AU2018100803A4 - Activation apparatus and method for an assay device - Google Patents

Abstract

The present invention relates to the field of testing and measurement. In one form the invention provides an activation apparatus for an electronic assay device comprising: a sample port cover at one end thereof and; a formation at another end thereof, which is adapted for operative association with and control of a PCB detection circuit of the electronic assay device; wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB detection circuit and allow access to the sample port. Figure 4 LA LFLO AYS iP T TLIN Figure 4

Description

The present invention relates to the field of testing and measurement. In one form the invention provides an activation apparatus for an electronic assay device comprising: a sample port cover at one end thereof and; a formation at another end thereof, which is adapted for operative association with and control of a RGB detection circuit of the electronic assay device; wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB detection circuit and allow access to the sample port.

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2018100803 15 Jun 2018

AUSTRALIA

Patents Act 1990

PI/00/002 Regulation 3.2B

ORIGINAL

COMPLETE SPECIFICATION

INNOVATION PATENT

Application No.

Lodged: 15 June 2018 innovation Title: ACTIVATION APPARATUS AND METHOD FOR AN ASSAY DEVICE

The following statement is a full description of this innovation, including the best method of performing it known to the Applicant,

2018100803 15 Jun 2018

ACTIVATION APPARATUS AND METHOD FOR AN ASSAY DEVICE

RELATED APPLICATIONS [001] This application claims priority to Australian Provisional Patent Application No. 2017902281 in the name of LUMOS Diagnostics Pty Ltd (formerly NPLEX Pty Ltd), which was filed on 15 June 2017, entitled “Activation Apparatus and Method for an Assay Device” and the specification thereof is incorporated herein by reference in its entirety and for all purposes.

FIELD OF INVENTION [002] The present invention relates to the field of testing and measurement. In particular, the present invention relates to a diagnostic device and method for detecting the presence of a biological analyte. It will be convenient to hereinafter describe the invention in relation to a medical immunoassay test, however it should be appreciated that the present invention is not limited to that use, only. For example, the present invention may be implemented in the use of a device for one or a combination of medical, in-vitro diagnostic, veterinary care, or any industry that is interested in quantifying biological markers in a sample.

BACKGROUND ART [003] Throughout this specification the use of the word “inventor” in singular form may be taken as reference to one (singular) inventor or more than one (plural) inventor of the present invention.

[004] It is to be appreciated that any discussion of documents, devices, acts or knowledge in this specification is included to explain the context of the present invention. Further, the discussion throughout this specification comes about due to the realisation of the inventor and/or the identification of certain related art problems by the inventor. Moreover, any discussion of material such as documents, devices, acts or knowledge in this specification is included to explain the context of the invention in terms of the inventor’s knowledge and experience and, accordingly, any such discussion should not be taken as an admission that any of the material forms part of the prior art base or the common general knowledge in the relevant art in Australia, or elsewhere, on or before the priority date of the disclosure and claims herein.

2018100803 15 Jun 2018 [005] In a typical diagnostic test, lateral flow assays may be employed, and an example lateral flow test is illustrated in Figure 1. Lateral flow assays are immunoassay based diagnostic tests that rely on capillary flow of liquid through a membrane containing a capture reagent. Along the way, a colored detector reagent (conjugate), usually gold colloid, containing a detector antibody is re-hydrated and flows with the sample through the membrane. A visual, or at least electronically measurable, result is obtained at the completion of the test, when lines appear in the viewing/test area.

[006] Lateral flow assay strips are very sensitive to ail kinds of pollutants and environmental considerations. To ensure their integrity is maintained they need to be protected from conditions that may comprise one or more of the following:

• temperature extremes • humidity extremes • any contaminating pollutants; either during storage or in the application environment [007] Electronic assay test readers are used to reliably remove human error associated with detecting the presence or absence of the test line. This can be achieved by way of a stimulating LED in combination with a detection sensor used to generate an electronic signal proportional to the intensity of the test line. This electronic signal is measured by way of an on-board microprocessor, with the test result displayed to the operator either quantitatively or qualitatively as would be appreciated by those skilled in the art.

[008] In typical use, electronic readers are applied to single and/or multi use endapplications that drive the cost of goods to be as cheap as possible and as such every component designed into the device should be assessed for criticality and expense. As such, they are typically battery powered devices, designed to operate from a coin cell battery or similar and therefore the energy consumed before the reader is required to be used needs to be minimized to ensure an optimal or at least reasonable shelf life.

[009] Further, the device should be activated prior to the addition of the sample, otherwise the test is likely to be compromised. Therefore, to ensure maximum reliability there needs to be a definitive workflow that is followed by the operator to ensure the

2018100803 15 Jun 2018 reader is activated at the correct time, and before the operator is likely to add the sample.

[0010] An example diagnostic device for detecting the presence of an analyte in a fluid sample is disclosed in US 8,828,329 (Sturman et al), which uses ambient light sensing to activate the device. The device disclosed by Sturman et al comprises a casing having a display, a test strip mounted in the casing, a processor mounted in the casing, and a first sensor mounted in the casing and operatively coupled to the processor. The processor is configured to receive a signal from the first sensor when the device is exposed to ambient light thereby causing the device to become activated. The device includes a light shield that exerts pressure across a width of the test strip to prevent fluid channelling along the length of the test strip. The processor is configured to present an early positive test result reading when a measured value exceeds a predetermined early reading threshold value at any time after a predetermined early testing time period. However, Sturman et al requires additional electronics, the battery is still connected to the analog current measurement circuit during the long periods of storage prior to testing and, it does not have a method to protect the test strip. The device of Sturman et al succeeded to the extent it has because although it is using an additional sensor for reader activation it is a relatively low-cost component. It is also activated by removing it from its sealed container which ensures the device is active when the sample is applied. Sturman et al, requires the device to be housed in a sealed foil pouch to ensure darkness during operation which is an additional expense in material and process. Also detection circuitry will be constantly on waiting for a light stimulus which will be a drain on the battery, reducing shelf life.

