Claims:
CLAIMS
We claim:
1. An automatic system and process for detecting agglutination, said system comprises:
atleast two typical panels;
atleast one reagent chamber provided with atleast one chamber to hold reagent and to allow reaction between sample and reagent;
atleast one capillary tube for uptake of sample;
atleast one capillary cap to close the system before and after uptake of sample through capillary tube;
atleast one air filter to prevent cross flow of the samples from one reagent chamber to another reagent chamber and reagent chamber to the pistion inside system and to allow passage of air;
atleast one rod in every reagent chamber or coating inner walls of reagent chamber with glass to blend sample with reagent;
atleast one piston which transfer sample from capillary tube to reagent chambers, wherein said piston is fixed to transparent top panel of system.
2. The system as claimed in claim 1, wherein said reagent chamber further comprising:
• two panels i.e., colored bottom panel and transparent top panel made up of by any means;
• colored bottom panel is of any color for clear observation and comprises concave half cylindrical u shaped groovings which acts as reagent chambers to hold reagent and to allow reaction between sample and reagent;
• colored bottom panel contains rod or coating with glass which provides blending of sample and reagent;
• transparent top panel is in transparent color and acts as transparent window to facilitate clear visibility of the agglutination observed in system;
• transparent top panel contains u-shaped grooving in the bottom to perfectly forms cylindrical reagent chambers, when harmonizely fixed with colored bottom panel;
• when transparent top panel is mounted on colored bottom panel, three sides of both transparent top panel and colored bottom panel are closed and on the forth side jointly facilitates at least one passage for capillary tube;
• at least one reagent chamber formed by joining of transparent top panel and colored bottom panel;
• at least one reagent chamber to hold reagent and to allow reaction between sample and reagent;
• plurality of passages provided for capillary tubes, facilitates plurality of sample uptake at a given point of time at point of care;
• reagent chamber may be of tubular or by any shape means.
3. The capillary tube as claimed in claim 1, wherein it is of different diameters and different length to provide predetermined uptake of samples of variable volumes as per requirement of assay analysis and is made up of by any means.
4. The capillary tube as claimed in claim 1, wherein it contains circular rib to hold individual capillary tube and contains rectangular rib to hold plurality of capillary tubes which perfectly fits in to forth side of system up on harmonized fixing of transparent top panel and colored bottom panel.
5. The capillary cap as claimed in claim 1, wherein it prevents leak of reagents during storage and assay analysis and is made up of by any means of rubber material.
6. The rod in every chamber as claimed in claim 1, wherein it is made of glass, ceramic or similar material and used to blend sample with reagent and is made up of by any means.
7. The reagent chamber as claimed in claim 1, wherein glass coating on inner walls of reagent chamber used to blend sample with reagent and is made up of by any means
8. The piston as claimed in claim 1, wherein it is fixed to transparent top panel of reagent chamber and facilitates provision for air filter through which air release and suction takes place and it is made in any shape means and any size means.
9. The piston as claimed in claim 1, wherein it is further comprising:
• spring provides mechanical support to piston;
• spring used for smooth movement during suction of sample through capillary tube;
• spring locator is in oval shape and uses to hold spring on top side and air filter on bottom side;
• o-ring which prevents air leaks during piston movement and keeps the system device airtight;
• piston cap is in oval shape and uses to close piston system;
• lubricant is applied on the inside wall of piston cap for smooth movement over o-ring.
10. The air filter as claimed in claim 1, wherein it facilitates air release and suction as air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber and also prevents cross flow of the samples from one chamber to another chamber and chamber to piston inside system.
11. An automatic system and process for detecting agglutination,wherein said process comprises;
• opening capillary tube outer end by removing capillary cap from system;
• drop of sample is brought into contact with the capillary tube outer end with the piston in compressed state;
• sample drawn into the capillary tube is transferred to reagent chambers on release of piston which has spring action;
• close system with capillary cap;
• gentle tilting of system at an angle to blends sample with reagent in reagent chamber
• rods present inside the chamber (or) glass coating on inner walls of reagent chamber provides desired blend action between sample and reagent inside chamber;
• observe the presence of particulate matter through transparent top panel of system in each chamber;
12. The process as claimed in claim 11, wherein piston is compressed initially, by which suction of sample at point of care achieved by outer end of capillary tube.
13. The process as claimed in claim 11, wherein on release of piston transfers sample from capillary tube to reagent chamber and followed by gentle tilting of system at an angle blends sample with reagent in reagent chamber.
14. The process as claimed in claim 11, wherein said air filter facilitates air release and suction. As air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber.
15. The process as claimed in claim 11, wherein equal amounts of sample drawn into different chambers through different capillary tubes by maintaining dimensions of respective capillary tubes of each chamber and variable volume of sample drawn into different chambers through different capillary tubes by varying dimensions of respective capillary tubes of each chamber.
