WO2015187091A1

WO2015187091A1 - Analysis device and method of operation thereof

Info

Publication number: WO2015187091A1
Application number: PCT/SG2014/000256
Authority: WO
Inventors: Hui-ming CHEN
Original assignee: Chen Hui-Ming
Priority date: 2014-06-04
Filing date: 2014-06-04
Publication date: 2015-12-10

Abstract

An analysis device for detecting an analyte from a sample, the analysis device including a housing having an inlet for receiving at least part of the sample, a detector for detecting the analyte directly or indirectly, and a connector that operatively connects the analysis device to a processing system to allow the processing system to control the analysis device, receive data from the detector and determine an indicator at least partially based on the data.

Description

ANALYSIS DEVICE AND METHOD OF OPERATION THEREOF

Background of the Invention

[0001] The present invention relates to an analysis device and method of operating an analysis device for analysing a sample,^"" such -as a sample of bodily fluid or tissue from a subject to monitor the health of the subject, or for analysing other substances such as food stuffs or the like.

Description of the Prior Art

[0002] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not, be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

[0003] With the aging global population, the cost of healthcare is expected to rise dramatically, putting financial burdens on subjects and their families. Many countries are already faced with a medical infrastructure deficiency, a lack of hospital beds, shortage of medical staff, and over-crowding in Accident & Emergency Wards. Although many subjects are already finding the cost of healthcare prohibitive, national health bodies are anticipating raising new taxes to fund healthcare needs of their aging population.

[0004] The task of finding a balance between rising demand and over-consumption due to misallocation of resources is a challenging one. Repeat visits, demand for specialist care even for simple ailments, and performing unnecessary testing are all typical signs of over- consumption. The traditional structure of clinics and hospitals cannot match resources to the right needs and demands.

[0005] In seeking to address these issues, some countries incorporate independent GP clinics into the hospital infrastructure. Other initiatives, like home care services, are an inefficient use of resources particularly when used for simple tasks like taking blood pressures, measure heart rates, and monitoring glucose levels. [0006] There have been some attempts by smart phone manufacturers and mobile application companies to offer basic momtoring via sensors such as, for example, using optoelectronic sensor technology, so that consumers can keep tabs on common vital signs such as heart rates and blood oxygen levels. There are also devices/applications which seek to measure stress levels, sleep patterns, and moods, but they are limited in their functionality. [0007] More complex applications to measure glucose, acidity and protein levels use the camera function of the smart phone to measure and conduct optical analysis of colorimetric assays (i.e. convert colour readings from the photo-picture to data for analysis). However, these applications suffer due to colour variations, shadows, background ambience, camera sensitivity, lighting intensities, sensor types, distance, angle variations, types of lens, focus sharpness, pixel variations, and camera software. These limitations make it difficult to obtain precise and accurate readings consistently, and data averages are commonly calibrated from algorithms leading to more approximate values.

[0008] Furthermore, external devices that are attached to smart phones to "control" external lighting variations and distances do not fully resolve the above limitations, or address the internal variations between various mobile device models and their respective capabilities.

[0009] Diagnosis of diseases caused by bacteria and viruses such as, for example, HFMD (Hand, Foot and Mouth Disease), HIV, dengue fever, and influenza is beyond the current scopes and capabilities of the above described sensor-based mobile applications for wearable or mobile devices. [0010] Traditional diagnostic testing such as blood tests and/or analysing urine samples can take from an hour to several days. Current diagnostic methods used in the hospital are:

a) - Enzyme Linked Immuno-Sorbent Assay (ELISA) - 1 to 2 hours

b) - Polymerase Chain Reaction (PCR) - 3 to 5 hours.

c) - Bacterial culture, e.g. blood culture (5 - 7 days) [0011] Apart from being time consuming, these tests are also usually expensive and require the sample to be sent to a medical laboratory. Typically, when a subject consults a doctor, the need of the subject to know their medical condition is immediate, but if a test like a blood test is required, then often a return visit is necessary. For subject/doctor contact to be meaningful and helpful there is a need for it to be in real time and efficient.

[0012] Failure to provide such results quickly and onsite can result in high emotional stress for the subject, high costs, and an increase in return visits which can contribute to long waiting times.

[0013] The present invention seeks to address at least the above mentioned issues. Summary of the Present Invention

[0014] In one form the invention seeks to provide an analysis device for detecting an analyte from a sample, the analysis device including:

a) a housing having an inlet for receiving at least part of the sample;

b) a detector for detecting the analyte directly or indirectly; and

c) a connector that operatively connects the analysis device to a processing system to allow the processing system to:

i) control the analysis device;

ii) receive data from the detector; and,

iii) determine an indicator at least partially based on the data.

[0015] Typically the device includes at least one reagent, wherein the detector detects, directly or indirectly, a reaction, interaction or binding between the at least one reagent, or a derivative thereof, and the analyte.

[0016] Typically the at least one reagent is an enzyme. [0017] Typically the device includes a microchannel extending from the inlet to the detector, the microchannel being used to transport at least part of the sample from the inlet to the detector.

[0018] Typically the detector is positioned to detect analyte at an analysis portio of the microchannel. , [0019] Typically the analysis portion includes an immobilised capture agent for binding the analyte. [0020] Typically the capture agent is an antibody or antigen.

[0021] Typically the capture agent is immobilised on an inner wall surface of the microchannel. -

[0022] Typically the analysis portion includes a filler material, and the capture agent is immobilised on the filler material. [0023] Typically the filler material includes at least one particle, bead, fiber, paper strip or combination thereof.

[0024] Typically the filler material is a porous material.

[0025] Typically the at least one reagent is located in the microchannel.

[0026] Typically the device includes a pump for driving fluid in the microchannel toward the analysis portion.

[0027] Typically the at least one reagent is positioned in the microchannel upstream from the analysis portion.

[0028] Typically the device includes a wash buffer positioned in the microchannel between the reagent and the analysis portion. [0029] Typically the connector is an audio jack.

[0030] Typically the processing system generates signals and provides the signals to the audio jack, the signals being for at least one of controlling the analysis device and supplying power to the analysis device.

[0031] Typically the analysis device scavenges power from the signals. [0032] Typically the audio jack is a"½eadphone jack.

[0033] Typically the audio jack includes first and second outputs, a ground and input connections, and wherein in use, the processing system:

a) provides a pump control signal via a first output for controlling a pump; b) provides an illumination source control signal via a second output for controlling an illumination source; and,

c) receives signals from the detector via the input.

[0034] Typically the detector is a colorimetric detector. [0035] Typically the device is a single use device.

[0036] Typically the processing system is at least one of:

a) part of a separate electronic device;

b) part of the analysis device; and,

c) part of an embedded system.

[0037] Typically the processing system is part of a portable communication device. [0038] Typically the portable communication device is smart phone or tablet. [0039] Typically the device includes a plurality of micro channels. [0040] Typically the device includes a sample collector.

[0041] Typically the sample is or is derived from at least one of:

a) bodily fluid of a subject;

b) bodily tissue of a subject; and,

c) food stuffs.

[0042] Typically the device includes a test strip receiving portion.

[0043] Typically the indicator is indicative of a presence, absence or concentration of the analyte.

[0044] Typically the processing system:

a) compares the indicator to stored criteria; and

b) generates an output based on the results of the comparison.

[0045] In one form the invention seeks to provide a diagnostic system including : a) an analysis device for detecting an analyte from a sample of bodily fluid or tissue, the analysis device including:

i) an inlet for receiving at least part of the sample;

ii) a detector for detecting the analyte directly or indirectly; and

iii) a connector for connecting the analysis device to a processing system; and, a processing system, the connector thereby permitting the processing system to: i) control the analysis device; and

ii) receive data from the analysis device.

[0046] Typically the connector is an audio jack.

[0047] Typically the audio jack is a headphone jack. [0048] Typically the audio jack includes left and right output channels, a ground and input channel.

[0049] Typically the analysis device further includes:

a) a microchannel including at least one reagent therein; and

b) a pump for pumping the reagent in the microchannel toward the detector, wherein the inlet is such that a received sample is positioned to come into contact with the at least one reagent.

[0050] Typically the pump is powered and/or controlled by the processing system at least in part via one of left or right output channels of an audio jack.

[0051] Typically the analysis device further includes an illumination source, and the illumination source is powered and/or controlled by the processing system at least in part via one of the left or right output channels of the audio jack.

[0052] Typically the processing system receives data from the detector at least in part via the input channel of the audio jack.

[0053] Typically activity of the pump is influenced by electrical feedback directly from the detector.

[0054] Typically the processing system is part of an electronic device. [0055] Typically the electronic device includes an audio socket.

[0056] Typically the electronic device is a portable communication device.

[0057] Typically the portable communication device is a smart phone or tablet.

[0058] In one form the invention seeks to provide a method of operating a diagnostic system, the diagnostic system including:

a) an analysis device for detecting an analyte from a sample of bodily fluid or tissue, the analysis device including:

i) a sample receiving part for receiving at least part of the sample;

ii) a microchannel including at least one reagent therein;

iii) a pump for driving the reagent toward the sample;

iv) a detector for detecting a direct or indirect reaction, interaction or binding between the reagent and the analyte; and

v) a connector for connecting the analysis device to a processing system, the connector permitting the processing system to:

(1) control the analysis device; and

(2) receive data from the analysis device, wherein, once the analysis device ^"is loaded and connected to the processing system, the method, which is performed by the processing system, includes the steps of:

(a) activating the pump such that the reagent is driven toward the sample;

(b) receiving data from the detector indicative of a direct or indirect reaction, interaction or binding between the reagent and the analyte; and

(c) processing the data from the detector to provide an analysis result.