[0011] US 7,799,275 (Duesbury et al) discloses a diagnostic test device comprising means for sampling a liquid biological sample and means for reacting the sample with at least one reagent to provide one or more visible indicia. The device has an optical detector for detecting the presence of the one or more indicia. The device also comprises means for causing at least part of the optical detector to move over the one or more indicia Accordingly, physical movement is instigated by sample application to activate the reader as the sample is being applied. Duesbury et al requires a moving part to actuate the test, which is an additional reliability issue, and the battery is still connected. Duesbury et al does not have a method to protect the test strip from contaminants. There is no known commercial product that incorporates this method,

2018100803 15 Jun 2018 potentially because of the increased cost and complexity and reduced positional accuracy.

[0012] US 9,274,098 (Elder et al) discloses an analyte meter, which is configured to digitally test for the presence of a test strip in the meter and for the presence of a sample in the test strip prior to activating an analog current measurement circuit of the meter. A test strip port connector having a plurality of contacts receives an inserted test strip in which the contacts electrically connect to electrodes on the test strip for digitally detecting both the presence of a test strip and a sample added to the test strip. A control circuit monitoring the contacts maintains the analyte meter in a low power mode until detecting both the test strip and the sample, whereupon the control circuit activates the meter and enables an analog analyte measurement circuit. Accordingly, the analyte meter of Elder et al has sensors on the strip to detect when the strip is inserted as well as when the sample is applied to the strip. However, as above, elder et al requires additional electronics, and the battery is remains connected. Furthermore, Elder et al does not have a method to protect the test strip. Moreover, it is considered that the product of Elder et al would likely not work in single and/or multi use application as the power requirements would be too inhibitory for a prolonged period of time.

[0013] US 8,328,719 (Young et al) discloses a meter that includes a user interface enabling the user to take a specific action, leading them directly to data input options. The user interface is designed to enable first selected information to be entered by a user directly after receiving a result and making it more likely to engage a patient by making it easy and simple to enter important information, which may enable capture of the information thought to be most pertinent e.g. premeal and postmeal information, enhancing the understanding by patients and their carers of the patient's control. Display and buttons for turning the device on and running the test are provided. However, again Young et al requires additional electronics, the battery remains connected, and it does not have a method to protect the test strip. There is no way to ensure the reader is active when the sample is applied. Furthermore, this application would likely not work in the single/multi use application as the power requirements would be too inhibitory for a prolonged period of time.

[0014] US publication No. 2016/0025670 (O’Reilly) discloses individually packaged test devices and methods of manufacturing such individually packaged test devices,

2018100803 15 Jun 2018 along with use of such individually packaged test devices, and test device cards comprising two or more test devices. In particular, O’Reilly discloses a test device comprising: a test strip having first and second major surfaces and comprising: a proximal portion for bearing contacts for a metering device, an intermediate portion for receiving a sample comprising a test area on the first major surface, the test area comprising at least one test component; a separable distal portion; and in which the test device further comprises; a cover leaf (optionally a removable cover leaf) having a portion (optionally a removable portion) extending over at least part of one of the major surfaces of the test strip so as to seal the test area and having a non-removable portion attached to the separable distal portion of the test strip. Essentially, O’Reilly discloses a method for covering the test area to restrict moisture ingress but again, it requires additional parts to activate the reader and the battery remains connected at all times.

[0015] The preceding discussion of background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.

SUMMARY OF INVENTION [0016] It is an object of the embodiments described herein to overcome or alleviate at least one of the above noted drawbacks of prior art systems or to at least provide a useful alternative to prior or related art systems.

[0017] In a first aspect of embodiments, there is provided an activation apparatus for an electronic assay device comprising:

a sample port cover at one end thereof and;

a formation at another end thereof, which is adapted for operative association with and control of a PCB detection circuit of the electronic assay device;

wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB detection circuit and allow access to the sample port.

2018100803 15 Jun 2018 [0018] The formation at an end of the activation apparatus may be adapted for operative association with and control of the PCB detection circuit by way of one or a combination of:

attenuating energisation of the PCB detection circuit;

isolating the PCB detection circuit from a power source of the PCB detection circuit;

deactivating the PCB detection circuit; and holding the PCB detection circuit in one of an unpowered or low-power state.

[0019] Preferably, the formation comprises one end of an integral strip of material which is adapted to conform to the construction of an electronic assay device. The formation may also be adapted to connect to or be inserted in the PCB detection circuit of the electronic assay device.

[0020] In another aspect of embodiments described herein there is provided an activation apparatus for an electronic assay device comprising:

a sample port cover at one end thereof and;

an insert at another end thereof, which is adapted to isolate a PCB detection circuit from a power source of the PCB detection circuit;

wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB circuit and allow access to the sample port.

[0021] In preferred forms the apparatus comprises material that is one or a combination of opaque and electrically insulating. Furthermore, the apparatus may comprise an integral strip adapted for removal from the electronic assay device. Preferably, the integral strip is adapted to be removed by a user of the electronic assay device. The electronic assay device may comprise a diagnostic reader in preferred embodiments.

[0022] In another aspect of embodiments there is provided a method of activating an electronic assay device comprising the steps of:

2018100803 15 Jun 2018 with an integral strip of material, covering a sample port of the assay device and, controlling a PCB detection circuit of the assay device; and, removing the integral strip of material from the assay device to activate the PCB detection circuit and allow access to the sample port prior to applying a sample to the assay device.