16. The system as claimed in claim 1, wherein said system directed towards a standalone device to provide a system and process of an agglutination to detect blood group, bacteria, virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.
, Description:FORM 2
THE PATENT ACT 1970
(39 OF 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
TITLE OF THE INVENTION:
“ AN AUTOMATIC SYSTEM AND PROCESS FOR DETECTING AGGLUTINATION ”
APPLICANT NAME: BIONLINE DIAGNOSTICS (OPC) PRIVATE LIMITED Applicant Nationality: INDIAN
Applicant Address: 509, PRAGATHI NAGAR, HYDERABAD, TELANGANA-500090,
INDIA
PREAMBLE TO THE DESCRIPTION:
The following specification particularly describes the invention and the manner in which it is to be performed:-

TECHNICAL FIELD OF THE INVENTION
[001] The disclosed subject matter relates generally to an automatic system and process for detecting agglutination. The present invention relates to an agglutination device to detect Blood Group, Bacteria, Virus and proteins in whole blood samples or plasma or serum for rapid and early detection. More particularly, the present disclosure relates medical field for detection of agglutination at point of care according to preloaded reagents and arrangment.
BACKGROUND OF THE INVENTION
[002] Generally it will take more time and much more human effort to diagnose any blood related tests or in any other means. Detection of antigen/antibodies in a fluid test sample is one of the widely practicing technique in the field of biological reasearch and development of human and veternery medicine based up on particle agglutination, including latex particle agglutination in biomolecule detection assays processs. Eventhough agglutination assay procedures have advantages of being simple, widely applicable, and nonhazardous and also generally rapid, producing results in a short time, whereas they are lack in Exact detection in sharp colour development and/or requirements of large volumes of sample due to which agglutination assays are typically overlooked for analytical purposes in favor of enzyme-linked immunosorbent assays (ELISA).
[003] Currently, various following techniques are available in the market for the determination of agglutination such as:
US9244065B1 entitled "Systems, devices, and methods for agglutination assays using sedimentation" discloses methods for conducting agglutination assays using sedimentation. Aggregates may be exposed to sedimentation forces and travel through a density medium to a detection area.
US8211365B2 entitled "Immunodiagnostic test cards having indicating indicia" discloses an immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.
WO1999051982A3 entitled "Method for automated erythocytic blood group determination" discloses a method for erythocytic blood group determination, whereby commercially available disposable microtiter plates with a pointed bottom are used to an advantageous effect. Albumin is added to the antiserum in such a way that the concentration of albumin amounts to 0.05-2.2 mg/ml, preferably 0.2 1.0 mg/ml. This process corresponds to a traditional sedimentation method without any centrifugal phase or sample shaking phase. Sample preparation can be easily automated, especially when known types of pipetting machines are used. Sedimentation images show a clear difference between positive and negative reactions. Evaluation, especially in the case of photometric optical evaluation of sedimentation images, is easy from a technical point of view and the inventive method can be automated in a reliable manner. As a result it is possible to obtain a high sample through-flow with very few errors for a low cost in terms of material outlay.
US5413913A entitled "Erythrocyte agglutination assay" discloses an erythrocyte agglutination assay, the agglutination reagent comprises at least one erythrocyte binding molecule coupled to at least one specific analyte binding molecule wherein the erythrocyte binding molecule does not cause agglutination when incubated with erythrocytes in the absence of analyte (in the case of a direct assay) or analyte binding reagent (in the case of an indirect assay). Preferably, the erythrocytes are endogenous to the blood sample to be tested, that is, a whole blood sample is assayed. Mixtures of conjugates and conjugates of analyte analogues with erythrocyte binding molecules may also be used as agglutination reagents. The reagents and their use in direct or indirect assays is disclosed.
EP2833146A1 entitled "Latex particles for agglutination assay" discloses A latex particle for high-sensitive agglutination assay and a reagent for agglutination assay including the particle are provided. The latex particle barely initiates non-specific reactions and can readily prepare diagnostic agents. A latex particle for agglutination assay including a polymerizable monomer having a phenyl group, a polymerizable monomer having a phenyl group and a salt of sulfonic acid, and a polymerizable monomer represented by Formula (1):
CH2=CR1-COO(CH2CH2O)n-R2 (1)
where R1 represents a hydrogen atom or a methyl group; R2 represents a hydrogen atom or a methyl group; and n is 1=n<20, wherein the density of functional groups derived from the polymerizable monomer represented by Formula (1) on the surface of the particle is 0.05 to 0.5 µmol/m2.
[004] And also, Typhoid is an endemic febrile disease caused by Salmonella typhi. Typhoid is a major concern of public health. The organism usually enters the body by consumption of contaminated food or water and penetrates the intestinal wall. After that it multiplies and enters blood stream within 24-72 hours resulting in enteric fever and bacteremia. After an incubation period of 10 to 14 days, early symptoms of typhoid, like headache, fever, loss of appetite, bradycardia, splenomegaly etc. appear. Typhoid is diagnosed either by blood culture or by detection of its antigens or by the detection of its antibodies in the blood.