[0059] Typically the processing system is part of an electronic device with a display, the method further including the step of displaying the analysis result on the display. [0060] Typically the device includes the step of checking the position of the reagent in the microchannel using feedback from the detector.

[0061] Typically the device includes the step of comparing the analysis result against a stored criteria to provide a diagnosis result. [0062] Typically the device includes the step of allowing a prescribed period to pass between mixing of the reagent and the analyte, and performing step b).

[0063] Typically the connector is an audio jack and wherein the method includes step includes receiving an electrical signal from the detector via the input channel of the audio jack. [0064] Typically the step of activating the pump includes generating and transmitting an electrical signal to the pump via the left or right output channels. .

[0065] Typically the method includes activating an illumination source simultaneously or prior to receiving data from the detector.

[0066] Typically an electrical signal is transferred via a left or right output channel of an audio jack to activate the illumination source.

[0067] Typically the method further includes the step of activating the pump to flush the sample and reagents from the microchannel.

[0068] In one_. form the invention seeks to provide a method of monitoring the health of a subject, the method including the steps of:

a) collecting a sample body fluid or tissue from the subject;

b) inserting the sample into an analysis device;

c) connecting the analysis device to a portable communication device;

d) transmitting an analysis result to a server for comparison; and

e) receiving a diagnosis result on the portable communication device from the server.

[0069] A method for monitoring the health of a population, the method including:

a) collecting a sample body fluid or tissue from at least one subject;

b) inserting the sample into an analysis device;

c) connecting the analysis device to a portable communication device;

d) transmitting an analysis result to a server.

[0070] Typically the method further includes the step of transmitting the details and location of the at least one subject to the server. [0071] Typically the method includes storing the details, location and analysis result of the at least one subject.

[0072] In one form the invention seeks to provide an analysis device for detecting an analyte from a sample, the analysis device including:

a) a housing having an inlet for receiving at least part of the sample;

b) a detector for detecting the analyte directly or indirectly; and

c) a processing system to:

i) control the analysis device;

ii) receive data from the detector; and,

iii) determine an indicator at least partially based on the data. Brief Description of the Drawings

[0073] An example of the present invention will now be described with reference to the accompanying drawings, in which: -

[0074] Figure 1A is a schematic diagram of an example of a diagnostic system including an analysis device;

[0075] Figure IB is a flow chart of an example of a diagnostic process using the diagnostic system of Figure 1 A;

[0076] Figure 2 is a schematic diagram of an example of a distributed computer architecture;

[0077] Figure 3 is a schematic diagram of an example of a processing system of Figure 2;

[0078] Figure 4 is a schematic diagram of an example of a computer system of Figure 2;

[0079] Figure 5 is a flow chart of a second example of a diagnostic process using a diagnostic system;

[0080] Figure 6 is an example of an analysis device with a headphone jack connection for connection to a smart phone;

[0081] Figure 7 is a flow diagram showing an example of the process steps performed in operating the, analysis device according to one example;

[0082] Figure 8 is schematic diagram of the internal architecture of an analysis device according to one example;

[0083] Figure 9 is a flow diagram showing an example of the process steps performed in operating the analysis device according to one example; [0084] Figure 1 OA shows an example of a multichannel arrangement in an analysis device according to one example typically used for enzymatic testing;

[0085] Figure 10B shows a single channel arrangement with and without a filler material in an analysis device according to one example typically used for immunological testing;

[0086] Figure 11 is a schematic diagram showing an example of a cloud based subject monitoring system including an analysis device that can be integrated with a portable communication device; and,

[0087] Figure 12 is a schematic diagram showing an example of a cloud based subject monitoring system showing examples of cloud based processing functionality;

Detailed Description of the Preferred Embodiments

[0088] An example of a diagnostic system including an analysis device will now be described with reference to Figure 1 A.

[0089] In this example, the diagnostic system includes an analysis device 1 10, for detecting an analyte in a sample, such as a bodily fluid or tissue. The analysis devices typically include a housing 111 having an inlet 112 for receiving at least part of the sample, a detector 113 for detecting the analyte directly or indirectly, and a connector 114 that operatively connects the analysis device to a processing system 100 to allow the processing system to control the analysis device, receive data from the detector, and determine an indicator at least partially based on the data. The processing system can be connected to one or more other computer systems via a network architecture, as will be described in more detail below. [0090] An example of analysis process will now be described with reference to Figure IB.

[0091] In this example, at step 150 a sample may optionally be prepared. This can be achieved in any suitable manner and can include acquiring the sample, for example from a subject, and optionally treating the sample, for example through mixing with a solvent, or the like. [0092] At step 160, the sample is inserted into the inlet 112 of the analysis device. [0093] At step 170, the processing system 100 controls the analysis device, for example to cause further automated sample preparation or interaction with reagents, to activate the detector or the like, as will be described in more detail below.

[0094] At step 180, the processing system receives data from the detector allowing the processing system 100 to determine an indicator based on the data at step 190. In this regard, the indicator could be of any suitable form and could include a numerical and/or graphical representation indicative of a concentration of an analyte within the sample, and/or a diagnosis of a presence, absence, degree of a condition and/or a recommendation of an intervention or other associated action.

[0095] It will be appreciated from this that the processing system 100 can be of any suitable form that can generate control signals for controlling the analysis device, as well as to receive data from the detector and use this to generate an indicator. In one example, the processing system includes an electronic processing device, such as a microprocessor, and in one preferred example is a mobile communications device such as a mobile phone or the like. The processing system can be a stand-alone device and/or may be integrated into a distributed architecture, to allow for remote processing of data, as will be described in more detail below.

[0096] Accordingly, the analysis device 11.0 can be used to analyse a wide range of samples typically derived from bodily fluid from humans, or other animals, and such samples may include blood, urine, sweat, synovial fluid, cerebral spinal fluid (CSF) or tears. Furthermore, analysis devices as described herein may be configured/calibrated to detect any one or a number of analytes. Particular embodiments include devices that are able to detect the presence, absence or concentration of glucose, cholesterol, liver enzymes (e.g. ALT, AST), antigens and/or immunological markers such as antibodies (IgE, IgG etc.). It will be appreciated that the sample may also be body tissue derived from subjects, such as humans or other animals, such as skin or hair. The sample may also comprise food stuffs such as milk, eggs, chicken, fish, or water. In such examples, the device can have particular application in the detection and monitoring of food poisoning outbreaks. For example, samples of chicken could be tested for the presence of Salmonella or E.coli. Food and water could also be tested before consumption, to determine whether it is safe to eat or drink. [0097] In use, the user need simply insert the sample into the inlet and then allow analysis of the sample to be performed substantially automatically, with an indicator being provided by way of output. The indicator can be tailored to the user, so that it is in the form that the user can understand, such as a simple instruction to take defined action, an indication of the level of the analyte, or the like. Accordingly, particularly when used in conjunction with a processing system such as a mobile phone or the like, this allows users to perform at home testing, allowing basic monitoring to be performed without requiring medical intervention.

[0098] A number of further features will now be described.

[0099] Typically, the analysis device includes at least one reagent, and the detector detects, directly or indirectly, a reaction, interaction or binding between the at least one reagent, or a derivative thereof, and the analyte. The use of reagents can be beneficial in that they will allow for the detection of analytes that cannot otherwise be detected using electronic sensing techniques or the like. Additionally, this can allow for detection of analytes in concentrations that would not otherwise be detectable. However, it will be appreciated that in some embodiments, the detector may be configured to detect the presence, absence or concentration of the analyte directly, without a reagent.

[0100] In most cases, the at least one reagent includes an enzyme and the detector is configured to detect a physical sign of the reaction between the enzyme and the analyte, like a colour change. It will be appreciated however, that the reagent may also include other types of molecules/compounds, such as those that are capable of producing a detectable effect once stimulated. For example, the reagent may include fluorescent or phosphorescent molecules/compounds, which are tailored to bind, to the analyte, and, when appropriate radiation is applied, the molecules fluoresce or phosphoresce to indicate the presence, absence or concentration of the analyte. The reagents are typically pre-loaded in the analysis device, and are adapted for single use only with the analysis device being either disposed or returned for reconditioning. As an alternative, the reagents can be provided as part of a removable/replaceable part of the analysis device. Thus, reagents could be provided in a tube or embedded in a test strip or test pad, which is exposed to the sample and then provided to the inlet, allowing a colour changes to be detected by the detector. In this example, it will be appreciated that the analysis device could be re-used, with the tube, strip or pad being replaced as required. [0101] The analysis device typically includes a microchannel, with the detector positioned to detect analyte at an analysis portion of the microchannel. In some examples, the microchannel extends from the inlet to the detector, and is used to transport at least part of the sample from the inlet to the detector. It will be appreciated however that the inlet, or alternative sample receiver, may receive and position the analyte appropriately for the detector and/or in fluid communication with microchannel by other means. The use of a microchannel allows the sample to be moved in a controllable manner to the detector, whilst also allowing the detector to be situated remotely of the inlet thereby ensuring that the detector is not adversely affected by contaminants entering the inlet.

[0102] The analysis portion of the microchannel may include an immobilised capture agent for binding the analyte. For example, the capture agent may be an antibody, antigen, protein receptor or the like. The capture agent may be immobilised on an inner wall surface of the microchannel. Alternatively or additionally, the analysis portion may also include a filler material, and the capture agent may be immobilised on the filler material. The capture agent can be used to retain the analyte within the channel whilst reactions with other reagents are performed.