[0023] In the above method, the step of controlling the PCB detection circuit may comprise one or a combination of:

attenuating energisation of the PCB detection circuit;

isolating the PCB detection circuit from a power source of the PCB detection circuit;

deactivating the PCB detection circuit;

holding the PCB detection circuit in one of an unpowered or low-power state.

[0024] In another aspect of embodiments described herein there is provided a method of activating an electronic assay device comprising the steps of:

covering a sample port of the assay device and isolating a PCB detection circuit of the assay device from a power source of the PCB detection circuit with an integral strip of material;

removing the integral strip of material from the assay device to activate the PCB circuit and allow access to the sample port prior to applying a sample to the assay device.

[0025] In preferred embodiments for single/multi use electronic assay reader devices, the invention uses a simple, cheap, integral plastic tab to serve multiple functional roles. It preserves battery life, facilitates activation of the reader on demand, mandates a correct assay workflow and protects the sensitive assay strip from damaging environmental extremes and degrading contaminants.

2018100803 15 Jun 2018 [0026] Embodiments of the present invention solve the sample port contamination problem, the battery power consumption problem, the reader activation problem as well as the workflow problem by way of a simple, cheap, plastic puil-tab. Said pull-tab is designed and positioned to provide both an electrical insulation to disconnect the battery from the circuit, and as a cover to protect the sample port from any contaminants/poliutants or humidity variations within the device. Further, the pull tab needs to be removed to enable the operator to add the sample to the sample port. Removal of the pull tab facilitates electrical connection of the battery to the PCB and therefore activates the reader, in effect ensuring the correct workflow steps are followed.

[0027] Other aspects and preferred forms are disclosed in the specification and/or defined in the appended claims, forming a part of the description of the invention.

[0028] In essence, embodiments of the present invention stem from the realization that prior art includes no description or implementation for a single, very low cost, solution to each of the problems of on-demand device activation, battery power preservation, assay integrity preservation and deterministic workflow control. Although each of these problems may be addressed with specific solutions individually, as a combination there is no single solution that addresses them all.

[0029] Further scope of applicability of embodiments of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the disclosure herein will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS [0030] Further disclosure, objects, advantages and aspects of preferred and other embodiments of the present invention may be better understood by those skilled in the relevant art by reference to the following description of embodiments taken in conjunction with the accompanying drawings, which are given by way of illustration only, and thus are not limitative of the disclosure herein, and in which:

Figure 1 illustrates a conventional diagnostic test based on lateral flow assays;

2018100803 15 Jun 2018

Figure 2 is a perspective view of an electronic assay device incorporating an activation apparatus in accordance with a preferred embodiment of the invention;

Figure 3 is a perspective view of the electronic assay device of Figure 2 incorporating an activation apparatus in accordance with a preferred embodiment of the invention showing the activation apparatus in the removed state;

Figure 4 is a side component view of an electronic assay device incorporating an activation apparatus in accordance with a preferred embodiment of the invention.

DETAILED DESCRIPTION [0031] In a preferred embodiment, the design of an electronic assay device includes an electronic board design that facilitates the operation of the activation apparatus as described herein. The positioning of the sample port relative to the battery itself or indeed relative to an appropriate feature used to insulate the battery is sufficient to enable the use of the invention that will serve multiple functional roles. It preserves battery life, facilitates activation of the reader on demand, mandates a correct assay workflow and protects the sensitive assay strip from damaging environmental extremes and degrading contaminants.

[0032] The images of Figure 4 highlight the key components of the electronic assay reader. The strip part referenced with 10 in all images of Figures 2 to 4 identifies the preferred embodiment of the invention in its most basic form. Removal of the strip (notionally to the left in each image) results in the spring component on the electrical pcb making contact with the battery and therefore activating the pcb. Removal of the strip also allows access to the sample port. This ensures that the pcb is in an activated state prior to the sample being applied to the sample port.

[0033] A small coin cell or equivalent battery may be used in the assay device with limited capacity. It is important that parasitic current draw is minimized during storage to maximize shelf life. The preferred embodiment in the form of a cover member electrically insulates or isolates the battery from the electrical circuit and therefore provides the best method of conserving energy possible. As well as preserving battery life, the cover member also protects the sensitive assay strip from pollutants and humidity variations,

2018100803 15 Jun 2018 activates the reader on demand, and ensures the correct workflow by restricting the addition of the sample prior to reader activation.

[0034] If the sample is applied by the operator to the test strip prior to the reader being activated, the test strip is likely to be compromised and the test invalidated. By covering the sample port with the activating apparatus of an embodiment of the invention, the operator cannot apply the sample out of the required order because in removing the activating apparatus cover, the reader is activated. As well as preserving battery life, the cover member also protects the sensitive assay strip from pollutants and humidity variations, activates the reader on demand, and ensures the correct workflow by restricting the addition of the sample prior to reader activation.

[0035] Lateral flow strips are very sensitive to all kinds of pollutants and environmental considerations. Therefore it is an important function of the cover member to seal the sample port and protect the strip. The cover member also serves the dual function of disconnecting the battery from the circuit, thereby preserving battery life and proving a safe method of activating the test. Workflow is also physically mandated by preventing the addition of the sample without first activating the reader.

[0036] Preferred embodiments of the invention provide a very cheap device, so every component is significant to some extent. In this way a single, extremely cheap, part solves multiple problems with the one solution. This single part is both cheap (fractions of a cent) and simple.

[0037] The cover member could completely seal the sample port, as well as the gap in the plastics it transitions through to disconnect the battery; thereby providing an hermetic seal. It may also be combined with a desiccant inside of the housing to maintain low humidity environment in the presence of a low leakage rate.

