DIAGNOSTIC TEST DEVICE WITH IMPROVED USE AND VISUAL DETECTION OF THE RESULT OF AN ANALOGICAL TEST.

Abstract

The present invention relates to diagnostic test devices that provide enhanced communication to a user regarding either the proper functioning of the test device or an analog test result provided by the test device. The diagnostic test devices may include one or more sensors effective for indicating the application of a sufficient volume of a test fluid and / or may include one or more light sources positioned to illuminate the analog test result to improve its visibility and understanding.

Description

DIAGNOSTIC TEST DEVICE WITH IMPROVED USE AND VISUAL DETECTION OF THE RESULT OF AN ANALOGICAL TEST FIELD OF INVENTION The present invention relates to diagnostic testing devices that provide connectivity to the user. More particularly, the testing devices include elements that provide specific information to the user, for example, through visual means. BACKGROUND OF THE INVENTION Many types of ligand receptor assays have been used to detect the presence of various substances in bodily fluids, such as urine, saliva, or blood. Some commercially available assays are designed to provide a quantitative determination, but in many circumstances, only a positive / negative qualitative indication is required. Examples of such qualitative assays include blood typing, pregnancy tests, and many types of urinalysis.U.S. Patent No. 6,485,982, which is incorporated herein by reference in its entirety, describes a diagnostic test cell or device comprising an elongated outer housing containing an inner permeable material (such as fiberglass) capable of transporting an aqueous solution by capillary action, absorption, or simple wetting. The housing defines a sample inlet and interior regions, designated as a test volume and a reservoir volume. The reservoir volume is disposed in a section of the test cell that is separate from the inlet and filled with adsorbent material. The reservoir acts to receive a fluid sample transported along a flow path defined by the permeable material and extending from the inlet and through the test volume.Within the test volume is a test site comprising a first protein having a specific binding site for a first epitope of the ligand immobilized in fluid communication with the flow path (e.g., bound to the permeable material or to latex particles trapped in, or attached to, the permeable material). A window, such as an orifice or a transparent section of the housing, allows observation of the test site through the housing wall. Use of the test cell requires a conjugate comprising a second protein bound to colored particles, such as a metallic sol or colloid, preferably gold. The conjugate can take two distinct forms, depending on whether the assay is designed to exploit the sandwich or competitive technique. U.S. Patent No. 7,045,342, which is incorporated herein by reference in its entirety, describes a diagnostic testing device comprising a two-phase chromatographic medium. The two-phase substrate consists of a release medium bonded to a capture medium located downstream of the release medium. The release and capture media preferably comprise two different materials or phases, having distinct specific characteristics. The two phases are bonded to form a single fluid path such that a solvent front can travel unimpeded from the proximal (upstream) end of the release medium to the distal (downstream) end of the capture medium. For tests such as those described above, visually observable indicators may be preferred. Such indicators can be provided digitally (e.g., a digital reading on a liquid crystal display (LCD) or similar screen). Alternatively, such indicators can be provided in an analog form, which has typically included the presence of agglutination or color change at a defined site in the assay. While digital indicators may provide greater ease of reading the test result, such digital diagnostic testing devices may be more expensive and have a greater chance of electronic reading errors.Analog tests can be more reliable with fewer opportunities for malfunction; however, they can be difficult to use due to the inability to determine when a sufficient sample volume has been applied and / or visual difficulties in viewing the analog test result(s). For these and other reasons, it would be beneficial to provide a personal test device with improved communication between the test device and the user. SUMMARY OF THE INVENTION The present invention relates to diagnostic testing devices that include elements useful for performing a test and for providing test-related information on a screen. In one exemplary embodiment, a pregnancy testing device may be provided and may include elements for performing a test on a fluid sample applied to a recipient limb to identify the presence of human chorionic gonadotropin (hCG) in the sample, which is indicative of a pregnancy. Testing devices according to the present invention may provide enhanced communication from the testing device to a user, making the device easier for the user to operate, improving the understanding of the included test results, and increasing user comfort with the device and the user's assurance of its reliability. The test devices according to the present invention may incorporate one or more digital features that improve the device's usability and / or enhance the interpretation of the test results it provides. These digital features may also allow the test result to be provided in analog form, if desired, to reduce the overall cost of the test device and maintain its simplicity while still providing the improvements resulting from the inclusion of the digital features. For example, the test devices may incorporate one or more fluid sensors, timers, lights, and memory components.Convergence test devices may also include one or more control components and one or more power supplies to facilitate the execution of digital functions to improve the interpretation of analog test results. In one or more embodiments, the present invention may be particularly related to a diagnostic testing device comprising: a housing having a viewing window; a sample receiving member extending between a proximal end positioned within the housing and a distal end extending out of the housing; a test member positioned within the housing, the test member extending between a distal end in fluid communication with the proximal end of the sample receiving member and a proximal end such that a portion of the test member is visible through the viewing window; a fluid sensor in communication with the sample receiving member and configured to provide a signal; a power source; and a light source configured to provide illumination visible from the outside.and a control component configured to automatically supply power from the power source to the light source for one or more periods of time after receiving the signal from the fluid sensor. In further embodiments, the diagnostic test device may be further defined in relation to one or more of the following statements, which may be combined in any number and order. The test member may comprise a release means in fluid communication with a capture means, and in which a portion of the capture means is visible through the viewing window. The test device can be configured to detect the presence of an analyte in a fluid sample applied to the sample-receiving member. The presence of the analyte can be indicated by an analog signal that is visible through the display window. The analyte can be selected from the group consisting of human chorionic gonadotropin (hCG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone, estrogen, progesterone, testosterone, one of their metabolites, and combinations thereof. At least the portion of the test member that is visible through the viewing window may be permeable to light. The fluid sensor can be configured as an electrical circuit that includes the sample receiving member. The fluid sensor may include a pair of electrical contacts that are physically separated and in contact with the sample-receiving member. The pair of electrical contacts can be in electrical connection with the control component. The fluid sensor can be configured to signal that a fluid applied to the sample-receiving member is present in a volume suitable for the test device to perform a specific test. The light source can be placed inside the housing so that the test member is between the light source and the viewing window. The source may include a light-emitting diode (LED) and a light guide. The LED can be positioned so that it is offset from the viewing window, and the light guide is configured to transmit light from the LED to the viewing window. The light guide can define a lighting zone positioned within the housing so that the test member is between the lighting zone and the viewing window. The light source can be seen through the viewing window. The light source may be visible through a section of the housing. The control component can be configured to execute one or more functions after receiving the signal from the fluid sensor, said one or more functions being effective in providing indications to a user that a sufficient volume of a fluid sample has been applied to the sample-receiving member. The