[0103] The filler material may be described as "3 dimensional" and may include at least one particle, bead, fiber (such as, for example, a glass fiber), paper strip or combination thereof. By introducing a filler material into the analysis portion of the microchannel, the surface area available for the capture agent, and therefore binding of the analyte is significantly increased. This in turn can increase the efficiency, sensitivity, analysis time and/or detection limits of the analysis device.

[0104] It will be appreciated that the filler material may be any material that increases the surface area for binding within the analysis portion of the microchannel. For example, the filler material may also be a porous material. [0105] Alternative to an antibody, antigen or protein receptor, the inner wall surface or surface of the filler material may be coated with a particular molecule/compound that has an affinity for the analyte. The surface may also have a particular shape or morphology particularly suited to attract or trap the analyte. [0106] A pump is provided for driving fluid in the microchannel toward the analysis portion. This can be used to urge the sample from the inlet to the analysis portion, where it then binds to the capture agent.

[0107] Additionally, the at least one reagent is also typically located in the microchannel, with the pump operating to drive reagent, which is typically preloaded up-stream from the analysis portion, towards the analysis portion of the microchannel such that the reagent can react, interact or bind with the captured analyte. It will be appreciated that alternate variations may have the reagent deposited subsequent to the analyte, such as through the main inlet or another inlet, and may not be preloaded in the microchannel of device. However, the above arrangement allows a single pump to be used to initially draw the analyte into the analysis portion, where it is bound to the capture agent and held in position, with the pump flow then being reversed to allow the captured analyte to be exposed to the pre-loaded reagent. Thus, this allows a single pump to be used, whilst still allowing the sample to be exposed to pre-loaded reagent. This allows the analysis device to be preloaded and used as a single use disposable device. [0108] Optionally, in the examples where the reagent is preloaded, a wash buffer may be positioned in the microchannel between the reagent and the analysis portion. In use, after the analyte is loaded into the analysis device, the pump may be operated to flush the sample with the wash buffer, such that the sample is primed for the reagent. The reagent would then follow to bind, interact or react with the analyte. , [0109] In some versions of the analysis device, the device may be preloaded with a plurality of reagents, and may include a plurality of microchannels. By preloading the reagents in separate microchannels, the separate reagents may be pumped in sequence or simultaneously to meet the analyte at the detector. Alternatively, the multiple reagents may be preloaded in series in a single microchannel, in a particular sequence. [0110] The pump itself may be manual or electronically powered. In this regard, power can be scavenged from the processing system, as will be described in more detail below, but in the event that sufficient power is not available, as an alternative, the pump can be operated manually. It will also be appreciated that in some embodiments, the analysis device may not include a pump, for example, if using a paper based strip as part of a cholesterol test. Additionally, it will be appreciated that the pump may be optionally operated for some tests and not for others.

[0111] The device may also include a waste cavity to which the sample may be directed after testing. The waste cavity may include an immobilising agent such as a gel, or magnetic beads, to ensure that any fluids or other products supplied to the waste cavity cannot be removed therefrom. Additionally a neutralising agent or a chaotropic agent, may be provided to neutralise any harmful solutions, organisms, or the like. Or alternatively a sample preservative can be included to ensure the prepared sample is suitable for further analysis using other equipment or assays.

[0112] The analysis device as described herein also includes a connector that permits the analysis device to be operatively connected to a processing system to allow the processing system to control the analysis device, and in particular to receive data from the detector and determine an indicator at least partially based on the data.

[0113] It will be appreciated that the connector may be any means that permits the device to communicate, power and/or send data to the processing system. For example, the connector may be a plug-in type connector such as mini/standard USB or audio/headphone jack. The connector may also be a non-plugin type connector, such as wireless or Bluetooth adapters, or Near Field Communication (NFC) or RFID type connectors, in which case the connector may use indicative coupling to allow power to be provided to the analysis device. It will also be appreciated that the processing system may be intrinsic to the device, for example, as part of an embedded system, or as a microcontroller/microprocessor with appropriate firmware.

[0114] However, in one example the connector is an audio jack, and the processing system generates signals and provides the signals to the audio jack, the signals being for at least one of controlling the analysis device and supplying power to the analysis device, by allowing the analysis device to scavenge power from the signals. The audio jack is typically a headphone jack and includes first and second outputs, a ground and input connections. In use, the processing system provides a pump control signal via the first output for controlling the pump, an illumination source control signal via the second output for controlling an illumination source and, receives signals from the detector via the input connection. The use of a headphone jack is particularly beneficial as this is typically ubiquitous across a range of different devices, and is often more familiar for use by individuals than other connectors. Accordingly, this maximises the likelihood that a user will be able to use the analysis device and that the analysis device will be compatible with an available processing system.

[0115] The processing system is typically part of an electronic device which includes an audio socket, and is preferably a portable communication device such as a smart phone or tablet. Thus, in such diagnostic systems, the connector may be an audio jack and typically includes left and right output channels, a ground and input channel.

[0116] Typically, the processing system receives data from the detector at least in part via the input channel of the audio jack. Furthermore activity of the pump may be influenced by electrical feedback, directly from the detector. This permits the position of the reagent in the microchannel to be checked/regulated in real-time. For example, whilst the pump is operated, any significant change in the base line reading of the detector, such as when reagent comes in to view at the analysis portion of the microchannel (causing a colour change), may trigger the pump to stop operating.

[0117] Apart from power, the analysis device may also utilise other components or functionality of the electrical device to which it is connected. For example, when the processing system is part of a typical smart phone, vibration mode, heat sinks, or heating elements may contribute to encouraging or accelerating the reaction between the reagent and the analyte.

[0118] Typically, the indicator is indicative of a presence, absence or concentration of the analyte. Furthermore, the processing system typically operates to compare the indicator to stored criteria and generates an output based on the results of the comparison. The output may then be displayed to a user or transferred to a cloud based server or other location if, for example, the processing system is communicable with a greater Wide Area- -Network. This may be particularly applicable in the instances where the processing system is part of a portable communications device. For example the processing system may form part of a smart phone or tablet.

[0119] For illustration, the indicator may represent glucose concentration in a sample of blood from a 25 year old male. The processing system of the portable communication device may then compare the indicator against normal blood glucose reference ranges for males of this age group either locally on the device, or non locally via internet connection to cloud based server. The results of the comparison could then be displayed to the user and, alternatively or additionally, be stored on the cloud based server.

[0120] Alternatively, the indicator could be in the form of an instruction to seek medical attention, further diagnosis or the like. The indicator can also be in the form of a link to other relevant information. For example, when the analysis device is used for diagnosing diseases during an outbreak, such as influenza, the indicator could provide advice such as to seek medication or requesting that the users quarantine themselves. This could include a link to more detailed information as to how best to manage the condition. [0121] As well as being displayed to the user, the indicator could be stored for later reference and/or could be provided to a third party. For example, when tracking an outbreak of a condition, it may be important that authorities are informed of the results of the analysis, so they are able to understand the extent of the outbreak and track the spread of contagions. Thus, in one example, the indicator could be provided to a medical professional associated with the user, or another third party.

[0122] It will also be appreciated that a range of different detectors may be used depending on the analysis methodology. For example, the detector may be a spectroscopic, photoelectric, electric (potential state, voltage, current), spectrum, colorimetric, or fluorescence detector. An illumination source, such as an LED, is also typically provided and the activity thereof is often synchronised with the operation of the detector to allow for a reading to be taken. .

[0123] The analysis device may be a single use, disposable device or may be reusable. When formed as a. single use, disposable device, the device typically receives power from the processing system to which it can be connected.. [0124] The processing system may comprise or form part of any suitable electrical device having the appropriate connection. Typically the electronic device is a portable communication device and in particular a smart phone or a tablet. In one form, the headphone jack of the analysis device may be plugged into the headphone socket of the smart phone or tablet. This is a particularly beneficial combination as the majority of the population own or have access to a phone, whilst interaction via a headphone socket ensures compatibility with devices regardless of manufacturer. Additionally, the use of the headphone connector allows connection to other devices, such as computer systems or the like, thereby maximizing the ability of user to use the analysis device. [0125] It will be appreciated that in both the disposable and reusable forms the device may have its own power source such as a battery, or may have its own power generation means such as a solar panel. It will also be appreciated that with non-plugin type connection between the analysis device and the processing system (e.g. wireless/Bluetooth), power to operate the device may be provided by induction. [0126] In some examples, the device may additionally include a sample collector that may assist in the collection of the sample and/or aid insertion of the sample into the inlet of the device. For example, the sample collector may include a lancet for piercing the skin in the process of obtaining a blood sample from a subject. This can assist in ensuring the user is able to successfully collect a sample, although it will be appreciated that other sample collection mechanisms, such as a needle and syringe or the like could be used.

[0127] The analysis device as described may also include additional inlets or chambers to receive test strips or other pre-prepared samples. In some forms, the test strip may be inserted into the main inlet of the device.

[0128] It will be appreciated that the analysis device may form part of a greater diagnostic system including the processing system.

[0129] As mentioned above a method of operating a diagnostic system can also be provided, the diagnostic system including an analysis device for detecting an analyte from a sample, such as bodily fluid or tissue, the analysis device including a sample receiving part for receiving at least part of the sample, a microchannel including at least one reagent therein a pump for driving the reagent toward the sample, a detector for detecting a direct or indirect reaction, interaction or binding between the reagent and the analyte, and a connector for connecting the analysis device to a processing system, the connector permitting the processing system to control the analysis device and receive data from the analysis device, wherein, once the analysis device is loaded and connected to the processing system, the method, which is performed by the processing system, includes the steps of:

a) activating the pump such that the reagent is driven toward the sample;

b) receiving data from the detector indicative of a direct or indirect reaction, interaction or binding between the reagent arid the analyte; and

c) processing the data from the detector to provide an analysis result.