[0038] The cover member may also disconnect the battery directly, or a feature that is included on the PCB within the device to facilitate the disconnection of the battery. For example a metal spring-form contact as shown in Figure 4.

[0039] Alternatively, there is the option of not completely disconnecting battery. The device may remain always powered in a low power mode during storage. Pursuant to this, removal of the cover member may form an electrical contact to wake up the device from the low power mode. Although some battery consumption may be required during

2018100803 15 Jun 2018 storage in this configuration, the power consumption is reduced. In this respect, in comparison over the prior art of Sturman et al the power consumption is reduced because the PCB detection circuit is not required to be continuously monitoring for a change to activate the device. As a result, shelf life is improved.

[0040] Accordingly, a formation at an end of the cover may be provided, which is adapted for operative association with and control of a PCB detection circuit of the electronic assay device, wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB detection circuit and allow access to the sample port. The formation may be adapted for operative association with and control of the PCB detection circuit by way of one or a combination of: attenuating energisation of the PCB detection circuit; isolating the PCB detection circuit from a power source of the PCB detection circuit; deactivating the PCB detection circuit; and holding the PCB detection circuit in one of an unpowered or low-power state. Preferably, the formation comprises one end of an integral strip of material comprising the cover and which is adapted to conform to the construction of an electronic assay device. The formation may also be adapted to connect to or be inserted in the PCB detection circuit of the electronic assay device.

[0041] The cover member may cover a number of sample ports if multiple tests are included.

[0042] The cover member may be designed to also act as the sample collection/preparing mechanism to harvest the sample of interest and facilitate putting it into the sample port. For example, a swab, tongue scraper, etc.

[0043] The cover member may include information specific to the type of test that is being run and/or specific warnings for that test [0044] The cover member may incorporate a humidity indicator I chemical blotting paper in the tab to indicate compromised sealing of packaging, i.e. moisture ingress. This may be similar to the indicators found in electronics packaging.

[0045] The cover member may be manufactured out of heat sensitive (colour changing) tape that displays an instruction (word/symbol/warning) when temperature is outside of the operating temperature range.

2018100803 15 Jun 2018 [0046] The cover member may include a stiffener/feature/key to one end of the tab, which can later be inserted into a recess in the plastic case to crack it open; particularly to help battery removal and safe disposal after use.

[0047] The cover member may incorporate a feature such that it’s removal or actuation could act as a switch to activate Bluetooth and make the device discoverable.

[0048] The cover member may incorporate a custom insignia such as, for example, a barcode or 2D QR code on the tab, which could be used to pair the device via Bluetooth to a smart phone.

[0049] The cover member may incorporate the battery as part of its manufacture such that moving it in one orientation results in connection of the battery and activation of the reader. Once testing is complete, the cover member may be completely removed, taking the battery at the same time and facilitating safe disposal.

[0050] User experience prototypes of a reader device have been provided with pull tab designs and battery disconnect feature. Informal UX trials have been conducted that found that users were comfortable using the device and correctly removed the pull tab to activate the reader prior to applying the sample. It has been confirmed that the device powers on correctly upon removal of pull tab.

[0051] In an exemplary embodiment, a basic workflow may be employed as follows:

1) Remove product from packaging

2) Collect sample as per instructions for use

3) Remove pull tab to activate device (Steps 2 and 3 may be reversed depending on the method of sample collection, for example, direct urine sample collection)

4) Confirm device has activated and is ready for use via status indicator

a) Device performs self-diagnostic tests including but not limited to sufficient battery level, presence/absence of strip, LED/photodiode output functional (maximum detection level), LED/photodiode disables correctly (minimum detection level), absence of excessive ambient light, integrity of light barriers, check microprocessor internals, integration capacitor shorting switch operation. Other means for testing the viability of the strip I reader combination may be included as would be appreciated by the person skilled in the art

2018100803 15 Jun 2018

b) Device performs pre-test background measurements on dry strip by applying excitation and measuring reflected light level

c) Establish baseline levels for each test line, control line and background location

d) Display indication that test is ready to run

5) Apply sample to reader sample port

6) Test is automatically run and result is displayed after approximately 5-10 minutes to the user on the results display.

a) Periodic measurements taken to identify a change from background signifying sample application and start of test

b) Begin test timer count

c) Measure test line absorbance by applying excitation and measuring reflected light level

d) Measure background absorbance adjacent to the test line

e) Measure control line absorbance

f) If control line reaches threshold level before test time expires, final assay determination for each test line can be made

g) Apply algorithm to acquired data for assay result determination

h) Display result

i) Permanent shutdown [0052] While this invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification(s). This application is intended to cover any variations uses or adaptations of the invention following in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth.

[0053] As the present invention may be embodied in several forms without departing from the spirit of the essential characteristics of the invention, it should be understood that the above described embodiments are not to limit the present invention unless otherwise specified, but rather should be construed broadly within the spirit and scope of the invention as defined in the appended claims. The described embodiments are to be considered in all respects as illustrative only and not restrictive.

2018100803 15 Jun 2018 [0054] Various modifications and equivalent arrangements are intended to be included within the spirit and scope of the invention and appended claims. Therefore, the specific embodiments are to be understood to be illustrative of the many ways in which the principles of the present invention may be practiced, in the following claims, any means-plus-function clauses are intended to cover structures as performing the defined function and not only structural equivalents, but also equivalent structures. For example, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface to secure wooden parts together, in the environment of fastening wooden parts, a nail and a screw are equivalent structures.

The following sections I -VII provide a guide to interpreting the present specification.

I. Terms [0055] The term “product” means any machine, manufacture and/or composition of matter, unless expressly specified otherwise.

[0056] The term “process” means any process, algorithm, method or the like, unless expressly specified otherwise.