one or more functions may include supplying power from the power source to the light source for a preset period of time. The control component may include a timer. The control component can be configured to supply power from the power source to the light source for one or more preset time periods measured by the timer. The control component can be configured to supply power from the power source to the light source for a first preset time period and a second preset time period, the first preset time period and the second preset time period not overlapping. The first preset time period can be triggered by the fluid sensor signal. The second preset time period can be activated based on the passage of an estimated time for the completion of a test for which the diagnostic test device is configured. The control component can be configured to supply power from the power source to the light source so that the light source provides one or more flickering effects. In one or more embodiments, the present invention may further relate to methods for improving the ease of use of a diagnostic test device. For example, such methods may comprise: preparing the test device to include: a housing having a viewing window; a sample-receiving member extending outward from the housing; a test member positioned within the housing to be in fluid communication with the sample-receiving member and such that a portion of the test member is visible through the viewing window; a fluid sensor in communication with the sample-receiving member and configured to provide a signal; a power source; a light source configured to provide illumination through the viewing window; and a control component.and configure the control component to: provide one or more indications to a user that a sufficient volume of a fluid sample has been applied to the sample-receiving member; and automatically supply power from the power source to the light source after an estimated time has elapsed to complete a test for which the diagnostic test device is configured. In further embodiments, the methods may be further defined in relation to one or more of the following statements, which may be combined in any number and order. The one or more signals may comprise the supply of energy from the power source to the light source for a predetermined period of time. The test device can be configured to detect the presence of an analyte in a fluid sample applied to the sample receiving member and provide an analog signal that is visible through the display window. The visibility of the analog signal can be improved by the presence of illumination through the viewing window provided by the light source as the estimated time for the completion of the test that the diagnostic test device is set to perform passes. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is described particularly with reference to the following figures; however, these figures are provided to illustrate only preferred embodiments of the invention, and the invention is not intended to be limited to them. Figure 1 is a perspective view of a test device according to an exemplary embodiment of the present invention. Figure 2 shows a top view of the lateral flow test components according to an exemplary embodiment of the present invention comprising a deposition absorbent material, a two-phase substrate, and a sample receiving member. Figure 3 shows a top view of a two-phase substrate for use in a test device according to an exemplary embodiment of the present invention. Figure 4 shows a perspective view of the internal components of a test device according to an exemplary embodiment of the present invention. Figure 5 shows an enlarged view of a section of the internal components of a test device according to an exemplary embodiment of the present invention. Figure 6 shows an enlarged view of an additional section of the internal components of a test device according to an exemplary embodiment of the present invention. Figure 7 shows a partial view of the internal components of a test device according to the present invention in a partially disassembled state. Figure 8 shows a partial view of a portion of the internal components of a test device according to an exemplary embodiment of the present invention. Figure 9 shows a partial cross-sectional view of a test device according to an exemplary embodiment of the present invention. Figure 10 is an illustration of a circuit according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION The present invention will now be described in more detail with reference to specific embodiments and, in particular, to the various drawings provided in this patent application. In fact, the invention can be embodied in many different ways and should not be interpreted as being limited to the embodiments set forth in this patent application; rather, these embodiments are provided to enable this invention to meet applicable legal requirements. As used in the specification and in the appended claims, the singular forms a, an, the, and a include plural referents unless the context clearly dictates otherwise. In one aspect, the present invention relates to a test device, such as an over-the-counter (OTC) or point-of-care (POC) test device, for detecting an analyte in a sample. The device generally includes components suitable for performing an assay, such as a lateral flow assay, and also includes components suitable for communicating assay-related information to an individual. Test components, broadly defined, may comprise a proximal portion (e.g., a sample-receiving member) in fluid communication with a distal portion (e.g., a reservoir). The proximal and distal portions may be interconnected by a substrate material, which may itself form all or part of the proximal and / or distal portion of the device. A sample (e.g., urine) may be applied directly or indirectly to the proximal portion of the device for transport to the distal portion. Preferably, the sample flows through the substrate to come into contact with one or more antibodies bound to or otherwise deposited on the substrate. The antibodies may be designed and / or selected to recognize a variety of analytes.In specific embodiments, a test device according to the present invention may be useful for the detection of human chorionic gonadotropin (hCG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone, estrogen, progesterone, testosterone, a metabolite thereof, and combinations thereof. Other analytes may also be included in the description herein. The devices described in this patent application can utilize a variety of techniques to detect the presence of an analyte. One example is a sandwich technique in which one or more detection antibodies are used, each comprising a binding site or member that binds to an epitope on the analyte for detection. A labeled antibody binds to the analyte to form a complex in the sample. The analyte, bound to the labeled antibody(ies), then binds to one or more capture antibodies to form a sandwich, comprising the capture antibody, the analyte (or antigen), and the labeled antibody. Each sandwich complex thus produced consists of three components: a capture antibody, an antigen, and a labeled antibody.An antibody used in this patent application may be a polypeptide substantially encoded by an immunoglobulin gene or genes, or fragments thereof, that can specifically recognize and bind to an antigen. The recognized immunoglobulin genes include the kappa, lambda, alpha, gamma, delta, epsilon, and mu constant region genes, as well as immunoglobulin variable region genes. Antibodies include fragments, such as Fab', F(ab)2, Fabo, and Fv fragments. The term antibody may also include antibody fragments produced by modifying whole antibodies or those synthesized de novo using recombinant DNA methodologies, and may further include humanized antibodies produced using conventional techniques. Although polyclonal antibodies may be used, monoclonal antibodies are preferred.A capture antibody according to the invention may be an antibody bound to a substrate directly or indirectly, such as a solid substrate. The capture antibody may include at least one binding member that binds specifically or preferably to a particular distinct epitope of an antigen. In the sandwich technique, the composition of each sandwich complex can vary depending on the specific labeled antibody (and therefore the specific antigen) included. Multiple different types of sandwiches can be produced in the same assay. Sandwich-type complexes are progressively formed as the test sample, containing the analyte, is continuously moved along the substrate of the device.As more and more of the labeled analyte / antibody complex is immobilized in a sandwich configuration with the capture antibody(ies) at the capture site, the labeler components aggregate and become detectable. This is because the accumulation of sandwich complexes at the capture site can be detected in various ways, such as by visual inspection of, for example, the development of color at the capture site (i.e., an analog test result), or by a digital readout resulting from electronic analysis of the aggregate at the capture site, as described later in this patent application. Although the sandwich technique is provided as an exemplary embodiment, the devices