[0130] The processing system may be part of an electronic device with a display and the method may further include the step of displaying the analysis result on the display of the electronic device. The method may also further include the step of checking the position of the reagent in the microchannel using feedback from the detector. This step may ensure that the detector, or an associated illumination source such as an LED, is not inappropriately activated before the reagent has reached the sample, and can therefore aid in the prevention of invalid measurements being taken by the detector.

[0131] The method may further include the step of comparing the analysis result against a stored criteria to provide a diagnosis result. For example in obtaining a blood glucose result for a 25 year old male, the processing system may compare the result against a locally stored or cloud-based reference ranges for males of this age group, and then display the comparison to the user.

[0132] The method may further include the step of allowing a prescribed period to pass between mixing of the reagent and the analyte, and performing step b) ([0129] above). Once the at least one reagent and analyte have mixed, it may take time for a physical effect, detectable by the detector, to occur. Thus an incubation period may be used in some instances to reduce power wastage and ensure an accurate reading is taken by the detector.

[0133] Typically the connector is an audio jack. The audio jack may include left and right output channels, a ground, and an input channel. In such instances step a) ([0129] above) includes generating and transmitting an electrical signal to the pump via the left or right output channels, and step b) ([0129] above) includes receiving an electrical signal from the detector via the input channel of the audio jack. [0134] The method may also further include the step of activating an illumination source simultaneously or prior to receiving data from the detector. Typically an electrical signal is transferred via the left or right output channel to activate the illumination source.

[0135] The method may further include the step of activating the pump to flush the sample and reagents from the microchannel into a waste compartment. [0136] The processing system can implement a software application, such as an application for a mobile phone that enables an electronic device, which has a processing system, to perform the above described methods. The application may be for a smart phone or tablet, and would typically utilise the processing system of the smart phone or tablet to perform the above described methods. Alternatively, the processing system may be intrinsic to the device, and could be in the form of or include appropriate firmware.

[0137] In one example, the process is performed by one or more processing systems operating as part of a distributed architecture, an example of which will now be described with reference to Figure 2.

[0138] In this example, a base station 201 is coupled via a communications network, such as the Internet 202, and/or a number of local area networks (LANs) 204, to a number of processing systems 203. It will be appreciated that the configuration of the networks 202, 204 are for the purpose of example only, and in practice the base station 201 and processing systems 203 can communicate via any appropriate mechanism, such as via wired or wireless connections, including but not limited to mobile networks, private networks, such as an 802.11 networks, the Internet, LANs, WANs, or the like, as well as via direct or point-to- point connections such as Bluetooth, or the like.

[0139] In one example, the processing systems 203 can be coupled to an analysis device 110 and to the base station 20 l_r which can include a server 210 coupled to a database 211 (example server 210 and database 211 will be described with reference to Figure 3 below). The base station 201 can be used to assist in analysing data from the analysis device, generating indicators or the like. The processing systems 203 can also be adapted to analyse data and generate the indicators, or alternatively provide the data to the base station 201 for analysis. [0140] Whilst the base station 201 is shown as a single entity, it will be appreciated that the . base station 201 can be distributed over a number of geographically separate locations, for example by using servers 210 and/or databases 211 that are provided as part of a cloud based environment.

[0141] However, the above described arrangement is not essential and other suitable configurations could be used.

[0142] An example of a suitable server 210 is shown in Figure 3. In this example, the server 210 includes at least one microprocessor 300, a memory 301, an optional input/output device 302, such as a keyboard and/or display, and an external interface 303, interconnected via a bus 304 as shown. In this example the external interface 303 can be utilised for connecting the server 210 to peripheral devices, such as the communications networks 202, 204, databases 211, other storage devices, or the like. Although a single external interface 303 is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided.

[0143] In use, the microprocessor 300 executes instructions in the form of applications software stored in the memory 301 to allow analysis of data or the like to be performed, as well as to perform any other required processes, such as communicating with the processing systems 203. The applications software may include one or more software modules, and may be executed in a suitable execution environment, such as an operating system environment, or the like. [0144] Accordingly, it will be appreciated that the server 210 may be formed from any suitable server, or other suitably programmed processing system, such as a PC, web server, network server, or the like. In one particular example, the server 210 is a standard server such as a 32-bit or 64-bit Intel Architecture based server, which executes software applications stored on non- volatile (e.g., hard disk) storage, although this is not essential. However, it will also be understood that the server could be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement. [0145] As shown in Figure 4, in one example, the processing system 203 includes at least one microprocessor 400, a memory 401, an input/output device 402, such as a keyboard and/or- display, and an external interface 403, interconnected via a bus 404 as shown. In this example the external interface 403 can be utilised for connecting the processing system 203 to peripheral devices, such as the communications networks 202, 204, databases 211 , the analysis device 110, other storage devices, or the like. Although a single external interface 403 is shown, this is for the purpose of example only, and in practice multiple interfaces using various methods (eg. Ethernet, serial, USB, wireless or the like) may be provided.

[0146] In use, the microprocessor 400 executes instructions in the form of applications software stored in the memory 401 to allow communication with the base station 201, or analysis of data, displaying of indicators or the like.

[0147] Accordingly, it will be appreciated that the processing systems 203 may be formed from any suitable server, such as a suitably programmed PC, Internet terminal, lap-top or the like. More typically the processing systems 203 are in the form of portable devices such as hand-held PC, smart phone, PDA, or the like. However, it will also be understood that the processing systems 203 can be any electronic processing device such as a microprocessor, microchip processor, logic gate configuration, firmware optionally associated with implementing logic such as an FPGA (Field Programmable Gate Array), or any other electronic device, system or arrangement.

[0148] Examples of the process of using an analysis device will now be described in further detail. For the purpose of these examples, it is assumed that the server 210 maintains a user account including relevant information regarding the user, such as medical record information, or the like, which could be provided during a registration process.

[0149] It is also assumed that the server 210 interacts with a software application (e.g. mobile app) hosted by the processing systems 203, via a communications network, or the like, depending on the particular network infrastructure available.

[0150] To achieve this the server 210 of the base station 201 typically executes applications software for communicating with the software application (e.g. mobile app), analysing data or the like, with actions performed by the server 210 being performed by the processor 300 in accordance with instructions stored as applications software in the memory 301 and/or input commands received from a user via the I/O device 302, or commands received from the processing system 203.

[0151] It will also be assumed that the user interacts with the software application (e.g. mobile app) via a GUI (Graphical User Interface), or the like presented on the processing system 203. Actions performed by the processing system 203 are performed by the processor 400 in accordance with instructions stored as applications software in the memory 401 and/or input commands received from a user via the I/O device 402. [0152] However, it will be appreciated that the above described configuration assumed for the purpose of the following examples is not essential, and numerous other configurations may be used. It will also be appreciated that the partitioning of functionality between the processing systems 203, and the base station 201 may vary, depending on the particular implementation.

[0153] An example of a method of using a diagnosis system will be described in more detail with reference to Figure 5. For this purpose, it is assumed that the processing system 203 is in the form of a mobile phone or other communications device that communicates with a server 210, allowing the process to be performed in a distributed fashion. However, it will also be appreciated that this is not essential, and alternatively, the process could be performed in a standalone device, in which case steps performed by the server 210, will instead be performed locally within the processing system 203. Additionally, the processing system 203 could be integrated into the analysis device 110 as previously described.

[0154] In this example, at step 500 a sample is collected from the user. This may be achieved utilising known sampling techniques, and can include collecting a saliva, blood sample or the like. At step 510 the sample is analysed using the analysis device. In particular, the sample is inserted into the inlet of the analysis device 1 10, with the analysis device 110 being controlled by the processing system 203, thereby allowing the sample to be analysed. The specific sequence of events will depend on the specific implementation of the sampling device, and an example will be described in more detail below. ^{^}[0155] At step 520, the processing system 203 receives data from the analysis device 110. The data would typically be indicative of a concentration of analyte within the sample. The exact nature of the data will depend on the particular sensing mechanism used and could include for example, colorimetric information or the like. In one example, the detector senses a colour of the sample after this has reacted with one or more of reagents, with this being indicative of the analyte concentration. Thus, the data received from the analysis device may include colour information, such as RGB data, HSI data or the like.

[0156] At step 530, in this example, the processing system 203 provides the data to the server 210 together with an identifier. The identifier is typically indicative of an identity of the analysis device and can be used by the server 210 to ascertain the type of test being performed. Thus, in one example, each type of analysis device 110 will have a respective identifier, with this being used by the processing system 203 and/or server 210, to determine the test which has been performed.

[0157] The identifier may be embodied as coded data on the analysis device housing, and could be either manually readable, such as an alpha-numeric code, or could be machine readable, such as a barcode, QR code or the like, allowing this to be detected utilising a sensor such as a barcode scanner, or imaging device such as a camera forming part of the processing system 203.

[0158] The identifier can also be indicative of an identity of the user, allowing the processing system 203 or server 210 to further identify the user on which testing is being performed. For example, a user may order a number of analysis devices, each of which is a single use disposable device provided by a supplier. Each analysis device can have a unique identifier, which is used not only to identify the nature of the test being performed, but which is also associated with the user that has ordered the device. This association can be stored in the database 211, allowing the server 210 to subsequently identify the user from the identifier. It will be appreciated that this allows the user to be identified without the user having to provide any information and independently of the processing system 203 used.

