Apparatus and method for assaying liquid samples - Patents.com

Abstract

The devices, systems, and kits for assaying liquid samples include a reader and a test strip. The test strip may include a disposable cassette. The system may include a test strip mounting structure configured to receive the cassette in a predetermined orientation. The apparatus includes a processor and memory, both configured to perform an assay on the liquid sample. The apparatus may include a display configured to generate pattern-encoded data related to the results of the assay.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 112,703, filed November 12, 2020, the disclosure of which is incorporated by reference in its entirety herein. [Background technology]

[0002] In medicine or bioscience, it is often desirable to be able to determine the presence or concentration of a particular target substance in a biological and / or liquid sample. Although many methods are known for performing such assays, conventional methods often require the use of expensive equipment. This can clearly limit the availability and cost-effectiveness of certain scientific and / or specialized skills that require or are made effective by the use of such assays.

[0003] Devices and systems have been developed that can be used at home by untrained consumers. These include, for example, commercially available pregnancy and ovulation testing devices, such as the Clearblue® Fertility Monitor. Such testing devices generally require complicated usage procedures and are prone to inadvertent user error that may prevent accurate test results from being obtained. Thus, systems and methods for performing assays at low cost and / or increased convenience are desirable.

[0004] It should be noted that this Background is not intended to aid in determining the scope of the claimed subject matter, nor is it intended to be construed as limiting the claimed subject matter to implementations that solve some or all of the disadvantages or problems presented above. Discussion of any technology, document, or reference in this Background section should not be construed as an admission that the material described is prior art to any of the subject matter claimed herein. Summary of the Invention

[0005] This disclosure includes the following [1] to

[31] . [1] A first housing portion; A second housing portion; a test strip mounting location associated with at least one of the first housing portion and the second housing portion; a user operable connection configured to selectively enable an open and closed configuration of the first housing portion relative to the second housing portion; Equipped with the coupling portion is configured such that a user may place the first and second housing portions in the open configuration to expose the test strip loading location, place a test strip in the test strip loading location, and place the first and second housing portions in the closed configuration to perform an assay on the test strip. Liquid sample assay device. [2] The liquid sample assay device described in [1] above, wherein the first housing portion forms a lid configured to cover the second housing portion with the test strip mounting position disposed between the first housing portion and the second housing portion. [3] The liquid sample assay device according to any one of [1] to [2] above, wherein the connecting portion comprises a hinge. [4] A liquid sample assay device according to any one of [1] to [3] above, wherein the test strip mounting location is configured to engage with a housing of a test strip cassette. [5] The liquid sample assay device described in [4] above, wherein the test strip cassette is a disposable, single-use test strip cassette. [6] A liquid sample assay device according to any of [1] to [5] above, comprising one or more sample sensors associated with at least one of the first housing portion and the second housing portion. [7] A liquid sample assay device according to any one of [1] to [6] above, wherein the liquid sample assay device forms a handheld housing. [8] A liquid sample assay device according to any one of [1] to [7] above, wherein the test strip mounting position is configured to accept a test strip without sliding. [9] A liquid sample assay device according to any one of [1] to [8] above, comprising a display associated with at least one of the first housing portion and the second housing portion.

[10] A kit for conducting a liquid assay for one or more analytes, comprising: The liquid sample assay device according to any one of [1] to [9] above, a plurality of test strips configured to engage the test strip mounting locations of the liquid sample assay device; A kit comprising:

[11] A device for assaying a liquid sample, comprising: a housing configured to receive the test strip in a predetermined orientation such that a portion of the test strip is disposed within the device and a portion of the test strip extends outside of the device; at least one sensor within the housing configured to generate a signal indicative of a change in a characteristic of the sample strip; a display configured to generate a machine-readable pattern encoding data associated with the signal; and A device comprising:

[12] The device of

[11] , wherein the housing has a hinged lid.

[13] The device of

[12] , wherein the at least one sensor is mounted on an underside of the hinged lid.

[14] The device of

[13] , wherein the at least one sensor is disposed on a printed circuit board fixed to the underside of the lid.

[15] The device of

[14] , wherein the at least one sensor protrudes from the printed circuit board.

[16] The device of any one of

[11] to

[15] above, wherein the display comprises an e-paper display.

[17] The device of any one of

[11] to

[16] , wherein the machine-readable pattern comprises a non-human-readable pattern.

[18] The device of any one of

[11] to

[17] , wherein the machine-readable pattern comprises a QR code.

[19] The device of any one of

[11] to

[17] , wherein the data relating to the signal comprises a final assay output.

[20] A device according to any one of

[11] to

[19] above; a mobile device hosting a software program configured to cause the mobile device to read a machine readable code; A system for assaying a liquid sample comprising:

[21] The system described in

[20] , wherein the software program is configured to obtain or derive a final assay output from the information encoded in the machine-readable code and display the obtained or derived final assay output to a user.

[22] The system of any one of

[20] or

[21] , wherein the software program is configured to access a network resource in response to reading the machine-readable code.

[23] The system described in

[22] , wherein the software program is configured to obtain a final assay output from the accessed network resource and display the obtained final assay output to a user.

[24] A method for assaying a liquid sample, the method comprising: placing the liquid sample on a portion of a test strip; placing a portion of the test strip into a reader comprising a sensor and a display; generating a signal indicative of a change in a characteristic of the test strip using the sensor; generating a machine-readable pattern on said display encoding data associated with said signal; A method comprising:

[25] The method according to

[24] , comprising the step of reading the machine-readable pattern with a handheld device.

[26] The method according to

[25] above, further comprising the step of displaying the final assay output to the user on a display of the handheld device.

[27] A test strip cassette for performing a liquid assay, the test strip cassette comprising: Housing and a lateral flow test strip within the housing; an opening in the housing exposing a portion of the lateral flow test strip; a first alignment feature associated with the opening configured to align a sensor in a test strip reader with the exposed portion of the lateral flow test strip; 1. A test strip cassette comprising:

[28] The test strip cassette of

[27] above, wherein the housing includes a second alignment mechanism configured to align the housing with a test strip mounting position in a reader.

[29] The test strip cassette of any one of

[27] or

[28] , wherein the first alignment feature comprises an inclined wall defining at least a portion of an edge of the opening.

[30] The test strip cassette of any one of

[28] or

[29] , wherein the second alignment mechanism comprises a recess formed in the housing.

[31] The test strip cassette of any one of

[28] to

[30] , wherein the second alignment feature is on the opposite side of the housing from the first alignment feature. In some embodiments, a device for assaying a liquid sample is provided, the liquid sample assay device comprising: a first housing portion, a second housing portion, a test strip mounting location associated with at least one of the first housing portion and the second housing portion, and a user-operable coupling configured to selectively enable open and closed configurations of the first housing portion relative to the second housing portion, the couplings configured such that a user may place the first and second housing portions in the open configuration to expose the test strip mounting location, place a test strip in the test strip mounting location, and place the first and second housing portions in the closed configuration to perform an assay on the test strip.

[0006] A device for assaying a liquid sample, the device comprising: a housing configured to receive a test strip in a predetermined orientation such that a portion of the test strip is disposed within the device and a portion of the test strip extends outside the device; at least one sensor within the housing configured to generate a signal indicative of a change in a characteristic of the sample strip; and a display configured to generate a machine-readable pattern encoding data associated with the signal.

[0007] 1. A test strip cassette for performing a liquid assay, the test strip cassette comprising: a housing; a lateral flow test strip within the housing; an opening in the housing that exposes a portion of the lateral flow test strip; and a first alignment feature associated with the opening configured to align a sensor in a test strip reader with the exposed portion of the lateral flow test strip.

[0008] It is understood that various configurations of the present technology will become apparent to those skilled in the art from this disclosure, and that various configurations of the present technology have been shown and described by way of example. As will be understood, the present technology is capable of other different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the present technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not restrictive.

