Test device for lateral flow assay

Abstract

A test device (160) is disclosed that includes a test assembly (170) for a lateral flow assay. The test assembly (170) includes a liquid sample receiving interface (106) disposed on a support structure (104) that defines a planar surface. The liquid sample receiving interface (106) is configured to receive a liquid sample. The test assembly (170) includes at least one test strip (108.1, 108.2) fluidly connected to the liquid sample receiving interface (106). The test strip (108.1, 108.2) includes a capillary wick (110.1), which is fluidly connected to the liquid sample receiving interface (106) and includes at least one test portion (112.1, 112.2), each of which includes at least one reactive material configured to react with at least one specific analyte in a predetermined manner. The test device (160) comprises an optical sensor (111) arranged and configured to detect light reflected from at least one test portion (112.1, 112.2) and convert the detected light into an electrical signal representative of the intensity and / or color of the detected light, a conversion unit (116) for converting the electrical signal into digital data representative of the intensity and / or color of the detected light, and a transmitter unit (113) for wirelessly transmitting the digital data.

Description

[Technical Field]

[0001] The present invention relates to a test device for a lateral flow assay. [Background technology]

[0002] Lateral flow assays, also known as lateral flow immunochromatographic assays, are devices for detecting the presence (or absence) of a target analyte in a sample. Typically, these tests are used in medical diagnostics, either for at-home testing, point-of-care testing (POCT), or laboratory use. The technology is based on a series of capillary beds capable of spontaneously transporting fluid, for example, by capillary action.

[0003] WO 2019 / 145374 discloses a test assembly for a lateral flow assay, comprising a liquid sample receiving interface configured to receive a liquid sample and at least one test strip. The at least one test strip is fluidly connected to the liquid sample receiving interface and comprises a capillary wick. The capillary wick is also fluidly connected to the liquid sample receiving interface and comprises at least one test portion. The test portion comprises at least one reactive material configured to react in a predetermined manner with at least one pre-specified analyte. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of the present invention to provide an improved test device for lateral flow assays. [Means for solving the problem]

[0005] According to the present invention, the above-mentioned problems are solved by a testing device including a test assembly. The test assembly has a liquid sample receiving interface configured to receive a liquid sample. The liquid sample receiving interface is disposed on a support structure defining a plane. The test assembly includes at least one test strip fluidly connected to the liquid sample receiving interface. The test strip includes a capillary wick fluidly connected to the liquid sample receiving interface. The capillary wick includes at least one test portion. The test portion includes at least one reactive material configured to react in a predetermined manner with at least one specific analyte.

[0006] The test apparatus further includes an optical sensor, a conversion unit, and a transmitter unit. The optical sensor is configured to respond to incident light and provide an electrical signal representative of a characteristic of the incident light, such as intensity, color, or polarization. The conversion unit is part of the optical sensor or is operably connected to the optical sensor and is configured to convert the electrical signal into digital data representative of the electrical signal, and the transmitter unit is configured to wirelessly transmit the digital data.

[0007] The components and subcomponents of the test equipment are as follows: The test equipment is a test assembly; Optical sensors and A conversion unit; Transmitter unit and It is equipped with: The test assembly comprises: a support structure; a sample receiving interface; at least one test strip; and the test strip comprises: - Capillary wick is provided, · Has at least one test part.

[0008] The optical sensor, the conversion unit and the transmitter unit may be disposed on a support structure of the test assembly, or alternatively, the optical sensor, the conversion unit and the transmitter unit may be attached to a cover unit of the test apparatus.

[0009] The optical sensor of the test device is positioned and configured to detect light reflected from at least one test portion and provide an electrical signal representative of the intensity and / or color of the detected light. The optical sensor may be, for example, a single pixel photodiode or a CMOS sensor or a CCD sensor.

[0010] After converting the detected light into an electrical signal, the electrical signal is provided to a conversion unit.

[0011] The conversion unit is configured to convert the electrical signal into digital data representing the intensity and / or color of the detected light. The conversion unit may be part of the optical sensor. The conversion unit may be a separate component of the test apparatus. Alternatively, the conversion unit may be part of the transmitter unit. Preferably, the conversion unit is or includes an analog-to-digital converter (ADC) for converting the electrical signal into digital data representing the intensity and / or color of the detected light. The conversion unit may be configured to convert the electrical signal at 8 bits.

[0012] The conversion unit is operatively connected to the transmitter unit, for example via a data bus, for providing digital data to the transmitter unit.