[0159] At step 540 the server 210 uses the identifier to determine the test being performed, which in turn can be used in analysing the data received from the detector. Thus, if the test is a glucose test, the analysis of data will be different from if a test is a cholesterol test or the like. Accordingly, the server 210 accesses the database 211 and uses the identifier to determine type of test being performed and the associated data analysis is required. At step 550, the server 210 utilises the test and data to determine an analyte concentration. Thus the server 210 will interpret the colour information and use this to determine the relative abundance of the analyte in the sample. [0160] At step 560 the server 210 determines an indicator at least in part using the analyte concentration. The indicator can be of any suitable form and in one example could simply include an indication of the analyte concentration. Thus, in the case of a diabetic, the user may be familiar with the meaning of glucose concentration level, in which case a numerical indication of the glucose level could be returned to the processing system 203, allowing this to be displayed to the user at step 570.

[0161] However, more typically additional processing may be performed in order to provide greater clinical guidance. This could include for example, indicating whether a diabetic needs an insulin injection or other intervention.

[0162] As part of this process, the server 210 may access medical information regarding the user. This can be achieved utilising the identifier to access stored medical information in the database 211, such as a medical record or the like. This additional information can be utilised in interpreting the analyte concentration. For example, this could be used to determine whether there has been an increase or decrease in the analyte concentration over time allowing the indicator to be generated. [0163] As part of this process, the server 210 may also compare the determined analyte concentration to one or more thresholds with the outcome of the compressor being used to generate the indicator. Thus, for example, the server 210 may determine a "normal" range of analyte concentrations based either on previous measurements for the user, or alternatively derived from a reference population. In the event that the concentration is outside the normal range, an indicator in the form of a notification of intervention could be generated.

[0164] At step 570 the server 210 transfers the indicator to the processing system 203 allowing this to be displayed to the user. [0165] Accordingly, in the above described example, a software application (e.g. mobile app) installed on the user processing 203, such as a mobile phone or the like, can be used to communicate with a remote server, for example situated in a cloud based environment, allowing detailed analysis of the analyte concentration to be performed. During this process, the unique identifiers can be used to identify the user, thereby ensuring privacy requirements are met. This also allows complex analysis to be performed which may not otherwise be feasible utilising a mobile phone or similar processing system 203. Additionally this further has the benefit that any required information can be stored and updated centrally, meaning the user can perform the above designed process using any processing system 203 and it is not required that they are using their own processing system. However, as previously described, the above steps could be performed locally within the processing system 203, which could be part of or coupled to the analysis device 110.

[0166] In this regard, it will be further appreciated that when the analysis device connector includes a headphone jack plug, this can be utilised on any standard processing system, in particular any mobile phone. This advantageously allows the user to perform tests even in circumstances where they do not have access to their own processing system 203. In this instance, the user could simply borrow another individual's processing system 203, quickly install the software application (e.g. mobile app) and then perform the test.

[0167] Accordingly, it would be appreciated that above described process provides a simple mechanism allowing any individual to perform the test and without requiring access to any particular equipment other than the analysis device.

[0168] One exemplary embodiment shall now be described with reference to Figures 6 to 12.

[0169] This example describes a point-of-care self-administered subject monitoring system that integrates a disposable analysis device (DAD) with a subject's portable communication device such as a smart phone, or tablet. The subject's portable communication device is such that it is able to transmit and receive data to other processing systems as part of a Wide Area Network (WAN) or wireless network, for example a cloud based environment. However, it will be appreciated that similar techniques could also be applied to integrated and/or reusable devices, in which only reagents are replaced and the detector and any associated electronics are re-used. [0170] In brief, to take a measurement, the DAD, which is pre-configured for a particular analytical test, is connected to the portable communication device. A subject sample (e.g. blood) is collected and inserted into an inlet of the DAD, which is then activated via a mobile application downloaded onto the portable communication device. A measurement is taken, and data indicative of that measurement is received by the portable communication device. The data may be either displayed to the subject or transmitted to a cloud based server for comparison against a reference range, or after analytics.

[0171] In one example, the DAD is a single-use disposable device, specifically built for a particular test and/or diagnostic measurement. The reagents and/or compounds for a particular biochemical analytical test are preloaded within one or more microchannels of the DAD and the housing is constructed such that it ensures a self-contained, inert internal environment protected from environmental or accidental contamination. The sample and/or reagents are thus protected from hygroscopic, light, or atmospheric degradation and other byproduct contamination from mishandling, to ensure the bio-chemical analysis is accurate and reliable. However, as previously mentioned, this is not essential, and alternatively, the reagents could be provided as part of a replaceable component, such as a test tube, strip, or pad, which could be exposed to the sample, and then provided to the detector allowing a colour change, or other suitable reaction to be determined.

[0172] In more detail (as shown in part by the flow diagrams of Figures 7 and 9), the subject or consumer, with or without the aid of a medical professional (e.g. doctor or nurse) obtains a disposable analysis device (601) and connects it to their smart phone (602), tablet or other portable communication device. The DAD is selected dependent on the ailment of the subject and/or the diagnostic test required. It will be appreciated that there may be variety of different types of DADs each constructed and/or configured differently, with different components, depending on the analyte to be detected. [0173] To activate/operate the DAD, the subject downloads a mobile application that configures his/her portable communication device such that it is able to communicate, control and/or power the DAD. Each DAD has a specific use, for example, one DAD may be purchased to test for Hand Foot and Mouth Disease (HFMD), whilst another may be purchased to test blood glucose levels. [0174] An identifier corresponding to the type of DAD, usually a QR code (alternatives may include bar code, 2-D bar code, biometric data, or alphanumeric code) is incorporated on the DAD or on the packaging of the DAD. Using the smart phone or tablet, the subject scans/inputs the identifier code at step 700, so that the downloaded mobile application is configured for that particular type of DAD. Once the DAD is connected, the mobile application activates, communicates with the device, and begins a fail-safe process to ensure the DAD connected corresponds to the scanned QR code or a subject's inputted selection at step 710 and if not the user is prompted at step 720 to check the QR code and DAD correspond to each other, for example allowing the correct code to be scanned or correct DAD to be connected. As part of this process the software application (e.g. mobile app)can look up a DAD type corresponding to the code, for example by querying a server or internal records.

[0175] At step 730, the downloaded application may also communicate with a cloud based database to identify whether a particular subject is using a DAD and/or the mobile application for the first time. This may be achieved by utilizing a user/user ΡΓΝ (User ^" Personal Identification Number), mobile device identification, phone number, biometrics or other identification record.

[0176] If a DAD or a mobile applications is being used for the first time, the mobile application is updated to the latest version at step 740 and new records created (for the particular subject/device etc) in the cloud based database. This first time usage is recognised and the application updated if necessary and then launched at step 750.

[0177Γ Generally only a single mobile application is required and used for all DAD devices. However, it will be appreciated that there may be separate particular mobile applications that correspond to particular DAD devices.

[0178] Instructions on how to operate the DAD may be found on its packaging and/or step by step instructions with photos may be shown on the user interface of the portable communication device, using the mobile application.

[0179] Following these instructions at step 760, the subject/consumer collects a sample at step 770, with the sample being mserted into an inlet of the DAD. The sample may, for example, be saliva, urine, blood, sweat, food (eg fish, milk, meat, egg, peanuts etc), tears and/or hair (e.g. when looking for drug abuse). A sample collector may be used to facilitate sample collection, and may include a lancet to pierce the subject's skin. It will be appreciated that the DAD may also be used to analyse clinical samples.

[0180] The sample is spontaneously taken up by the inlet device on the DAD in a single step. Some particular DADs may require loading test strip depending on the best diagnostic methodology. A test strip would also be receivable in a single step.

[0181] The mobile application prompts the user for confirmation to proceed with performing the analysis and, once confirmation is received the sample is read at step 780, as will be described in more detail below. [0182] The DAD conducts the biochemical procedure for the analysis within the housing and measurements taken from an internal detector are converted via algorithms into data that is then sent via a headphone jack to the portable communication device for display to the user. Subsequently or simultaneously, the data may also be transmitted via the internet to a cloud based server for comparison with stored criteria, such as stored reference ranges. [0183] Indicator results in the form of reports, graphs, or charts may be returned to the screen of a user's smart phone or tablet in real-time for viewing. Relevant voice recordings, videos or tables or hyperlinks may also be provided to the user. With the subject/user's permission, a data record for the subject may be kept on the cloud based server and may be accessible by the subject or doctor at anytime and anywhere to observe historical trends, reports, benchmarks and patterns in the subject's disease profile.

[0184] Following completion of the process, the used DAD can be disposed.

[0185] A typical DAD device will now be described in more detail with reference to Figure 8.

[0186] The device 801 includes a microchannel 802 preloaded with a reagent 803 and a wash buffer 804. A pump 805 controls movement of fluid through the microchannel 802 and is configured to drive the reagent and the wash buffer toward the colorimetric detector 806. In this regard, the sample is typically mixed with reagent and a reaction, interaction or binding between the reagent and the analyte causes a colour change (or other detectable effect), which can be detected by the colorimetric detector. In this regard, the colorimetric detector 806 can have an associated illumination source 809, which in this example is in the form of an LED, positioned at an analysis portion 808 of the microchannel 802, allowing the sample to be exposed to illumination and assist with detection of the colour change. [0187] In use, a sample from the user is received in the inlet 807, which in this instance, is an extension of the microchannel 802. A one way valve may be utilised to maintain the sample within the microchannel after it is loaded in the inlet. The sample is transported to the analysis portion 808 of the microchannel, which is positioned between the detector 806 and corresponding illumination source 809. This can be achieved by operating the pump to draw the sample in, or alternatively might happen through diffusion, capillary action or another transport mechanism.