described in this patent application relating to the improved communication aspects are not limited to this underlying technique.Rather, other techniques can be used to identify an analyte in a test sample and form a detectable signal based on the presence or absence of the analyte in the sample. Exemplary means of generating a detectable signal may include the use of a conjugate comprising one or more antibodies linked to detectable labeling components (e.g., colored particles, such as colloidal particles or a metal sol). One or more of the antibodies used in the disclosed devices (e.g., one or two) may be labeled. Any detectable label recognized in the art as useful in various assays may be used. In particular, the detectable labeling component may include compositions detectable by reflective, spectroscopic, photochemical, biochemical, immunochemical, or chemical means. As such, the labeling component produces a detectable signal. For example, suitable labels include soluble dyes, fluorescent dyes, chemiluminescent compounds, radioisotopes, electron-dense reagents, enzymes, colored particles, or dioxygenin.The marker component can generate a measurable signal, such as radioactivity, fluorescent light, color, or enzymatic activity, which can be used to identify and quantify the amount of marker bound to a capture site. Therefore, the label component can also represent the presence or absence of a particular antigen bound to it, as well as a relative amount of the antigen (e.g., relative to a known standard, a threshold standard, or a different standard). The test devices of the present invention can be configured to provide an analog test result, where the test result is interpreted by a device user through visual inspection of the analog result. In particular, the analog result can be the formation of a colored section on a test strip, a colored line, a colored symbol, or the like.Devices configured to provide an analog test result may be cheaper and / or simpler to manufacture and may present fewer opportunities for malfunction due to a problem with the electronic components. The devices currently described can thus be specifically adapted to improve the ability to interpret an analog test result. However, if desired, in some embodiments, one or more aspects of the present invention may be used in a test device that is configured to provide a digital result. In such embodiments, the labeled materials may be detected by using suitable electronic components, including hardware and software, and thus communicated to a user via a digital signal or similar means.Further details on the production of digital signals in personal use trials are provided, for example, in U.S. patents numbers 7,214,542 to Hutchinson; 7,220,597 to Zin et al.; and 7,499,170 to Sasaki et al., which are incorporated in this patent application by reference. The devices according to the present invention may include one or more internal standards or controls that allow determining whether the signal development is a true indication of the presence or absence of the analyte in the sample or is merely an artifact, such as that caused by nonspecific sorption. For example, a negative control site may be prepared identically to the test site, except that the capture antibody is omitted. Therefore, although the conjugate will reach the negative control site, it will be added solely due to nonspecific binding. Similarly, the device may include a positive control, such as an authentic sample of the analyte for detection immobilized at the positive control site. An alternative control site may be located downstream of the capture site and have at least one capture antibody (e.g., a protein) immobilized thereon.Such a control site can function to capture and immobilize the labeled antibody that has not been captured at the capture site. For example, such a control site may include polyclonal antiserum specific to the labeled antibody immobilized at it to indicate proper assay function. In some embodiments, a two-phase chromatographic medium (substrate / test strip) can be used in the described assays and may comprise an upstream release medium bonded to a downstream capture medium. The release and capture media may comprise two different materials or phases with distinct characteristics. The two phases may be bonded to form a single fluid path so that a solvent front can travel unimpeded from the proximal (upstream) end of the release medium (which may be defined as a proximal portion of the two-phase medium) to the distal (downstream) end of the capture medium (which may be defined as a distal portion of the two-phase medium). Generally, a sample-receiving member may be provided at the proximal end of the two-phase substrate, and a reservoir of absorbent material may be located beyond the two-phase substrate. In other embodiments, a three-phase chromatographic medium (substrate / test strip) may be used in the described assays and may comprise a capture medium overlaid at one end by a release medium and at the opposite end by a reservoir. The three-phase substrate may be in fluid communication with a sample-receiving member at the end thereof comprising the release medium. In certain embodiments, the use of a two-phase or three-phase chromatographic medium can improve the speed and sensitivity of an assay, such as those described in U.S. Patent No. 6,319,676, U.S. Patent No. 6,767,714, U.S. Patent No. 7,045,342, and U.S. Publication No. 2012 / 0083044, which are incorporated herein by reference, including, without limitation, for the purpose of describing two-phase and three-phase chromatographic media. Methods for manufacturing chromatographic media are also described in detail in U.S. Patent No. 5,846,835, the description of which is incorporated herein by reference in its entirety. Reagents for detecting, labeling, and capturing an analyte of interest may be disposed of in the release and capture media. In certain embodiments, one or more labeled conjugates may be placed in the release medium, each of which may include a binding member (e.g., an antibody) that can be reactive with a particular site (sometimes referred to as the first epitope, second epitope, etc.) on the analyte of interest. The labeled conjugates may further comprise one or more detectable markers (or labels), as described herein. The delivery medium can be formed from a substance that allows the release of reagents deposited on it, which may include reagents that bind in a releaseable (i.e., not permanently) manner to the delivery medium. The primary function of the delivery medium is to first support and then release and transport various immunological components of the assay, such as a labeled conjugate and / or a captureable conjugate, which are capable of binding to the analyte of interest. The delivery medium can be formed from any material capable of capturing, releasing, and transporting various immunological components of the assay, such as the labeled assay component (e.g., an absorbent hydrophilic material). The capture medium can be formed from a material that allows the immobilization of reagents for the detection of the analyte's presence in the test fluid. Immobilization can refer to any interaction that results in the antibodies or analytes binding irreversibly to the substrate in such a way that they are not appreciably removed by washing, for example, during a single use of the device. The capture medium can comprise hydrophilic polymeric materials, such as microporous films or membranes, that allow the protein reagents to be immobilized directly onto the membrane by passive adsorption without the need for chemical or physical fixation, although fixation is not necessarily excluded. The release medium and the capture medium can be joined by any suitable means. For example, the two media can be joined by overlapping the downstream edge of the release medium over the upstream edge of the capture medium. The various media components of the two-phase or three-phase substrate can be adhered to a transparent polymer film or an opaque sheet, thus holding the media in place. Alternatively, the media can be connected by a non-overlapping butt joint and still be attached to an underlying support. Diffusible and non-diffusible reagents can be applied to the release and capture media, respectively, using any suitable technique. In one embodiment, diffusible antibody reagents can be applied to the release medium by direct application onto the surface of the medium and allowed to dry into a band. Generally, the reagents can be immobilized using absorption, adsorption, or ionic or covalent coupling, according to any suitable method. In one embodiment, a test device 10 according to the present invention may comprise a housing that defines a sample inlet, a test volume, and a reservoir volume, as illustrated in Figure 1.The housing 19 may include a sampling end 19a and a gripping end 19b, which may include a recessed portion 20 shaped to allow users to place their thumb in the recess and their index finger on the underside of the housing to securely grip the test device 10. Within the housing 19 are the functional components that form a test member. The test member may be a single strip or a combination of strips of materials useful for providing a test. For example, the test member