TECHNICAL FIELD
[0001] The present disclosure relates to the field of medical devices. More
particularly the present disclosure relates to a device for detecting antibodies.
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] Health workers (operation theatre or blood bank staff) in hospitals
and clinics are often prone to needle stick injury by accident. Not just health workers but housekeeping and janitorial workers in public sites, including hotels, airports, indoor and outdoor recreational venues, theatres, retails stores, and schools are at daily risk of exposure to contaminated syringes. The accidental puncture of the skin by needles may inject infectious fluids into the body and lead to transmission of blood-borne diseases, placing those exposed at increased risk of infection from disease causing pathogens, such as the Hepatitis B virus, Hepatitis C virus and Human Immunodeficiency Virus (HIV).
[0004] Existing arts related to needle stick injury include devices that act
as safety measures before needle stick injury occurs. These may include improved
designs, puncture resistant disposal or capping procedures. Such techniques are
prevention devices that reduce the chances of injury. There are no existing
techniques that provide post-infection detection or care for needle stick injury.
[0005] There is, therefore, a need of an improved device that is capable of
detecting severity level of needle stick injury and is free from the above discussed problems.
OBJECTS OF THE PRESENT DISCLOSURE
[0006] Some of the objects of the present disclosure, which at least one
embodiment herein satisfies are as listed herein below.

[0007] It is an object of the present disclosure to provide a device for
simultaneous detection of antibodies generated by needle stick injury specifically
by infectious diseases of ADDS, Hepatitis B and Hepatitis C.
[0008] It is an object of the present disclosure to provide a device for
simultaneous detection of antibodies, which is easy to use.
[0009] It is an object of the present disclosure to provide a device for
simultaneous detection of antibodies, which is cost effective.
[0010] It is an object of the present disclosure to provide a device for
simultaneous detection of antibodies, which is easy to portable and easy to carry.
SUMMARY
[0011] The present disclosure relates to the field of medical devices. More
particularly the present disclosure relates to a device for detecting antibodies.
[0012] An aspect of the present disclosure pertains to an antibody's
detection device. The device includes a frame with a receptor at one end, and the receptor is configured to be contacted with a blood sample of a person. One or more reactants configured in the frame, and the one or more reactants are configured to react with the blood sample to detect presence of one or more antibodies in the blood sample. One or more markings on the frame, wherein the one or more markings are configured to indicate presence of one or more antibodies in the blood sample when an intensity of the one or more antibodies is more than a pre-defined threshold value.
[0013] In an aspect, the one or more reactants may comprise any or
combination of reactants comprises any or combination of enzyme and is used to
detect the presence of the protein and the levels of protein are detected. Antibody
detection may be done either via nontreponemal or treponemal tests.
Nontreponemal tests identify active or recent infections and become negative after
disease treatment; treponemal tests identify current and distant infection.
[0014] In an aspect, the one or more antibodies may comprise any or
combination of HAV IgM, HBsAg, HB core IgM and HCV.

[0015] In an aspect, the blood sample may be taken from a person having
a needle stick injury.
[0016] In an aspect, the pre-defined threshold value may be 8 -
12mlU/mL.
[0017] 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
[0018] The accompanying drawings are included to provide a further
understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.
[0019] In the figures, similar components and/or features may have the
same reference label. Further, various components of the same type may be distinguished by following the reference label with a second label that distinguishes among the similar components. If only the first reference label is used in the specification, the description is applicable to any one of the similar components having the same first reference label irrespective of the second reference label.
[0020] FIG. 1 illustrates exemplary representation of a device for
detecting antibodies in a sample, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION
[0021] 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 falling within the scope of the present disclosure as defined by the appended claims.
[0022] In the following description, numerous specific details are set forth
in order to provide a thorough understanding of embodiments of the present
invention. It will be apparent to one skilled in the art that embodiments of the
present invention may be practiced without some of these specific details.
[0023] The present disclosure relates to the field of medical devices. More
particularly the present disclosure relates to a device for detecting antibodies.
[0024] The present disclosure elaborates upon an antibody's detection
device. The device includes a frame with a receptor at one end, and the receptor is
configured to be contacted with a blood sample of a person. One or more reactants
configured in the frame, and the one or more reactants are configured to react with
the blood sample to detect presence of one or more antibodies in the blood
sample. One or more markings on the frame, wherein the one or more markings
are configured to indicate presence of one or more antibodies in the blood sample
when an intensity of the one or more antibodies is more than a pre-defined
threshold value.
[0025] In an embodiment, the one or more reactants can comprise any or
combination of
[0026] In an embodiment, the one or more antibodies can comprise any or
combination of HAV IgM, HBsAg, HB core IgM and HCV.
[0027] In an embodiment, the blood sample can be taken from a person
having a needle stick injury.
[0028] In an embodiment, the pre-defined threshold value can be 8 -
12mlU/mL.
[0029] FIG. 1 illustrates exemplary representation of a device for
detecting antibodies in a sample, in accordance with an embodiment of the present
disclosure.

