DESC:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003

COMPLETE SPECIFICATION
(See Section 10 and Rule 13)

Title of invention:
A PORTABLE DIAGNOSIS SYSTEM FOR EXTRACTION AND INTEGRATED PCR TESTING
APPLICANT:
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
An Indian Entity having address:
PLOT NO 99-B, LONAVALA INDUSTRIAL CO-OPERATIVE ESTATE LTD, NANGARGAON, LONAVALA, PUNE – 410401 MAHARASHTRA, INDIA.
The following specification particularly describes the invention and the manner in which it is to be performed.

CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY
The present application do claim priority from its provisional application filed on 16th September 2022 under the application number of 202221053149.
TECHNICAL FIELD
The present disclosure relates to a compact diagnosis system. Particularly, the present subject matter relates to a portable diagnosis system enabling extraction and PCR testing. More particularly, the present invention provides a system that automates a series of steps beginning from the extraction of the biomolecule and PCR testing.
BACKGROUND
Environmental samples typically include impurities that interfere with PCR amplification and DNA quantitation. Samples are taken and added to an aqueous buffer. Cells from the sample are lysed, releasing their DNA into the buffer. After removing insoluble cell components, the remaining soluble DNA-containing extract is treated which causes rapid precipitation of impurities. Centrifugation provides a supernatant that can be used or diluted for PCR amplification of DNA, or further purified. The method may provide a DNA-containing extract sufficiently pure for PCR amplification within 5–10 minutes. Nucleic Acid (NA) extraction is used in many types of biological research including molecular biology, forensics, pathology, environmental research, and drug discovery. This is well known in the art that Polymerase chain reaction (PCR) is a technique for nucleic acid amplification, which has been widely used in molecular biology. However, owing to limitations such as large size, high power consumption, and complicated operation, PCR system have only reached in hospitals or research institutions of larger cities. Despite the technology known so well still there are various troubleshoots in the system and it involved huge amount of money to maintain such equipments.
Nowadays, the diagnostic health care system suffers majorly because of increasing pressure and lack of adequate laboratories and infrastructure. Further, laboratories require different kinds of equipment to perform the tests which are expensive and equipments are heavy weight and require larger space to accommodate the various tests. Further, it is also studied that available technology of diagnostic machinery has turned out to be for limited population leading to large scale exclusion of poor patients from affordable health care. Particularly focusing on PCR (Polymerase Chain Reaction) testing equipment we find that most of these systems are large and heavy weight leading to constraints on transportation and maintenance.
Further, available marketed equipments are primarily designed for large capacity and large sample size making it unaffordable for smaller size testing. In such scenarios the fees for such tests are expensive and is unaffordable for population at large. In remote geographical areas like hilly or desert areas, where the population is sparse and overall health infrastructure is minimum such large systems are not available leading to exclusion to masses from utilizing the healthcare provisions.
It’s a long felt need to have an automated DNA extraction system include integration with laboratory information management systems, full start-to-finish automation, error control, and safeguards against contamination. Therefore, a diagnosis system that is portable and compact, and lightweight equipped to conduct nucleic acid extraction and PCR testing thus providing highly reliable inputs to health care professionals at low cost and reduced time is highly desirable is the need of the hour.
Thus, the present invention address to the above long-felt needs. It discloses a portable diagnosis system, which is compact and lightweight with optimized cycle time.
OBJECT OF THE INVENTION AND SUMMARY
The present invention provides a portable diagnosis system enabling extraction and PCR testing. The entire design of this system is devoted to producing a high precision, rapid throughput unit at a cost lower than previously attainable. This section is not intended to identify essential features of the claimed subject matter, nor it is intended to be used in determining or limiting the scope of the claimed subject matter.
An object of the present invention is to provide a portable diagnosis system enabling integrated PCR and extraction in an automated manner.
It is another object of the present invention is to produce a high precision, rapid throughput unit at a cost lower than previously attainable.
It is another object of the present invention to provide a system that is easily portable and table-top mounted.
It is another object of the present invention to provide a system having a tip holder assembly to perform a series of steps from extraction to PCR cycle in an automated manner without any human intervention.
It is another object of the present disclosure to provide a system enabling the centre distance adjustment mechanism to the tip holder assembly to carry out a predefined programmed procedure for extraction as well as integrated PCR in an automated manner.
