINI; Ramesh MAMDAPURKAR; Nikhil SANE
Original assignee: Diasys Diagnostics India Pvt. Ltd.
Priority date: 2019-04-30
Filing date: 2020-02-07
Publication date: 2020-11-05

Abstract

The present disclosure provides a biosensing device for testing blood plasma from a sample of undiluted blood. The device comprises a sample loading pad that is adapted to receive the blood sample. The sample loading pad is made of a material that is adapted to selectively absorb red blood corpuscles (RBCs), thereby separating the plasma component from the RBCs. The sample loading pad is coupled to a plasma suction membrane that is configured to extract the plasma component from the sample loading pad and transport it along its length. The plasma suction membrane is coupled to a sensor and the sensor has a formulation provided on it such that the formulation receives the plasma being transported. The formulation reacts with the plasma to generate an electrochemical signal that is particular to the formulation. Analysis of the electrochemical signal provides information of the plasma particular to the formulation used.

Description

A BIOSENSING DEVICE FOR SEPARATING BLOOD PLASMA AND TESTING

THEREON

TECHNICAL FIELD

[0001] The present disclosure relates generally to the field of blood analysis. In particular, the present disclosure relates to a device for quick testing of blood plasma.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Blood plasma analysis is an important and common tool to diagnose various health parameters. However, a significant limitation to the implementation of such an analysis is the complexity involved in the logistics of the process. Firstly, the apparatus for separation of plasma from the blood sample is quite big and energy intensive. Further, there is a requirement for a skilled person to operate it. This limits the mobility of the apparatus and thereby, its access to more remote areas. One way to overcome this issue is to extract a sample of blood at the remote area and then bring it to the apparatus. However, the quality of the blood sample can get affected during transport.

[0004] Another disadvantage is the time it takes for separating blood and plasma from the sample as the process is not very efficient thereby also requiring a higher quantity of blood sample. The blood requirement can be high, especially in cases when multiple tests are required.

[0005] Once the plasma is separated from the blood sample, for any test to be conducted, there is required the process of testing each sample of tire plasma for a different set of parameters. Again, in case of remote locations, this means that a large quantity of reagents would be required at the remote location.

[0006] There is, therefore, a requirement in the art, for a means to quickly separate blood from plasma in a blood sample and detect the required parameters at the same time.

Further, the means is required to be compact, to use minimal energy and to be portable. [0007] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0008] In some embodiments, the numbers expressing quantities or dimensions of items, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term“about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0009] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value felling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g.“such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0010] Groupings of alterative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

OBJECTS

[0011] A general object of the present disclosure is to provide a biosensing device for testing blood plasma.

[0012] Another object of the present disclosure is to provide a biosensing device where the testing of blood plasma is not prone to haematocrit errors.

[0013] Another object of the present disclosure is to provide a biosensing device for testing multiple parameters of the blood plasma per sample of blood.

[0014] Another object of the present disclosure is to provide a device for quick separation of red blood corpuscles (RBCs) and plasma from a sample of blood.

[0015] Another object of the present disclosure is to provide a device that requires a small quantity of undiluted blood as sample.

[0016] Another object of the present disclosure is to provide a device for separation of blood and plasma that can be easily implemented into an existing practice.

SUMMARY

[001h The present disclosure relates generally to the field of blood analysis. In particular, the present disclosure relates to a device for quick testing of blood plasma.

[0018] In an aspect, the present disclosure provides a biosensing device for testing blood plasma, the device comprising: a laminated comprising: a sample loading pad to receive a blood sample, the sample loading bed disposed at base of the housing, wherein the pad is adapted to selectively absorb red blood corpuscles (RBCs) thereby separating plasma component and RBCs in the blood sample; a plasma suction membrane disposed over the sample loading pad and fluidically coupled to it, the plasma suction membrane comprising at least one arm and configured to extract at least a fraction of the plasma component from the sample loading pad and transport it along the at least one arm via capillary action; and a sensor coupled to the at least one arm of the plasma suction membrane, the sensor provided with a formulation at a location on the sensor such that the formulation receives the plasma component being transported in the at least one arm, wherein the sensor is configured to detect an electromagnetic signal generated due to interaction of the formulation and the plasma which, when tapped, enables determination of one or more parameters of the plasma component associated with the formulation.

[0019] In an embodiment, the plasma suction membrane transports the plasma component via capillary action thereby enabling the at least one arm of the plasma suction membrane to be oriented in any angle with respect to the sample loading pad in the plane of the sample loading pad.