[0009] Various embodiments are described in detail in conjunction with the figures described below, with an emphasis on highlighting advantageous features. These embodiments are for illustrative purposes only, and any scale that may be illustrated therein is not intended to limit the scope of the disclosed technology. These drawings include the following figures, in which like numerals indicate like parts: [Brief description of the drawings]

[0010] [Figure 1] 1 shows a block diagram of a system for assaying a liquid sample, according to some exemplary embodiments.

[0011] [Diagram 2] [FIG. 2A] A reader for testing an assay, according to some exemplary embodiments.

[0012] [FIG. 2B] illustrates some components of the reader of FIG. 2A, according to some exemplary embodiments.

[0013] [FIG. 2C] A block diagram of a test strip for an assay according to some exemplary embodiments.

[0014]

[0023] FIG. 2D illustrates an example graph of a signal provided by a sensor of the reader of FIGS. 2A-2C, according to some example embodiments.

[0015] [Diagram 3] [FIG. 3A] A handheld probe for receiving data regarding an assay from a reader, according to some exemplary embodiments.

[0016]

[0023] FIG. 3B illustrates some components of the probe of FIG. 3A, according to some exemplary embodiments.

[0017] [Figure 4] 2 illustrates a block diagram of exemplary components of the reader of FIG. 1, according to some exemplary embodiments.

[0018] [Diagram 5] 2 shows a block diagram of exemplary components of the probe of FIG. 1 in accordance with some exemplary embodiments.

[0019] [Figure 6] 6 shows a block diagram of an example embodiment in which the probe of FIG. 4 is configured to accept the reader of FIG. 5, according to some example embodiments.

[0020] [Figure 7]6 shows a block diagram of a single housing integrating some components of the reader of FIG. 4 and some components of the probe of FIG. 5 according to some exemplary embodiments.

[0021] [Figure 8] 8 shows a block diagram of an exemplary embodiment of the single device and / or housing of FIG. 7 configured to receive a cassette with test strips to be assayed, according to some exemplary embodiments.

[0022] [Figure 9] 1 shows a perspective view of an exemplary embodiment of an apparatus configured to receive a cassette comprising a sample to be assayed, according to some exemplary embodiments.

[0023] [Figure 10] FIG. 13 illustrates a perspective view of the device of FIG. 12 with a cassette disposed therein, according to some exemplary embodiments.

[0024] [Figure 11] 1 illustrates a system comprising an apparatus configured to accept a cassette comprising a sample to be assayed, according to some exemplary embodiments.

[0025] [Figure 12] 1 illustrates another system comprising another device configured to receive a cassette comprising a sample to be assayed, according to some exemplary embodiments.

[0026] [Figure 13A] 10A-10C show various exemplary screenshots of a display of a device of a system for assaying samples in a cassette, according to some exemplary embodiments. [Figure 13B] 10A-10C show various exemplary screenshots of a display of a device of a system for assaying samples in a cassette, according to some exemplary embodiments.

[0027] [Figure 14] [FIG. 14A] A perspective top view of a device configured to receive in a closed configuration a cassette comprising a sample to be assayed, according to some exemplary embodiments.

[0028] [Figure 14B] A perspective bottom view of the device of Figure 14A is shown.

[0029] [Figure 15] FIG. 15A illustrates a perspective top view of a test strip cassette according to some exemplary embodiments.

[0030] FIG. 15B illustrates a side cross-sectional view of a test strip cassette according to some exemplary embodiments.

[0031] [Figure 16] 15 shows a perspective view of the device of FIG. 14 in an open configuration, according to some exemplary embodiments.

[0032] [Figure 17] 15 illustrates another perspective view of the device of FIG. 14 in an open configuration with a battery cover installed, according to some exemplary embodiments.

[0033] [Figure 18] 15 illustrates another perspective view of the device of FIG. 14 in an open configuration with a test strip disposed in a test strip loading position, according to some exemplary embodiments.

[0034] [Figure 19] 15 illustrates an exploded view showing components of the device of FIG. 14, according to some embodiments.

[0035] [Figure 20] 15 illustrates a cutaway top perspective view of the device of FIG. 14 in an open configuration, according to some exemplary embodiments.

[0036] [Figure 21]15 illustrates a cutaway bottom view of the device of FIG. 14 in an open configuration, according to some exemplary embodiments.

[0037] [Figure 22] 15 illustrates a cutaway side view of the device of FIG. 14 in an open configuration, according to some exemplary embodiments.

[0038] [Figure 23] 15 illustrates a cutaway side view of the device of FIG. 14 in a closed configuration, according to some exemplary embodiments.

[0039] [Figure 24] 22 shows an enlarged view of the cassette and mounting structure of FIG. 21.

[0040] [Diagram 25] 24 shows an enlarged view of the cassette and mounting structure of FIG. 23.

[0041] [Figure 26] 1 shows a flowchart of another method for testing an assay and reading the results of such a test, according to some exemplary embodiments.

[0042] [Figure 27] 1 shows a flowchart of a method for testing an assay and reading the results of such a test, according to some exemplary embodiments.

[0043] [Figure 28] 13 shows a flowchart of another portion of a method for testing an assay and reading the results of such a test, according to some exemplary embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] The following description and examples detail some exemplary implementations, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that there are numerous variations and modifications of the invention that fall within the scope of the invention. Therefore, the description of a specific exemplary embodiment should not be considered as limiting the scope of the invention.

[0045] definition Analyte: The term analyte refers to any substance or chemical component, such as, but not limited to, a fluid, e.g., water, alcohol, or any other diluent. Analytes include, but are not limited to, naturally occurring substances, man-made substances, metabolites, and reaction products, e.g., proteins, carbohydrates, nucleic acids, fats, hormones, antigens, antibodies, amino acids, vitamins, components of organisms, components of cells of organisms, including any molecular components of animals, plants, viruses, parasites, bacteria, fungi, and / or chemical compounds or products produced or consumed by such organisms or their cells. The term analyte also includes any drug or pharmaceutical composition that has been or can be introduced into an organism.

[0046] App: An app is a software application program. The term app is typically applied to software programs that can run on smartphone hardware running smartphone operating systems, e.g., iOS and Android. These are often called mobile apps. Although mobile apps are generally designed to run on mobile devices, mobile apps may also run on non-mobile devices, e.g., desktop or laptop computers running operating systems compatible with mobile apps.

[0047] Final Assay Result Output: A final assay result output is a presentation of the assay results that constitutes actionable or other directly useful information to a user of the assay. Final assay result outputs include, but are not limited to, a binary output indicating the presence or absence of an analyte, or a numerical estimate of the amount of analyte present in the sample. A test error indication may also be a final assay result output.

[0048] Processor: A processor is an electronic circuit configured to retrieve instructions from a memory and perform one or more arithmetic, logical, data storage, and / or data output operations defined by the retrieved instructions. A processor may perform these operations sequentially or simultaneously. A processor may be any conventional general-purpose single or multi-chip processor found in consumer devices, such as personal computers, laptop computers, smartphones, etc. Additionally, a processor may be any conventional special purpose processor, such as a digital signal processor, a graphics processor, or a microcontroller.

[0049] Processing Circuit: A processing circuit is any arrangement of electrical or electronic components configured to receive one or more analog or digital signals or data as inputs and, in response, generate one or more analog or digital signals or data as outputs. A processing circuit may comprise one or more buffers, voltage dividers, filters, logic gates, adders, etc. A processor comprises a processing circuit, which may include one or more processors and memories. However, a processing circuit does not necessarily implement all or a portion of the functionality associated with a processor as described above.

[0050] E-Paper: A commercially available, low-power display technology with bi-stable pixels that can sustain an image written to the display essentially indefinitely without consuming power.

[0051] QR Code: A two-dimensional array of black squares on a white background that encodes information having a structure standardized in ISO / IEC 18004.

[0052] Software and Programs: The terms software or programs refer to instructions stored in memory in machine-readable form, human-readable form, or both, that are executable by a processor when compiled into a machine-readable form. Software may be written in a variety of programming languages, such as, but not limited to, various versions of C and JavaScript. In some environments, software may also be referred to as firmware.