In accordance with above mentioned above-mentioned objects, a portable diagnosis system (100) with integrated PCR and extraction is disclosed. The portable diagnosis system (100) may comprise a base structure (101). The base structure has an extraction assembly for extraction of nucleic acid mounted over it along with an integrated real time PCR assembly (112). The portable diagnosis system (100) may further comprise an extraction assembly comprising a deck assembly (106, 300) and a tip holder assembly (109), mounted on the base (101).
Further the PCR assembly (112), the deck assembly (106, 300) and the tip holder assembly (109) are functionally coupled with each other to reduce cycle time for each step involved in extraction and PCR.
Further the tip holder assembly (109, 200), may be configured to move in X axis, Y axis, and Z axis of a cartesian coordinate. Further, in another aspect the tip holder assembly may be configured to freely move in all possible 360-degree angles, wherein the movement of the tip holder is supported by a robotic arm-like structure. The robotic arm as disclosed in the present invention may include not limiting to a finger clamp or spider crab arms (701), wherein the finger clamp is able to move freely in all possible direction to perform automated steps of extraction followed by PCR. The tip holder assembly (109, 200) may further comprise more than one tip wherein the linear distance between tips is changeable. Further, the deck assembly (106, 300) may comprise a flap cover mounted on the top surface, wherein the flap cover is configured to retain the set of cartridges (301) and tubes in position. Further, the deck assembly (106, 300) may comprise a thermoshaker magnet assembly.
BRIEF DESCRIPTION OF DRAWINGS
The present invention is described with reference to the accompanying figures.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which are:
Figure 1 illustrates a portable diagnosis system 100 with nucleic acid extraction with integrated PCR testing.
Figure 1A, illustrates a closer view of the portable diagnosis system 100 in accordance with an exemplary embodiment of the present disclosure.
Figure 1B, illustrates another view of the portable diagnosis system 100 in accordance with an exemplary embodiment of the present disclosure.
Figure 1C, illustrates a closer and side view of the portable diagnosis system 100 in accordance with an exemplary embodiment of the present disclosure.
Figure 2 illustrates a tip holder assembly 200 in accordance with an exemplary embodiment of the present disclosure.
Figure 2A, 2B, 2C, and 2D illustrates different views of the CDA mechanism 205 in accordance with the exemplary embodiment.
Figure 2E (I, II, III, IV) illustrates different views of robotic arm/spider crab arm of Syringe assembly connected to the tip holder assembly 200 in accordance with an exemplary embodiment of the present disclosure.
Figure 3A, Figure 3B and Figure 3C illustrates a view of an exemplary deck assembly 300 from different angles showing open flap cover 302 in accordance with an exemplary embodiment.
Figure 3D illustrate a view of an exemplary deck assembly 300 on the portable device in accordance with an exemplary embodiment.
Figure 4 illustrates a thermoshaker and magnet assembly 400 in accordance with an exemplary embodiment.
Figure 5 illustrates a syringe assembly in accordance with an exemplary embodiment.
Figure 6 illustrates an Optical assembly 114 in accordance with an exemplary embodiment.
Figure 7 (A) illustrates an all-in-one cartridge in accordance with an exemplary embodiment.
Figure 7 (B) illustrates a (10) ten-well cartridge in accordance with an exemplary embodiment.
Figure 7 ( C) illustrates an (8) eight-well cartridge in accordance with an exemplary embodiment.
Figure 7 (D) illustrates PCR caps in accordance with an exemplary embodiment.
Figure 8 illustrates a view of an exemplary Thermocycler showing Optical assembly 114 and analyzer detector in accordance with an exemplary embodiment.

DETAILED DESCRIPTION
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The term PCR (Polymerase Chain Reaction) can be interchangeably used as thermal cycler, PCR, Real-time PCR, Quantitative real-time PCR (Q-RT PCR), Reverse Transcriptase PCR (RT-PCR), Multiplex PCR, Nested PCR, Long-range PCR, Single-cell PCR, Fast-cycling PCR or the like.