[0188] The DAD 801 includes a headphone jack connector 810 for connection to the headphone socket of the smart phone, tablet or other potable communication device. The headphone jack includes a left and right output channel 811, 812, an input (mic) channel 813 and a ground channel 814. The processing system of the smart phone or other portable communication device transmits signals that controls and powers the components of the DAD 801 via these connections.

[0189] For example, in the configuration as shown, signals for controlling the pump are sent by the right channel 812, and signals for activating the illumination source (LED) are sent through the left channel 811. Signals from the detector are received via the input (mic) channel 814. There is also a feedback 815 loop from the detector leading back to the pump 805 which can be utilised in positioning of the reagent. It will be appreciated that alternate connection configurations may be used between the DAD and processing system of the portable communication device depending on internal structure and components of the DAD, and the type of connector used to link the devices.

[0190] The DAD may also include a waste chamber 816 to receive the sample and reagents after the test has completed. The waste chamber may include chemicals that either preserve the sample for re-use or destroy the sample for privacy. [0191] Example operation of the DAD of Figure 8 will now be described with reference to Figure 9.

[0192] In this example, at step 900 the sample is initially loaded, for example at step 770 of the above described process. In this example, the sample includes a bodily fluid, such as blood, urine, saliva, etc, which is sucked into the microchannel via natural capillary force with a controlled volume, such as 5-10μί. In this regard, it will be appreciated that the presence of fluid in the microchannel can be used to control the amount of the sample which can be received.

> [0193] At step 910 there is a 5 to 10 min pause to allow for incubation, and in particular for binding of analyte to a capture agent provided in the analysis portion 808 of the microchannel 802.

[0194] At step 920, either right or left channels are used to apply voltage (DC or modulated AC) to the electrode of the pump to move the preloaded wash buffer to start a washing process (10 sec). In the current example, this includes applying a voltage >3V to the left channel. [0195] At step 930, either the left or right channels are used to apply voltage (typically >3V DC or modulated AC) to the electrode of the pump to move the preloaded reagent to the analysis portion 808. This typically requires pump operation for approximately 3 sec, but it will be appreciated that this will depend on the position of the reagent in the microchannel.

[0196] During this process, the detector 806 is used to detect a colour change to identify if the reagent has reached the analysis portion at step 940. In particular, position checking can be provided by a feedback loop from the microchannel using a photoelectric method to confirm the position of the reagent in real time. In the event that the reagent is not in position, pumping continues until this occurs.

[0197] At step 950, the reagent and sample are incubated for an incubation period to allow for colorimetric results to be visualised. This is typically approximately 5 to 10 min, but may vary depending on the test being performed. [0198] At step 960, the LED light is activated on the basis of signals from either the right or left channel (DC or modulated AC) and reading of analog signal from the detector via the microchannel conducted simultaneously to allow for detection of the colour of the reagent and sample.

[0199] At step 970, data in the form of a voltage obtained from the detector 806 is received by the software application (e.g. mobile app)and analysed to determine an actual concentration of analyte. This can involve using data fitting techniques, for parameter analysis or the like, ensuring an accurate concentration is determined.

[0200] At step 980, an indicator, including an actual concentration or representation such as a chart or the like, can be displayed on a graphic user interface of the software application (e.g. mobile app), with this information also simultaneously being provided to a cloud-based server.

[0201] At step 990, the pump is activated, for example by applying a voltage to the same channel as in 930, flushing remaining reagents and user's sample into the waste chamber 816, to thereby eliminate all personal data, before the DAD is disposed. This can be performed concurrently with the analysis and display performed during steps 970 and 980 as shown, or alternatively could be performed once this has been completed.

[0202] As would be appreciated, the analysis portion/microchannel arrangement may vary between particular DADs. One particular arrangement is shown in Figure 10A . Here the DAD includes two reagents A, B positioned in separate microchannels 1001, 1002, which feed into a primary microchannel 1003 for mixing with the analyte. The analyte may react with both reagent A and reagent B, or a product thereof, to cause a colour, change that is detected by a colorimetric detector. Such an arrangement^" is typical for enzymatic type analysis.

[0203] The microchannel arrangement in Figure 10B is different and is particularly suited to immunological testing. Here a capture agent (for example, an antibody, antigen or protein receptor) is coated to an inner wall of the microchannel 1101 and, alternatively or additionally to a filler material 1102. The capture agent has an affinity for the analyte and binds the analyte, immobilising the analyte in the microchannel 1103. The reagents A and B are positioned in series within a single microchannel 1103. To mix with the analyte, the reagents are then flushed in sequence over the analyte. The colour change may be the result of binding or a reaction with analyte. It may also be the case that the bound reagent is a fluorescent or phosphorous compound which is subsequently stimulated to be detected by an appropriate detector. [0204] The use of a filler material extends the surface area for the capture agents and therefore the amount of bound analyte. It therefore shortens the time taken for the test when compared to conventional enzyme-linked immunosorbent assay (ELISA) techniques. Current ELISA sample-to-result time is approximately 40 - 60 minutes for blood and urine assays, and 60 - 90 minutes for a saliva assay. The presently described analysis device seeks to achieve a sample-to-result time of 10 - 15 minutes.

[0205] In addition to the use of a filler material, increasing the performance of the reagents' action may also be achieved by other means, such as by using other components of the portable communication device. For example, vibration mode of the smart phone may be operated, as well as heat sinks or heating elements. For power, solar energy conversion and electrical pulses/charging (contact or contactless) may be utilised.

[0206] The DAD 's integration to a portable communication device allows it to harvest the electrical energy therefrom, for its operation (e.g. of the pump) and for transmitting and receiving digital data (e.g. from the detector). It will be appreciated that in addition to an audio jack connection the DAD may receive power and/or be controlled by the portable commumcation device via other connection types such as via USB, Blue-tooth, touch-screen, voice activated receivers, flashlight connections, Near Field Communication (NFC) and RFID activations.

[0207] The software's algorithms manage the process and convert the analog signal from the detector to digital data and subsequently a cloud based processing system. [0208] The system performs the diagnostics, testing, measurements and provides digital readings that are reliable, accurate and quantifiable. Essentially, the point-of-care (POC) system brings the medical laboratory in a clinical environment to a point of care and provides the same level of analysis and tests using the same parameters. Thus, the subject monitoring system can restructure healthcare for firstline users (consumers)., For certain testing eg restructure for some infections or diseases, such as Dengue Fever, qualitative tests providing Yes/No test results and readouts are also covered and available.

[0209] It is envisaged that the monitoring system could produce results, analytics, reports, videos, voice-recorded messages, graphs, screen shots, pictures, drawings and even recommendations and hyperlinks to web-sites for related health information etc.

[0210] First line users could be a school, a military base etc to monitor or prevent spread of epidemics.

[0211] Another possibility is that when sufficient data is collected, the mobile application could also provide the outputs using the same mobile phone's processor, making it a self- contained Total-Testing Diagnostic and Reporting device. Similarly, data transfer could be in un-compressed or compressed forms depending on size and scale of data files.

[0212] It will be appreciated that the user gets results back in real-time (from the 2nd Processor i.e. Cloud Server, in this illustration)^ say within a few minutes. Real-time may be defined as on-going process but has a user's expectation of not having to wait too long. (e.g. approximately 10-15 minutes) The user can then discard or recycle the DAD. The user can now read, interpret, or get consultation or recommendation from the results or diagnosis as the results may be stored on the mobile device or cloud based processing system.

[0213] In combination with the DAD, the cloud-based linkage capability serves to provide first a line medical support system, and a subject monitoring system. [0214] Using this POC system, a wide array of self- administered medical tests can be made available to large numbers of consumers, thereby effectively restructuring the medical care system to a POC self-administered one. In this regard, it is likely that a Pareto-principle will result in a large number of tests falling into the category of an acceptable or manageable range i.e. does not lead to a health crisis, or there is no need for immediate medical attention. Thus this first line healthcare approach may, in one aspect, be seen as a screening system to prevent or reduce wastage or inefficiency in the medical healthcare system. [0215] For illustration purposes, the test results may provide quantitative readings or qualitative ones such as, "Yes/No" or "Pass/Fail" or "Green/ Amber/Red" etc and may be categorised into any one of a range of possible categories of recommendations/results.

[0216] For example the recommendations may include:

a) Continue Monitoring (where a Pareto Principle 80/20, majority will fall into this category).

b) Consult a Doctor.

c) Get Immediate medical attention.

d) Call a Doctor hotline.

e) Call a Doctor for diagnosis consultation.

f) Make an appointment with a Doctor.

g) Learn more (voice recordings, hyperlinks etc)

[0217] The option to call a doctor may include direct activation from within the mobile application to Skype, Online, Voice call, text-based and other digital communication in seeking to open real-time dialog between a doctor/medical professional and the consumer/subject for consultation / diagnosis.

[0218] The consumer/subject is encouraged to utilise the full functionalities of the IoT (Internet of things) applications and other network and/or medical support services, provided under a cloud functionality management system, as shown in Figure 12. Through the use of realtime data, analytics and data mining techniques, subject interaction would facilitate and support benchmarking, determination of norms and standards, statistical values, and concept hierarchies etc. All these could be used to provide invaluable information to healthcare professionals when diagnosing users' results with other biometric information.