[005] One of the most adapted methods for diagnosing the typhoid fever is the performance of "Widal test", a serological test based on the detection of antibodies in the blood. This test is based on the fact that antibodies against typhoid, remain in the blood of infected person, bind to the bacteria and results in the clumps formation which is referred as "Widal Agglutination".
[006] Major limitation of aforesaid techniques is that they require sophisticated and elaborate laboratory facilities which includes skilled manpower, pipettes, tips, slides, centrifuge to perform limiting their use in view of resource limited settings.
[007] And also in all the existing technologies, technician has to expose to samples and reagent during and after test, which may lead to unwanted problems to technician.
[008] One of the important limitation in the present generation of all aforesaid techniques is that, they requires minimum 4-5 hours to perform the tests and to receive results.
[009] Another important limitation in aforesaid techniques is that, they analyze only single assay either related to blood or serum or analysis of infections, but unable to perform multiplexity at a time.
[010] In the light of the aforementioned discussion, there exists a need for an automatic system and process for detecting agglutination with novel techniques that would overcome the above-mentioned disadvantages and address the needs for specific industries.
[011] Hence in light of aforesaid there exists need of an automatic system and process for detecting agglutination which does not require sophisticated and elaborate laboratory facilities which includes skilled manpower, pipettes, tips, slides, centrifuge to perform limiting their use in view of resource limited settings.
[012] Hence in light of aforesaid there exists need of an automatic system and process for detecting agglutination which does not require reagents which are highly expensive.
[013] Hence in light of aforesaid there exists need of an automatic system and process for detecting agglutination which gives results within fraction of minutes.
[014] Hence in light of aforesaid there exists need of an automatic system and process for detecting agglutination which perform multiplexity of ABO Blood Grouping, Analysis of bacterial and viral infections, fevers and sexually transmitted diseases, and also detection of proteins, bacteria and viruses in blood samples at a time.
[015] So, a fully automatic system and process for detecting agglutination containing Capillary tube for collection of defined blood sample, Reagent Chamber (colored bottom panel on one side and transparent top panel on other side), Rod or glass coating for movement of liquid in chambers, air filter separating chambers and piston and also prevents cross flow of liquids between chambers and chambers and piston, Spring locator, spring and piston cap to act as a mechanical piston for uptake and transfer of sample from capillary tube to reagent chamber, O-ring to prevent air leaks during piston movement, Antibodies, Ag and conjugate reagents for agglutination reaction and processing automatically as per analytical assay requirements.
[016] And also present applicant’s invention is a stand alone device that doesn’t require pipettes or equipment or slides to perform the assay and results can be obtained within seconds reducing the time to get results on comparison with all existing techniques and also it is a closed container which does not facilitates spillage of blood samples or reagent before, during or after test providing maximum safety.
OBJECTS OF THE INVENTION
[017] The main object of the present invention is to provide a system and process of an agglutination device to detect Blood Group, Bacteria, Virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.
[018] It is another object of the present invention to provide the process and system of a stand alone device that doesn’t require pipettes or equipment or slides to perform the assay and results can be obtained within seconds reducing the time to get results on comparison with all existing techniques and also it is a closed container which doesn’t facilitates spillage of blood samples or reagents before, during or after test.
BRIEF SUMMARY OF THE INVENTION
[019] The following information presents a simplified summary of the disclosure in order to provide a basic understanding of the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.
[020] The present disclosure has been provided a stand alone device to provide a system and process of an agglutination to detect Blood Group, Bacteria, Virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.
[021] According to an aspect of the present invention, a system to detect agglutination at point of care, said system comprises Colored bottom panel, Transparent top panel, Reagent Chamber, capillary tubes to collect defined amount of blood and mechanical piston to transfer blood from capillary tube to Reagent chambers, Air filter which separates chambers from piston and also it prevents cross flow of liquids between chambers and chamber to piston, O-ring to prevent air leaks during piston movement.
[022] Another aspect of the present invention, wherein the chamber equipped with a rod for easy movement of liquid in the air tight reagent chamber.
[023] According to an aspect of the present invention, a process to detect agglutination at point of care, said process comprises the following steps:
- First prick the finger with pricking needle.
- The drop of blood is then brought into contact with the capillary tube of the device with the piston in the compressed state.
- The blood that is drawn into the capillary tube is then transferred to the reagent chambers by simply releasing the piston which is having a spring action.
- The reagents in the reagent chamber are slowly mixed with sample by gentle tilting the device at angle for several times.
- Presence of particulate matter is considered as agglutination.
[024] Another aspect of the present invention to provide the process and system of a stand alone device that doesn’t require pipettes or equipment or slides to perform the assay and results can be obtained within seconds reducing the time to get results on comparison with all existing techniques and also it is a closed container which doesn’t facilitates spillage of blood samples or reagent before, during or after test.