may be a test strip as described in this patent application, comprising a two-phase or three-phase substrate, for use in a test. A sample-receiving member 12 may be partially disposed within the housing 19, extending outward from it, and may be covered by a removable cap 14.More specifically, the sample-receiving member 12 can extend between a proximal end 12a positioned within the housing 19 and a distal end 12b extending outward from the housing. The test member 18 can also extend between a distal end 18b in fluid communication with the proximal end 12a of the sample-receiving member and a proximal end 18a such that a portion of the test member 18 is visible through a viewing window 40 formed in the housing 19. In use, a test sample passes from the sample receiving member 12 to the test member 18, as a chromatographic substrate, where the sample is in reactive contact with the test site (e.g., the capture site) and, optionally, with one or more control sites. A viewing window 40 on the top of the housing 19 defines a region that allows the user to observe the test results as they become detectable. As described in this patent application, becoming detectable may specifically relate to the accumulation of sandwich-like complexes at the capture site, which can be detected in various ways, such as by visual inspection of color formation within the viewing window 40 as a result of an analog test. This specifically may be the aggregate at the capture site as described later in this patent application.In the illustrated embodiment, the viewing window 40 allows for the visualization of the analog signal, such as a colored indicator of the accumulation of marked complexes at the test site visible through the viewing window. Furthermore, the components necessary to form an electronic communication circuit can be retained within the housing of the test device, as described elsewhere in this patent application. In the use of an exemplary assay, a sample passes through the inlet defined by the sample receiving member 12 and into a housing 19, where it comes into contact with the test member 18, which includes a release medium 30 and a capture medium 32. If the analyte of interest is present in the sample, it binds to one or more labeled antibodies that are releasably bound to the release medium 30. The sample, now comprising analyte-labeled antibody conjugates, absorbs the release medium 30 and forms a sandwich complex with one or more capture antibodies immobilized in the capture medium 32 (which defines a capture site or test site). As the sample front passes through the capture site, a complex comprising the analyte, the labeled antibody, and the capture antibody is formed. This sandwich complex can be analyzed by detecting the presence of the label at the capture site.The detection, in particular, can be achieved through a visual inspection of a color formed in the display window as an analog signal. However, if desired, the detection can include, at least in part, a digital readout on, for example, an LCD (liquid crystal display). Although the present invention is largely described in terms of direct devices / direct detection, it is also intended that other devices (i.e., affinity-based devices) be covered in this patent application. Affinity-based devices operate on similar principles but rely on indirect binding (where one member of an affinity pair (e.g., biotin) is present in a captureable conjugate (and subsequently in any diffusible sandwich complex formed therefrom) and the other member of the affinity pair (e.g., avidin) is present in the capture medium section of the substrate). Figure 2 shows an example of lateral flow test components that may be present in a device 10 as illustrated in Figure 1. These test components may comprise a sample-receiving member 12, a two-phase chromatographic substrate 18, and a reservoir absorbent material 16. When the device is brought into contact with a fluid sample, the fluid is transported by capillary action, absorption, or simple wetting along the downstream flow path through the sample-receiving member 12, along the chromatographic substrate 18, and into the reservoir absorbent material 16, generally as represented by the arrow. The sample-receiving member 12 may also serve as a filter that can remove particulate matter and interfering factors from a sample.The sample-receiving member 12 is preferably an absorbent hydrophilic material that facilitates the absorption and transport of a fluid sample to the two-phase chromatographic substrate 18. Such materials may include cellulose acetate, hydrophilic polyester, or other materials with similar properties. A combination of absorbent materials may also be used. As mentioned above, a filtration medium may also be included to limit the introduction of sample contaminants into the test site. In certain embodiments, the sample-receiving member 12 may be omitted, and the two-phase substrate release medium 18 may itself act as the sample-receiving member. Such embodiments of the test materials are useful for performing strip tests.By providing a reservoir of absorbent material (e.g., absorbent paper made of long cotton fluff fibers or cellulosic materials) positioned beyond the chromatographic substrate, a relatively large volume of the test fluid and any analyte it contains can pass through the test area, facilitating background removal and thus improving sensitivity. The absorbent in the reservoir generally facilitates capillary action along the chromatographic substrate and absorbs excess fluid contained within the device. Figure 3 illustrates in greater detail an exemplary two-phase chromatographic substrate 18, comprising a release medium 30 and a capture medium 32 joined to form a single fluid pathway. A band 26 of labeled binding element, for example, a metal-antibody sol, can be releasably disposed on the release medium 30. In one embodiment, the labeled binding element is in a dehydrated form. As the fluid sample passes through band 26, the labeled binding element is trapped in the fluid, reconstituted (in the case of a dehydrated binding member), and binds to a particular analyte or analytes of interest present in the fluid sample. Consequently, the resulting complex comprising a binding antibody, a labeling component, and an analyte for identification (for example, hCG) travels along with the forward sample until it reaches the capture site 34.In this particular embodiment, the capture site includes at least one immobilized capture antibody that binds to a different epitope of the analyte. Consequently, a sandwich complex is formed that includes the desired analyte at the capture site 34. If desired, a control site 36 may be present. As can be seen in Figure 1, a portion of the capture medium (particularly a portion that includes at least the capture site) is visible through the viewing window 40. For further details on various test devices, methods of use, and parameters thereof, see, for example, U.S. Patents Nos. 5,739,041; 6,046,057; 6,277,650; 6,319,676; 6,767,714; 7,045,342; 7,763,454; 7,776,618 and 8,211,711 of Nazareth et al., and U.S. Patent Applications Nos. 2002 / 0042082, 2004 / 0171174; 2008 / 0213920; 2010 / 0051350; 2010 / 0239460; 2010 / 0240149; 2010 / 0261293; 2010 / 0267166; and 2011 / 0201122 of Nazareth et al., and 2012 / 0083044 of Sturman et al.; which are incorporated in this patent application by reference in their entirety. In addition to the test member, these devices may incorporate one or more components configured to provide one or more digital functions that can enhance a consumer's ability to use the device and / or enhance a consumer's ability to visualize the result of the analog test. For example, Figure 4 shows the internal components of a test device according to an exemplary embodiment with the housing removed. As shown therein, the test device may include a power source, which, as illustrated, is a battery 50 with a positive contact 51 and a negative contact (not visible) on a printed circuit board (PCB) 55. One or more batteries may be used. Alternatively or additionally, the power source may comprise a capacitor or other suitable element. One or more control components 60 may also be included in the test device and, in particular, may be placed on PCB 55. The control component 60 may, in some examples, include electronic components such as processing circuits configured to perform data processing, application execution, or other processing, control, or management services according to one or more exemplary implementations. The processing circuit may include a processor embedded in a variety of forms, such as at least one processor core, microprocessor, coprocessor, controller, microcontroller, or other computing or processing devices that include one or more integrated circuits, such as an ASIC (application-specific integrated circuit), an FPGA (field-programmable gate array), or some combination thereof.In some examples, the processing circuit may include memory coupled to or integrated with the processor, which may store data, instructions for computer programs executable by the processor, some combination thereof, or similar. A control component 60 may be adapted or configured to perform one or more functions as described later in this patent application and may specifically