[0020] In another embodiment, the plasma suction membrane comprises one or more arms configured to extract at least a fraction of the plasma component from the sample loading pad and transport the plasma component along the one or more arms of the plasma suction membrane. In another embodiment, the device comprises a sensor for each of the one or more arms of the plasma suction membrane, each sensor coupled to an arm of the plasma suction membrane. In another embodiment, the plasma suction membrane is disposed in any of an“I” configuration having one arm and a‘Ύ” configuration having three arms. In another embodiment, the required blood sample is not more than 15 mL.

[0021] In another embodiment, the generated electrochemical signal is detected by the corresponding sensor on which the interaction between the formulation and the plasma component occurs. In another embodiment, the electrochemical signal is detected as a current and, wherein the current is tapped from one or more leads electrically coupled to the sensor.

[0022] In another embodiment, the sensors are electrochemical biosensors made of any or a combination of screen-printed carbon, gold, platinum, palladium and sputtered gold sheet.

[0023] In another embodiment, the sample loading pad is made of a porous composite polyester material.

[0024] In another embodiment, the plasma suction membrane is made of a nitrocellulose material.

[0025] In another embodiment, the device is encased in a housing made of plastic.

[0026] In another embodiment, the device is configured to be loaded onto a device holder.

[0027] In an aspect, the present disclosure provides a system for testing blood plasma, the system comprising: a biosensing device for testing blood plasma, the device comprising: a laminated assembly comprising: a sample loading pad to receive a blood sample, the sample loading bed disposed at base of the housing, wherein the pad is adapted to selectively absorb red blood corpuscles (RBCs) thereby separating plasma component and RBCs in the blood sample; a plasma suction membrane disposed over the sample loading pad and fluidically coupled to it, the plasma suction membrane comprising at least one arm and configured to extract at least a fraction of the plasma component from the sample loading pad and transport it along the at least one arm via capillary action; and a sensor coupled to the at least one arm of the plasma suction membrane, the sensor provided with a formulation at a location on the sensor such that the formulation receives the plasma component being transported in the at least one arm, wherein the sensor is configured to detect an electromagnetic signal generated due to interaction of the formulation and the plasma which, when tapped, enables determination of one or more parameters of the plasma component associated with the formulation; a device holder configured to hold the device and be electrically coupled to the device to enable extraction of the generated electrochemical signal; and a computing device configured to be electrically coupled to the device holder to access the generated electrochemical signal, wherein the electrochemical signal is analysed based on the formulation that generated the electrochemical signal to enable determination of one or more parameters of the plasma component associated with the formulation.

[0028] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF DRAWINGS

[0029] The accompanying drawings are included to provide a further understanding of the present invention and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present invention and, together with the description, serve to explain the principles of the present invention.

[0030] FIG. 1 illustrates an exemplary representation of a biosensing device for testing blood plasma after separating plasma from a blood sample, in accordance with an embodiment of the present disclosure. [0031] FIG. 2 illustrates an exemplary assembly of the proposed biosensing device for testing blood plasma, in accordance with an embodiment of the present disclosure.

[0032] FIG. 3 illustrates an exemplary representation of process of loading a blood sample onto the proposed biosensing device, in accordance with an exemplary embodiment of the present disclosure.

[0033] FIG. 4 illustrates an exemplary representation of process of analysing the parameters extracted from the proposed biosensing device, in accordance with an exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

[0034] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives felling within the spirit and scope of the present disclosure as defined by the appended claims.

[0035] If the specification states a component or feature‘'may^"’,“can”,“could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0036] As used in the description herein and throughout the claims that follow, the meaning of“a,”“an,” and“the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, tire meaning of“in” includes“in” and“on” unless the context clearly dictates otherwise.

[0037] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alteratives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.

[0038] The use of any and all examples, or exemplary language (e.g.,“such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non - claimed element essential to the practice of the invention.

[0039] In an aspect, the present disclosure provides a biosensing device for testing blood plasma from a sample of undiluted blood. The device comprises a sample loading pad that is adapted to receive the blood sample. The sample loading pad is made of a material that is adapted to selectively absorb red blood corpuscles (RBCs), thereby separating the plasma component from the RBCs. The sample loading pad is coupled to a plasma suction membrane that is configured to extract the plasma component from the sample loading pad and transport it along its length. The plasma suction membrane is coupled to a sensor and the sensor has a formulation provided on it such that the formulation receives the plasma being transported. The formulation reacts with the plasma to generate an electrochemical signal that is particular to the formulation. Analysis of the electrochemical signal provides information of the plasma particular to the formulation used.