SUMMARY OF THE INVENTION
[025] The following information presents a simplified summary of the disclosure in order to provide a basic understanding of the reader. This summary is not an extensive overview of the disclosure and it does not identify key/critical elements of the invention or delineate the scope of the invention. Its sole purpose is to present some concepts disclosed herein in a simplified form as a prelude to the more detailed description that is presented later.
[026]According to exemplary embodiments of the present disclosure is directed towards a standalone device to provide a system and process of an agglutination to detect Blood Group, Bacteria, Virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.
[027] According to an aspect of the present invention, an automatic system and process for detecting agglutination, said system comprises; atleast two typical panels; at least one reagent chamber provided with atleast one chamber to hold reagent and to allow reaction between sample and reagent; atleast one capillary tube for uptake of sample; atleast one capillary cap to close the system before and after uptake of sample through capillary tube; atleast one air filter to prevent cross flow of the samples from one reagent chamber to another reagent chamber and reagent chamber to the pistion inside system and to allow passage of air; atleast one rod in every reagent chamber or coating inner walls of reagent chamber with glass to blend sample with reagent; atleast one piston which transfer sample from capillary tube to reagent chambers, wherein said piston is fixed to transparent top panel of system..
[028] It is another aspect of the present invention, wherein said reagent chamber further comprising:
• two panels i.e., colored bottom panel and transparent top panel made up of by any means;
• colored bottom panel is of any color for clear observation and comprises concave half cylindrical u shaped grooving’s which acts as reagent chambers to hold reagent and to allow reaction between sample and reagent;
• colored bottom panel contains rod or coating with glass which provides blending of sample and reagent;
• transparent top panel is in transparent color and acts as transparent window to facilitate clear visibility of the agglutination during assay;
• transparent top panel contains u-shaped grooving in the bottom to perfectly forms cylindrical reagent chambers , when harmonizely fixed with colored bottom panel;
• when transparent top panel is mounted on colored bottom panel, three sides of both transparent top panel and colored bottom panel are closed and on the forth side jointly facilitates at least one passage for capillary tube;
• at least one reagent chamber formed by joining of transparent top panel and colored bottom panel;
• at least one reagent chamber to hold reagent and to allow reaction between sample and reagent;
• Plurality of passages provided for capillary tubes, facilitates plurality of sample uptake at a given point of time at point of care;
• Reagent chamber may be of tubular or by any shape means.
[029] It is another aspect of the present invention, wherein said capillary tube is of different diameters and different length to provide predetermined uptake of samples of variable volumes as per requirement of assay analysis and is made up of by any means.
[030] It is another aspect of the present invention, wherein said capillary tube contains circular rib to hold individual capillary tube and contains rectangular rib to hold plurality of capillary tubes which perfectly fits in to forth side of system up on harmonized fixing of transparent top panel and colored bottom panel.
[031] It is another aspect of the present invention, wherein said capillary cap prevents leak of reagents during storage and assay analysis and is made up of any means of rubber material.
[032] It is another aspect of the present invention, wherein said rod in every chamber is made of glass, ceramic or similar material and used to blend sample with reagent and is made up of by any means.
[033] It is another aspect of the present invention, wherein said glass coating on inner walls of reagent chamber used to blend sample with reagent and is made up of by any means.
[034] It is another aspect of the present invention, wherein piston is fixed to top part of reagent chamber and facilitates provision for air filter through which air release and suction takes place and it is made in any shape means and any size means.
[035] It is another aspect of the present invention, wherein said piston further comprising:
• spring provides mechanical support to piston;
• spring used for smooth movement during suction of sample through capillary tube;
• spring locator is in oval shape and uses to hold spring on top side and air filter on bottom side;
• o-ring which prevents air leaks during piston movement and keeps the device airtight;
• piston cap is in oval shape and uses to close piston system;
• lubricant is applied on the inside wall of piston cap for smooth movement over o-ring.
[036] It is another aspect of the present invention, wherein said air filter facilitates air release and suction as air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber and also prevents cross flow of the samples from one chamber to another chamber inside system and chamber and piston.
[037] According to an aspect of the present invention, an automatic system and process for detecting agglutination, said process comprises;
• opening capillary tube outer end by removing capillary cap from system;
• drop of sample is brought into contact with the capillary tube outer end with the piston in compressed state;
• sample drawn into the capillary tube is transferred to reagent chambers on release of piston which has spring action;
• close system with capillary cap;
• Gentle tilting of system at an angle to blends sample with reagent in reagent chamber
• rods present inside the chamber (or) glass coating on inner walls of reagent chamber provides desired blend action between sample and reagent inside airtight chamber;
• Observe the presence of particulate matter through transparent top panel of system in each chamber;
[038] It is another aspect of the present invention, wherein piston is compressed initially, by which suction of sample at point of care achieved by outer end of capillary tube.