interact with one or more components of the test device to provide one or more digital functions. In one or more embodiments, the test device may include a fluid sensor 70, which may be a single component or a combination of multiple components functioning as a unit. The fluid sensor 70 is preferably configured to provide a signal that can be delivered to and interpreted by one or more additional components of the test device. For example, the fluid sensor 70 may be in communication (wired or wirelessly) with one or more control components 60 so that a signal from the fluid sensor can be interpreted by the control component and, optionally, used to provide one or more additional functions to the test device. The fluid sensor 70 (or at least one component of the fluid sensor) is preferably in communication with one or more components of the test device configured for fluid conveyance.This may include, for example, the sample receiving member 12, the release means 30, the capture means 32, and / or the reservoir 16. If desired, a plurality of fluid sensors may be in communication with a plurality of test device components to provide a plurality of signals that can be combined or interpreted separately by the control component 60 to perform one or more functions. In some embodiments, the communication may be physical contact between the fluid sensor 70 (or at least one fluid sensor component) and one or more test device components. An exemplary embodiment of a fluid sensor 70 is illustrated in general in Figure 4 and shown in greater detail in Figure 5. As seen there, the fluid sensor comprises a pair of electrical contacts (71, 72) that are physically separated and in contact with the sample-receiving member 12. The pair of electrical contacts (71, 72) can specifically be configured to be electrically connected to the control component 60 and / or the power source 50. As illustrated in Figure 4 and Figure 5, the electrical contacts 71 and 72 each include an electrical extension 71a and 72a, respectively, which extends to be in direct connection with the PCB 55 (e.g., attached to the electrical connectors 56 on the PCB; see Figure 6). Alternatively, electrical contacts 71 and 72 can be in a cable connection with PCB 55 in which the electrical wires are connected at opposite ends to an electrical contact (72, 72) and thePCB. In some embodiments, the fluid sensor can be specifically configured as an electrical circuit that includes the sample-receiving member 12. More specifically, the electrical contacts (71, 72), the electrical extensions 71a and 72a (or alternative connectors), and suitable electrical circuits present on the PCB (e.g., the control component 60 and the battery 50, as well as any printed circuit board) can form an open electrical circuit with the sample-receiving member 12 essentially functioning as a switch. When the sample-receiving member is substantially dry, no electrical current can flow between the electrical contacts (71, 72), but once the liquid sample is applied to the sample-receiving member 12, the liquid bridging the electrical contacts (71, 72) can close the circuit and thus allow current to flow through the electrical circuit.The establishment of an electrical current flow through this electrical circuit can function as the signal provided by the fluid sensor. Although this is described in relation to the sample receiving member 12, it is understood that other parts of the test device configured for the passage of liquid (e.g., the release medium 30, the capture medium 32, and / or the reservoir 16) can function similarly as part of an electrical circuit and, therefore, as part of a fluid sensor. When the sample-receiving member is used as described above, the fluid sensor can be configured to indicate that a fluid applied to the sample-receiving member is present in a volume sufficient for the test device to perform a specific test. Other analog test devices that operate by transporting liquids through a medium may not provide a complete test if an insufficient volume of liquid is applied to the test medium. For example, the distal end 12b of the sample-receiving member 12 may appear wet, but it may be difficult to determine whether the portion of the sample-receiving member located inside the device housing 19 is fully wetted.By placing the electrical contacts (71, 72) on or near the proximal end 12a of the sample-receiving member, the fluid sensor will only be activated if a sufficient volume of the liquid sample is applied to the sample-receiving member to absorb and substantially fill the proximal end of the sample-receiving member 12. Due to the overlap of the sample-receiving member 12 and the release medium 30, if a sufficient volume of liquid sample is present to completely absorb the proximal end 12a of the sample-receiving member, it can be determined that there is a sufficient volume of sample to pass through the test strip and complete the test. As described later, initiating a signal from the fluid sensor can be used to perform one or more additional functions of the test device. In one or more embodiments, the test devices of the present invention may include one or more additional light sources. An individual light source may be configured to provide a single color of light or a plurality of different light colors. A single light source may be used to provide an illumination effect to a single part of the test device, or a single light source may be used to provide an illumination effect to a plurality of different parts of the test device simultaneously or at different times. A light source may include any component effective for providing light output and, in particular, may include one or more light-emitting diodes (LEDs). For example, a single LED may be present and may be configured to emit light of a single color (e.g., white light, red light, etc.) or it may be configured to emit light of multiple different colors.For example, an RGB LED can be used to emit light in red, blue, and green, and these colors can be mixed as needed to produce a wide variety of different colors. In other embodiments, a plurality of LEDs (e.g., two, three, four, or more) can be included in the device, and the individual LEDs can be configured to emit a single color or a plurality of colors. In some embodiments, a light source can be configured to provide illumination that is visually apparent on the outside of the housing 19. For example, in some embodiments, a light source can be configured to illuminate specifically through the viewing window of the test device. This can be achieved through a variety of configurations. For example, as shown in Figure 7, the light source can comprise an LED 62 that is placed directly on the PCB 55. However, if desired, the LED 62 can be located elsewhere on the test device and can be electrically connected to the PCB 55 via appropriate wiring. The light source can be positioned within the housing 19 such that the test member 18 lies between the light source and the viewing window 40. This can be particularly advantageous when the light source is configured to illuminate through the viewing window 40. In such embodiments, at least the portion of the test member 18 visible through the viewing window 40 can be light-permeable. For example, the capture medium 32 can be configured to be light-permeable so that illumination behind the capture medium can enhance the visualization of the test results (e.g., color formation at the capture site 34).In other embodiments, the test member 18 may be substantially lightproof, but the test member and housing 19 may be of such size that the illumination behind the test member is visible around the edges of the test member, so that the viewing window 40 is still illuminated by the light source, and the display of the test results may be further improved. In some embodiments, the light source may include an LED 62 and a light guide 65. The use of a light guide 65 allows the LED 62 to be placed directly on the PCB 55 while simultaneously providing illumination at a distant location on the PCB. Referring to Figure 7, the internal components of the test device are shown in part, with certain components offset for ease of visualization. Specifically, when assembled, the light guide 65 is positioned so that a shielding section 66 is placed over the LED 62. The shielding section 66 may be configured to substantially or completely block light transmission through it (e.g., by being opaque). As shown in Figure 7, the bottom of the shielding section 66 is open so that light from the LED 62 can pass through it to other parts of the light guide 65.The light guide 65 extends away from the LED 62 and toward the sample receiving member 12. The combined release medium 30, capture medium 32, and reservoir 16 are then placed on the light guide 65. As illustrated, the light guide 65 further defines an illuminable chamber 67, and when fully assembled, the test member 18 (and particularly the capture medium 32, in some embodiments) is between the illuminable chamber and the viewing window 40 formed in the housing 19. The illuminable chamber 67 thus illustrates one embodiment of an illumination zone that may be present in the housing. As discussed later, one or more illumination zones can be provided in a variety of locations within