[0053] Browser and Web Page: A browser is a computer program that provides a computer with the functionality to execute syntax that may be included in a web page. The computer may be connected to a computer network, which may be, and typically is, the Internet. As used herein, a browser and web page provide a computer connected to a network (e.g., the Internet) with functionality that is at least sufficient to request, retrieve, and display at least some network resources, including the web page itself, and to execute at least some links contained within or referenced in the retrieved web page to retrieve other web pages specified by the links. A web page may contain references, e.g., Uniform Resource Locators (URLs) and / or Universal Resource Identifiers (URIs), to other network resources, including images or other data that are retrieved by the browser from a network or cache memory when executing the web page, and may also contain and / or reference programs, libraries, style sheets, scripts, etc. that are executed by the browser when executing the web page. Any of these items that are accessed, used, and / or retrieved during the browser engine execution of web page syntax are considered to be included as components of a "web page" as that term is used herein. Examples of browsers include, but are not limited to, Internet Explorer and Edge, distributed by Microsoft, and Chrome, distributed by Google. Exemplary web page syntaxes that a browser engine may execute are the HyperText Markup Language (HTML) promulgated by the World Wide Web Consortium (W3C), and various versions of client-side scripting languages, such as JavaScript.

[0054] Server: The term server refers to a software program configured for computer hardware to respond to client access requests to use or retrieve network resources. The term server also refers to computer hardware running server software. "Server" often has a functional term applied to the server software and / or hardware, e.g., a server that indicates the functionality of a print server, file server, or web server.

[0055] Internet: A globally interconnected system of computers and computer networks that evolved from ARPANET and NSFNET during the late 1980s and early 1990s that may utilize the TCP / IP network communications protocols.

[0056] Cloud Service: A collection of network resources configured to support the operation of one or more software programs executing on one or more user devices, e.g., a desktop or laptop computer or a smartphone.

[0057] Network Resource Identifier: A definition of a network resource (e.g., by storage location and file name) used by a client computer to specify the network resource in an access request issued by the client computer to a network. A network resource identifier may be thought of as similar to the "location" of a network resource, e.g., an image or a web page. Currently, when the network is the Internet, a network resource identifier is known as a URL formatted according to RFC 3986 of the Internet Engineering Task Force (IETF). For the purposes of this disclosure, any format for specifying a network resource in a client access request issued to a network is within the definition of the term network resource identifier. Network resource identifiers, including URLs, as currently defined on the Internet may further include data identifying the network resource, plus data that a server hosting the network resource associated with the network resource identifier may use for purposes other than identifying the requested network resource.

[0058] Website: A collection of network resources that includes at least some web pages that share a common network resource identifier portion, e.g., a set of web pages that have URLs that share a common domain name but different path names.

[0059] Web Server: A server that contains functionality for responding to requests issued to a network by a browser, including requests to receive network resources, e.g., web pages. Currently, browsers and web servers format their requests and responses according to the HyperText Transfer Protocol (HTTP) promulgated by the IETF and W3C. In some embodiments, a web server may be a content server.

[0060] Network Resource: A web page, file, document, program, service, or other form of data or instructions that is stored on a network node and accessible for retrieval and / or other use by other network nodes.

[0061] Algorithm: A connected sequence of two or more data processing operations. A software program is an implementation of an algorithm.

[0062] 1 shows a block diagram of a system for performing an assay and outputting the results of an assay procedure, according to some exemplary embodiments. The system may include any one or more of a reader 100, a probe 120, a computing device configured to run an app 145, and a server 150, which may be one or more of a node of a local area network, a web server, and / or an entity or collection of entities hosting an internet-connected cloud service.

[0063] As described in detail below in connection with one or more other figures, the reader 100 may be configured to accept a test strip 102 containing a sample thereon and perform an assay of the sample by generating a signal or other form of test data indicative of the presence and / or estimated amount or concentration of an analyte in the sample at one or more locations on the strip 102 at one or more time points. The test strip 102 may include a porous carrier and one or more reagents forming a lateral flow immunoassay test strip. The structure and functionality of such strips are well known, an example being the test strip described in U.S. Pat. No. 10,823,726, which is assigned to the present applicant and is incorporated herein by reference in its entirety. A wide variety of technologies are available for reading lateral flow assay test strips, which may be optical, resistive, or magnetic in nature.

[0064] The reader 100 may also output an indication of the presence and / or estimated amount or concentration of the analyte to one or more other devices, such as the probe 120, the computing device 140, and / or the server 150. Typically, the sensing technology on the front side of the reader 100 generates a series of raw data points indicative of a characteristic of the test strip 102 at one or more time points during the assay process. This data may be pre-processed, such as with filters, if necessary, and then further processed to generate a final assay output. This further processing to generate the final assay output may include baseline correction, comparison to a threshold, linear or non-linear fitting, calibration, etc., to generate the final assay output. The final assay output may include a text or other binary indication of the presence or absence of the analyte, may be a numerical estimate of the concentration of the analyte in the sample, or may be another mathematical manipulation of the raw and / or pre-processed data to generate an output that conveys assay result information in a manner actionable or otherwise useful to a user of the assay.

[0065] In some embodiments, the reader 100 and the test strip 102 are integrally configured as a single-use, disposable device. To reduce the manufacturing costs of a disposable product, in some embodiments, the reader 100 may be configured to sense the levels of target substances at one or more locations and one or more times on the sample strip 102, but may not be configured to directly communicate those sensed levels to the computing device 140 and / or computing device 150, for example via a Bluetooth or WiFi connection, and may not be configured to determine whether one or more conditions of the test have been met to generate and / or output a final assay result. Manufacturing the reader 100 in this manner allows the reader 100 to be manufactured with reduced functionality and fewer components, and thus suitable for disposable, single-use applications. However, the disclosure is not so limited, and the reader 100 may in some embodiments be configured to directly communicate those sensed levels to the computing device 140 in a manner similar to how the probe 120 is configured, as described elsewhere in this disclosure.

[0066] The probe 120 may be configured to receive an output from the reader 100 indicative of the presence and / or sensed level of the analyte on the strip 102. In some embodiments, the received output may be one or more raw or minimally processed data values ​​generated by the sensor technology used by the reader, such as strip reflectance or conductivity values ​​measured by the reader at different times and / or different locations on the test strip 102. In some embodiments, the reader 100 output received by the probe 120 may be a single processed binary indication, such as "present" or "absent," or a single analyte concentration estimate generated by the processing circuitry of the reader 100. The probe 120 may further communicate one or more indications of the sensed presence or level of the analyte on the test strip 102 to one or more other devices, such as the computing device 140 and / or the server 150. In some embodiments, the probe 120 is configured to communicate the reader 100 output or the processed reader output directly to a separate computing device 140. For example, this communication may be via a wireless connection implementing a standard protocol, e.g., Bluetooth. In some embodiments, the probe 120 is configured to indirectly communicate the reader 100 output to the computing device 140 via a wide area network 130, which may include, for example, a portion of the Internet and / or any other suitable wired or wireless network or portion thereof. This may be performed via a WiFi connection to a router for communication over the Internet. In some embodiments, the probe 120 may essentially function as a relay device that does not perform significant data processing on the output that the probe 120 receives from the reader 100. In some embodiments, the probe 120 is configured to process raw or pre-processed data received by the reader to generate a final assay output using processing circuitry located in the probe 120 and transmit this processed output to the computing device 140 and / or server 150.The probe 120 may additionally or alternatively be configured to display one or more indications of the sensed level of the target substance on the sample strip 102 from the reader 100, and / or processed information derived at least in part therefrom, and / or a final assay output. Thus, in such embodiments, although not shown in FIG 1, the probe 120 may further include a display configured to externally present information, which may be human readable and / or machine readable.