[0219] In addition to the ability to collate large amounts of data, and real-time data, the significance of GPS locations of mobile phones is clearly invaluable in the understanding and provision of location-based medical attention to address the spread of diseases. For example, this functionality could be accessed anywhere in the world as it is cloud-based, bringing the mobile devices in direct linkage. For example, portable communication devices utilizing the cloud management system could upload their GPS coordinates along with diagnostic results. This would allow functionality such as monitoring the spread of disease, or the prevalence of diseases in a certain geographic population. An overview of a Wide Area Network / Wireless Network utilizing the devices of the present system is shown in Figure 11.

[0220] It will also be appreciated that the cloud's database or any databases in which a user record is kept can provide a historical data record of past measurements or results. This allows and provides opportunities for data analytics, data mining and monitoring of trends for user's improvements or deteriorations. - .

[0221] Furthermore, records of actions and even notifications may be sent to a subject's device (e.g. smart phone or tablet) as part of the point-of-care healthcare system. Unlike when using load physical servers, connecting to local physical networks, the cloud-based system described, that can be integrate with the DAD device, can be virtually linked/connected to/from anywhere in the world with today's IoT applications easily providing superior care services, health data and information beyond traditional networks.

[0222] There may be services such as notifications or reminders for testing, scheduled medicine consumption for a third-party, such as a family-member or doctor. For example if a scheduled test is taken, an automatic notification could be sent to the subject's GP alerting the GP of the results.

[0223] One particular advantage would be the ability to integrate with a country's National Healthcare Information System or particular medical specialist centers. This can happen in several ways, for example:

• When a user sees a doctor, his historical tests/diagnoses could be accessed with .._.. permission, m a hospital environment, subjects' historical results and trends could be retrieved to supplement subject database records to further facilitate diagnosis and care.

• A user can perform the analysis test using the DAD (or other analysis device as described herein) by himself/herself before visiting the doctor. Costs are saved if there is no necessity to visit the doctor.

• With a user's permission, the National Healthcare body can get access to test results and trends. [0224] Utilizing the DAD and the cloud based management system, global organizations such as the World Health Organisation can quickly monitor pandemics as, for example, mobile devices are GPS enabled and location services can be used to monitor the geographical spread of disease.

[0225] In remote areas such as outlying villages and rural towns where professional help and care are not conveniently or physically close, the DAD can provide a significant first line healthcare assistance because of its portability, reliability and ease of use. Travellers anywhere in the world can get access to their historical test results with mobile phone access or conduct self-tests anytime and seek medical advice online or via phone access with their doctor.

[0226] The POC subject monitoring system would allow the use of analytics and data mining of test results, benchmarking etc. to provide preventive health care such that users may, if desired, obtain information on relevant health concerns, doctors and treatments, information on national health care services and subsidies, and the availability or sale of generic medicine with the help of the national body or hospitals, etc. Other information could be obtained such as biometrics, demographics and other lifestyle activities to further provide analytics for preventive care.

[0227] It will be appreciated the above described services, products and applications may be provided by the cloud functionality management system, as described herein and are assisted by a range of factors including:-

• The exploding ownership of smartphones and other mobile and portable electronic devices. ^'

» A disposable analysis device (DAD) as described herein can provide a reliable and accurate diagnostic device independent of the types of mobile phones and other mobile/portable devices. The device is also isolated and protected from accidental contamination and free from device variations.

• Cloud based functionality provides results in real time addressing a subject's need for an immediate result.

• Fail-safe, permission-based access and encryption provides reliability and provides user privacy. • Permission-based access also can allow subject care to be a superior step-up when information is shared with care givers, doctor and hospitals, to provide tailored and superior healthcare.

• It is cheap relative to expensive laboratory tests. Essentially, the DAD brings the laboratory tests to the user in realtime and connects to a cloud-based functionality management system to really enhance healthcare management.

. · First line Subject/User self-administered tests provide cost savings and better allocation of scarce healthcare resources in any country.

• Cloud-based technology and Internet of Things (IoTs) applications allow networks to be formed anywhere in the world and access any place and anytime via mobile phone.

[0228] The analysis devices and diagnostic systems as described herein provide a number of advantages over existing systems such as, for example:

• They are cheap relative to laboratory tests, and results may be received in realtime (10 - 15 minutes as opposed 1 hour to 7 days). Can also utilise user phone data plan and the only cost is disposable analysis device.

• Can leverage off existing portable communication device components, e.g. to provide power to analysis devices and/or to accelerate reaction rate.

• They are able to test both Enzymatic and ELIS A diagnostics, and make available thousands of tests at POC. Over 1000 tests with established protocols using 2 reagents in most test kits. They can also accommodate more than 2 reagents.

• They are simple, and for example:

o Incorporate a Fail-safe to check to ensure the right device is used

o Allow a user to test a wide range of substances such as urine, saliva, tears, sweat, blood (painless lancet), food (e.g. fish, meat, milk, egg, peanuts etc) and hair (e.g. for drug abuse)

o Are easy to use: sample inlet and spontaneously loaded. ^; ■ o Can provide clinical samples testing for all the above areas.

• Headphone jack is universal, independent of the different brands and models of portable devices, although other input/out connection means can potentially be used. • Cloud based technology permits access anywhere at any time. Also permits the development of a significant Healthcare Information System that have long- tail commercial and marketing models.

• Easy distribution via government-backed and/or commercial distribution channels.

• Provide a concrete and significant restructuring opportunity to the Healthcare system from the traditional to one with POC Subject Self administration as the front line. For example, a possible healthcare system using the POC subject monitoring system could provide :- o government subsidies

o no queue at hospitals and clinics

o less unproductive visits

o immediate results on health concerns

o monitoring - self, shared, notified

o integration to National Healthcare System

o may be able to lower insurance cost

o privacy.

• Ability to Encrypt data for transmission - provides security and privacy.

[0229] As described the concept brings a high bio-tech product leveraging and integrating with the growing smart mobile devices by bringing a test laboratory to a Point-of-Care so that a subject can self-administer numerous diagnostics and tests to deliver quantifiable and accurate results at a fraction of the cost in realtime and utilizing cloud technology, analytics and data mining to provide enhancement to targeted care management.

[0230] The system provides an analysis device that incorporates mobile hardware, data transfer, biological, fluidics, chemical reactions and colorimetrics, electrical harvesting and electronics, detection tools and algorithms.

[0231] In one example, the analysis device can be a single use disposable device incorporating a detector and associated electronics, as well as reagents required to perform specific tests. In this instance, the analysis device is typically coupled to a separate processing system, allowing interpretation of results to be performed based on data received from the detector. In this instance, the processing system can advantageously be a commercially available device, such as a mobile phone, tablet or the like, adapted to perform analysis using specific software applications installed thereon. Additionally and/or alternatively, the processing system could communicate with a remote server allowing further processing, analysis or storage of results to be performed. In this example, the analysis device is typically straightforward and cheap to manufacture, allowing this to be used as a disposable single-use device, whilst minimising the size of the device by using separate processing capabilities.

[0232] In another example, the analysis device incorporates processing system functionality, such as an integrated processing device, FPGA or the like. In this instance, the analysis device can incorporate all functionality required in order to perform a test and could therefore include a display, input/output, or the like. In general, this will make the analysis device larger and more expensive to manufacture, but avoids the need for a separate reading device. In this example, the analysis device typically uses a reusable component incorporating reagents, such as a test tube, pad or strip, allowing this component to be replaced as required.

[0233] In summary the point of care subject monitoring system may include the following features:

a) Headphone Jack to insert to mobile devices

b) Mobile application to give instructions, fail-safe checks, receive reports, etc, offer options for other services

c) Disposable or reusable analysis device - proprietary micro-channel, software, energy (electrical) harvesting, electronic measurement and algorithm for converting analog data to digital data, transmitting via ear-jack

d) Large range of analysis devices

e) Reports, charts, graphs, pictures and photos

f) Standardization and calibration

g) Bio-tech - size reduction, concentration, coating

h) Reagents - commercially available, protocols established

i) Colorimetric test - achieve consistency, reduce significantly in size

j) Novel architecture to increase reaction rate to get quick test results in minutes k) Algorithm - conversion analog to digital, operating system 1) Encryption - data security and user privacy

m) A recommendation system for recommending appropriate medical care according to diagnostic recommendation categories to enhance the first-line consumer medical care system.

[0234] This system has particular advantages over existing devices which have deficiencies. For example, sensor-based devices have very limited range; heart rate, sugar level, blood, pressure, cholesterol, moods, stress levels, body temperature. The HIV test is limited as it is an oral swap kit without electronic components.

[0235] As previously noted, camera-based smartphones with mobile phone apps have wide variations and do not provide the accuracy required. [0236] Optional embodiments of the present invention may also be said to broadly consist in the parts, elements and features referred to or indicated herein, individually or collectively, in any or all combinations of two or more of the parts, elements or features, and wherein specific integers are mentioned herein which have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0237] It will be appreciated that various forms of the invention may be used individually or in combination.

[0238] The term subject includes any living system, and in particular can include human, or non-human subjects. Thus, whilst the above examples have focussed on a subject such as a human, it will be appreciated that the apparatus and techniques described above can be used with any animal, including but not limited to primates, livestock, performance animals, such as race horses, or the like.