[0013] The transmitter unit is configured to transmit digital data wirelessly, preferably to an external receiving device, using a predetermined wireless communication protocol such as Bluetooth, Near Field Communication (NFC), or Wi-Fi or RFID, etc. In particular, the transmitter unit may be or comprise an NFC chip and NFC coil or a Radio Frequency Identification (RFID) tag or transponder or a circuit chip with Wi-Fi embedded or a circuit chip with Bluetooth embedded.

[0014] Transmitter units based on technologies such as NFC or RFID that do not require a permanent energy supply are preferred: the energy required to power such a transmitter unit is provided by a so-called initiator.

[0015] A transmitter unit configured to transmit data via NFC or RFID preferably has one or more antennas that function as a radio frequency (RF) interface for transmitting electromagnetic signals representing digital data to one or more further antennas of an external device by means of electromagnetic induction. The antennas typically have one or more coils, each with four or five turns.

[0016] The initiator may be an external device that provides a carrier field that is modulated by the transmitter unit to transmit digital data. Preferably, to power the transmitter unit, the transmitter unit draws energy from the external device via an NFC or RFID link. Therefore, the test device itself does not need to include an energy storage unit, e.g., a battery, to power the transmitter unit, especially in cases where the transmitter unit is NFC- or RFID-enabled.

[0017] The testing device according to the present invention is a single device that receives a liquid sample, e.g., a bodily fluid such as blood, from a patient, processes the received liquid sample through a microfluidic system including a capillary wick having at least one test portion, and allows the received bodily fluid to be analyzed for the presence of a specific analyte. The evaluation of the presence or absence of a specific analyte in the liquid sample is performed externally, e.g., directly on an external device that receives the digital data. The external device may be a smartphone or tablet, preferably with NFC or RFID capabilities, and configured to function as an initiator device. The external device may also be used to further transmit the digital data, e.g., to a personal computer or server for evaluation.

[0018] In order to extract a liquid sample, e.g., from a body or a container, and transport the liquid sample to the liquid sample receiving unit, the liquid sample receiving unit is preferably sized and configured to be coupled to a piercing element, e.g., a lancet or needle.

[0019] The optical sensor, the conversion unit, and the transmitter unit may be disposed on a support structure together with the microfluidic component as separate components. The optical sensor, the conversion unit, and the transmitter unit may be fabricated using electronic packaging, for example, 3D packaging. Thus, using 3D packaging, a compact three-dimensional integrated circuit can be designed by stacking components. After 3D packaging the integrated circuit including the optical sensor, the conversion unit and the transmitter unit can be attached to a support structure or a cover unit. Alternatively, a chip having the optical sensor, the conversion unit, and the transmitter can be manufactured using wafer-level packaging (WLP). The optical sensor, the conversion unit, and the transmitter unit may be placed in a protective package for incorporation into a test device.

[0020] In some embodiments, the optical sensor, the conversion unit, and the transmitter unit are mounted on a circuit board that is attached as a module to a support structure or a cover unit. The circuit board may be flexible, for example, a flexible board made of polyimide such as Kapton, polyetheretherketone (PEEK), liquid crystal polymer (LCP), or FR4. Rigid or semi-flexible circuit boards can alternatively be used. In particular, the optical sensor, the conversion unit, and the transmitter can be integrated onto a thin FR4 board. The circuit board may be a printed circuit board (PCB), which is preferably flexible, for example, an FR4 PCB. Alternatively, the printed circuit board may be a rigid or semi-rigid printed circuit board.

[0021] Mounting at least one of the optical sensor, the conversion unit and the transmitter unit on the cover unit of the testing device is advantageous as it leaves more space on the support structure, for example for arranging components of a microfluidic system.

[0022] In particular, the antenna of the transmitter unit can be integrated into the test device using in-molding. In cases where the test device has a cover unit that is attached to a support structure and thus forms a closed housing, the transmitter antenna can be integrated into the housing, for example, attached to the inside of the lid portion of the cover unit by in-molding. Alternatively, the transmitter unit antenna can be integrated into the same chip or circuit as the rest of the transmitter electronics, optical sensor, and conversion unit. For example, the antenna can be integrated into the PCB.

[0023] Preferably, the test device includes an optical facility including one or more optical elements positioned and configured to direct light reflected from at least one test portion to the optical sensor and / or to direct light emitted from the light source to at least one test portion. The optical elements may be mirrors, lenses, or waveguides. The optical elements may be used, for example, to form an optical path connecting at least one test portion of the test strip to the optical sensor.

[0024] For example, a mirror can be used to direct the light reflected from the test portion, and a lens can be used to focus the light reflected from the mirror onto the optical sensor. A waveguide can also be used to direct the light reflected from at least one test portion onto the optical sensor. One end of the waveguide can be shaped to focus the light onto the optical sensor.

[0025] The optical facility is particularly advantageous when the test part and the optical sensor are not aligned, i.e., when the test part is not in the direct field of view of the optical sensor.