[0057] Each process (whether called a method, algorithm or otherwise) inherently includes one or more steps, and therefore all references to a “step” or “steps” of a process have an inherent antecedent basis in the mere recitation of the term ‘process’ or a like term. Accordingly, any reference in a claim to a ‘step’ or ‘steps’ of a process has sufficient antecedent basis.

[0058] The term “invention” and the like mean “the one or more inventions disclosed in this specification”, unless expressly specified otherwise.

[0059] The terms “an embodiment”, “embodiment”, “embodiments”, “the embodiment”, “the embodiments”, “one or more embodiments”, “some embodiments”, “certain embodiments”, “one embodiment”, “another embodiment” and the like mean “one or more (but not all) embodiments of the disclosed invention(s)”, unless expressly specified otherwise.

2018100803 15 Jun 2018 [0060] The term “variation” of an invention means an embodiment of the invention, unless expressly specified otherwise.

[0061] A reference to “another embodiment” in describing an embodiment does not imply that the referenced embodiment is mutually exclusive with another embodiment (e.g., an embodiment described before the referenced embodiment), unless expressly specified otherwise.

[0062] The terms “including”, “comprising” and variations thereof mean “including but not limited to”, unless expressly specified otherwise.

[0063] The terms “a”, “an” and “the” mean “one or more”, unless expressly specified otherwise.

[0064] The term “plurality” means “two or more”, unless expressly specified otherwise.

[0065] The term “herein” means “in the present specification, including anything which may be incorporated by reference”, unless expressly specified otherwise.

[0066] The phrase “at least one of’, when such phrase modifies a plurality of things (such as an enumerated list of things), means any combination of one or more of those things, unless expressly specified otherwise. For example, the phrase “at least one of a widget, a car and a wheel” means either (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car, (v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, a car and a wheel. The phrase “at least one of’, when such phrase modifies a plurality of things, does not mean “one of each of’ the plurality of things.

[0067] Numerical terms such as “one”, “two”, etc. when used as cardinal numbers to indicate quantity of something (e.g., one widget, two widgets), mean the quantity indicated by that numerical term, but do not mean at least the quantity indicated by that numerical term. For example, the phrase “one widget” does not mean “at least one widget”, and therefore the phrase “one widget” does not cover, e.g., two widgets.

[0068] The phrase “based on” does not mean “based only on”, unless expressly specified otherwise. In other words, the phrase “based on” describes both “based only on” and “based at least on”. The phrase “based at least on” is equivalent to the phrase “based at least in part on”.

2018100803 15 Jun 2018 [0069] The term “represent” and like terms are not exclusive, unless expressly specified otherwise. For example, the term “represents” do not mean “represents only”, unless expressly specified otherwise. In other words, the phrase “the data represents a credit card number” describes both “the data represents only a credit card number” and “the data represents a credit card number and the data also represents something else”.

[0070] The term “whereby” is used herein only to precede a clause or other set of words that express only the intended result, objective or consequence of something that is previously and explicitly recited. Thus, when the term “whereby” is used in a claim, the clause or other words that the term “whereby” modifies do not establish specific further limitations of the claim or otherwise restricts the meaning or scope of the claim.

[0071] The term “e.g.” and like terms mean “for example”, and thus does not limit the term or phrase it explains. For example, in the sentence “the computer sends data (e.g., instructions, a data structure) over the Internet”, the term “e.g.” explains that “instructions” are an example of “data” that the computer may send over the Internet, and also explains that “a data structure” is an example of “data” that the computer may send over the Internet. However, both “instructions” and “a data structure” are merely examples of “data”, and other things besides “instructions” and “a data structure” can be “data”.

[0072] The term “i.e.” and like terms mean “that is”, and thus limits the term or phrase it explains. For example, in the sentence “the computer sends data (i.e., instructions) over the Internet”, the term “i.e.” explains that “instructions” are the “data” that the computer sends over the Internet.

[0073] Any given numerical range shall include whole and fractions of numbers within the range. For example, the range “1 to 10” shall be interpreted to specifically include whole numbers between 1 and 10 (e.g., 2, 3, 4, . . . 9) and non-whole numbers (e.g., 1.1,

I. 2, . . . 1.9).

II. Determining [0074] The term “determining” and grammatical variants thereof (e.g., to determine a price, determining a value, determine an object which meets a certain criterion) is used in an extremely broad sense. The term “determining” encompasses a wide variety of actions and therefore “determining” can include calculating, computing, processing,

2018100803 15 Jun 2018 deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing, and the like.

[0075] The term “determining” does not imply certainty or absolute precision, and therefore “determining” can include estimating, extrapolating, predicting, guessing and the like.

[0076] The term “determining” does not imply that mathematical processing must be performed, and does not imply that numerical methods must be used, and does not imply that an algorithm or process is used.

[0077] The term “determining” does not imply that any particular device must be used. For example, a computer need not necessarily perform the determining.

III. indication [0078] The term “indication” is used in an extremely broad sense. The term “indication” may, among other things, encompass a sign, symptom, or token of something else.

[0079] The term “indication” may be used to refer to any indicia and/or other information indicative of or associated with a subject, item, entity, and/or other object and/or idea.

[0080] As used herein, the phrases “information indicative of’ and “indicia” may be used to refer to any information that represents, describes, and/or is otherwise associated with a related entity, subject, or object, [0081] Indicia of information may include, for example, a symbol, a code, a reference, a link, a signal, an identifier, and/or any combination thereof and/or any other informative representation associated with the information.

[0082] In some embodiments, indicia of information (or indicative of the information) may be or include the information itself and/or any portion or component of the information. In some embodiments, an indication may include a request, a solicitation, a broadcast, and/or any other form of information gathering and/or dissemination.