[0067] The computing device 140 may be configured to execute an app 145, which may be configured to receive, process, and / or output raw or processed data, e.g., assays performed by the reader 100. In some embodiments, the computing device 140 may be a smartphone, tablet, personal computer, server, or any other suitable computerized user terminal. The computing device 140 may be configured to receive, directly or indirectly, one or more indications of the received sensed levels of analytes on the test strip 102 from the probe 120. Based at least in part on these indications, the app 145 may be configured to determine whether one or more conditions of the test have been met and / or display the results of such determination to the user. In some embodiments, the app 145 is additionally or alternatively configured to display one or more indications of the sensed levels of the target substances on the test strip 102 and / or processed information derived at least in part therefrom. Thus, in such an embodiment, although not shown in FIG. 1, computing device 140 may further include a display configured to externally present information that may be human-readable and / or machine-readable.

[0068] In some embodiments, at least a portion of the processing of the received indication of the sensed level of the target substance on the sample strip 102 and / or the determination of whether one or more conditions of the test have been met may be performed remotely from the app 145 and / or computing device 140 by a remote computing device 150, which may be, for example, a server, a cloud computing system, or any other suitable computing device.

[0069] In some embodiments, the computing device 140 and / or server 150 are configured to receive one or more indications of the received sensed level of the target substance on the sample strip 102 directly or indirectly from the probe 120, determine whether one or more conditions of the test have been met, and / or display to a user one or more indications of the sensed level of the target substance on the sample strip 102 and / or processed information derived at least in part therefrom.

[0070] FIG. 2A illustrates a reader 100 according to some exemplary embodiments. FIG. 2B illustrates an exploded view of some components of the reader 100 shown in FIG. 2A. As shown in FIGS. 2A and 2B, the reader 100 includes a housing 115. The housing 115 includes an opening for receiving a sample on a test strip 102, one or more openings for one or more light sources, e.g., LEDs 108a, 108b, 108c, and an opening 107 for ambient light sensing capabilities, which will be described further below. Within the housing 115, the reader 100 may further include a battery 101, a plurality of LEDs 108a-108c, an ambient light sensor proximate the opening 107, a sample strip 102, at least one sensor 103 / 104, and an integrated circuit 110 including a processing circuit that may include a processor 105 and a memory 106 (shown in FIG. 4).

[0071] The battery 101 is configured to provide power to any of the components of the reader 100. In some embodiments, the LEDs 108a-108c may comprise an LED configured to emit red light, an LED configured to emit yellow light, and an LED configured to emit green light. However, the disclosure is not so limited and the LEDs 108a-108c may be configured to emit light of any color or colors within or outside the human visible spectrum.

[0072] The test strip 102 is configured to receive a sample, such as an analyte suspended in an aqueous or non-aqueous solvent. In some embodiments, the test strip 102 comprises a lateral flow immunoassay strip that may include antibodies labeled with a reflective substance, such as gold particles, latex beads, or any other suitable optically reflective or absorbing substance configured to migrate along the test strip 102 to provide a detectable indication of the presence, absence, and / or amount of the analyte in the sample.

[0073] For example, the sensor 103 / 104 may be an optical detection mechanism or any other suitable detector configured to sense a characteristic (e.g., reflectance) of a first portion of the test strip 102 that changes when at least one of a liquid, an analyte, and / or a label moves to a portion of the test strip 102 being sensed by the sensor 103 / 104.

[0074] The photodetector 107 is an optional mechanism configured to enable ambient light around the reader 100 to reach another photodetection mechanism in the housing 115 and communicate a signal indicative of the level of ambient light to the processing circuitry 110 for waking up the processor 105 and / or other components of the reader 100 from a low power sleep mode. Thus, the reader 100 may be stored in a bag 160 that is substantially opaque to the type or bandwidth of light that the photodetector 107 is configured to sense, such that when the reader 100 is placed in the bag 160 and the bag 160 is sealed, the reader 100 is powered down or in a low power sleep mode, conserving power and extending the useful battery life of the reader 100.

[0075] Upon exiting the low power sleep mode and transitioning to the operating mode, the processing circuit 110 may be configured to illuminate the first LED 108a in a first color (e.g., green) to indicate to a user that the reader 100 is ready to accept a liquid sample onto the test strip 102.

[0076] The reader 100 may be configured to sample signals from one or more sensors 103 / 104 according to a sampling interval (e.g., once per second) during data collection of the test strip 102. In some embodiments, the sensor signals indicate a relative or absolute value of the amount of light from the sample strip 102 that reflects and / or otherwise impinges on the one or more sensors.

[0077] Once a sample is detected on the test strip 102, either immediately or after a predetermined period of time (e.g., 10 seconds), the processing circuit 110 may be configured to illuminate the second LED 108b in a second color (e.g., yellow) to indicate to a user that the reader 100 is analyzing the test strip 102.

[0078] In some embodiments, the processing circuit 110 may illuminate the second LED 108b for a predetermined time interval that corresponds to the sampling interval (eg, 10 minutes).

[0079] At the end of the sampling interval, the processing circuit 110 may be configured to turn off the second LED 108b and illuminate the third LED 108c with a third color (e.g., red). It will be appreciated that the processing circuit 110 may be configured to turn on or off any of the LEDs 108a-108c according to any desired information or test sequence to be delivered to a user. In some embodiments, rather than utilizing multiple LEDs 108a-108c, one or more LEDs or other light sources capable of multi-color illumination may instead be utilized that are configured to provide the same signal as any one or more of the LEDs 108a-108c.

[0080] Memory 106 may be significantly limited (e.g., 40 bytes) to reduce manufacturing costs of reader 100. However, the disclosure is not so limited and memory 106 may have any suitable capacity.

[0081] In some embodiments, the processor 105 may be configured to read signals from one or more sensors according to a predetermined sampling interval (e.g., once per second) during the data collection period, but the processor 105 may be further configured to store only the Nth signal or sample from one or more sensors 103 / 104, where N is an integer greater than 1, such as, but not limited to, equal to 7 or 14. Thus, in some embodiments, to reduce the amount of memory required to store signals and / or readings from one or more sensors 103 / 104, the processor 105 may be configured to store in the memory 106 only the 7th or 14th, respectively, sensor sample from each of the first sensor 103 and the second sensor 104, and discard (e.g., not store) the remainder. However, the samples that are subsequently discarded may still be used by the processor 105 in real time or near real time for error, variance detection, and / or other signal processing functions. In some embodiments, the reader 100 does not perform any calculations on the signal values ​​stored in memory 106, but only stores them for future communication to the probe 120 and eventual processing by another device in the system of FIG. 1 (e.g., the probe 120, the computing device 140 and / or the computing device 150).

[0082] As previously described, upon completion of data collection for the sample strip 102, the processing circuit 110 may illuminate the third LED 108c. To transmit the stored assay data to another device, the processing circuit 110 may be configured to encode the sampled data stored in the memory 106 as an intensity modulation of the illumination output of the third LED 108c. In some embodiments, the processing circuit 110 accomplishes this by controlling the illumination output intensity of the third LED 108c according to a carrier frequency (e.g., 38 kHz) modulated by the stored bit serial data signal. The data output rate may be, for example, 1200 baud, or approximately 833 microseconds (μs) per bit. Thus, in some embodiments, a 38 kHz intensity modulation of the illumination output of the LED for 833 μs may indicate a "1" bit, and an 833 μs period with no intensity modulation of the LED illumination may indicate a "0" bit. A wide variety of well-known encoding schemes may be used to randomize the bit stream and / or perform error detection or correction of the transmitted data. In some embodiments, the processing circuit 110 is configured to repeat the modulated readout of the data stored in the memory 106 a predetermined number of times, a predetermined amount of time, or in an infinite loop. In some embodiments, the processing circuit 110 is configured to modulate one or more escape characters (e.g., hex01 or hex10) onto a carrier frequency to indicate the beginning and / or end of the data stream of bits being read out, for example as stored in the memory 106. As described in more detail below, the probe 120 may be configured to decode the data stream modulated onto the illumination intensity of the third LED 108c and transfer or relay the extracted data directly or indirectly to the computing device 140 using different modes of electronic communication, for example wireless RF transmission methods including Bluetooth and WiFi.