[0026] The optical arrangement is also particularly advantageous when a test strip has two or more test portions, for example, three test portions. In this case, the optical element of the optical arrangement is preferably configured and arranged to direct light reflected from any of the three test portions toward the optical sensor. A correspondingly configured optical element may have three mirror surfaces that are inclined relative to one another, such that light reflected from any of the test portions is directed toward the optical sensor upon reflection from one of the three inclined mirror surfaces. Thus, the optical element may typically have multiple reflective surfaces, for example, multiple facets, that are configured and arranged to direct light reflected from one or more of the test portions arranged along the length of the test strip toward the optical sensor. An external receiving device can receive digital data from the transmitter unit, the digital data representing the light intensity and / or color of the light reflected from one or more of the test portions of the test strip.

[0027] Generally, the use of optical facilities allows for more flexible positioning of the test strip and optical sensor in the testing device, e.g., on a support structure, because an optical path can be formed connecting the test portion and the optical sensor. Such an optical path can be angled or curved, e.g., when using a waveguide.

[0028] If the test device has a cover unit, the optical sensor can be attached to the cover unit. Such a cover unit is preferably configured to be permanently or removably attached to the support structure to form, together with the support structure, a closed housing. Advantageously, the cover unit can be attached only to the support structure in one or more distinct positions to ensure accurate alignment of the at least one test part and the optical sensor.

[0029] The housing preferably contains all components of the test device, namely the microfluidic system with the test strip, the optical sensor, the conversion unit and the transmitter unit.

[0030] Preferably, the surface of the test device is small relative to its volume, has as few gaps as possible, and is smooth, thereby reducing the risk of invasiveness.

[0031] Preferably, the test device with the cover unit attached to the support structure has a cylindrical shape and a height of 3 cm or less, preferably less than 2 cm, more preferably less than 1.5 cm, and even more preferably less than 1 cm, and a diameter of 5 cm or less, preferably less than 4 cm, more preferably less than 3 cm, and even more preferably less than 2.5 cm.

[0032] Alternatively, the test device may have a cubic or rectangular base area with sides having a length of 5 cm or less, preferably less than 4 cm, more preferably less than 3 cm, and even more preferably less than 2.5 cm, and the test device has a height of 3 cm or less, preferably less than 2 cm, more preferably less than 1.5 cm, and even more preferably less than 1 cm.

[0033] It is advantageous to be able to design the testing device as a relatively small and compact device. In cases where the testing device has a cover unit attached to a support structure, the cover unit and support structure preferably form a small and compact housing having a closed outer surface, except for the sample-receiving interface. Preferably, no push buttons or other moving parts are integrated into the housing walls. Preferably, no windows or displays are integrated into the housing walls. However, the walls of the cover unit that define the outer surface of the cover unit may be flexible to allow manual actuation of mechanical and / or electrical components within the testing device.

[0034] The testing device is thus a closed device that can communicate with external devices via the transmitter unit. Once the liquid sample is received by the sample receiving interface, no further user interaction is required to begin processing and analysis of the liquid sample.

[0035] The test device preferably has a relatively small outer surface relative to the volume of the test device. Preferably, the ratio S / V between the outer surface S and the volume V is between 6.0 and 0.8 [1 / cm], more preferably between 5.0 and 1.0 [1 / cm], even more preferably between 4.5 and 1.2 [1 / cm], and even more preferably between 4.0 and 1.4 [1 / cm].

[0036] In embodiments in which the test device includes a cover unit, the optical sensor is preferably positioned facing the support structure. In embodiments in which the test strip, and particularly one or more test portions of the test strip, face a sidewall of the test device, i.e., are positioned at a 90° angle relative to the optical sensor, the optical elements of the optical facility are preferably configured and arranged to redirect light reflected from the one or more test portions toward the optical sensor at approximately 90°, i.e., perpendicular to the support structure. Thus, in some embodiments of the test device, at least one test portion and the optical sensor are positioned at a 90° angle relative to each other, and the optical elements are positioned and configured to redirect light reflected from at least one test portion from the at least one test portion to the optical sensor at a 90° angle.

[0037] The test apparatus may optionally include at least one light source positioned and configured to illuminate the at least one test portion. The one or more light sources are provided as part of the test apparatus to illuminate the at least one test portion. The light source preferably includes a light emitting diode (LED). The light source preferably is connected to an energy storage unit and / or an optional power management unit. In cases where the transmitter unit is configured to draw energy from an external device, the one or more light sources may also be powered by energy drawn from the external device while the NFC or RFID connection is established.