[0040] Typically, testing of an undiluted sample of blood is susceptible to haematocrit errors. In order to overcome this limitation, only the plasma component of the blood is tested. Embodiments described herein relate generally to the field of blood analysis, and, in particular, to a device for quick testing of blood plasma. [0041] FIG. 1 illustrates an exemplary representation of a biosensing device for testing blood plasma after separating plasma from a blood sample, in accordance with an embodiment of the present disclosure. In an embodiment, the device 100 comprises a sample loading pad 102 on which a blood sample is placed.

[0042] In an alternate embodiment, the sample loading pad 102 can be coupled to a capillary mechanism that allows for transfer of blood from a location outside the device to the sample loading pad 102.

[0043] In another embodiment, the sample loading pad 102 is made of a porous, composite material such as a polyester matrix and is capable of absorbing the blood sample and selectively absorbing only the red blood corpuscles (RBCs) in order to separate the RBC and plasma components from the blood sample.

[0044] In another embodiment, the device 100 comprises a plasma suction membrane

104 that is physically coupled to the sample loading pad 102. In another embodiment, the plasma suction membranes 104 can be in various configurations such as‘Ί”,‘Ύ” etc. The configuration used depends on the number of plasma samples that are required from the device 100. For instance, "I" Configuration has a single arm and allows for a single plasma sample, and“Y” configuration has three arms and allows for three plasma samples and so on.

[0045] In another embodiment, the plasma suction membranes 104 extract the plasma separated in the sample loading pad 102 and transfers the plasma from the sample loading pad 102 through capillary action. The capillary action enables the plasma suction membrane 104 to be placed at any angle with respect to the sample loading pad 102 and still be able to extract the plasma from the sample loading pad 102. In an embodiment, the plasma suction membranes 104 are made of a nitrocellulose membrane.

[0046] In another embodiment, one or more sensors (106-1, 106-2...106-n; hereinafter, individually or collectively designated 106) are attached to each of the one or more arms of the plasma suction membrane 104. Each sensor 106 can be an electromagnetic biosensor configured to sense an electromagnetic signal generated due to interaction between the plasma and a formulation, the formulation being placed on a designated location on the sensor 106 where the formulation can receive the plasma rising in the plasma suction membrane 104. The generated electromagnetic signal can be indicative of a particular set of parameters of the plasma that is specific to the formulation that generates the electromagnetic signal. Each sensor 106 can have leads (1 10-1, 110-2... 110-n; hereinafter, individually or collectively designated 110) that can be tapped outside the device.

[0047] In another embodiment, the biosensing device 100 is laminated and can be used in the form of a strip. In an additional embodiment, the biosensing device 100 can be encased in a plastic case 112 such that leads of the sensors 106 can be accessed. A provision is provided in the casing for sample of blood to be placed such that it can be absorbed by the sample loading pad 102.

[0048] FIG. 2 illustrates an exemplary assembly of the proposed biosensing device for testing blood plasma, in accordance with an embodiment of the present disclosure. In an embodiment, the biosensing device assembly 200 comprises a bottom case 202 which is made of a bottom cover on which is placed an adhesive pad. The bottom cover can be made of plastic.

[0049] In another embodiment, one or more sensors (204-1, 204-2...204-n; hereinafter, individually or collectively designated 204) are placed on the adhesive pad. In an exemplary embodiment, the sensors 204 can be made of any or a combination of screen-printed carbon, gold, platinum palladium and sputtered gold. Each sensor 204 can be an electromagnetic biosensor configured to sense an electromagnetic signal generated due to interaction between the plasma and a formulation 206, the formulation 206 being placed on a designated location on the sensor 204 where the formulation can receive the plasma. The generated electromagnetic signal can be indicative of a particular set of parameters of the plasma that is specific to the formulation 206 that generates the electromagnetic signal, configured to sense a particular set of parameters from the plasma. The sensors 204 have a designated location 206 on which specific formulations can be placed that are capable of sensing a corresponding set of parameters from the plasma. The designated location is such as to allow the formulation to come in contact with the plasma. Each sensor 204 can have leads 208 (208-1, 208-2...208-n; hereinafter, individually or collectively designated 208) that can be tapped outside the device.