[039] It is another aspect of the present invention, wherein on release of piston transfers sample from capillary tube to reagent chamber and followed by gentle tilting of system at an angle blends sample with reagent in reagent chamber.
[040] It is another aspect of the present invention, wherein said air filter facilitates air release and suction as air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber uptake.
[041] It is another aspect of the present invention, wherein equal amounts of sample drawn into different chambers through different capillary tubes by adjusting dimensions of respective capillary tubes of each chamber.
[042] It is another aspect of the present invention, wherein said system directed towards a standalone device to provide a system and process of an agglutination to detect blood group, bacteria, virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.
[043] Other aspects and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[044] In the following, numerous specific details are set forth to provide a thorough description of various embodiments. Certain embodiments may be practiced without these specific details or with some variations in detail. In some instances, certain features are described in less detail so as not to obscure other aspects. The level of detail associated with each of the elements or features should not be construed to qualify the novelty or importance of one feature over the others.
[045] FIG. 100 illustrates a projected view of an automatic system and process for detecting agglutination having colored bottom panel, transparent top panel, reagent chamber, capillary tube, capillary cap, rod, air filter, piston, spring locator, o-ring, spring and piston cap according to the present invention.
[046] FIG. 200 illustrates a projected view of transparent top panel of an automatic system and process for detecting agglutination having transparent top panel, passage for capillary tube, passage for air filter, passage for mechanical piston and a groove for o-ring according to the present invention.
[047] FIG. 300 illustrates a projected view of colored bottom panel of an automatic system and process for detecting agglutination having colored bottom panel, reagent chamber and passage for capillary tube according to the present invention.
[048] FIG. 400 illustrates a projected view of capillary tube of an automatic system and process for detecting agglutination having capillary tube, cylindrical tube and circular or rectangular rib to hold capillary tubes in position according to the present invention.
[049] FIG. 500 illustrates a projected view of capillary cap of an automatic system and process for detecting agglutination having capillary cap and engravings to close capillary tubes according to the present invention.
[050] FIG. 600 illustrates a projected view of air filter of an automatic system and process for detecting agglutination having air filter according to the present invention
[051] FIG. 700 illustrates a projected view of spring locator of an automatic system and process for detecting agglutination having spring locator, compartments that are open to reagent chambers, projection to hold spring on top side and passage to attach air filter on bottom side according to the present invention.
[052] FIG. 800 illustrates a projected view of spring of an automatic system and process for detecting agglutination having spring according to the present invention.
[053] FIG. 900 illustrates a projected view of piston cap of an automatic system and process for detecting agglutination having piston cap, projection to hold spring and inside peripheral projection to lock piston according to the present invention.
[054] FIG. 1000 illustrates a projected view of rod and o-ring of an automatic system and process for detecting agglutination having rod and o-ring according to the present invention
[055] FIG. 1100 illustrates a projected view of an automatic system and process for detecting agglutination showing two views of the system i.e., Before assay analysis and Results after analysis according to the present invention
[056] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.
[057] In the drawings, the same reference numerals and any acronyms identify elements or acts with the same or similar structure or functionality for ease of understanding and convenience. The drawings will be described in detail in the course of the following Detailed Description.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[058] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[059] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. A standalone device to provide a system and process of an agglutination to detect Blood Group, Bacteria, Virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement. The automatic system is economical in the way that it saves time, labor, cost as well as energy.
[060] Referring to FIG. 100 is a diagram, depicting an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.100A illustrates side view of An automatic system for detecting agglutination.
Fig.100B illustrates cross sectional view of An automatic system for detecting agglutination.
Fig.100C illustrates front view of An automatic system for detecting agglutination.
Fig.100D illustrates front view of piston of An automatic system for detecting agglutination.
Fig.100E illustrates top view of An automatic system for detecting agglutination.
Fig.100F illustrates top view of An automatic system for detecting agglutination without capillary cap.
An automatic system for detecting agglutination 100 includes colored bottom panel 101 which forms multiple reagent chambers and facilitates passage for capillary tube 104, transparent top panel 102 which joins harmonizely with colored bottom panel 101 and provides a clear view to detect result of assay analysis, reagent chamber 103 to hold reagent and to allow reaction between sample and reagent, capillary tube 104 for uptake of sample in defined volumes and it fits in to engraving formed by the harmonized fixing of both transparent top panel 102 and colored bottom panel 101, capillary cap 105 to close the system, rod 106 to blend sample with reagent, air filter 107 to prevent cross flow of the samples from one chamber to another chamber and chamber to piston inside system and to allow passage of air, mechanical piston 108 which is fixed to transparent top panel 102 and with its mechanical action only suction of sample at point of care occurs and transfer sample from capillary tube to reagent chambers, spring 111 which provides mechanical support to piston, spring locator 109 is in oval shape and had projection to hold spring 111 on top side and flat surface to attaché air filter 107 on bottom side, o-ring 110 which prevents air leaks during piston movement and keeps system airtight and piston cap 112 is in oval shape and uses to close piston system and so forth. Lubricant is applied inside of piston cap 112 for smooth movement of cap during operation. The reagent chambers 103a, 103b, 103c, and 103d are in concave shape and are formed by engraving of colored bottom panel 101 and are equipped with reagents and rod 106 or glass coating of inner walls of reagent chamber allows the blending of sample with reagent during assay.