[0083] Figure 3A shows a probe 120 for receiving data from a reader 100, according to some example embodiments. Figure 3B shows the probe of Figure 3A being held by a user. Figure 3C shows some components of the probe 120 shown in Figures 3A and 3B.

[0084] As shown at least in Figure 3A, the probe 120 comprises a housing 135. The housing 135 comprises an opening for each light source, e.g., LED 128, an opening for a power switch or button 122, and an opening for a light sensor 127, e.g., a light detection mechanism. As shown at least in Figures 3C and 5, within the housing 135, the probe 120 may further comprise a battery 121, a light source, e.g., LED 128, a switch 122, a light sensor 127, a transceiver module 125 (e.g., a Bluetooth transceiver chip), and one or more RC circuits or chips 124 necessary for operation of the probe 120 as described anywhere herein.

[0085] The battery 121 is configured to provide power to any component of the probe 120. In some embodiments, the battery 121 is replaceable. In some embodiments, the LED 128 may be configured to emit light of any color or colors. Activating the switch 122 turns on the probe 120 and illuminates the LED 128, providing a visual indication that the probe 120 has been activated. In some embodiments, activating the switch 122 also transitions the transceiver module 125 from a low power or deep sleep mode to a functional mode. In some embodiments, in such a deep sleep mode, the transceiver module 125 may be configured to consume a small amount of power, e.g., 50 nanoamps (nA), which may be a current lower than the inherent self-discharge rate of the battery 121 itself. This allows for a long battery life when the probe 120 is in a non-use mode for an extended period of time.

[0086] When turned on, the probe 120 is configured to optically read data being communicated, for example, by the modulated illumination of the LED 108c of the reader 100. For example, when the LED 108c of the reader 100 is illuminated, a user may hold the probe 120 in their hand and aim the light sensor 127 at the LED 108c of the reader 100. The light sensor 127 is configured to communicate a signal to the transceiver module 125 indicative of the illumination modulation of the LED 108c in the reader 100.

[0087] In some embodiments, transceiver module 125 is a Bluetooth module, e.g., a programmable transceiver chip manufactured by Nordic Semiconductor. However, any wireless communication transceiver chip capable of performing the functions described herein is contemplated. Thus, transceiver module 125 may also include a processor, logic, memory, antennas, oscillators, capacitors, inductors, filters, and any other conventional transceiver components necessary to perform the functions described herein.

[0088] The transceiver module 125 is configured to decode the signal from the optical sensor 127, package and / or encode at least the decoded data (e.g., bits previously stored in the memory 106 of the microchip 110 of the reader 100) into a second wireless communication format (e.g., Bluetooth), and transmit the encoded data directly or indirectly (e.g., via the WAN 130) to a computing device 140 configured to execute an app 145, at least as described above in connection with FIG. 1.

[0089] Thus, the probe 120 may act as a relay, translator, and / or gateway between the reader 100 and the computing device 140. In some such embodiments, data collected by the reader 100 is not analyzed or substantially processed by either the reader 100 or the probe 120, but instead is collected and stored by the reader 100, extracted, converted or packaged into a second communication format, relayed by the probe 120, and analyzed by the app 145 of the computing device 140. In this manner, a positive or negative result or concentration determination of the sample strip 102 is analyzed and determined by the app 145 of the computing device 140, rather than the reader 100 or the probe 120. By designing the system in this manner, either or both of the reader 100 and the probe 120 may be reduced in functionality and therefore made with fewer components and in a simpler and less expensive manner. Of course, as discussed above in connection with FIG. 1, at least a portion of this analysis may also, or alternatively, be performed by utilizing an intermediate computing device 150 or the like, e.g., cloud computing resources.

[0090] 6 is a block diagram of an exemplary embodiment in which the probe 120 is configured to receive the reader 100 in a predetermined orientation, according to some exemplary embodiments. In the previous exemplary embodiment, the user points the probe 120 toward the reader 100 such that the light sensor 127 of the probe 120 can sense or read data from the illumination of the LED 108c of the reader 100. In some other embodiments, the probe 120, e.g., the housing 135 of the probe 120, may be physically configured (e.g., formed) to receive the reader 100 and position the sample strip 102 therein with the light sensor 127 of the probe 120 facing the LED 108c of the reader 100, as shown, for example, in FIG. 6. In some such embodiments, the probe 120 may also have a lid 150 configured to allow the reader 100 to be positioned by the user.

[0091] Figure 7 is a block diagram of a single device and / or housing 700 that integrates some components of the reader 100 and some components of the probe 120, according to some exemplary embodiments. Figure 8 is a block diagram of a side view of the device 700, according to some exemplary embodiments. As shown, the device 700 may include a battery 701, a first sensor 703 and a second sensor 704, a microchip 710 including a processor 705 and a memory 706, a switch 722, a transceiver module 725, an RC circuit 724, and a display 708, which may be substantially similar or the same as the battery 101 / 121, the first sensor 103 and a second sensor 104, the microchip 110 including the processor 105 and the memory 106, the switch 122, the transceiver module 125, the RC circuit 124, and the LEDs 108a-108c / 128, respectively, as described above in connection with the reader 100 and / or probe 120. As described in more detail below, in some embodiments, display 708 comprises one or more light sources, e.g., LEDs, configured to independently indicate one or more states of device 700 and / or configured to collectively indicate one or more states of device 700.

[0092] The device 700 further includes a sample 702, which may be substantially identical to the sample on the test strip 702, except that rather than being placed in a separate reader 100, the sample on the test strip 102 is placed in a plastic cassette 707 or housing that is physically placed in the device 700 during data collection and / or analysis and may then be discarded. The cassette 707 may be devoid of any electronics. In some such embodiments, the device 700 may further include a clampable lid 750, similar to the lid 150 of the probe 120 described in connection with FIG. 6, configured to snap onto the cassette 707. This may differ from sliding the sample strip 102, 702 into the tester, at least because the device 700 is configured to snap onto and / or completely surround the cassette 707.

[0093] Since the reader 100 and probe 120 may be physically located within the same device 700 and communicate directly and electronically with one another, the function of the device 700 may be substantially as described above for the reader 100 and probe 200, except that alignment and optical or IR reading between the reader and probe is not required. Instead, when a cassette 707 having a sample 702 therein is properly located within the device 700, the LED 708 may be configured to function as described above for either the LEDs 108a-108c of the reader 100 or the LED 128 of the probe 120, and the data stored in the memory 706, as received from the first sensor 703 and the second sensor 704, may be transferred directly from the processing circuitry 710 to the transceiver module 725, with or without any of the previously described carrier / data modulation and / or XOR encoding with alternating "1's" and "0's." Additionally, data may be transferred from the processing circuit 710 to the transceiver module 725 in real-time (e.g., as the data is stored in memory 706) or in the aforementioned delayed cache manner, which occurs after a predetermined complete data collection interval (e.g., 10 minutes).

[0094] 7 and 8 may represent a reduced cost and reduced adverse environmental impact compared to some other embodiments because only the cassette 707 containing the test strips 702 and no other electronics is disposed of. All electronics previously placed in the reader 100 that would otherwise be discarded after a single use are disposed in the device 700.

[0095] In yet other embodiments, all of the functionality of the probe 120 and / or apparatus 700 may be located within and processed directly by the computing device 140 on which the app 145 executes. In some such embodiments, the computing device 140 may be equipped with a camera configured to read the blinking LED 108c. In some such embodiments, the computing device 140 may be configured similar to the embodiment of the probe 120 shown in FIG. 6 such that the reader 100 can be mounted on or pointed towards the computing device 140 where such a camera can read the blinking LED 108c. In some embodiments, the reader 100, probe 120, apparatus 700 and / or computing device 140 may alternatively or additionally be configured to communicate utilizing a multi-level coding scheme enabling complex and / or efficient signaling patterns incorporating simultaneous blinking and / or flashing of any two or more of the LEDs 108a-108c, or blinking one or more LEDs in a multi-color and / or multi-tempo signaling protocol.