In accordance with the present invention, a compact and portable system for extraction integrated with a PCR is disclosed. The system may comprise a plurality of assemblies provided for performing extraction and PCR. In accordance with the exemplary embodiment, PCR may be performed by a thermocycler. The thermocycler (Figure 8) may comprise an optical assembly (114) and an analyser detector assembly (112). The optical assembly as exemplified in (FIGURE 6) may be configured to receive and accommodate PCR tubes or any tubes for analysis. Further, the optical assembly may comprise optical components like LED (not displayed under FIGURE 8) or another light source for providing excitation or other functional aspects. The analyser assembly may be functionally coupled with the optical assembly to perform diagnostic analysis. Further, the thermocycler with an integrated extraction system may be housed/mounted in a housing. The housing may be compact in size so as to fit on a tabletop. The optical assembly may be placed in the housing in such a way that PCR tubes or any tubes may be transferred from the extraction system via a tip holder assembly to the thermocycler.
In an embodiment, the optical assembly of the present invention may comprise optical components for providing excitation or other functional aspects, wherein the optical component for excitation is located preferably in the present invention is at the bottom (Figure 8) of the optical assembly. Wherein, the optical components can also be placed on any one side of the optical assembly.
In accordance with an exemplary embodiment, an extraction system as disclosed may comprise the tip holder assembly (105). The extraction system may further comprise a deck-plate assembly (106) and a syringe assembly (108), wherein the assemblies work in an automated manner without human interference.
In another exemplary embodiment, the plurality of receptacles on the deck assembly for holding tubes and consumables (including but not limiting to reagents, buffers, extraction composition, PCR composition) required for extraction and PCR may be grouped as a first set for holding PCR tubes, a second set for accommodating extraction tube, a third set for holding PCR caps, a fourth set for storing PCR cartridge, a fifth set for storing sample tubes, a sixth set for storing tip cartridge, a seventh set for storing extraction cartridge. Further, the plurality of receptacles may be grouped into various sets. Each set may be distinct from each other with respect to function, performance, and structure. The sets may be further arranged in a defined pattern on the deck-plate assembly based on the functionality of each set. The placement of a plurality of tips, cartridges, and tubes in the plurality of receptacles may be designed in such a manner that the cycle time for the extraction process is optimum. Further, such placement of cartridges, tubes, and tips in the plurality of receptacles of the deck-plate assembly may be designed in such a manner to reduces cross-contamination during the extraction process. Furthermore, the placement of different sets as disclosed (Fig 3A, 3B, 3C, and 3D) herein can vary depending on the user requirements and the test to be performed. Wherein, Deck assembly is customized to accommodate the tubes containing test samples and consumables arranged in sequence order depending on the sample to be analysed. The plurality of receptacles is further configured to accommodate or hold a plurality of cartridges, and a plurality of tips.
In another embodiment, the present invention provides a cartridge that may be selected from but not limiting to a 8 well cartridge (Figure 7C), all in one cartridge (Figure 7A), a cartridge of 10 wells (Figure 7B) which includes but not limiting to test sample containing nucleic acid, extraction reagents, buffers for extraction and PCR preparation, tip piercer, PCR tubes and cap holders, pipettes tips, and a combination thereof that is used for nucleic acid extraction and PCR cycle preparation used for analysis purposes in a thermocycler (PCR machine).
The deck-plate assembly may further comprise a flap cover (111). The flap cover may be provided on the top surface of the deck plate assembly, and configured to securely restrain the tubes, cartridges, and tips placed in the plurality of receptacles of the deck-plate assembly. The tubes, the cartridges, and the tips need to be securely retained so that the tip holder assembly may access them easily. Further, the tip holder assembly may be configured to move in the direction of the X-axis, Y-axis, and/or Z-axis in a cartesian coordinate form with respect to the deck plate assembly while accessing, the cartridges, the tubes, and the tips consisting of piercing tip and pipette tips.
In an embodiment, the present invention provides a deck plate assembly that can be moved in forward and reverse directions for the user to place the consumables, test sample at the beginning of the protocol run. To ensure that the deck assembly is aligned to its desired position, the base plate is provided with a sensor to detect the position of the deck plate assembly and to align it with the desired position before the protocol is initiated. Further, in case of any interruption during the processing of a system, the sensor checks for any offset from the original position and accordingly adjusts the position of the deck assembly. The sensor is located in the base plate.