[0038] Preferably, in a test device having a light source, the light source is arranged to emit light toward at least one test portion. The light is reflected by the test portion and detected by an optical sensor. An optical facility including a plurality of optical elements can be used to redirect light emitted from the light source toward the at least one test portion and / or to redirect light reflected from the at least one test portion to the optical sensor. Thus, the optical facility can form an optical path connecting the light source to the test portion and / or an optical path connecting the test portion to the optical sensor. For example, a waveguide can be used to guide light emitted from the light source to the test portion, and a mirror can be used to redirect light reflected from the test portion to the optical sensor, which is attached, for example, to a cover unit of the test device. Thus, the test device can include an optical facility including one or more optical elements arranged and configured to direct illumination light emitted by the at least one light source toward at least one test portion.

[0039] Preferably, the light source used to illuminate the at least one test zone is configured to emit light in a color corresponding to the color the test zone will assume in the event that a particular analyte is present in the received liquid sample. The change in color of the test zone to the color of the light emitted by the light source increases the intensity of the light reflected from the test zone, which in turn indicates whether the particular analyte is present in the liquid sample.

[0040] Preferably, the optical sensor is calibrated before use of the test device or as part of the manufacturing process of the test device. Calibration involves detecting the light intensity reflected from an unused test strip when the light source is switched on and when the light source is switched off, thereby determining the maximum and minimum possible intensity values. This allows for a more accurate assessment of the light intensity generated by the test portion after exposure to an analyte. The calibration data may be stored on a server or in a local memory included in the test device, accessible by an external device, for example, via NFC or RFID. For example, the calibration data may be transmitted when an NFC or RFID link is established between the test device and an external device and used by the test device for evaluation purposes, for example.

[0041] In cases where the test strip has more than one test portion, e.g., two or three test portions, or even a test portion matrix, a single light source can be used to illuminate all of the test portions present on the test strip. The light intensity of the light reflected from the multiple test portions is related to the presence or absence of a particular analyte in the liquid sample. A trained neural network can be used to analyze the digital data signal representing the digital data to determine which of the multiple test portions has changed color in response to the presence of a particular analyte.

[0042] Preferably, the test strip has more than one test portion, i.e., at least two test portions, each configured to react with a different one of the analytes. Preferably, the color that one test portion assumes when a particular analyte is present in the received sample liquid is different from the color that the other test portion assumes when a different analyte is present in the received sample liquid. For example, the test strip may include a test portion matrix having multiple test portions, each configured to indicate the presence of a different one of the analytes. Such a test portion matrix may be, for example, a 4x4 test portion matrix or a 5x5 test portion matrix.

[0043] A light source may be present for each of the plurality of test portions of the test strip, preferably with a one-to-one correspondence between one of the plurality of test portions and one of the plurality of light sources. Preferably, the light source assigned to one of the plurality of test portions is configured to emit light in a color corresponding to the color that the test portion will assume in the presence of a particular analyte in the received liquid sample. A lens may be provided for each light source, the lens being positioned and configured to focus the light emitted by the light source onto its assigned test portion. A waveguide may also be provided for each light source, positioned and configured to guide the light emitted by the light source to its assigned test portion.

[0044] Preferably, if two or more light sources are present, at least two of the light sources can be controlled independently, i.e., can be switched on and off independently of each other by controlling a switch. For this purpose, the test device can be equipped with a microcontroller that can receive control commands from an external device via an established NFC or RFID link. This also allows for spatial resolution of at least two test sections.

[0045] When a test strip has two or more test zones, it may be advantageous to provide two or more independently controllable light sources, each emitting light of a different color, to determine the color of the test zone. For example, three LEDs may be used: one LED emitting red light, one LED emitting green light, and one LED emitting blue light. Each LED may sequentially illuminate multiple test zones, capturing the intensity of the red, green, or blue light reflected from the multiple test zones. The captured intensity values ​​may be combined to generate a color value for each test zone. If an intensity image (grayscale image) is recorded for each illumination, a color image may be generated from the intensity images. The external device may be configured to process the intensity images separately, with each intensity image represented by image data. The image data may be analyzed by a trained neural network fed with a color matrix or the combined intensity matrix. In an alternative embodiment of the neural network, the neural network may be trained to classify digital data representing the electrical signal provided by a single pixel of the single-pixel optical sensor. The classification neural network in these embodiments may provide immediate test results. The trained neural network may be implemented within the test device by a processing unit, a memory connected to the processing unit, and software, or alternatively or additionally, the trained neural network may be part of an external device configured to communicate with the test device.