the housing by a variety of configurations. In some embodiments, the LED 62 can be positioned laterally with respect to the viewing window 40 so that the light guide 65 is configured to transmit light from the LED 62 to the viewing window. The presence of the illuminable chamber 67 can be useful to provide a drill-through effect through the viewing window 40. Such lateral positioning is intended to encompass any configuration in which the light-emitting element (e.g., the LED 62) is not placed directly within the field of view, where the light is externally visible. Therefore, lateral positioning may indicate that the light-emitting element is positioned to the rear, front, sideways, or in any direction in order to be compensated for from the viewing window 40 or from any other section of the device from which the light is intended to be visually apparent. In other embodiments, the light guide 62 may have a different construction. For example, the light guide may be substantially in the form of an elongated member with any desired cross-sectional shape (e.g., round, square, triangular, etc.) and may be configured to transmit light to a variety of positions in the test device. For example, the light guide 62 (optionally in a shape other than the one illustrated) may extend a greater distance into the sample-receiving member 12 so that the light can define an illumination zone that is visible through the sampling end 19a of the housing 19. As a further example, Figure 8 illustrates an embodiment in which the housing 19 is configured to define a well 69 in a lower portion thereof. The well 69 in particular may be defined, at least in part, by a plurality of walls 68 that extend upwards a distance from an inner surface of a lower portion 19c of the housing 19. In the exemplary embodiment, a protective section 66 is again positioned over the LED, and the protective section may be translucent so that light transmission is limited or opaque so that light transmission is completely occluded. The protective section 66 includes an opening 66a therein, and a light guide 65 extends outwards from the opening. The light guide 65 is positioned within the well 69 defined by the walls 68 and thus may create an additional option for an illumination zone within the device.As before, the test member 18 (and particularly the capture means 32, in some embodiments) can be positioned between the well 69 and the viewing window 40 formed in the housing 19 so that the light from the light guide 65 can shine through it. In some embodiments, one or more surfaces forming the well (for example, the walls 68 and / or the lower surface 19c of the interior of the housing 19) can be configured to enhance the illumination of the light guide. For example, one or more of these surfaces can have a light-reflecting finish (for example, a light-reflecting white color, a mirrored finish, a metallic finish, or the like) so that the light from the light guide 65 is at least partially reflected from one or more surfaces and out of the well 69. Such a finish can also be applied to an interior surface of the illuminable chamber 67 described above.Furthermore, the finish, shape, size, and / or positioning of the light guide can be configured to provide substantially uniform illumination through the viewing window 40 or through another part of the housing. For example, when the light guide is positioned behind the test strip, there may be a tendency for more light to pass around the test strip than through it. Therefore, the light guide can be positioned more centrally within the viewing window so that the light intensity is greater directly behind the test strip. This makes the light passing around the test strip appear more evenly distributed with the light passing through it. Similarly, applying the finish to the well as described above can also be used for this purpose. In other embodiments, the housing 19 may include one or more additional openings 41 besides the viewing window 40, and the light source may be configured to provide illumination through one or more of these additional openings. Furthermore, as already noted, the test device may include a plurality of light sources and / or a plurality of light guides to be configured to provide illumination at a plurality of locations in or through the housing 19. In some embodiments, the device can be configured so that light is visible through one or more parts of the housing in the absence of an actual opening. For example, one or more sections of the housing 19 can be configured to be sufficiently thinned to allow light to pass through the thinned portion. Figure 9 illustrates an exemplary embodiment, showing a partial cross-section of the device with functional components positioned between an upper portion 19d and a lower portion 19c of the housing 19. An LED 62 is positioned on the PCB 55 and configured to transmit light through the light guide 65 via the shielding section 66.In the illustrated embodiment, the protective section 66 has an extension 57 defined by the dashed lines that extends through the PCB and into a light cavity 21 defined by a thinned section of the lower part 19c of the housing 19. Because the housing is thinned in the area of ​​the light cavity 21, light is visible through the housing wall even in the absence of an actual opening. This is an example of an illumination zone that does not necessarily require a physical opening in the housing for the light to be externally visible. In further embodiments, an illumination effect can be provided by other means. For example, as an alternative to, or in addition to, the light cavity 21, a series of micro-perforations can be arranged in a portion of the housing wall such that light is visible through the micro-perforations.By providing visible lighting effects through the bottom 19c of the housing, it is possible to provide signals of different device functions to a user even when the device is placed upside down. The control component 60 of the present test device can be configured to perform one or more digital functions that can improve the ease of use of the test device and / or the ease of evaluating the test result provided by the test device. For example, in some embodiments, the control component 60 can be configured to automatically supply power from the power source to the light source for one or more periods of time after receiving the signal from the fluid sensor. Figure 10 shows an exemplary embodiment of an electrical circuit 80 in the test device. As shown there, the control component 60 (or controller) can be electrically connected to all the electrical contacts (71, 72), the LED 62, and the battery 50.The control component 60 can direct the execution of one or more programmed programs or functions, and such functions may, in some embodiments, depend on first receiving a signal from the fluid sensor (e.g., through electrical contacts 71 and 72). In one or more embodiments, the control component 60 can be configured to perform one or more functions to provide a user with indications that a sufficient volume of a fluid sample has been applied to the sample-receiving member 12. As noted above, the fluid sensor can be configured so that an electrical circuit is completed between the electrical contacts (71, 72) once a liquid sample applied to the sample-receiving member 12 has traveled a sufficient distance to make contact with the electrical contacts. The completion of the electrical circuit can serve as a signal for the control component to supply power from the power source (e.g., the battery 50) to the light source (e.g., the LED 62) for a preset period of time.The light source illumination can also serve as an indicator to the user that a sufficient volume of the liquid sample has been applied to the sample-receiving member. This can substantially prevent problems associated with insufficient liquid sample application (e.g., resulting in an incomplete test) as well as with applying too much liquid sample (e.g., flooding the test device). The instructions accompanying the test device may specify that the liquid sample should be applied to the sample-receiving member until the indicator light illuminates. This provides the user with a clear indication that the correct volume of liquid sample has been applied to the sample-receiving member and allows them to be informed that the test can then proceed. In embodiments using a single light source, the light source may be illuminated for only a limited time. For example, the light from LED 62 may pass through the light guide 65 and illuminate the display window 40 of the test device for a limited time before switching off. Therefore, the control component 60 may include an integrated timer. The control component 60 may thus be configured to supply power from the power source to the light source for one or more preset time periods measured by the timer. In embodiments where a plurality of light sources are used, the light source may be re-illuminated only for a predetermined period of time. Alternatively, the light source may remain illuminated throughout the test once the sensor has signaled that a sufficient volume of liquid has been applied to the sample-receiving member 12. For example, illumination through the sampling end 19a of the housing 19 and / or illumination