2018100803 15 Jun 2018

IV. Forms of Sentences [0083] Where a limitation of a first claim would cover one of a feature as well as more than one of a feature (e.g., a limitation such as “at least one widget covers one widget as well as more than one widget), and where in a second claim that depends on the first claim, the second claim uses a definite article “the” to refer to the limitation (e.g., “the widget”), this does not imply that the first claim covers only one of the feature, and this does not imply that the second claim covers only one of the feature (e.g., “the widget” can cover both one widget and more than one widget).

[0084] When an ordinal number (such as “first”, “second”, “third” and so on) is used as an adjective before a term, that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term. For example, a “first widget” may be so named merely to distinguish it from, e.g., a “second widget. Thus, the mere usage of the ordinal numbers “first” and “second” before the term “widget” does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets. For example, the mere usage of the ordinal numbers “first” and “second” before the term “widget” (1) does not indicate that either widget comes before or after any other in order or location; (2) does not indicate that either widget occurs or acts before or after any other in time; and (3) does not indicate that either widget ranks above or below any other, as in importance or quality. In addition, the mere usage of ordinal numbers does not define a numerical limit to the features identified with the ordinal numbers. For example, the mere usage of the ordinal numbers “first” and “second” before the term “widget” does not indicate that there must be no more than two widgets.

[0085] When a single device or article is described herein, more than one device/article (whether or not they cooperate) may alternatively be used in place of the single device/article that is described. Accordingly, the functionality that is described as being possessed by a device may alternatively be possessed by more than one device/article (whether or not they cooperate).

[0086] Similarly, where more than one device or article is described herein (whether or not they cooperate), a single device/article may alternatively be used in place of the more than one device or article that is described. For example, a plurality of computer20

2018100803 15 Jun 2018 based devices may be substituted with a single computer-based device. Accordingly, the various functionality that is described as being possessed by more than one device or article may alternatively be possessed by a single device/article.

[0087] The functionality and/or the features of a single device that is described may be alternatively embodied by one or more other devices which are described but are not explicitly described as having such functionality/features. Thus, other embodiments need not include the described device itself, but rather can include the one or more other devices which would, in those other embodiments, have such functionality/features.

V. Disclosed Examples and Terminology Are Not Limiting [0088] Neither the Title nor the Abstract in this specification is intended to be taken as limiting in any way as the scope of the disclosed invention(s). The title and headings of sections provided in the specification are for convenience only, and are not to be taken as limiting the disclosure in any way.

[0089] Numerous embodiments are described in the present application, and are presented for illustrative purposes only. The described embodiments are not, and are not intended to be, limiting in any sense. The presently disclosed invention(s) are widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill in the art will recognise that the disclosed invention(s) may be practised with various modifications and alterations, such as structural, logical, software, and electrical modifications. Although particular features of the disclosed invention(s) may be described with reference to one or more particular embodiments and/or drawings, it should be understood that such features are not limited to usage in the one or more particular embodiments or drawings with reference to which they are described, unless expressly specified otherwise.

[0090] The present disclosure is not a literal description of all embodiments of the invention(s). Also, the present disclosure is not a listing of features of the invention(s) which must be present in all embodiments.

[0091] Devices that are described as in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise. On the contrary, such devices need only transmit to each other as necessary or desirable, and may actually refrain from exchanging data most of the time. For example, a machine in

2018100803 15 Jun 2018 communication with another machine via the Internet may not transmit data to the other machine for long period of time (e.g. weeks at a time). In addition, devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries.

[0092] A description of an embodiment with several components or features does not imply that all or even any of such components/features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present invention(s). Unless otherwise specified explicitly, no component/feature is essential or required.

[0093] Although process steps, operations, algorithms or the like may be described in a particular sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to the invention(s), and does not imply that the illustrated process is preferred.

[0094] Although a process may be described as including a plurality of steps, that does not imply that all or any of the steps are preferred, essential or required. Various other embodiments within the scope of the described invention(s) include other processes that omit some or all of the described steps. Unless otherwise specified explicitly, no step is essential or required.

[0095] Although a process may be described singly or without reference to other products or methods, in an embodiment the process may interact with other products or methods. For example, such interaction may include linking one business model to another business model. Such interaction may be provided to enhance the flexibility or desirability of the process.

2018100803 15 Jun 2018 [0096] Although a product may be described as including a plurality of components, aspects, qualities, characteristics and/or features, that does not indicate that any or all of the plurality are preferred, essential or required. Various other embodiments within the scope of the described invention(s) include other products that omit some or all of the described plurality.

[0097] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. Likewise, an enumerated list of items (which may or may not be numbered) does not imply that any or al! of the items are comprehensive of any category, unless expressly specified otherwise. For example, the enumerated list “a computer, a laptop, a PDA” does not imply that any or all of the three items of that list are mutually exclusive and does not imply that any or all of the three items of that list are comprehensive of any category.

[0098] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are equivalent to each other or readily substituted for each other.

[0099] All embodiments are illustrative, and do not imply that the invention or any embodiments were made or performed, as the case may be.

Vi. Computing [00100] It will be readily apparent to one of ordinary skill in the art that the various processes described herein may be implemented by, e.g., appropriately programmed general purpose computers, special purpose computers and computing devices. Typically a processor (e.g., one or more microprocessors, one or more micro-controllers, one or more digital signal processors) will receive instructions (e.g., from a memory or like device), and execute those instructions, thereby performing one or more processes defined by those instructions.

[00101] A “processor” means one or more microprocessors, central processing units (CPUs), computing devices, micro-controllers, digital signal processors, or like devices or any combination thereof.