[061] Referring to FIG. 200 is a diagram, depicting transparent top panel of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.200A illustrates top view of transparent top panel of An automatic system for detecting agglutination.
Fig.200B illustrates side view of transparent top panel of An automatic system for detecting agglutination.
Fig.200C illustrates bottom view of transparent top panel of An automatic system for detecting agglutination.
Fig.200D illustrates front view of transparent top panel of An automatic system for detecting agglutination.
Transparent top panel of An automatic system for detecting agglutination 200 includes transparent top panel 201 which joins harmonizely with colored bottom panel 101 and provides a clear view to detect result of assay analysis, passage for capillary tube 202 in engraving position to hold capillary tube 104, passage for air filter 203 to place an air filter 107 on bottom side of transparent top panel, passage for piston 204 to place piston 108 on the top side of transparent top panel, the passage is in oval shape and also it can be changed as per requirement.
[062] Referring to FIG. 300 is a diagram, depicting colored bottom panel of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.300A illustrates top view of colored bottom panel of An automatic system for detecting agglutination.
Fig.300B illustrates side view of colored bottom panel of An automatic system for detecting agglutination.
Colored bottom panel of An automatic system for detecting agglutination 300 includes colored bottom panel 301 which joins harmonizely with transparent top panel 102 and facilitates half cylindrical concave engravings forms in to reagent chambers 302, reagent chambers 302 contains reagent and allows sample into it as entire assay analysis takes place in it, passage for capillary tube 303 in engraving position to hold capillary tube 104.
[063] Referring to FIG. 400 is a diagram, depicting capillary tube an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.400A illustrates side view of capillary tube of An automatic system for detecting agglutination.
Fig.400B illustrates cross sectional view of capillary tube of An automatic system for detecting agglutination.
Capillary tube of An automatic system for detecting agglutination 400 includes capillary tube 401 with which defined volumes of sample is drawn into different chambers through different capillary tubes by adjusting dimensions of respective capillary tubes of each chamber, cylindrical tube 401a of capillary tube 401 and circular/rectangular rib 401b of capillary tube which holds capillary tube in respective engraving forms by harmonized fixing of transparent top panel 102 and colored bottom panel 101.
[064] Referring to FIG. 500 is a diagram, depicting capillary cap of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.500A illustrates top view of capillary cap of An automatic system for detecting agglutination.
Fig.500B illustrates bottom view of capillary cap of An automatic system for detecting agglutination.
Fig.500C illustrates side view of capillary cap of An automatic system for detecting agglutination.
Fig.500D illustrates cross sectional view of capillary cap of An automatic system for detecting agglutination.
Capillary cap of An automatic system for detecting agglutination 500 includes rectangular capillary cap 501 contains small engravings 502 for fitting of capillary tubes 104 into it and it closes the system from outer end of capillary tube 104 and on the close of system, capillary cap prevents loss of reagents during transport, storage and assay analysis.
[065] Referring to FIG. 600 is a diagram, depicting air filter of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments. Air filter of an automatic system for detecting agglutination 600 includes oval shaped air filter 601 facilitates release of air from chamber which facilitates building of vacuum in the reagent chamber 103 which allows suction of sample by capillary action and once sample is in the capillary tube suction of air through the air filter will transfer sample from capillary tube to reagent chamber 103. Air filter 601 also prevents cross flow of the samples between chambers and from reagent chamber to piston inside system.
[066] Referring to FIG. 700 is a diagram, depicting spring locator of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.700A illustrates top view of spring locator of An automatic system for detecting agglutination.
Fig.700B illustrates side view of spring locator of An automatic system for detecting agglutination.
Spring locator of an automatic system for detecting agglutination 700 includes spring locator 701 is in oval shape and contains projection 701a to hold spring on top side and flat bottom 701c to contact with air filter 107 on bottom side. And also spring locator 701 contains compartments 701b that are open to reagent chambers.
[067] Referring to FIG. 800 is a diagram, depicting spring of an automatic system and process for
detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.800A illustrates side view of spring of An automatic system for detecting agglutination. Fig.800B illustrates top view of spring of An automatic system for detecting agglutination. Spring of an automatic system for detecting agglutination 800 includes spring 801 in spiral shape and provides mechanical support to piston 108. Spring is used for smooth movement during suction of sample through capillary tube 104 at point of care;
[068] Referring to FIG. 900 is a diagram, depicting piston cap of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.900A illustrates side view of piston cap of An automatic system for detecting agglutination. Fig.900B illustrates top view of piston cap of An automatic system for detecting agglutination. Fig.900C illustrates cross sectional view of piston cap of An automatic system for detecting agglutination.