[0046] Light reflected from the at least two test portions is reflected to and detected by the optical sensor. An optical element can be provided that is positioned and configured to redirect the light reflected from the at least two test portions to the optical sensor. By controlling the switch, the light source can be switched on and off sequentially, allowing each test portion to be read out individually in sequence. Thus, the optical sensor can be used to sequentially detect incident light reflected by the at least two test portions and sequentially convert light reflected from one test portion of the plurality of test portions into an electrical signal representing the intensity and / or color of the light reflected by one test portion of the plurality of test portions. Thus, by switching the light source, a specific test portion can be selected and read out.

[0047] The one or more light sources are preferably arranged such that test portions of the test assembly are illuminated by the one or more light sources. For example, each test portion can be illuminated by a different one of the various LEDs in a one-to-one assignment. The light sources can be attached to the cover unit.

[0048] The one or more light sources can be used in combination with an optical sensor to determine the fill level of a solution chamber, optionally included in the test assembly, which contains a buffer solution. Alternatively or additionally, the one or more light sources can be used in combination with an optical sensor to obtain the degree of wetting of a capillary wick, for example, to check whether the amount of liquid sample applied is sufficient.

[0049] The timer function can be performed by one or more light sources and / or optical sensors.

[0050] The timer function may include detecting receipt of a liquid sample and storing a flag along with a timestamp in the transmitter unit indicating the operation time of the test device. Thus, an external device can read the flag and begin acquiring digital data from the test device only after a predetermined time has elapsed. The time of calibration of the test device may be stored in the transmitter unit along with the flag. The external device can read the flag and acquire digital data from the test device only if the current time is within a specific period selected such that the calibration is expected to remain accurate. The flag may also be stored along with a timestamp providing the manufacturing time of the test device, such that the test device reads the flag and acquires digital data from the test device only if the test device has not reached its shelf life.

[0051] The transmitter unit has energy harvesting capability and is therefore configured to receive energy wirelessly from an external initiator device during transmission, for example, via electromagnetic induction. This can be achieved by the transmitter unit for short-range wireless communication. In particular, if the transmitter unit has energy harvesting capability, no additional voltage and / or current supply, for example, a battery, is required for the test device.

[0052] The external device can acquire digital data from the received electromagnetic signal and store and / or further process and / or directly visualize the acquired digital data on a monitor. Furthermore, other receiving devices within range, but not acting as external initiator devices, can also receive the digital data.

[0053] In particular, if the test device comprises a transmitter unit with energy harvesting capabilities, the test device preferably comprises a power management unit (PMU) configured to provide the received power for powering electronic and / or electromechanical components of the test device, the power management unit preferably comprising a voltage stabilization circuit, in particular a capacitor.

[0054] The power management unit may be part of the transmitter unit and may be operably connected to the antenna of the transmitter unit, e.g., the NFC coil of the transmitter unit. The power management unit may be a separate component of the test apparatus and may be operably connected to the transmitter unit for energy harvesting.

[0055] Optionally, the power management unit may comprise an energy storage unit, for example a primary or secondary battery or a capacitor, in particular a supercapacitor, for storing energy drawn from the external device during transmission. Energy can thus be transferred from the external initiator device to the test device by inductive coupling via the established NFC or RFID link. Such an external initiator device thus also comprises an NFC chip and an NFC coil, and transmits a carrier signal to the NFC coil of the test device.

[0056] A transmitter unit supporting energy harvesting can be used to power and / or control other electronic and / or electromechanical components, such as a microcontroller, a sensor, or a valve, or a micropump, or an actuator of the test device. Such sensors may be configured to detect and classify viral DNA, for example, to perform a polymerase chain reaction (PCR) to replicate viral DNA.

[0057] If the transmitter unit supports energy harvesting, it can operate without a battery by drawing power from an external device via the established NFC or RFID link. The NFC or RFID link typically operates over distances of a few centimeters, e.g., up to 5 cm, 10 cm, or 20 cm, and in some cases, up to 60 cm. Energy harvesting of up to 30 mW, for example, can be achieved via the NFC or RFID link.

[0058] The test device can provide various operational status information during use of the test device. For example, the test device can include a digital signal processor to analyze digital data signals representing the intensity and / or color reflected from at least one test zone to determine whether blood extraction was successful, whether buffer solution was delivered, whether reactive material in the test zone reacted with the analyte, or whether light intensity was sufficient. Additional sensors can be present within the test device to sense temperature, pressure, or humidity and provide the respective temperature, pressure, or humidity data to an external initiator device via an NFC link.

[0059] The transmitter unit may be part of a transceiver unit configured to transmit digital data and receive control commands. Such a transceiver is useful in cases where the test device comprises further components such as microcontrollers, sensors or valves or micropumps or actuators and / or other electromechanical components.