2018100803 15 Jun 2018 [00102] Thus a description of a process is likewise a description of an apparatus for performing the process. The apparatus that performs the process can include, e.g., a processor and those input devices and output devices that are appropriate to perform the process.

[00103] Further, programs that implement such methods (as well as other types of data) may be stored and transmitted using a variety of media (e.g., computer readable media) in a number of manners. In some embodiments, hard-wired circuitry or custom hardware may be used in place of, or in combination with, some or all of the software instructions that can implement the processes of various embodiments. Thus, various combinations of hardware and software may be used instead of software only.

[00104] The term “computer-readable medium” refers to any medium, a plurality of the same, or a combination of different media, that participate in providing data (e.g., instructions, data structures) which may be read by a computer, a processor or a like device. Such a medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, optical or magnetic disks and other persistent memory. Volatile media include dynamic random access memory (DRAM), which typically constitutes the main memory. Transmission media include coaxial cables, copper wire and fibre optics, including the wires that comprise a system bus coupled to the processor. Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infra-red (IR) data communications. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read.

[00105] Various forms of computer readable media may be involved in carrying data (e.g. sequences of instructions) to a processor. For example, data may be (i) delivered from RAM to a processor; (ii) carried over a wireless transmission medium; (iii) formatted and/or transmitted according to numerous formats, standards or protocols, such as

Ethernet (or IEEE 802.3), SAP, ATP, Bluetooth™, and TCP/IP, TDMA, CDMA, and 3G;

2018100803 15 Jun 2018 and/or (iv) encrypted to ensure privacy or prevent fraud in any of a variety of ways well known in the art.

[00106] Thus a description of a process is likewise a description of a computerreadable medium storing a program for performing the process. The computer-readable medium can store (in any appropriate format) those program elements which are appropriate to perform the method.

[00107] Just as the description of various steps in a process does not indicate that all the described steps are required, embodiments of an apparatus include a computer/computing device operable to perform some (but not necessarily all) of the described process.

[00108] Likewise, just as the description of various steps in a process does not indicate that all the described steps are required, embodiments of a computer-readable medium storing a program or data structure include a computer-readable medium storing a program that, when executed, can cause a processor to perform some (but not necessarily all) of the described process.

[00109] Where databases are described, it will be understood by one of ordinary skill in the art that (i) alternative database structures to those described may be readily employed, and (ii) other memory structures besides databases may be readily employed. Any illustrations or descriptions of any sample databases presented herein are illustrative arrangements for stored representations of information. Any number of other arrangements may be employed besides those suggested by, e.g., tables illustrated in drawings or elsewhere. Similarly, any illustrated entries of the databases represent exemplary information only; one of ordinary skill in the art will understand that the number and content of the entries can be different from those described herein. Further, despite any depiction of the databases as tables, other formats (including relational databases, object-based models and/or distributed databases) could be used to store and manipulate the data types described herein. Likewise, object methods or behaviours of a database can be used to implement various processes, such as the described herein. In addition, the databases may, in a known manner, be stored locally or remotely from a device which accesses data in such a database.

2018100803 15 Jun 2018 [00110] Various embodiments can be configured to work in a network environment including a computer that is in communication (e.g., via a communications network) with one or more devices. The computer may communicate with the devices directly or indirectly, via any wired or wireless medium (e.g. the Internet, LAN, WAN or Ethernet, Token Ring, a telephone line, a cable line, a radio channel, an optical communications line, commercial on-line service providers, bulletin board systems, a satellite communications link, a combination of any of the above). Each of the devices may themselves comprise computers or other computing devices that are adapted to communicate with the computer. Any number and type of devices may be in communication with the computer.

[00111] In an embodiment, a server computer or centralised authority may not be necessary or desirable. For example, the present invention may, in an embodiment, be practised on one or more devices without a central authority. In such an embodiment, any functions described herein as performed by the server computer or data described as stored on the server computer may instead be performed by or stored on one or more such devices.

[00112] Where a process is described, in an embodiment the process may operate without any user intervention. In another embodiment, the process includes some human intervention (e.g., a step is performed by or with the assistance of a human).

[00113] It should be noted that where the terms “server”, “secure server” or similar terms are used herein, a communication device is described that may be used in a communication system, unless the context otherwise requires, and should not be construed to limit the present invention to any particular communication device type. Thus, a communication device may include, without limitation, a bridge, router, bridgerouter (router), switch, node, or other communication device, which may or may not be secure.

[00114] It should also be noted that where a flowchart is used herein to demonstrate various aspects of the invention, it should not be construed to limit the present invention to any particular logic flow or logic implementation. The described logic may be partitioned into different logic blocks (e.g., programs, modules, functions, or subroutines) without changing the overall results or otherwise departing from the true scope of the invention. Often, logic elements may be added, modified, omitted, performed in a

2018100803 15 Jun 2018 different order, or implemented using different logic constructs (e.g., logic gates, looping primitives, conditional logic, and other logic constructs) without changing the overall results or otherwise departing from the true scope of the invention.

[00115] Various embodiments of the invention may be embodied in many different forms, including computer program logic for use with a processor (e.g., a microprocessor, microcontroller, digital signal processor, or general purpose computer and for that matter, any commercial processor may be used to implement the embodiments of the invention either as a single processor, serial or parallel set of processors in the system and, as such, examples of commercial processors include, but are not limited to Merced™, Pentium™, Pentium II™, Xeon™, Celeron™, Pentium Pro™, Efficeon™, Athlon™, AMD™ and the like), programmable logic for use with a programmable logic device (e.g., a Field Programmable Gate Array (FPGA) or other PLD), discrete components, integrated circuitry (e.g., an Application Specific Integrated Circuit (ASIC)), or any other means including any combination thereof. In an exemplary embodiment of the present invention, predominantly all of the communication between users and the server is implemented as a set of computer program instructions that is converted into a computer executable form, stored as such in a computer readable medium, and executed by a microprocessor under the control of an operating system.