through the additional opening 41 may begin once the sensor has indicated that a sufficient volume of liquid has been applied to the sample-receiving member 12, and such illumination may continue indefinitely. Illumination of the light source through the viewing window 40 can be used to enhance the visualization of the test result. In embodiments where the viewing window 40 is illuminated as an indicator that a sufficient volume of liquid has been applied to the sample-receiving member, the viewing window 30 can remain illuminated to provide enhanced visualization of the test result. Alternatively, the control component 60 can be configured to supply power from the power source to the light source for a first preset time period and a second preset time period, the first and second preset time periods not overlapping.For example, lateral flow assays typically take approximately two to three minutes for the liquid sample to be absorbed into the sample receiving member 12, the release medium 30, the capture medium 32, and then into the reservoir 16 to ensure that any analyte in the liquid sample accumulates at the capture site 34 to provide the test result. Therefore, the control component 60 can be configured to illuminate the light source for a first illumination period, separated from the second illumination period by a period of non-illumination. The first and second illumination periods can be substantially equal. Alternatively, the first and second illumination periods can be of substantially different durations.In some embodiments, the first illumination period can be from approximately 5 seconds to approximately 45 seconds, from approximately 5 seconds to approximately 30 seconds, from approximately 10 seconds to approximately 30 seconds, or from approximately 10 seconds to approximately 20 seconds. This can provide sufficient time for a user to recognize that enough sample has been applied to the sample-receiving member 12 and to cease sample application. When the first illumination period ends, the user can thus be informed that the test is in progress. The start of the second illumination period can inform the user that the test is complete and the test result is ready for evaluation. As mentioned above, the first preset illumination period can be triggered by the fluid sensor signal.The second preset time period can be activated based on the elapsed time estimated for completing a test that the diagnostic test device is configured to perform. The time interval between the first illumination period and the second illumination period can be approximately 30 seconds to approximately 120 seconds, approximately 45 seconds to approximately 120 seconds, or approximately 60 seconds to approximately [missing information]. 120 seconds, or from approximately 45 seconds to approximately 90 seconds. The illumination for the second time period (e.g., indicating that the test is complete and improving the readability of the test result) can be for a preset time, such as approximately 30 seconds to approximately 300 seconds, approximately 30 seconds to approximately 240 seconds, approximately 30 seconds to approximately 120 seconds, or approximately 60 seconds to approximately 120 seconds. This may provide sufficient time for the user to evaluate the test results. Alternatively, the second illumination period can be indefinite and therefore persist until the power source is depleted. In some embodiments, the test device may include an activation switch (e.g., a power button). The activation switch can be used to turn the device on for use.Similarly, the activation switch can be used to turn off the light source after the test results have been viewed and the user is ready to dispose of the test device. The illumination may be substantially constant during the time periods described above, meaning the light is continuously on during the noted time period and continuously off between the noted time periods. In some embodiments, the illumination may be configured to provide one or more blinking or intermittent patterns. For example, the device may be configured to illuminate intermittently for one or more defined time periods. During one or more of these periods, the blinking may be substantially slow and steady. A slow, steady blink may indicate, for example, that the light source illuminates in an on / off pattern where the on and off times are substantially the same duration (e.g., approximately 1 second, approximately 1.5 seconds, approximately 2 seconds, approximately 2 seconds).5 seconds or approximately 3 seconds). The on and off times can be anywhere from approximately 1 second to approximately 5 seconds. In other embodiments, a blink pattern may be an accelerated blink pattern where the on and off times are relatively shorter, such as less than 2 seconds, less than 1.5 seconds, less than 1 second, or less than 0.5 seconds in duration. In still further embodiments, the blink pattern may be configured to change over time to, for example, substantially provide a countdown pattern. In this way, the blinking may start relatively slowly and then accelerate over time to indicate the progression of the test. One or more blink patterns may be interspersed with one or more extended periods of light being continuously on or continuously off.For example, the light might remain continuously on for a period of time to indicate that a sufficient amount of sample has been applied, and then begin to flash a pattern to indicate that the test is in progress. The flashing pattern might increase in speed as the test progresses until steady illumination indicates that the test has ended. Any combination of continuous on, continuous off, and flashing patterns can be used in this way. The control component 60 can be configured to manage the general functions of the test device and emit one or more types of illumination that a user can understand or interpret. If desired, a microprocessor can be used, provided that any additional hardware or software necessary to perform the functions of the test device (e.g., RAM or ROM) is also included. Commercially available controllers and processors can be adapted for use in accordance with the present invention. Preferably, the control component 60 includes programming (e.g., embedded software) that includes the required definitions of input signals and associated output signals to enable the controller to manage the functions of the test device, as described in this patent application. In one or more embodiments, the present invention further provides methods for improving the ease of use of a diagnostic test device. The methods may be applied particularly to improve the ease of use of a test device configured to detect the presence of an analyte in a fluid sample applied to the sample-receiving member and to provide an analog signal visible through the display window. Such methods may include preparing or providing a test device that is substantially as described in this patent application.In particular, the methods may include configuring the test device's control component to provide one or more indicators to a user that a sufficient volume of a fluid sample has been applied to the sample-receiving member, and automatically supplying power from the power source to the light source after an estimated time has elapsed for the completion of a test that the diagnostic test device is configured to perform. The visibility of the analog signal is enhanced by the illumination through the viewing window provided by the light source after the estimated time has elapsed for the completion of the test that the diagnostic test device is configured to perform. The terms approximately, around, or substantially, as used in this patent application, may indicate that certain enumerated values ​​or conditions are intended to be interpreted as involving the expressly enumerated value or condition and also values ​​or conditions that are relatively close to it. For example, a value of approximately a certain number or substantially as a certain value may indicate the specific number or value, as well as numbers or values ​​that vary (+ or -) by 5% or less, 4% or less, 3% or less, 2% or less, or 1% or less. Similarly, a statement approximately a certain condition or substantially as a certain condition may indicate that the condition is met exactly or that the condition comprises normal variations that would be expected to occur in manufacturing and / or that are acceptable variations that do not affect the purpose or use for the stated condition.In some modes of realization, the values ​​or conditions may be defined as express and, as such, the term approximately or substantially (and therefore the indicated variations) may be excluded from the express value. Many modifications and other embodiments of the invention set forth in this patent application will become obvious to a person skilled in the art to which these inventions belong, having benefited from the lessons presented in the preceding description. It should therefore be understood that the invention is not to be limited to the specific embodiments disclosed and that the modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are used in this patent application, they are used only in a generic and descriptive sense and not for the purpose of limitation.