[0060] Preferably, the transmitter unit and / or the transceiver unit, in particular their NFC chip, have a data bus interface, e.g. 2C interface. Via the data bus interface, the transmitter or transceiver unit can be connected via a data bus to, for example, a converter unit and / or a microcontroller.

[0061] Preferably, the transmitter unit and / or the transceiver unit, in particular their NFC chip, comprises a memory unit. The memory unit may include at least one of a volatile memory (e.g., a static random access memory (SRAM)) and a non-volatile memory, such as an erasable programmable read-only memory (EPROM), in particular an electrically erasable programmable read-only memory (EEPROM). In the memory unit, in particular the EEPROM, control commands for controlling electronic and / or electromechanical components of the test device can be stored.

[0062] The non-volatile memory can also be used to store digital data, for example, representing the intensity and / or color of light detected by the optical sensor. From the light intensity and / or color, it can be derived whether a particular analyte is present in the liquid sample, and the digital data can represent confidential patient information that can be linked to personal data or identifiers. Therefore, particularly in cases where immediate reading of the digital data is not possible at the time of its generation, in preferred embodiments the digital data is at least temporarily stored in a secure memory, for example the non-volatile memory of an NFC chip.

[0063] Preferably, the transmitter unit and / or transceiver unit, in particular their NFC chip, are 2 The digital control unit (DCU) includes at least one of a C controller, a pulse width modulation (PWM) controller, a general purpose I / O (GPIO), a command interpreter, and a memory controller.

[0064] Preferably, the transmitter unit and / or the transceiver unit, in particular their NFC chip, have at least one IO terminal pin for connecting electronic and / or electromechanical components of the test device.

[0065] The transceiver unit can receive control commands from an external device to control one or more optionally included electromechanical components of the testing device, such as a valve for controlling the amount of buffer supplied to a solution chamber or a micropump for pumping a body fluid to a test portion of at least one test strip, etc. To control the one or more optionally included electronic and / or electromechanical components, these components can be connected to a data bus of the transmitter unit or to IO pins of the transmitter unit for individually addressing one electromechanical component of the plurality of electromechanical components.

[0066] Via a data bus, the transceiver unit may be connected to a microcontroller configured to control one or more light sources and / or to control electronic and / or electromechanical components of the test equipment. The microcontroller may be used to control the electronic and / or electromechanical components of the test equipment in real time via control commands received by the transceiver unit. Such a microcontroller may be powered by energy drawn from an external device or by energy stored in an energy storage unit of the power management unit.

[0067] Through the liquid sample receiving interface of the test assembly, an external liquid sample can be delivered along the capillary wick to one or more test strips fluidly connected to the liquid sample receiving interface. In this manner, at least a portion of the liquid sample can be delivered through the capillary wick to at least one test portion of the capillary wick. Thus, the capillary wick has at least one transport portion and at least one test portion, and the liquid sample is delivered to the test portion of the capillary wick along the transport portion of the capillary wick.

[0068] The test portions of the test strip function as test units for a liquid sample, in which the presence or absence of a specific analyte is determined. The test portions are configured to indicate the presence or absence of at least one specific analyte in a liquid sample, such as a bodily fluid, upon exposure to the liquid sample. Preferably, the presence of a specific analyte in the liquid sample is indicated by each test portion via a color change in the test portion. Preferably, the color of each test portion indicating the presence of a specific analyte is known in advance so that it can be compared to a reference color for evaluation purposes.

[0069] This is possible because the reactive material of the test zone reacts with the liquid sample only if the liquid sample contains at least one specific analyte. For evaluation purposes, the test zone must be inspected. Typically, inspection of the test zone is performed directly with the naked eye, which often involves the user comparing the color of the test zone to various reference colors to find a match.

[0070] In the test device according to the present invention, direct inspection of the test portion with the naked eye is eliminated. In particular, it is not necessary that the test portion be actually directly visible with the naked eye from outside the test device. Therefore, lenses and / or windows for direct inspection of the test portion with the naked eye are not required. This allows for greater freedom in designing the test device, particularly relatively compact and small. For example, the test device may have a size that is too small for convenient inspection of the test portion with the naked eye. Furthermore, the arrangement of the test strips in the test assembly is not restricted by the need to provide a window for visual inspection of the test portion of the test strip.

[0071] Digital data representing the intensity and / or color of the light reflected from the test portion can be transmitted to an external initiator device and permanently stored in a storage medium thereof and / or visualized on a monitor of the external device or a monitor connected to the external device, so that the current state of the test portion upon light reflection can be repeatedly analyzed at subsequent times using different visualization capabilities.

[0072] The digital data can be processed, for example, using a digital signal processor in an external device, for example, to evaluate the presence or absence of at least one particular analyte in a provided liquid sample, and can be simultaneously transmitted to multiple different external devices for visualization and / or evaluation purposes.