[0096] 9 and 10 show perspective views of an exemplary embodiment of a device 700 and cassette 707 with a sample 702 to be assayed. For ease of explanation, only a subset of the components of device 700 are shown.

[0097] The device 700 may include a lid 750 that opens with a hinge assembly (not shown in detail in FIGS. 9 and 10 ) and is configured to receive the cassette 707 in a predetermined orientation. When the cassette 707 is properly placed at least partially within the device 700, the cassette 707 is configured to have an end extending from the device 700 that is configured to receive a sample to be assayed. In some embodiments, to facilitate proper placement of the cassette 707, the base of the device 700 includes a test strip mounting location that includes a recess having a shape complementary to the cassette 707. In some embodiments shown in FIG. 9 , the one or more sensors 703 / 704 may be positioned on the underside of the lid 750 such that when the cassette 707 is placed within the device 700 and the lid 750 is closed, the one or more sensors 703 / 704 are positioned directly above a respective portion of the test strip 702 within the cassette 707. In some embodiments, the device 700 may be configured to begin processing the cassette 707 when the lid 750 is closed.

[0098] 10, the LEDs 708 are located on the top surface of the device 700. Each of the LEDs 708 may be configured to light up and / or flash to indicate a different state or mode of the device 700. For example, one of the LEDs 708 may be configured to indicate that the device 700 is ready to process the cassette 707, one of the LEDs 708 may be configured to indicate that the device 700 is currently processing the cassette 707, one of the LEDs 708 may be configured to indicate a positive result regarding the processing of the cassette 707, one of the LEDs 708 may be configured to indicate a negative result regarding the processing of the cassette 707, and one of the LEDs 708 may be configured to indicate an invalid test result or an invalid cassette 707.

[0099] 9 and 10 depict a substantially square or rectangular form factor for device 700, the disclosure is not so limited and device 700 may have any suitable shape and / or form factor.

[0100] In some embodiments, the device 700 is configured with a display that displays a two-dimensional machine readable code, e.g., a QR code. For example, in at least embodiments according to Figs. 11 and 12, the display 708 of the device 700 may be configured to display a two-dimensional machine readable code 1402, e.g., a QR code, that can be read by a network-enabled computing device, e.g., the computing device 140. The two-dimensional machine readable code may encode data related to the assay performance, e.g., data related to a sampled sensor signal, e.g., an unprocessed or only partially processed sensor signal. In some embodiments, the two-dimensional machine readable code may encode a final assay result output indicative of the results of the assay. In some embodiments, the two-dimensional machine readable code may further encode a network resource identifier, e.g., a URL of a network service that receives data from the computing device 140, encoded in the two-dimensional machine readable code. The accessed network service may process the received assay data to generate a final assay result output, and incorporate the results by the network service into a web page that is sent back to the computing device 140, thereby displaying the results of the test to a user. In some embodiments, the QR code may include the reader ID (eg, identification information of the device 700 ) and / or the results and / or values ​​of the test performed on the cassette 707 .

[0101] In an embodiment according to FIG. 12, the cassette 707 may also include a code, e.g., a second QR code 1502, configured to identify, for example, the type of test for which the cassette 707 is configured (e.g., a test identifier for any one or more of bedbugs, mites, lice, etc.), the duration of the test of the cassette 707, positive and / or negative thresholds for the test of the cassette 707, a serial number, a lot number, an expiration date, and / or a hash code to ensure that the cassette 707 is authentic and not counterfeit.

[0102] A system according to any of Figures 11 and 12 may be substantially similar to the system of Figure 1, but includes an integrated apparatus 700 as described elsewhere herein, rather than a separate reader 100 and probe 120. A mobile device 140, which may be, for example, a mobile phone or a tablet, includes a camera 1410 configured to capture an image of the code 1402 on the apparatus 700 (see Figures 11 and 12) and / or the code 1502 on the cassette 707 (see Figure 12).

[0103] If the camera 1410 is configured to capture an image of the code 1502 on the cassette 707, the mobile device 140 may be configured to extract any of the aforementioned information encoded in the code 1502. Additionally and / or alternatively, the mobile device 140 may be configured to extract a subset of the aforementioned information encoded in the code 1502 and derive a different subset of the aforementioned information or other information that may not be encoded in the code 1502. For example, the code 1502 may encode a serial number of the cassette 707, and the mobile device 140 may be configured to extract the serial number from the code 1502 and then derive, request, or retrieve from another computing device 150 over the network 130 a lot number and / or expiration date based on the serial number. As another example, the code 1502 may encode a test identifier for the cassette 707, and the mobile device 140 may be configured to extract the test identifier number from the code 1502 and then derive, request, or retrieve from another computing device 150 via the network 130 the duration of the test and / or positive and / or negative thresholds for the test based on the test identifier. In some embodiments, the apparatus 700 may be configured to read or extract information directly from the cassette 707 when placed in the cassette 707, for example, via one or more electrical contacts communicatively connecting circuitry in the cassette 707 with circuitry in the apparatus 700, and / or via another sensor configured to read a pattern or code on the cassette 707. Once the mobile device 140 and / or the apparatus 700 have extracted, derived, or received sufficient information via request and retrieval, the apparatus 700 may perform the test on the cassette 707.

[0104] 13A shows a screen shot of the app 145 returning another set of information extracted, derived, or received via a request or search based on two codes (e.g., 1402, 1502). The cassette ID, lot number, and expiration date are shown in the first entry, and the different results of the test on the cassette 707 are shown in the second entry.

[0105] 13B shows another screenshot of the app 145 returning yet another set of information extracted, derived or received via a request or search based on two codes (e.g., 1402, 1502). The results of the test on cassette 707 are shown in a first entry, and the cassette ID, lot number and expiration date are shown in a second entry.

[0106] Exemplary embodiments of the apparatus 700 and / or cassette 707 are shown in further detail in one or more of the following figures.

[0107] Figures 14a and 14B show device 700 with cassette 707 disposed therein. Device 700 comprises a housing base 1710 and a lid 750 connected together via a hinge assembly 1750. A display 708 is shown displaying a QR code 1402 visible through an opening in the lid 750. An advantageous display technology for this application is known as E-Paper, which is an extremely low power persistent display; however, it will be appreciated that any display technology may be utilized. Figure 14B shows a perspective bottom view of device 700.

[0108] 15A and 15B show an exemplary embodiment of a test strip cassette 707. In this embodiment, the housing includes a sample application opening 712 and a test result viewing opening 714. As seen in FIG. 15, the test result viewing opening comprises at least a partial sloped wall around the edge of the opening, the function of which is further described below. The housing may be formed from a top and an opposing bottom.

[0109] 16-23, the lid 750 includes an opening 2234 (FIG. 19) through which the display 708 and the QR code 1402 are ultimately visible. In some embodiments, a printed circuit board (PCB) 2210 is configured to be disposed on the underside of the lid 750. While the PCB 2210 may include any electronics and / or circuitry of the device 700 as described anywhere herein, FIG. 16 specifically illustrates one or more sensors 703 / 704 and a battery 701 (e.g., three AAA batteries) disposed thereon. The battery cover 2220 is configured to be disposed on the top (or bottom) and sides of the battery 701. For example, FIG. 16 illustrates the device 700 with the PCB 2210 attached to the underside of the open lid 750 and the cassette mounting structure 2260 attached to the base shell 1710, with neither the cassette 707 nor the cover 2220 connected to the device 700. Figure 17 is similar to Figure 16, but shows device 700 with cover 2220 connected over battery 701. Figure 18 is similar to Figure 17, but shows device 700 with the lid open and completely flat, and with cassette 707 properly positioned on cassette mounting structure 2260. As shown, either or both of PCB 2210 and cassette mounting structure 2260 may be secured to lid 750 and base shell 1710, respectively, using screws.