Claims

1. A diagnostic test device comprising: a housing having a viewing window; a sample receiving member extending between a proximal end positioned within the housing and a distal end extending out of the housing; a test member positioned within the housing, the test member extending between a distal end in fluid communication with the proximal end of the sample receiving member and a proximal end such that a portion of the test member is visible through the viewing window; a fluid sensor in communication with the sample receiving member and configured to provide a signal; a power source; a light source configured to provide illumination visible from the outside;and a control component configured to automatically supply power from the power source to the light source for one or more periods of time after receiving the signal from the fluid sensor.

2. The diagnostic test device according to claim 1, wherein the test member comprises a release means in fluid communication with a capture means, and wherein a portion of the capture means is visible through the viewing window.

3. The diagnostic test device according to claim 1, wherein the test device is configured to detect the presence of an analyte in a fluid sample applied to the sample receiving member.

4. The diagnostic testing device according to claim 3, wherein the presence of the analyte is indicated by an analog signal that is visible through the display window.

5. The diagnostic test device according to claim 3, wherein the analyte is selected from the group consisting of human chorionic gonadotropin (hCG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone, estrogen, progesterone, testosterone, a metabolite thereof, and combinations thereof.

6. The diagnostic test device according to any of claims 1 to 5, wherein at least the portion of the test member that is visible through the viewing window is permeable to light.

7. The diagnostic test device according to any of claims 1 to 5, wherein the fluid sensor is configured as an electrical circuit including the sample receiving member.

8. The diagnostic test device according to claim 7, wherein the fluid sensor includes a pair of electrical contacts that are physically separated and in contact with the sample receiving member.

9. The diagnostic test device according to claim 7, wherein the pair of electrical contacts are in electrical connection with the control component.

10. The diagnostic test device according to any of claims 1 to 5, wherein the fluid sensor is configured to signal that a fluid applied to the sample-receiving member is present in a volume suitable for the test device to perform a specific test.

11. The diagnostic test device according to any of claims 1 to 5, wherein the light source is placed inside the housing so that the test member is between the light source and the viewing window.

12. The diagnostic test device according to any of claims 1 to 5, wherein the light source includes a light-emitting diode (LED) and a light guide.

13. The diagnostic test device according to claim 12, wherein the LED is positioned to be offset from the display window, and wherein the light guide is configured to transmit light from the LED to the display window.

14. The diagnostic test device according to claim 13, wherein the light guide defines an illumination zone positioned within the housing such that the test member is between the illumination zone and the viewing window.

15. The diagnostic test device according to any of claims 1 to 5, wherein the light source is visible through the viewing window.

16. The diagnostic test device according to any of claims 1 to 5, wherein the light source is visible through a section of the housing.

17. The diagnostic test device of any one of claims 1 to 5, wherein the control component is configured to execute one or more functions after receiving the signal from the fluid sensor, said one or more functions being effective in providing indications to a user that a sufficient volume of a fluid sample has been applied to the sample-receiving member.

18. The diagnostic test device according to claim 17, wherein one or more functions comprise supplying power from the power source to the light source for a predetermined period of time.

19. The diagnostic test device according to any of claims 1 to 5, wherein the control component includes a timer.

20. The diagnostic test device according to claim 19, wherein the control component is configured to supply power from the power source to the light source for one or more preset time periods measured by the timer.

21. The diagnostic test device according to any of claims 1 to 5, wherein the control component is configured to supply power from the power source to the light source for a first preset time period and a second preset time period, the first preset time period and the second preset time period not overlapping.

22. The diagnostic test device according to claim 21, wherein the first preset time period is activated by the fluid sensor signal.

23. The diagnostic test device according to claim 21, wherein the second preset time period is activated based on the passage of an estimated time to complete a test that the diagnostic test device is configured to perform.

24. The diagnostic test device according to any of claims 1 to 5, wherein the control component is configured to supply power from the power source to the light source so that the light source provides one or more flickering effects.

25. A method for improving the ease of use of a diagnostic test device, the method comprising: preparing the test device to include: a housing having a viewing window; a sample-receiving member extending outward from the housing; a test member positioned within the housing to be in fluid communication with the sample-receiving member and such that a portion of the test member is visible through the viewing window; a fluid sensor in communication with the sample-receiving member and configured to provide a signal; a power source; a light source configured to provide illumination through the viewing window; and a control component; and configuring the control component to: provide one or more indications to a user that a sufficient volume of a fluid sample has been applied to the sample-receiving member;and automatically supplies power from the power source to the light source after an estimated time has passed to complete a test for which the diagnostic test device is configured.

26. The method according to claim 25, wherein one or more steps comprise supplying energy from the power source to the light source for a predetermined period of time.

27. The method according to claim 25 or claim 26, wherein the test device is configured to detect the presence of an analyte in a fluid sample applied to the sample receiving member and provide an analog signal that is visible through the display window.

28. The method according to claim 27, wherein the visibility of the analog signal is enhanced by the presence of illumination through the viewing window provided by the light source as the estimated time to complete the test that the diagnostic test device is configured to perform elapses.

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