Piston cap of an automatic system for detecting agglutination 900 includes oval shaped piston cap 901 closes mechanical piston system and lubricant is applied on the inside wall of piston for free movement. Piston cap 901 contains projection 901a to hold spring and contains inside peripheral projection 901b to lock piston system.
[069] Referring to FIG. 1000 is a diagrams, depicting glass rod and o-ring respectively of an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.1000A illustrates glass rod of An automatic system for detecting agglutination.
Fig.1000B illustrates o-ring of An automatic system for detecting agglutination.
Rod of an automatic system for detecting agglutination 1000A includes rod 1001 of any material and any shape which facilitates blending of sample with reagent to form agglutination in reagent chamber 103. O-ring of an automatic system for detecting agglutination 1000B includes o-ring 1002 which prevents air leaks during piston movement and keeps the device airtight.
[070] Referring to FIG. 1100 is a diagram, depicting an automatic system and process for detecting agglutination, in accordance with one or more exemplary embodiments.
Fig.1100A illustrates top view of device with respective reagents A, B, D and -ve before assay analysis of an automatic system and process for detecting agglutination.
Fig.1100B illustrates top view of device with respective reagents A,B,D and -ve showing the results of agglutination after assay analysis of an automatic system and process for detecting agglutination.

[071] While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.
EXAMPLE 1
Blood Grouping by agglutination is a classic example for agglutination. The automated device was tested for its functionality using ABO Blood Grouping.
? Reagents Used:
The automatic-agglutination device for ABO Blood grouping consists of 4 reagent chambers as shown in Fig.1100A.
ABO Blood Grouping consists of following three reagents:
(a) Anti-A (IgM) Antibody,
(b) Anti-B (IgM) Antibody and
(c) Anti-D (IgM) Antibody.
? Quantities of Reagents and materials used:
• Reagent chamber 1 consists of 500ul of Anti-A (IgM) Antibody.
• Reagent chamber 2 consists of 500ul of Anti-B (IgM) Antibody.
• Reagent chamber 3 consists of 500ul of Anti-D (IgM) Antibody.
• Reagent chamber 4 consists of 500ul of PBS which acts as a control for lack of agglutination.
• The automatic-agglutination device consists of capillary tube with 1mm ID and 6mm length, this has a sample capacity of 4.7ul/capillary tube.
? Assay Procedure:
ABO Blood Grouping was performed by following steps:
1. Firstly finger is cleaned with alcohol swab and pricked with a pricking needle.
2. Capillary cap was removed from the device.
3. All four capillary tubes are brought into contact with blood drop on the finger while piston is in compressed state.
4. Once the sample is taken up by capillary tubes, piston was released to transfer the sample from capillary tube to reagent chamber.
5. Then capillary cap was placed back on the device.
6. Automatic agglutination device was tilted gently at an angle for 3-5 times.
7. The agglutination result observed from top view through transparent top panel of the device.
8. The results of the agglutination were shown in Fig.1100B.
? Result:
From the Fig.1100B agglutination was clearly seen in Reagent chamber 1 and Reagent chamber 3 indicating that the sample is A+. The presence of false positive is ruled out by the lack of agglutination in Reagent chamber 4.

CLAIMS
We claim:
1. An automatic system and process for detecting agglutination, said system comprises:
atleast two typical panels;
atleast one reagent chamber provided with atleast one chamber to hold reagent and to allow reaction between sample and reagent;
atleast one capillary tube for uptake of sample;
atleast one capillary cap to close the system before and after uptake of sample through capillary tube;
atleast one air filter to prevent cross flow of the samples from one reagent chamber to another reagent chamber and reagent chamber to the pistion inside system and to allow passage of air;
atleast one rod in every reagent chamber or coating inner walls of reagent chamber with glass to blend sample with reagent;
atleast one piston which transfer sample from capillary tube to reagent chambers, wherein said piston is fixed to transparent top panel of system.
2. The system as claimed in claim 1, wherein said reagent chamber further comprising:
• two panels i.e., colored bottom panel and transparent top panel made up of by any means;
• colored bottom panel is of any color for clear observation and comprises concave half cylindrical u shaped groovings which acts as reagent chambers to hold reagent and to allow reaction between sample and reagent;
• colored bottom panel contains rod or coating with glass which provides blending of sample and reagent;
• transparent top panel is in transparent color and acts as transparent window to facilitate clear visibility of the agglutination observed in system;
• transparent top panel contains u-shaped grooving in the bottom to perfectly forms cylindrical reagent chambers, when harmonizely fixed with colored bottom panel;
• when transparent top panel is mounted on colored bottom panel, three sides of both transparent top panel and colored bottom panel are closed and on the forth side jointly facilitates at least one passage for capillary tube;
• at least one reagent chamber formed by joining of transparent top panel and colored bottom panel;
• at least one reagent chamber to hold reagent and to allow reaction between sample and reagent;
• plurality of passages provided for capillary tubes, facilitates plurality of sample uptake at a given point of time at point of care;
• reagent chamber may be of tubular or by any shape means.