[0073] Errors or uncertainties in inspecting the test part due to, for example, the user's viewpoint or lighting conditions can be avoided by the test device because the light reflected from the test part can be detected under constant environmental conditions that can be optimized to meet the requirements of the optical sensor.

[0074] The test apparatus may optionally comprise a storage medium for storing the digital data before transmission by the transmitter unit.

[0075] The test device may be part of a test system comprising a test device and an external device, the test device configured to wirelessly transmit digital data and the external device configured to receive the digital data, such that the test device and the external device have compatible data interfaces and communication means for exchanging digital data and / or control commands.

[0076] The test system may further comprise a server operatively connected to the external device for transmitting processed or unprocessed digital data from the external device to the server for storage and / or evaluation purposes.

[0077] Preferably, the test strip has, in a planar state, a test strip centerline length, a test strip width, and a test strip thickness. The test strip preferably has two flat sides separated by the test strip thickness. The test strip thickness may have an extension that is shorter than the test strip centerline length and shorter than the test strip width.

[0078] In particular, when the test strip is rectangular in its planar state (ignoring its thickness), the test strip preferably has a test strip centerline length in the longitudinal direction, a test strip width in the width direction perpendicular to the longitudinal direction, and a test strip thickness in the thickness direction perpendicular to both the longitudinal and width directions, and the test strip thickness has a shorter or smaller extension than the test strip centerline length and the test strip width. In particular, when the test strip is rectangular, the test strip length and the length of the centerline in the middle of the test strip (hereinafter also referred to as the test strip centerline length) preferably equal the length of the longitudinal edges of the flat faces of the test strip.

[0079] Alternatively, in the planar state of the test strip, the edges of the flat sides may be curved (i.e., not straight). As a result, the test strip has a curved shape in its planar state. In this case, the test strip centerline length is the length of the centerline located midway between the longitudinal edges of the test strip. The test strip centerline length is test strip specific and is independent of the actual state (curved or planar) of the test strip.

[0080] The distance between the longitudinal ends of the planar and curved test strips may be less than the centerline length.

[0081] To further limit the outer dimensions of the test strip and thus its envelope, the test strip may be arranged non-planarly, i.e., bent or even curved in three dimensions. This includes, for example, test strips having straight longitudinal edges arranged in a curved state, such as folded, curled, or rolled rectangular test strips, test strips having curved longitudinal edges in a flat state, or test strips having curved longitudinal edges that are folded, curled, or rolled and therefore in a curved state.

[0082] In the test assembly, the width of the test strip preferably extends at an angle of less than 90° relative to the normal of the plane defined by the support structure, i.e., the test strip extends from the support structure. The test strip is also preferably curved, so that the shortest distance between the two longitudinal ends opposite each other from the centerline of the test strip is shorter than the centerline length of the test strip in a planar state. This shortest distance is defined herein as the length representing the smallest distance between the proximal end of the test strip, i.e., the section of the test strip that is in contact with or near the liquid sample receiving unit, and the distal end of the test strip where the test portion is located or is adjacent to the test portion.

[0083] It should be noted that a minimum distance between the longitudinal ends of a test strip that is shorter than the centerline length means that the test strip is curved in its planar state, or that the test strip is curved because it is arranged non-planar, or both. A test strip whose minimum distance between its longitudinal ends is shorter than its centerline length has a total effective extension or envelope of the test strip in its planar state that is shorter than the test strip centerline length. This, in turn, makes it possible to reduce the size of the test assembly compared to the minimum size that the test assembly would have if the test strip were arranged in a planar state. If the test strip is curved in a circular shape, the minimum distance between the longitudinal ends may be shorter than the maximum outer dimension of the test strip, while the maximum outer dimension of the test strip is still shorter than the test strip centerline length.

[0084] This advantageous spatial arrangement of test strips in the test assembly improves the utilization of space within the test assembly, which in turn allows the total size of the test assembly to be reduced without having to shorten the test strip centerline length, which in turn results in improved applicability and provides increased versatility.

[0085] By positioning the test strip in a curved manner and such that the width of the test strip extends at an angle of less than 90° relative to the normal to the plane defined by the support structure, i.e., by positioning the test strip non-parallel to the plane defined by the support structure, the size of the test assembly can be reduced compared to typical test assembly configurations in which the test strip is normally positioned directly on the support structure in a planar state. Alternatively, longer test strips can be used compared to known test assemblies in which the test strip is positioned on the support structure in a planar state.

[0086] Preferably, the test portion contains at least one reactive material configured to react in a predetermined manner with at least one specific analyte.