[0030] As illustrated, an antibody's detection device 100 can includes a
frame 102. The frame 102 can include a receptor 104 at one end. The receptor can
be made of but not limited to chemical ligand, two notable exceptions are viruses
which are pathogenic cells that can bind host cellular receptors to infect a cell.
The receptor 104 can be configured to be contacted with a blood sample of a
person. The person can have a needle spike injury. One or more reactants can be
configured in the frame 102, and the one or more reactants can be configured to
react with a sample to detect presence of one or more antibodies in the blood
sample. The sample can be collected from any source in the body comprising
antibodies including blood, urine, plasma, serum, feces, mucus, or oral fluid. The
frame 102 can be made of material that can be but not limited to be chosen from
from nylon, monel and titanium. One or more markings 106 can be configured in
the frame 102, and the one or more markings can be configured to indicate
presence of one or more antibodies in the blood sample when an intensity of the
one or more antibodies is more than a pre-defined threshold value.
[0031] In an embodiment, the one or more markings can include a control
line and test lines. The pre-defined threshold value of the one or more antibodies can be 8-12 mlU/mL.. The device can include a casing or housing that only exposes the sample well, test and control lines. The sample well may be exposed via an aperture through which the sample maybe introduced. The test and control lines may be exposed via an observation port with markings against the test lines. The sample can further include a flow fluid for promoting or facilitating flow of the sample through the flow path via capillary action. The amount of the sample to be used may be determined by a medical practitioner.
[0032] In an embodiment, the one or more antibodies can comprise any or
combination of HAV IgM, HBsAg, HB core IgM and HCV. The 'antibody' can be referred as a protein or complex protein or its fragment comprising a specific site for binding an antigen. The 'antigen' can be referred as a protein or its fragment belonging to a microorganism or a molecule that can bind specifically to a site on the antibody. Said protein or its fragment from the microorganism is capable of inducing antibody synthesis in an infected individual. The blood

sample can be taken from a person having a needle stick injury. The present disclosure facilitates detection of the one or more antibodies in the blood that can testify infection in the blood. If the severity or intensity level of the infection is more than the pre-defined threshold value, that can be indicated to the person with the help of one or markings in the frame. The person can take necessary steps to undo those infections and take timely treatment to avoid any serious health condition.
[0033] Timely detection of presence of a pathogen injected by needle stick
injury may be used to provide adequate and timely medical attention to a subject. The inventors of the present disclosure provide a device for detecting the presence of antibodies in a subject. The device may be for detecting infection caused by needle stick injury. The device can be based on any technique for detection including but not limited to, lateral flow assay, ELISA and the like, for simultaneous detection of HIV, hepatitis B virus and/or hepatitis C virus infected due to needle stick injury.
[0034] In an embodiment, the device for detection of one or more antibodies
can be associated with a needle stick injury in a person, can include a flow path comprising of: a) a sample well for receiving a sample upstream of the flow path; b) a conjugate area downstream of the sample well comprising one or more labeled antigens that bind specifically to the one or more antibodies in the sample to form one or more labeled complexes; c) one or more test lines downstream of the conjugate area comprising reagents for capturing the labeled complexes associated with an immune response; and d) a control line downstream of the conjugate area to indicate completion of assay.
[0035] In an embodiment, the device for detection of one or more antibodies
associated with a needle stick injury in a person, comprises a flow path comprising of: a) a sample well for receiving a sample upstream of the flow path; b) a conjugate area downstream of the sample well comprising one or more labeled antigens that bind specifically to the one or more antibodies in the sample to form one or more labeled complexes; c) a first test line downstream of the conjugate area comprising reagent A for capturing a labeled complex associated