[0239] Throughout this specification and claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers or steps but not the exclusion of any other integer or group of integers. [0240] Persons skilled in the art will appreciate that numerous variations and modifications will become apparent. All such variations and modifications which become apparent to persons skilled in the art, should be considered to fall within the spirit and scope that the invention broadly appearing before described.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS: 1) An analysis device for detecting an analyte from a sample, the analysis device including: a) a housing having an inlet for receiving at least part of the sample; b) a detector for detecting the analyte directly or indirectly; and c) a connector that operatively connects the analysis device to a processing system to allow the processing system to: i) control the analysis device; ii) receive data from the detector; and, iii) determine an indicator at least partially based on the data. 2) An analysis device as claimed in claim 1, further including at least one reagent, wherein the detector detects, directly or indirectly, a reaction, interaction or binding between the at least one reagent, or a derivative thereof, and the analyte. 3) An analysis device as claimed in claim 2, wherein the at least one reagent is an enzyme. 4) An analysis device as claimed in any one of the claims 1 to 3, further including a microchannel extending from the inlet to the detector, the microchannel being used to transport at least part of the sample from the inlet to the detector. 5) An analysis device as claimed in claim 4, wherein the detector is positioned to detect analyte at an analysis portion of the microchannel. 6) An analysis device as claimed in claim 5, wherein the analysis portion includes an immobilised capture agent for binding the analyte. 7) An analysis device as claimed in claim 6, wherein the capture agent is an antibody or antigen. 8) An analysis device as claimed in claim 6 or claim 7, wherein the capture agent is immobilised on an inner wall surface of the microchannel. 9) An analysis device as claimed in any one of the claims 6 to 8, wherein the analysis , portion includes a filler material, and the capture agent is immobilised on the filler material. 10) An analysis device as claimed in claim 9, wherein the filler material includes at least one particle, bead, fiber, paper strip or combination thereof. 11) An analysis device as claimed in claim 10, wherein the filler material is a porous material. 12) An analysis device as claimed in any one of claims 4 to 11, wherein the at least one reagent is located in the microchannel. 13)An analysis device as claimed in any one of claims 4 to 12, further including a pump for driving fluid in the microchannel toward the analysis portion. 14) An analysis device as claimed in any one of claims 4 to 13, wherein the at least one reagent is positioned in the microchannel upstream from the analysis portion. 15) An analysis device as claimed in any one of claims 4 to 14, further including a wash buffer positioned in the microchannel between the reagent and the analysis portion. 16) An analysis device as claimed in any one of the preceding claims wherein the connector is an audio jack. 17) An analysis device as claimed in claim 16, wherein the processing system generates signals and provides the signals to the audio jack, the signals being for at least one of controlling the analysis device and supplying power to the analysis device. 18) An analysis device as claimed in claim 17, wherein the analysis device scavenges power from the signals. 19) An analysis device as claimed in any one of the claims 16 to 18, wherein the audio jack is a headphone jack. 20) An analysis device as claimed in any one of the claims 16 to 19, wherein the audio jack includes first and second outputs, a ground and input connections, and wherein in use, the processing system: a) provides a pump control signal via a first output for controlling a pump; b) provides an illumination source control signal via a second output for controlling an illumination source c) receives signals from the detector via the input. 21) An analysis device as claimed in any one of the preceding claims, wherein the detector is a colorimetric detector. 22) An analysis device as claimed in any one of the preceding claims, wherein the device is a single use device. 23) An analysis device as claimed in any. one of the preceding claims, wherein the processing system is at least one of: a) part of a separate electronic device; b) part of the analysis device; and, c) part of an embedded system. 24) An analysis device as claimed in any one of the preceding claims, wherein the processing system is part of a portable communication device. 25) An analysis device as claimed in claim 24, wherein the portable communication device is smart phone or tablet. 26) An analysis device as claimed in claimed in any one of the preceding claims wherein the device includes a plurality of microchannels. 27) An analysis device as claimed in any one of the preceding claims, further including a sample collector 28) An analysis device as claimed in any one of the preceding claims, wherein the sample is or is derived from at least one of: a) bodily fluid of a subject; b) bodily tissue of a subject; and, c) food stuffs. 29) An analysis device as claimed in any one of the preceding claims, further including a test strip receiving portion. 30) An analysis device as claimed in any one of the preceding claims, wherein the indicator is indicative of a presence, absence or concentration of the analyte. 31) An analysis device as claimed in any one of the preceding claims, wherein the processing system: a) compares the indicator to stored criteria; and b) generates an output based on the results of the comparison. 32) A diagnostic system including : a) an analysis device for detecting an analyte from a sample of bodily fluid or tissue, the analysis device including: i) an inlet for receiving at least part of the sample; ii) a detector for detecting the analyte directly or indirectly; and iii) a connector for connecting the analysis device to a processing system; and, b) a processing system, the connector thereby permitting the processing system to: i) control the analysis device; and ii) receive data from the analysis device. 33) A diagnostic system as claimed in claim 32, wherein the connector is an audio jack. 34) A diagnostic system as claimed in claim 33, wherein the audio jack is a headphone jack. 35)A diagnostic system as claimed in claim 33 or claim 34, wherein the audio jack includes left and right output channels, a ground and input channel. 36) A diagnostic system as claimed in any one of the claims 32 to 35, wherein the analysis device further includes: a) a microchannel including at least one reagent therein; and b) a pump for pumping the reagent in the microchannel toward the detector, wherein the inlet is such that a received sample is positioned to come into contact with the at least one reagent. 37) A diagnostic system as claimed in any one of the claims 32 to 36, wherein the pump is powered and/or controlled by the processing system at least in part via one of left or right output channels of an audio jack. 38) A diagnostic system as claimed in any one of claims 32 to 37, wherein the analysis device further includes an illumination source, and the illumination source is powered and/or controlled by the processing system at least in part via one of the left or right output channels of the audio jack. 39)A diagnostic system as claimed in any one of claims 32 to 38, wherein the processing system receives data from the detector at least in part via the input channel of the audio jack. 40) A diagnostic system as claimed in any one of claims 32 to 39, wherein activity of the pump is influenced by electrical feedback directly from the detector. 41)A diagnostic system as claimed in claim any one of claims 32 to 40, wherein the processing system is part of an electronic device. 42) A diagnostic system as claimed in claim 41, wherein the electronic device includes an audio socket. 43) A diagnostic system as claimed in claim 41 or claim 42, wherein the electronic device is a portable communication device. 44) A diagnostic system as claimed in claim 43, wherein the portable communication device is a smart phone or tablet. 45) A method of operating a diagnostic system, the diagnostic system including: a) an analysis device for detecting an analyte from a sample of bodily fluid or tissue, the analysis device including: i) a sample receiving part for receiving at least part of the sample; ii) a microchannel including at least one reagent therein; iii) a pump for driving the reagent toward the sample; iv) a detector for detecting a direct or indirect reaction, interaction or binding between the reagent and the analyte; and v) a connector for connecting the analysis device to a processing system, the connector permitting the processing system to:

(1) control the analysis device; and

(2) receive data from the analysis device, wherein, once the analysis device is loaded and connected to the processing system, the method, which is performed by the processing system, includes the steps of:

(a) activating the pump such that the reagent is driven toward the sample;

(c) processing the data from the detector to provide an analysis result.

46) A method as claimed in claim 45, wherein the processing system is part of an electronic device with a display, the method further including the step of displaying the analysis result on the display.

47) A method as claimed in claim 45 or 46, further including the step of checking the position of the reagent in the microchannel using feedback from the detector.

48) A method as claimed in any one of the claims 45 to 47, wherein further including the step of comparing the analysis result against a stored criteria to provide a diagnosis result.

49) A method as claimed in any one of claim 45 to 48, further including the step of allowing a prescribed period to pass between mixing of the reagent and the analyte, and performing step v)(2)(b) of claim 45.

50) A method as claimed in any one of claims 45 to 49, wherein the connector is an audio jack and wherein the method includes step which includes receiving an electrical signal from the detector via the input channel of the audio jack.

51) A method as claimed in any one of the claims 45 to 50, wherein the step of activating the pump includes generating and transmitting an electrical signal to the pump via the left or right output channels. - 52) A method as claimed in any one of claims 45 to 51, wherein the method includes activating an illumination source simultaneously or prior to receiving data from the detector.

53) A method as claimed in claim 52, where an electrical signal is transferred via a left or right output channel of an audio jack to activate the illumination source.

54)A method as claimed in any one of the claims 45 to 52, wherein the method further includes the step of activating the pump to flush the sample and reagents from the microchannel.

55) A software application that enables an electronic device, which has a processing system, to perform the method of any one of the claims 45 to 54.

56) An application for a smart phone or tablet that utilises the processing system of the smart phone or table to perform the method of any one of the claims 45 to 54.

57) A method of monitoring the health of a subject, the method including the steps of:

a) collecting a sample body fluid or tissue from the subject;

b) inserting the sample into an analysis device as claimed in any one of claims 1-31 ; c) connecting the analysis device to a portable communication device;

d) transmitting an analysis result to a server for comparison; and

58) A method for monitoring the health of a population, the method including:

a) collecting a sample body fluid or tissue from at least one subject;

d) transmitting an analysis result to a server. „

59) A method as claimed in claim 58, wherein the method further includes the step of transmitting the details and location of the at least one subject to the server.

60) A method as claimed in claim 59, wherein the method includes storing the details, location and analysis result of the at least one subject.

61) An analysis device for detecting an analyte from a sample, the analysis device including: a) a housing having an inlet for receiving at least part of the sample;

b) a detector for detecting the analyte directly or indirectly; and

c) a processing system to:

i) control the analysis device; ii) receive data from the detector; and, iii) determine an indicator at least partially based on the data.