In another embodiment of the present invention, Tip holder assembly may comprise more than one tip holders. The said tip holder may be further configured to change the linear distance between themselves in real-time during the operation of the system. The distance between the tip holders may be changed using a Centre-Distance Adjustment mechanism (CDA) (Figure 2A, 2B, 2C, 2D). The CDA mechanism as disclosed may comprise a captive step motor. The captive motor may be connected to a motor support plate. The motor support plate (210) may be configured to move up and down in vertical direction. The motor support plate may be configured to have grooves, the grooves may be further configured to vary the centre distances between the tip holders. The tip holders may be mounted on L support blocks (215), and the L support blocks can slide on the sliding shaft (215) to adjust the distance between the tip holders of the tip assembly.
The tip holder assembly is an extension of the syringe assembly (108). Each individual tip holder may relate to individual syringe arm. The syringe assembly may further comprise a syringe motor, a syringe motor plate, a sliding guide, and a syringe attachment block, syringe piston rod. The syringe piston rod may be configured to move within the syringe body and create a working effect of a conventional syringe. The syringe assembly may further comprise a syringe body, wherein the piston rods of each of the individual syringes may be mounted on the syringe body.
In an embodiment, the advantageous and space-saving feature of the present invention lies wherein the used consumables are discarded by way of placing them in their original position after use. The consumables are placed in the original position after their use by tip-holder assembly, thus eliminating the need for a separate discard assembly and this saves space and contributes to the development of a compact and portable system.
Now referring to Figure 1, a portable diagnosis system 100 enabling extraction with integrated PCR is disclosed. The portable diagnosis system 100 may comprise a base structure 101. Mounted on the base structure 101 are a PCR assembly (also referred as Thermocycler) Figure 8 comprising of analyzer detector 112 and optical assembly 114 for performing real time PCR testing and an extraction assembly comprising of a deck assembly 106, a flap cover 111, a syringe assembly 108, and a tip holder assembly 105. The deck assembly 106 may comprise a plurality of receptables positioned on a top surface of the deck assembly 106 configured to accommodate a plurality of cartridges, a plurality of tubes including PCR tubes and sample tubes, a plurality of tips for piercing, and a plurality of pipetting tips /tip pipettes.
The deck assembly 106 may comprise a flap cover 111 to securely hold cartridges, tubes, piercing tips and tip pipettes from moving relative to the deck assembly 106 during the extraction process. Further the placement of the cartridges, the tubes, the tips and tip pipettes in the plurality of receptacles is such that, it enables reduction in extraction cycle time. The reduction in cycle time is further due to reduction in movement of the tip holder assembly 109 to access the cartridges, tubes, tips and pipettes while performing a task.
The tip holder assembly 109 may be configured to move in X, Y or Z co-ordinates wherein the X-axis passes axially through the longitudinal axis of the syringe. The sagittal plane represented by the Y- axis depicts the syringe is moving cranially or caudally. The z-axis passes transversally. The tip holder assembly may comprise a support frame having a X axis guide rail in X-axis 102. The X axis guide rail 102 may be configured to enable the movement of the tip holder assembly 109 in X direction. Further, the system 100 may comprise a Y axis guide rail 103 and 104 and both may be configured to move the tip holder assembly 109 in Y- axis direction. Further, the system 100 may comprise of the tip holder assembly to move tips in a straight motion while performing the extraction referring to it as Z-axis assembly configured to move the tip holder assembly 109 in a Z-axis direction. The tip holder assembly may be configured to freely move in all possible 360-degree angles, wherein the movement of the tip holder is supported by a robotic arm structure. The robotic arms or spider crab arms as illustrated in various views of Figure 2E (I, II, III, IV) can move freely like a wrist movement of hand depending on the test protocols. Wherein the robotic arm has a free degree of movement in all possible directions. The robotic arm as disclosed in the present invention is like a finger clamp or a spider crab arm, wherein the finger clamp can move freely in all possible directions to perform complete automated steps right from extraction upto PCR cycle.
In an embodiment of the present invention, the plurality of tip holders is assembled to grab the plurality of caps, and after grabbing the caps, the caps are placed with predefined pressure over the PCR tube using tip holder assembly. The tip holder assembly is further configured to lift the plurality of tips fitted with a cap and tap the same on the deck plate assembly to avoid or remove air bubble formation and this helps to get accurate results.
In another embodiment of the present invention, a PCR tube with a cap ready for PCR is first spun at a specified RPM using a Centrifuge 115, wherein the Centrifuge is placed in between the PCR assembly 112 and the thermoshaker assembly 107. The Centrifuge assembly 115 as disclosed herein is capable to spin a single PCR tube without any need for balancing. The Centrifuge assembly 115 used herein is a balance-free assembly and may be replaced with the spinner assembly. Further it has a covering lid 116 to safeguard in tubes in place when the centrifuge is set in motion.