[0110] FIG. 19 illustrates an exploded perspective view of the device 700 of any of FIGS. 14-18, according to some exemplary embodiments. The device 700 includes a base housing portion 1710 having a first portion 2242 of a hinge arrangement 1750, and a lid housing portion 750 having a second portion 2232 of the hinge arrangement 1750. A hinge pin 2250 may be configured to pass through an opening in each of the first portion 2242 and the second portion 2232 of the hinge arrangement 1750. In some embodiments, the second portion 2232 may be configured to be disposed between each of two laterally disposed aspects of the first portion 2242, as shown in FIG.

[0111] The base shell 1710 includes a cassette mounting structure 2260 configured to receive the cassette 707 such that at least an end of the cassette 707 extends outside the apparatus 700 .

[0112] 20-23 show different cutaway views of device 700 with all aspects of device 700 installed. Protruding housing 2215 forms a mounting location for one or more sensors 703 / 704 disposed on PCB 2210 (connected to the underside of lid 750). Cassette mounting structure 2260 is positioned on base housing portion 1710 such that when cassette 707 is placed into structure 2260 and lid 750 is closed, one or more sensors 703 / 704 are aligned directly over the correct portion of the test strip 702 to be analyzed in cassette 707.

[0113] 24 and 25 show the placement and alignment of cassette 707 relative to the test strip / cassette mounting structure 2260. As shown in FIG. 24, the mounting structure includes protruding pins 732 that mate with openings 730 in cassette 707 that are configured to receive pins 732 when cassette 707 is properly placed and oriented on the mounting structure 2260. FIG. 25 shows pins 732 mating with openings 730. Pins 732 and openings 730 form an alignment or registration feature for cassette 707 relative to mounting structure 2260.

[0114] 25, the sensor housing 2215 and test result viewing opening 714 are also configured to provide accurate alignment / registration of the one or more sensors to a desired position of the test strip to fit. In this embodiment, the viewing opening 714 on the cassette 707 has one or more inwardly sloping walls 716 around at least a portion of the viewing opening 714. The mounting structure 2215 for the one or more sensors has one or more protruding walls 2216 with a matching slope to fit snugly inside the result viewing opening 714. These alignment and registration structures, which may be provided together or separately in various embodiments, ensure that the user of the device obtains accurate and reproducible alignment of the test strip and sensor for each assay performed, helping to improve the accuracy of the test results.

[0115] 26 shows a flow chart of another method for testing an assay and reading the results of such a test, according to some exemplary embodiments. The method of FIG. 26 may correspond to or be applied to any of the devices described in this disclosure.

[0116] Block 2602 includes placing the liquid sample on a test strip that is placed in a reader. The test strip 702 may be placed in a cassette 707 that is removably positioned within the device 700.

[0117] Block 2604 includes generating a signal with a reader indicative of the change in a characteristic of the test strip.

[0118] Block 2606 includes generating a pattern on a display of the reader that encodes data related to the outcome of the assay performed by the reader based on the sampled sensor signal. For example, as previously described, the display 708 may generate a pattern (e.g., a barcode or QR code) that encodes data related to the outcome of the assay performed by the device 700.

[0119] In some embodiments, the method further includes utilizing an application running on the mobile device to cause the camera to generate an image of the pattern on a display of the reader and to decode data associated with the result based on the image. For example, as described above, an app 145 running on the mobile device 140 may cause the camera 1410 to generate an image of the pattern 1402 on the display 708 of the apparatus 700 and to decode data associated with the result based on the image.

[0120] In some embodiments, the app 145 may cause the camera 1410 to generate an image including simultaneously the second pattern 1502 on the cassette 707 and the pattern 1402 on the display 708 of the device 700. The app 145 may further decode the second data based on the image.

[0121] In some embodiments, the device 700 may read information directly from the cassette 707 via one or more electrical contacts that communicatively connect the cassette 707 to the device 700 when the cassette 707 is placed on a cassette carrier 2260 within the device 700.

[0122] In some embodiments, the sample strip 702 includes a reflective material (e.g., gold) and the characteristic sensed is the reflectance of the sample strip. In some embodiments, the first portion of the sample strip 702 is disposed between the initial portion and the second portion of the sample strip. The liquid sample received by the sample strip 702 is configured to move from the initial portion of the sample strip 702 toward the first and second portions. In some embodiments, the device 700 includes a hinged lid 750, and the first sensor 703 and the second sensor 704 are disposed on the underside of the lid 750 such that when the cassette 707 is placed in the carrier 2260 and the lid 750 is closed, the first sensor 703 and the second sensor 704 are disposed directly above the first and second portions, respectively, of the sample strip 702 in the cassette 707. In some embodiments, the first sensor 703 and the second sensor 704 are disposed on a PCB 2210 secured to the underside of the lid 750 such that when the cassette 707 is placed on the carrier 2260, the first sensor 703 and the second sensor 704 protrude from the PCB 2210 and into one or more recesses 2324 in the cassette 707. In some embodiments, the data related to the results of the assays includes at least one of a text of the result of the assay, a pictorial representation of the result of the assay, and a link to a web page configured to communicate at least one of the results of the assay, and a unique identifier of the device 700. In some embodiments, the cassette 707 includes a second pattern 1502 encoding second data related to at least one of the type of assay for which the cassette 707 is configured, the duration for running the assay, positive and / or negative thresholds associated with the assay, a unique serial number of the cassette 707, a lot number and / or expiration date, and a hash code.

[0123] 27 shows a flow chart of a method for testing an assay and reading out the results of such a test, according to some exemplary embodiments. The method may correspond to or be applied to any of the devices described in this disclosure.

[0124] Block 2702 includes placing the liquid sample at a location on the test strip of the reader. For example, as described above, a user may place the liquid sample at the beginning of the sample strip 102 of the reader 100.

[0125] Block 2704 includes generating a signal from a sensor of the reader indicative of a change in a characteristic of a portion of the test strip. In some embodiments, the characteristic is a reflectance of the sample strip 102.

[0126] Block 2706 includes utilizing a processor of the reader to sample the signals according to a predetermined sampling interval. For example, the processor 105 of the processing circuit 110 of the reader 100 is configured to sample signals from the one or more sensors according to a predetermined sampling interval (e.g., once per second) during data collection of the sample strip 102.

[0127] Block 2708 includes storing only a subset of the signal samples in the memory of the reader. For example, the memory 106 of the processing circuit 110 of the reader 100 may be configured to store only the Nth signal or sample for each of the first sensor 103 and the second sensor 104, where N is equal to an integer greater than 1, such as but not limited to 7 or 14.

[0128] 28 shows a flow chart of another portion of a method for performing an assay and reading out the results of such a test, according to some exemplary embodiments. The method of FIG. 28 may correspond to or be applied to any of the devices described in this disclosure. In some embodiments, the method of FIG. 28 may follow the method of FIG. 27.

[0129] Block 2802 includes aiming the light sensor of the probe at the light source of the reader. For example, a user may aim the light sensor 127 of the probe 120 at the LED 108c of the reader 100. In some embodiments, block 2802 may also include physically placing the reader 100 within the probe 120 in a predetermined orientation such that the light sensor 127 of the probe 120 faces the LED 108c of the reader 100, as described above in connection with FIG.

[0130] Block 2804 includes generating a signal indicative of the subset of samples utilizing a light sensor of the probe based on an illumination pattern of at least a first light source of the reader. For example, the light sensor 127 of the probe 120 may be configured to generate a signal indicative of the subset of samples based on a blinking pattern of the LED 108c of the reader 100.

[0131] Block 2806 includes packaging, utilizing a transceiver module of the probe, the signal indicative of the subset of samples into a predetermined wireless communication protocol format. For example, the transceiver module 125 of the probe 120 may be configured to package the signal indicative of the subset of samples generated by the optical sensor 127 of the probe 120 into a predetermined wireless communication protocol format. In some embodiments, the predetermined wireless communication protocol is Bluetooth.