[00116] Computer program logic implementing all or part of the functionality where described herein may be embodied in various forms, including a source code form, a computer executable form, and various intermediate forms (e.g., forms generated by an assembler, compiler, linker, or locator). Source code may include a series of computer program instructions implemented in any of various programming languages (e.g., an object code, an assembly language, or a high-level language such as Fortran, C, C++, JAVA, or HTML. Moreover, there are hundreds of available computer languages that may be used to implement embodiments of the invention, among the more common being Ada; Algol; APL; awk; Basic; C; C++; Conol; Delphi; Eiffel; Euphoria; Forth; Fortran; HTML; Icon; Java; Javascript; Lisp; Logo; Mathematica; MatLab; Miranda; Modula-2; Oberon; Pascal; Perl; PL/I; Prolog; Python; Rexx; SAS; Scheme; sed; Simula; Smalltalk; Snobol; SQL; Visual Basic; Visual C++; Linux and XML.) for use with various operating systems or operating environments. The source code may define and use various data structures and communication messages. The source code may be in a

2018100803 15 Jun 2018 computer executable form (e.g., via an interpreter), or the source code may be converted (e.g., via a translator, assembler, or compiler) into a computer executable form.

[00117] The computer program may be fixed in any form (e.g., source code form, computer executable form, or an intermediate form) either permanently or transitorily in a tangible storage medium, such as a semiconductor memory device (e.g, a RAM, ROM, PROM, EEPROM, or Flash-Programmable RAM), a magnetic memory device (e.g., a diskette or fixed disk), an optical memory device (e.g., a CD-ROM or DVD-ROM), a PC card (e.g., PCMCIA card), or other memory device. The computer program may be fixed in any form in a signal that is transmittable to a computer using any of various communication technologies, including, but in no way limited to, analog technologies, digital technologies, optical technologies, wireless technologies (e.g., Bluetooth), networking technologies, and inter-networking technologies. The computer program may be distributed in any form as a removable storage medium with accompanying printed or electronic documentation (e.g., shrink wrapped software), preloaded with a computer system (e.g., on system ROM or fixed disk), or distributed from a server or electronic bulletin board over the communication system (e.g., the Internet or World Wide Web).

[00118] Hardware logic (including programmable logic for use with a programmable logic device) implementing all or part of the functionality where described herein may be designed using traditional manual methods, or may be designed, captured, simulated, or documented electronically using various tools, such as Computer Aided Design (CAD), a hardware description language (e.g., VHDL or AHDL), or a PLD programming language (e.g., PALASM, ABEL, or CUPL). Hardware logic may also be incorporated into display screens for implementing embodiments of the invention and which may be segmented display screens, analogue display screens, digital display screens, CRTs, LED screens, Plasma screens, liquid crystal diode screen, and the like.

[00119] Programmable logic may be fixed either permanently or transitorily in a tangible storage medium, such as a semiconductor memory device (e.g., a RAM, ROM, PROM, EEPROM, or Flash-Programmable RAM), a magnetic memory device (e.g., a diskette or fixed disk), an optical memory device (e.g., a CD-ROM or DVD-ROM), or other memory device. The programmable logic may be fixed in a signal that is transmittable to a computer using any of various communication technologies, including, but in no way limited to, analog technologies, digital technologies, optical technologies,

2018100803 15 Jun 2018 wireless technologies (e.g., Bluetooth), networking technologies, and internetworking technologies. The programmable logic may be distributed as a removable storage medium with accompanying printed or electronic documentation (e.g., shrink wrapped software), preloaded with a computer system (e.g., on system ROM or fixed disk), or distributed from a server or electronic bulletin board over the communication system (e.g., the Internet or World Wide Web).

[00120] “Comprises/comprising” and “includes/including” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. Thus, unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, ‘includes’, ‘including’ and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”.

2018100803 15 Jun 2018

Claims (5)

1. An activation apparatus for an electronic assay device comprising: a sample port cover at one end thereof and;

a formation at another end thereof, which is adapted for operative association with and control of a PCB detection circuit of the electronic assay device;

wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB detection circuit and allow access to the sample port.

2. An activation apparatus as claimed in claim 1 wherein the formation is adapted for operative association with and control of the PCB detection circuit by way of one or a combination of:

attenuating energisation of the PCB detection circuit;

isolating the PCB detection circuit from a power source of the PCB detection circuit;

deactivating the PCB detection circuit;

holding the PCB detection circuit in one of an unpowered or low-power state.

3. An activation apparatus as claimed in claim 1 or 2 wherein the formation is adapted to connect to or be inserted in the PCB detection circuit of the electronic assay device.

4. An activation apparatus for an electronic assay device comprising: a sample port cover at one end thereof and;

an insert at another end thereof, which is adapted to isolate a PCB detection circuit from a power source of the PCB detection circuit;

wherein the activation apparatus, as a whole, is adapted for removal from one or a combination of the sample port and the PCB detection circuit to activate the PCB circuit and allow access to the sample port.

5.

A method of activating an electronic assay device comprising the steps of:

2018100803 15 Jun 2018 covering a sample port of the assay device and isolating a PCB detection circuit of the assay device from a power source of the PCB detection circuit with an integral strip of material;

removing the integral strip of material from the assay device to activate the PCB circuit and allow access to the sample port prior to applying a sample to the assay device.

1/2

2018100803 15 Jun 2018 (Ab/Ag prrpainlisns)

Barking Card

Figure 1

Figure 2 io

Figure 3

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2018100803 15 Jun 2018

Figure 4