Referring to Figure 1, illustrates a closer view of the portable diagnosis system 100. The portable diagnosis system 100 may comprise a thermoshaker and magnet assembly 107. The thermoshaker and magnet assembly 107 may be configured to intensive mixing and temperature control of samples for further processing. Further the thermoshaker and magnet assembly 107 may be positioned adjacent to the deck assembly 106. The deck assembly 106 comprising of plurality of receptables sets are arranged in a defined pattern based on the requirement of sample extraction. PCR tubes with a cap 110 may be placed adjacent to the thermoshaker and magnet assembly.
Now referring to Figure 1B, illustrates the back view of the portable diagnosis system 100. The portable diagnosis system 100 as shown may comprise a syringe assembly 108. The syringe assembly 108 may comprise syringes connected to the tip holder assembly 109. Further, each syringe may comprise a syringe body and a syringe piston rod. The syringe piston rod may be configured to move within the syringe body and create a working effect of a conventional syringe. Now referring to Figure 2, illustrates a tip holder assembly 200 in accordance with an exemplary embodiment of the present disclosure. The tip holder assembly 200 may comprise a motor 201 configured to provide actuating force to various components in the tip holder assembly 200. The motor 201 may be a stepper motor or any other type of motor based on the requirement of operation. Further, a motor shaft 202 may transfer the actuating force from motor 201 to the various components in the tip holder assembly 200. Further, the tip holder assembly 200 may comprise a CDA mechanism 205 The support plate 210 may be configured to give support to entire the CDA mechanism (CDAM) 205.
Further, the CDAM 205 may comprise the tip holders 204, a guide plate 207, a L support blocks 215 and a motor support plate 207. The motor support plate 207 may comprise a plurality of grooves 208. Further, a plurality of guide wheels may be fixed in the plurality of grooves 208 (Figure 2D).
Now referring to Figure 2A, 2B and 2C illustrates different views of the CDAM 205 in accordance with the exemplary embodiment. The Figure 2A show a stage at which the motor support plate 207 is vertically at the top position, whereby the distance between two adjacent metal tip holders may be minimum of at least 9 mm and may vary depending on the step to be performed during extraction and PCR testing. As motor 201 provides motion, the motor support plate 207 starts moving along the vertical axis in the downward direction.
Further, Figure 2B shows the distance between two adjacent tip holders may be any distance between minimum and maximum and may vary depending on the step to be performed during extraction and PCR testing.
In Figure 2C the distance illustrated between two adjacent tip holders may be maximum of at least 21 mm or more. The linear distance between the tip holders can vary based on the requirement of the extraction and PCR testing.
In an exemplary embodiment of the present disclosure, the tip holder assembly 200 may comprise tip ejection apparatus. The tip ejection apparatus may comprise a motor 206. Further, the motor 206 may be coupled to a lead screw. Further, a tip ejector plate 209 may be positioned just above the tip holder. The tip ejector plate 209 may be configured to eject the tip or caps at a desired location by moving the tip ejector plate 209 towards or away from the tip in the vertical direction.
Now referring to Figure 2D, illustrates a closer view of the motor support plate 207. Further the guide plate 207 may comprise the plurality of grooves 208.
The CDA mechanism as disclosed in Figure 2 and Figure 2A to 2D may comprise a captive step motor or motor 201 connected to a motor support plate 207. The motor support plate 207 may be configured to move up and down in vertical direction. The motor support plate 207 may be configured to have grooves 203, the grooves 203 may be further configured to vary the centre distances between the tip holders 204. The tip holders 204 may be mounted on L support blocks 215, and the L support blocks 215 can slide on the sliding shaft to adjust the distance between the tip holders of the tip assembly 204.
Referring to Figure 3D, illustrates a view of an exemplary deck assembly in portable diagnosis system in accordance with the present disclosure. The deck assembly 300 as disclosed may comprise a plurality of receptables 301. The plurality of receptables 301 may comprise cavities or holes to accommodate various cartridges, tubes, piercing tips, and tip pipettes. Further, the deck assembly 300 may comprise a flap cover 302. The flap cover 302 may be configured to securely hold the plurality of cartridges or sample tubes in a fixed position and protect the cartridges and tubes from any movement during the aspiration or dispersion from the tip holder assembly.