[0132] Block 2808 includes utilizing the transceiver module to transmit the signal packaged in the predetermined wireless communication protocol format to a computing device configured to analyze the subset of samples. For example, the transceiver module 125 of the probe 120 may be configured to transmit the signal packaged in the predetermined wireless communication protocol format to the computing device 140 (and / or the intermediate computing device 150), which is configured to analyze the subset of samples that are ultimately relayed from the memory 106 of the reader 100 via the probe 120 to the computing device 140 and / or the intermediate computing device 150.

[0133] In some embodiments, neither the reader 100 nor the probe 120 is configured to analyze or substantially process a subset of the samples of the first and second signals initially generated by the first and second sensors 103, 104 of the reader 100 in relation to determining the results of an assay of the liquid sample on the sample strip 102.

[0134] General principles of interpretation of the disclosure Various aspects of the novel system, apparatus, and method are described below in detail with reference to the accompanying drawings. However, the teaching disclosure may be embodied in many different forms and should not be construed as limited to the specific structure or functions presented throughout this disclosure. Rather, these aspects are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachings herein, one skilled in the art should understand that the scope of the disclosure is intended to cover any aspect of the novel system, apparatus, and method disclosed herein, whether implemented independently of any other aspect of the disclosure or combined with any other aspect of the disclosure. For example, a system or apparatus may be implemented, or a method may be implemented using any one or more of the aspects described herein. Furthermore, the scope of the disclosure is intended to cover such systems, apparatus, or methods implemented using other structures, functions, or structures and functions in addition to or other than the various aspects of the disclosure described herein. It should be understood that any aspect disclosed herein may be recited in one or more elements of a claim. Although some benefits and advantages of the preferred embodiments are mentioned, the scope of the disclosure is not intended to be limited to any particular benefit, use, or purpose. The detailed description and drawings are merely illustrative of the disclosure, rather than limiting, the scope of the disclosure being defined by the appended claims and their equivalents.

[0135] With respect to the use of plural to singular terms herein, those of skill in the art may convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for clarity.

[0136] When describing absolute values ​​of features or characteristics of things or acts described herein, the terms "substantially," "substantially," "essentially," "approximately," and / or other terms or phrases of degree may be used without the specific recitation of a numerical range. When applied to a feature or characteristic of things or acts described herein, these terms refer to a range of the feature or characteristic consistent with providing a desired functionality associated with that feature or characteristic.

[0137] When a single numerical value is given for a characteristic or property, it is intended to be interpreted as covering at least the deviation of that value within one significant digit of the given numerical value.

[0138] When a numerical value or numerical range is provided to define a feature or characteristic of an object or act described herein, a specific method of measuring the feature or characteristic may also be defined herein, whether or not the value or range is qualified in terms of degree. If a specific method of measuring the feature or characteristic is not defined herein, and there are different commonly accepted measurement methods for the feature or characteristic, the measurement method should be interpreted as the measurement method that is most likely to be adopted by a person of ordinary skill in the art, given the description and context of the feature or characteristic. In further cases, there are two or more measurement methods that are equally likely to be adopted by a person of ordinary skill in the art to measure the feature or characteristic, and the value or value range should be interpreted as being satisfied regardless of which measurement method is selected.

[0139] It will be understood by those of ordinary skill in the art that terms used in this specification, and particularly in the appended claims (e.g., the body of the appended claims), are intended as "non-limiting" terms unless otherwise specified (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but not limited to," etc.).

[0140] Where a particular number of introduced claim recitations is intended, such intent shall be expressly recited in the claim, and it will be further understood by those skilled in the art that in the absence of such recitation, no such intent exists. For example, to aid in understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the claim recitations. However, the use of such phrases should not be construed as meaning that the introduction of a claim recitation with the indefinite article "a" or "an" limits any particular claim that includes such an introduced claim recitation to an embodiment that includes only one such recitation, even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article, e.g., "a" or "an" (e.g., "a" and / or "an" should be construed to mean "at least one" or "one or more"), and the same applies to the use of definite articles used to introduce claim recitations. Moreover, even if a particular number of introduced claim recitations is explicitly recited, one of ordinary skill in the art will recognize that such recitation should ordinarily be interpreted to mean at least the recited number (e.g., an explicit recitation of "two recitations" without other modifiers ordinarily means at least two recitations, or more than two recitations).

[0141] Where conventions similar to "at least one of A, B, and C" are used, such configurations include systems having A only, B only, C only, A and B without C, A and C without B, B and C without A, and A, B, and C together. It will be further understood by those skilled in the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" is understood to include A without B, B without A, and A and B together.

[0142] Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the present disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the claims, principles, and novel features disclosed herein. The term "exemplary" is used exclusively herein to mean "serving as an example, instance, or illustration." An implementation described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other implementations.

[0143] Certain features described herein in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in a particular combination, and may even initially be claimed as such, one or more features from a claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination.

[0144] The methods disclosed herein include one or more steps or actions for achieving the described method. The method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims. [Explanation of symbols]

[0145] 100 Reader 101 Battery 102 Sample Strips 103 Sensors 104 Sensors 105 processors 106 Memory 107 Opening 108 LED 110 Processing circuit 115 Housing 120 Probe 121 Battery 122 Buttons 124 Chips 125 Transceiver Module 127 Optical Sensor 128 LED 130 Wide Area Network 135 Housing 140 Computer Devices 145 Apps 150 servers 160 Bags 700 equipment 701 Battery 702 Test Strips 703 First Sensor 704 Second Sensor 705 Processor 706 Memory 707 Plastic Cassette 708 Display 710 Microchip 712 Sample application opening 714 Test result observation opening 716 Inward slope wall 722 Switch 724 RC circuit 725 Transceiver Module 730 Opening 732 Protruding pin 750 Lid 1402 Code 1410 Camera 1502 Code 1710 Housing Base 1750 Hinge Assembly 2220 Cover 2210 Printed Circuit Board 2215 Protruding housing 2216 Projecting wall 2232 Second Part 2234 Opening 2242 First Part 2250 Hinge pin 2260 Cassette mounting structure 2324 Recess

Claims

1. A system including a liquid sample assay device and a test strip cassette, The liquid sample assay device comprises: A first housing portion; A second housing portion; and a cassette mounting structure attached to the second housing portion, the cassette mounting structure including a recess having a shape complementary to the test strip cassette; a user operable connection configured to selectively enable an open and closed configuration of the first housing portion relative to the second housing portion; Equipped with the interface is configured such that a user may place the first and second housing portions in the open configuration to expose the cassette mounting structure, place the test strip cassette in the cassette mounting structure, and place the first and second housing portions in the closed configuration to perform an assay on a test strip in the test strip cassette; the first housing portion forms a lid configured to cover the second housing portion with the cassette mounting structure disposed between the first housing portion and the second housing portion; the first housing portion contains all the electronic circuitry for performing an assay on a liquid sample; the test strip cassette is a disposable, single-use test strip cassette; the test strip cassette includes a sample application opening and a test result viewing opening; the second housing portion and the cassette mounting structure are configured to receive the test strip cassette in a predetermined orientation such that a portion of the test strip cassette including the test result viewing opening is disposed within the first and second housing portions and a remainder of the test strip cassette including the sample application opening extends outside the first and second housing portions; the liquid sample assay device comprising at least one sensor in the first housing portion, the sensor configured to generate a signal indicative of a change in a characteristic of the test strip; The system, wherein a sensor housing of the sensor and the test result viewing opening are configured to mate to provide alignment of the sensor with respect to a desired position of the test strip.

2. The system of claim 1 , wherein the connection comprises a hinge.

3. The system of claim 1 or 2, wherein the liquid sample assay device forms a handheld housing.

4. The system of claim 1 , wherein the cassette mounting structure is configured to receive the test strip cassette without sliding.

5. A system described in any one of claims 1 to 4, wherein the liquid sample assay device further comprises a display configured to generate a barcode or QR code (registered trademark) relating to the final assay result output.

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