3. The capillary tube as claimed in claim 1, wherein it is of different diameters and different length to provide predetermined uptake of samples of variable volumes as per requirement of assay analysis and is made up of by any means.
4. The capillary tube as claimed in claim 1, wherein it contains circular rib to hold individual capillary tube and contains rectangular rib to hold plurality of capillary tubes which perfectly fits in to forth side of system up on harmonized fixing of transparent top panel and colored bottom panel.
5. The capillary cap as claimed in claim 1, wherein it prevents leak of reagents during storage and assay analysis and is made up of by any means of rubber material.
6. The rod in every chamber as claimed in claim 1, wherein it is made of glass, ceramic or similar material and used to blend sample with reagent and is made up of by any means.
7. The reagent chamber as claimed in claim 1, wherein glass coating on inner walls of reagent chamber used to blend sample with reagent and is made up of by any means
8. The piston as claimed in claim 1, wherein it is fixed to transparent top panel of reagent chamber and facilitates provision for air filter through which air release and suction takes place and it is made in any shape means and any size means.
9. The piston as claimed in claim 1, wherein it is further comprising:
• spring provides mechanical support to piston;
• spring used for smooth movement during suction of sample through capillary tube;
• spring locator is in oval shape and uses to hold spring on top side and air filter on bottom side;
• o-ring which prevents air leaks during piston movement and keeps the system device airtight;
• piston cap is in oval shape and uses to close piston system;
• lubricant is applied on the inside wall of piston cap for smooth movement over o-ring.
10. The air filter as claimed in claim 1, wherein it facilitates air release and suction as air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber and also prevents cross flow of the samples from one chamber to another chamber and chamber to piston inside system.
11. An automatic system and process for detecting agglutination,wherein said process comprises;
• opening capillary tube outer end by removing capillary cap from system;
• drop of sample is brought into contact with the capillary tube outer end with the piston in compressed state;
• sample drawn into the capillary tube is transferred to reagent chambers on release of piston which has spring action;
• close system with capillary cap;
• gentle tilting of system at an angle to blends sample with reagent in reagent chamber
• rods present inside the chamber (or) glass coating on inner walls of reagent chamber provides desired blend action between sample and reagent inside chamber;
• observe the presence of particulate matter through transparent top panel of system in each chamber;
12. The process as claimed in claim 11, wherein piston is compressed initially, by which suction of sample at point of care achieved by outer end of capillary tube.
13. The process as claimed in claim 11, wherein on release of piston transfers sample from capillary tube to reagent chamber and followed by gentle tilting of system at an angle blends sample with reagent in reagent chamber.
14. The process as claimed in claim 11, wherein said air filter facilitates air release and suction. As air release creates vacuum on one end of capillary tube by which uptake of sample achieved at outer end and suction creates positive pressure for transfer of sample from capillary to reagent chamber.
15. The process as claimed in claim 11, wherein equal amounts of sample drawn into different chambers through different capillary tubes by maintaining dimensions of respective capillary tubes of each chamber and variable volume of sample drawn into different chambers through different capillary tubes by varying dimensions of respective capillary tubes of each chamber.
16. The system as claimed in claim 1, wherein said system directed towards a standalone device to provide a system and process of an agglutination to detect blood group, bacteria, virus and proteins in whole blood samples or plasma or serum for rapid and early detection at point of care according to preloaded reagents and arrangement.

DATE AND SIGNATURE:
Dated this October 7, 2019
Authorized Patent Agent Signature:
Authorized Patent Agent Name: Vijay Kumar Makyam
Authorized Patent Agent Number: IN/PA-2476

ABSTRACT
AN AUTOMATIC SYSTEM AND PROCESS FOR DETECING AGGLUTINATION
An agglutination device for rapid and early detection of Blood Group, Bacteria, Virus and Proteins in whole blood samples or plasma or serum at point of care, that is according to preloaded reagents and arrangements. It contains colored bottom panel, transparent top panel, capillary tube for collection of sample, capillary cap, air filter for separating chambers and piston and also prevents cross flow of liquids between chambers, rod, spring, spring locator, piston cap, O-ring to prevent air leaks during piston movement, reagent chamber containing Antibodies, Ag and Conjugate reagents for agglutination reaction and processing automatically as per analytical assay requirements. It is a stand alone, doesn’t require pipettes or equipment or slides to perform assay and results can be obtained within seconds reducing the time for results on comparison with existing techniques. It is a closed container which prevents spillage of blood samples or reagent before, during or after test.

DATE AND SIGNATURE:
Dated this October 7, 2019

Authorized Patent Agent Signature:
Authorized Patent Agent Name: Vijay Kumar Makyam
Authorized Patent Agent Number: IN/PA-2476