Further, Figure 3A, 3B and 3C illustrate view of the deck assembly 300 from different angles showing open flap cover 302.
Now referring to Figure 4 illustrates a thermoshaker and magnet assembly 400 in accordance with an exemplary embodiment. The thermoshaker and magnet assembly 400 may comprise a thermoshaker block 401. The thermoshaker block 401 may further comprise voids 408. The voids 408 may be configured to hold the samples. Further, a heating element 409 may be configured to generate heat and thermally treat the samples in the voids 408. The heating element 409 may be integrated inside the thermoshaker block 401.
In accordance with an exemplary embodiment, the thermoshaker and magnet assembly 400 may comprise a set of magnets 407.The set of magnets 407, creates an external magnetic field to make the beads stick to the outer edge of the sample-containing tube placed in the voids 408. The set of magnets (407) may be placed in the system (100) in such a manner that it may be introduced from either top or bottom or may slide from either side direction. In the present invention, the preferable direction used is sliding from the bottom. Further, the thermoshaker and magnet assembly 400 may comprise support 402. The thermoshaker block 401 may be mounted on the support 402. Further, a motor 403 may be provided at the base of the support 402. The motor 403 may be configured to provide actuating motion for shaking the thermoshaker block 401. Further, a motor mounting plate 404 may be provided adjacent to the motor 403. The motor mounting plate 404 may be configured to support a set of linear motors 405. The linear motor 405 may be further configured to move the set of magnets 407 in a linear direction. The thermoshaker and magnet assembly has a shaking module, wherein the shaking module is configured to shake the plurality of thermoshaker blocks 401 at pre-defined speed, time, and set to motion through an eccentric shaft and the plurality of springs.
Further, the thermoshaker and magnet assembly 400 in accordance with the exemplary embodiment may comprise a set of magnet end plates 406. The set of magnet end plates 406 may be configured to restrict the movement of the set of magnets 407.
In another exemplary embodiment of the thermoshaker and magnet assembly, 400 may comprise a homing mechanism and a homing sensor. The homing mechanism and the homing sensor are configured to align the thermoshaker block 401 centrally after coming to halt post shaking operation and avoiding misalignment. The homing mechanism may comprise a spring to dampen the unnecessary motion and stop the thermoshaker block 401 centrally.
Further the homing sensor may detect the position of the thermoshaker block 401, and check for any offset from the central position and accordingly adjust the same for the thermoshaker block 401. Now referring to Figure 5, illustrates a syringe assembly in accordance with an exemplary embodiment. The syringe assembly 108 as disclosed may comprise a motor 501, a motor plate 502, a motor support plate 507, and linear motion guides 503. The syringe assembly 108 may further comprise a plurality of syringe piston rods 504 assembled in a syringe attachment block 506 and a syringe body 505. The syringe assembly 108 may be configured in perpendicular direction to a tip holder assembly 109. The syringe assembly 108 is configured to enable the tip holder assembly 109 aspirate and dispense sample, tubes, tips and/or tip pipettes for extraction and PCR testing. The syringe assembly 108 enables the aspiration by creating a negative pressure in the tip holder, by moving the piston rod 504 to an extreme position in the syringe body 505.
According to the embodiment, the present invention provides a compact system which is a sample-to-result automation system, wherein the system eliminates the need for a bigger infrastructure and the capital cost involved in molecular labs. The total weight of the system is 15 to 50kg.
In another embodiment, the present invention provides an integrated system comprised of PCR assembly, deck plate assembly, syringe assembly, tip-holder assembly, Centrifuge, and thermal and mechanical shaker assembly wherein the designed portable system of the present invention automates all the lab operations with the flexibility to test multiple parameters with multiple samples at the same time.
In yet another embodiment, the system as disclosed in the present invention has features such as automatic barcode reading, auto-feed protocol, automatic self-sanitization, and LIMS (uni-directional or bi-directional) connectivity.
In an embodiment, the system as disclosed herein is capable of self-sanitization, wherein the self-sanitization is performed by using a UV lamp or any other method known in prior art.
In an embodiment of the present invention, the portable and compact system as disclosed in the present invention can be used alone or can be integrated such that a series of one or more of such independent systems can be connected using a user interface designed using software. More particularly, series systems can be connected in a series depending on the user requirements.