[0050] In another embodiment, a sample loading pad 210 is placed at a predetermined location in the device 200. The sample loading pad 210 is adapted to receive the blood sample, hi another embodiment, the sample loading pad 210 is made of a porous, composite material such as a polyester matrix and is capable of absorbing the blood sample and selectively absorbing only the red blood corpuscles (RBCs) in order to separate the RBC and plasma components from the blood sample.

[0051] In another embodiment, a plasma suction membrane 212 is placed on the sample loading pad 210. The plasma suction membrane 212 is so placed as to enable plasma from the sample loading pad 210 to be extracted and transported to the designated location on the sensor 204, and this can occur through the plasma suction membrane 212 via capillary action. The capillary action enables the plasma suction membrane 212 to be placed at any angle with respect to the sample loading pad 210 and still be able to extract the plasma from the sample loading pad 210. In an embodiment, the plasma suction membranes 212 are made of a nitrocellulose membrane.

[0052] In another embodiment, the plasma suction membranes 210 can be in various configurations such as“I”,“Y” etc. The configuration used depends on the number of plasma samples that are required from the device 200. For instance,“I” configuration has a single arm and allows for a single plasma sample, and“Y” configuration has three arms and allows for three plasma samples and so on.

[0053] In another embodiment, the biosensing device assembly 200 can be laminated and can be used in the form of a strip.

[0054] In another embodiment, a top cover 214 is placed on top of the bottom case 202 to encase the entire assembly case such that leads of the sensors 204 can be accessed. The top cover 214 can be made of plastic. A provision can be provided in the top cover 214 for sample of blood to be placed such that it can be absorbed by the sample loading pad 210.

[0055] The following sections describe an exemplary implementation of the proposed blood-plasma separation device of the embodiment of the disclosure. This description is solely for the demonstration of function and use of the proposed device. Those skilled in the art will appreciate that there can be other potential implementations of the proposed device and the present illustration may not be construed as a limitation to the use of the proposed device in any of the other potential implementations.

[0056] FIG. 3 illustrates an exemplary representation of process of loading a blood sample onto the proposed biosensing device, in accordance with an exemplary embodiment of the present disclosure. In an embodiment, the device 200 is encased in a plastic casing with a provision for loading the blood sample on the sample loading pad. In an exemplary embodiment, the sample loading pad is a whole blood separator of Type FR1, which is about 0.35 mm in thickness.

[0057] In another embodiment, the plasma suction membrane used is of “Y” configuration capable of generating three samples of plasma from one blood sample. In an exemplary embodiment, the plasma suction membrane is of type CNPC-SS12 with a pore size of 15 pm and a width of 25 mm.

[0058] In an exemplary embodiment, the device 200 can be allowed to reach an optimal temperature of operation of between 22 °C and 30 °C.

[0059] In another embodiment, a sample of blood is loaded onto the sample loading pad using a pipette. In an exemplary embodiment, the blood sample is undiluted human blood, and based on configuration of the plasma suction membrane, the quantity of blood required is about 10 mL for "I" configuration and about 15 mL for "I" configuration. In an exemplary- instance, the time taken for separation of the blood and plasma is about 30s.

[0060] In another embodiment, the device 200 can further be loaded onto a device holder 302, where the device holder 302 is configured to connect with a computing device to extract and analyse the parameters extracted from the plasma samples.

[0061] FIG. 4 illustrates an exemplary representation of process of analysing the parameters extracted from the proposed biosensing device, in accordance with an exemplary embodiment of the present disclosure. In an embodiment, the device holder 302, along with the device 200 can be connected to a computing device 402 for extraction and analysis of data obtained from the plasma samples. In an exemplary embodiment, the computing device is a QDx Instalab unit (hereinafter, also designated 402).

[0062] In an embodiment, once the plasma reaches the formulation area on the sensor, a reaction occurs between the two and generates an electrochemical signal that is detected by the sensor and that can be tapped from the lead connected to the sensor in the QDx Instalab unit 402. Using in-built calibration records, the QDx Instalab unit 402 automatically calculates the concentration of desired analyte in the sample that is specific to the sensor in the device 200. Once the test run is complete, the result is displayed on a screen and can also be printed via a thermal printer attached to the QDx Instalab unit 402. The device 200 is discarded after use.