with a first immune response; d) a second test line downstream of the first test line comprising reagent B for capturing a labeled complex associated with a second immune response; e) a third test line downstream of the second test line comprising reagent C for capturing a labeled complex associated with a third immune response; and f) a control line downstream of the third test line to indicate completion of assay.
[0036] In an embodiment, each of the first, second and third immune
response may be associated with a virus selected from hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). The device can be designed such that the sample flows through the conjugate area and the test lines to reach the control line via capillary action. In an embodiment, the flow path may be axial. Each test line (also referred as markings in the frame) can be associated with detection of different antibody. The first test line (can also referred as first marking) can be used to capture the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV. The reagent (also referred as reactant) A captures the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV.
[0037] In an embodiment, a second test line or marking can be used to
capture the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV. The reagent B captures the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV. A third test line can be used to capture the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV. The reagent C captures the labeled complex comprising antibody associated with immune response to hepatitis B virus, hepatitis C virus or HIV. The first test line can be used to detect the immune response associated with hepatitis B virus; the second test line may be used to detect the immune response associated with hepatitis C virus, and the third test line may be used to detect the immune response associated with HIV.

[0038] In an embodiment, the labeled complex is restrained and captured on
the test lines that enables detection of presence of the virus and is thus specific for the virus to be detected. The detection in this preferred embodiment may be done visually. Each antibody can be complexed with a different labeled antigen to give a differently detectable signal at the test line. Thus, multiple labeled antigens may be used for antibody specific complexation and distinguished detection. The reagent A, reagent B and reagent C can capture reagents associated with the capture of the labeled complex associated with one of hepatitis B virus, hepatitis C virus or human immunodeficiency virus. In a preferred embodiment, the reagent A is a capture reagent for capture of labeled complex of hepatitis B virus; the reagent B is a capture reagent for capture of labeled complex of hepatitis C virus; and the reagent C is a capture reagent for capture of labeled complex of HIV.
[0039] In an embodiment, if only a control line appears, then none of the
antibodies of HIV, HBV or HCV has been detected and the result is negative. In an embodiment, if the control line doesn't appear, the test has been unsuccessful and needs to be repeated. In an embodiment, if both the control line and any of the test lines of HIV, HBV or HCV appears, then the antibody specific to the disease has been detected and the result is positive for the particular antibody. The detection of multiple lines along with C line means the exposed individual has more than one infection.
[0040] Moreover, in interpreting the specification, all terms should be
interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" 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.

[0041] 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 OF THE INVENTION
[0042] The proposed invention provides a device for simultaneous
detection of antibodies generated by needle stick injury specifically by infectious
diseases of ADDS, Hepatitis B and Hepatitis C.
[0043] The proposed invention provides a device for simultaneous
detection of antibodies, which is easy to use.
[0044] The proposed invention provides a device for simultaneous
detection of antibodies, which is cost effective.
[0045] The proposed invention provides a device for simultaneous
detection of antibodies, which is easy to portable and easy to carry.

We Claim:
1. An antibodies detection device, the device comprising:
a frame with a receptor at one end, wherein the receptor is configured to be contacted with a blood sample of a person; and
one or more reactants configure in the frame, wherein the one or more reactants are configured to react with the blood sample to detect presence of one or more antibodies in a sample; and
one or more markings on the frame, wherein the one or more markings are configured to indicate presence of one or more antibodies in the sample when an intensity of the one or more antibodies is more than a pre-defined threshold value.
2. The antibodies detection device as claimed in claim 1, wherein the one or more antibodies comprises any or combination of HAV IgM, HBsAg, HB core IgM and HCV.
3. The antibodies detection device as claimed in claim 1, wherein the blood sample is taken from a person having a needle stick injury.
4. The antibodies detection device as claimed in claim 1, wherein the pre-defined threshold value is 8 - 12mlU/mL.