The construction of the system as described above, wherein the workflow of the entire process intended to be implemented therein may be understood by the following sequence of steps:
The below-listed advantages of the prevent invention should be used for exemplary limitations and should not limit the scope of the prevent invention.
• The system for portable diagnosis is easy to use and cost-effective.
• The system is compact, fully automated, and thus easy to transport.
• The system reduces time intervals between diagnoses/analyses.
• The system optimizes the health care system in times of scarcity of resources and manpower.
• The system provides a cost-effective solution for diagnosis requirements for the poor and areas with less health infrastructure.
• The system eliminates bigger infrastructure requirements.
• The system is designed to automate self sanitization.
• The system is a sample to result in application.
• Software-driven system eliminates human intervention.
• The multiple system can be networked together to achieve maximum throughput.
• enclosed system prevents contamination-free sample processing.
Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. However, one of ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated but is to be accorded the widest scope consistent with the principles and features described herein.
The foregoing description shall be interpreted as illustrative and not in any limiting sense. A person of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure.
The embodiments, examples and alternatives of the preceding paragraphs or the description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments unless such features are incompatible.
,CLAIMS:We claim:
1. A portable diagnosis system enabling integrated PCR and extraction process in a fully automated compact system comprising of:
a housing having a base structure (101) mounting on which are comprising of:
i) a deck plate assembly (106), wherein the deck plate assembly comprises a plurality of receptacles and a flap cover (111);
ii) a tip holder assembly (105), wherein the tip holder assembly (105) connected to a syringe assembly (108),
iii) a thermoshaker and magnet assembly configured to provide a motion for shaking the thermoshaker block (401); at pre-defined speed, time, along with inbuilt a homing mechanism and a homing sensor; and
iv) a Centrifuge assembly (115), for spinning the PCR tubes with a covering lid (116);
v) a PCR assembly (112), comprising of an optical assembly (114), wherein the optical assembly is configured to receive and accommodate one or more PCR tubes;
wherein, the PCR assembly (112), the deck assembly (106, 300), the Centrifuge assembly, and the tip holder assembly (109) are functionally coupled with each other to reduce cycle time for each step involved in the extraction and polymerase chain reaction in the automated manner along with a reduction in cross-contamination.

2) The portable diagnosis system as claimed in claim 1, wherein the housing of the said system is compact in size to fit on a tabletop.

3) The portable diagnosis system as claimed in claim 1, wherein tip holder assembly (105), is having the ability to move in X-Y-Z axis and/or 360-degree rotation.
4) The portable diagnosis system as claimed in claim 1, wherein the deck plate assembly comprise the plurality of receptacles are grouped in a defined pattern including but not limiting to a set for holding PCR tubes, a set for accommodating reagent for extraction tubes, a set for holding caps for PCR tubes, a set for holding reagent cartridges for PCR, a set for holding test sample tubes, a set for holding piercing tip and pipetting tips cartridge, and a set for holding extraction cartridge or a combination thereof such that each set of receptacles distinct from each other with respect to functionality, the action performed, and structurally and the sets are further arranged in a defined pattern on the deck-plate assembly based on the functionality of each set.
5) The portable diagnosis system as claimed in claim 1, wherein the flap cover (111) is provided on the top surface of the deck plate assembly, and configured to securely restrain the tubes, cartridges, and piercing tip and pipetting tips placed on the plurality of receptacles of the deck-plate assembly.
6) The portable diagnosis system as claimed in claim 1, wherein the homing mechanism and the homing sensor are configured to align the thermoshaker block (401) centrally after coming to a halt post-shaking operation to avoid misalignment.
7) The portable diagnosis system as claimed in claim 1, wherein a thermoshaker and magnet assembly further comprising of: a support 402; a plurality of spring mounted on the support; a thermoshaker block (401) mounted on the support, wherein the thermoshaker block comprises voids (408) to hold the test sample tubes and a heating element (409) to generate heat and to treat the test sample tubes in the voids (408); a set of magnets (407) to create an external magnetic field; a motor (403), a motor mounting plate (404); a set of magnet end plates (406); a shaking module, wherein the shaking module is configured to shake the plurality of thermoshaker blocks (401) and set to motion through an eccentric shaft and the plurality of springs.

Dated this 16th Day of September 2022