[0063] Thus, the present disclosure provides a biosensing device for testing blood plasma after separation of the plasma and the RBC in a blood sample that requires a small quantity of blood (about 10 - 15 mL) and is fast (separation can occur in about 30s). The device can be configured with multiple sensors to each to detect a different set of parameters of the blood plasma. The device is portable and requires minimal energy and skill to operate making it accessible even in remote areas.

[0064] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive patient matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “includes” and “including” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refer to at least one of something selected from the group consisting of A, B, C ....and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc. The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practised with modification within the spirit and scope of the appended claims.

[0065] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art. ADVANTAGES

[0066] The present disclosure provides a biosensing device for testing blood plasma.

[0067] The present disclosure provides a biosensing device where the testing of blood plasma is not prone to haematocrit errors.

[0068] The present disclosure provides a biosensing device for testing multiple parameters of the blood plasma per sample of blood.

[0069] The present disclosure provides a device for quick separation of red blood corpuscles (RBCs) and plasma from a sample of blood.

[0070] The present disclosure provides a device that requires a small quantity of undiluted blood as sample.

[0071] The present disclosure provides a device for separation of blood and plasma that can be easily implemented into an existing practice.

Claims

We Claim:

1. A biosensing device for testing blood plasma, said device comprising:

a laminated assembly comprising:

a sample loading pad to receive a blood sample, said sample loading bed disposed at base of the housing, wherein the pad is adapted to selectively absorb red blood corpuscles (RBCs) thereby separating plasma component and RBCs in the blood sample;

a plasma suction membrane disposed over the sample loading pad and fluidically coupled to it, said plasma suction membrane comprising at least one arm and configured to extract at least a fraction of the plasma component from the sample loading pad and transport it along the at least one arm via capillary action; and

a sensor coupled to the at least one arm of the plasma suction membrane, said sensor provided with a formulation at a location on the sensor such that the formulation receives the plasma component being transported in the at least one arm,

wherein the sensor is configured to detect an electromagnetic signal generated due to interaction of the formulation and the plasma which, when ripped, enables determination of one or more parameters of the plasma component associated with the formulation.

2. The device as claimed in claim 1, wherein the plasma suction membrane transports the plasma component via capillary action thereby enabling the at least one arm of the plasma suction membrane to be oriented in any angle with respect to the sample loading pad in the plane of the sample loading pad.

3. The device as claimed in claim 1, wherein the plasma suction membrane comprises one or more arms configured to extract at least a fraction of the plasma component from the sample loading pad and transport the plasma component along the one or more arms of the plasma suction membrane.

4. The device as claimed in claim 3, wherein the device comprises a sensor for each of the one or more arms of the plasma suction membrane, each sensor coupled to an arm of the plasma suction membrane.

5. The device as claimed in claim 3, wherein the plasma suction membrane is disposed in any of an“I” configuration having one arm and a“Y” configuration having three arms.

6. The device as claimed in claim 5, wherein the required blood sample is not more than 15 mL.

7. The device as claimed in claim 1, wherein the generated electrochemical signal is detected by the corresponding sensor on which the interaction between the formulation and the plasma component occurs.

8. The device as claimed in claim 7, wherein the electrochemical signal is detected as a current and, wherein the current is tapped from one or more leads electrically coupled to the sensor.

9. The device as claimed in claim 1, wherein the sensors are electrochemical biosensors made of any or a combination of screen-printed carbon, gold, platinum, palladium and sputtered gold sheet.

10. The device as claimed in claim 1, wherein the sample loading pad is made of a porous composite polyester material.

11. The device as claimed in claim 1, wherein the plasma suction membrane is made of a nitrocellulose material.

12. The device as claimed in claim 1, wherein the device is encased in a housing made of plastic.

13. The device as claimed in claim 1, wherein said device is configured to be loaded onto a device holder.

14. A system for testing blood plasma, said system comprising:

a biosensing device for testing blood plasma, said device comprising:

a laminated assembly comprising:

wherein the sensor is configured to detect an electromagnetic signal generated due to interaction of the formulation and the plasma which, when tapped, enables determination of one or more parameters of the plasma component associated with the formulation;

a device holder configured to hold the device and be electrically coupled to the device to enable extraction of the generated electrochemical signal; and a computing device configured to be electrically coupled to the device holder to access the generated electrochemical signal,

wherein the electrochemical signal is analysed based on the formulation that generated the electrochemical signal to enable determination of one or more parameters of the plasma component associated with the formulation.