[0087] Each test strip, or at least some of the test strips, of the plurality of test strips can include a test portion configured to react in a predetermined manner with a different one of a variety of specific analytes. Alternatively, to improve the accuracy of the test assembly or to enable semi-quantitative assessment of a predetermined analyte, two or more test strips can have one or more test portions with predetermined reactive materials having the same or different sensitivities.

[0088] In some embodiments of the test device, the width of the test strip extends at an angle of less than 90° relative to the normal of the plane defined by the support structure, i.e., the test strip is tilted relative to the plane of the support structure, or in other words, the test strip width is not parallel to the plane, and the test strip is curved, resulting in an effective extension that is shorter than the centerline length of the test strip in its planar state.

[0089] In an alternative embodiment, the test strip centerline length is greater than the maximum linear extent of the support structure in a plane.

[0090] The liquid sample receiving interface may be part of a test strip and may be configured to receive a liquid sample. Alternatively, the liquid sample receiving interface may be part of a liquid sample receiving unit. The liquid sample receiving unit is preferably disposed on a support structure defining a plane. In some cases, it is advantageous for the liquid sample receiving unit to be a separate unit having a liquid sample receiving interface and connected to at least one test strip.

[0091] Preferably, the support structure of the test assembly has a maximum linear extension in a plane of less than 5 cm. In some embodiments, the maximum linear extension in a plane is 4 cm or less, preferably less than 3 cm, and more preferably less than 2.5 cm. Preferably, the support structure has an aperture having a diameter of less than 4 mm and configured to provide access to the liquid sample receiving interface and thus allow the introduction of a liquid sample. More preferably, the aperture is sized and designed, preferably in the form of a lancet or needle, to cooperate with the liquid sample providing unit to provide the liquid sample to the liquid sample receiving unit.

[0092] Preferably, the support structure has a flat or planar geometric shape that defines a plane. Alternatively, the support structure may not be flat, and the perimeter of the support structure may define the plane. In yet another alternative, neither the support structure nor the perimeter directly defines a plane, but rather the plane is defined by an averaging of spatial positions of at least a portion of the support structure or perimeter.

[0093] Preferably, the liquid sample receiving unit comprises an absorbent material, which is preferably configured to be saturated with a liquid sample delivered to the liquid sample receiving unit via the liquid sample receiving interface, and which may be a porous hydrophilic material, preferably comprising cellulose, polyester, modified polyester or similar materials such as microstructured or sintered polymers.

[0094] The capillary wick of the test strip may be disposed directly on the liquid sample receiving interface or may be in direct contact with the liquid sample receiving unit, thereby allowing liquid to be transported directly from the latter to the former by capillary action. Alternatively, the test strip may not be in direct physical contact with the liquid sample receiving interface or liquid sample receiving unit, but may be connected to the liquid sample receiving interface or liquid sample receiving unit via a microfluidic connection system.

[0095] Generally, the test assembly preferably includes exactly one test strip. However, the test assembly may also include two or more test strips, particularly at least two test strips. The at least two test strips may be arranged spirally so that they each have a different projection on the plane defined by the support structure. Alternatively, the test strips may be arranged on top of each other along a direction perpendicular to the plane defined by the support structure, whereby the test strips share the same projection on the plane. In other words, the total width of the test strips arranged on top of each other corresponds to the sum of the test strip widths of the individual test strips. Alternatively, the two configurations described above may be included, i.e., the test assembly includes at least two subsets of at least two test strips, each subset having a different projection on the plane defined by the support structure, which projection is shared by all test strips belonging to the subset.

[0096] At least one test strip of the test assembly may be positioned such that the angle formed between the width direction and the plane defined by the support structure is constant at each longitudinal position along the length of the test strip. Thus, the angle between the width direction of the test strip and the normal to the plane defined by the support structure is constant for each point along the centerline length of the test strip. This configuration allows for optimal use of space within the test assembly. In certain embodiments, this angle is less than 45°. In preferred embodiments, this angle is less than 10°. In more preferred embodiments, this angle is less than 5°. In one embodiment, this angle is 0°. In the latter case, the test strip is positioned perpendicular (within manufacturing limits) to the plane defined by the support structure.

[0097] Preferably, the capillary wick of at least one test strip comprises a porous hydrophilic material, preferably cellulose, polyester, modified polyester, or similar material such as a microstructured or sintered polymer.

[0098] Advantageously, the test assembly is configured to deliver the liquid sample from the liquid sample receiving interface or liquid sample receiving unit along the capillary wick to the test portion so that all points along the liquid sample transport front reach the test portion substantially simultaneously. The transport front should be understood as the time-varying position of the boundary that separates the area of ​​the capillary wick containing the liquid sample from the area of ​​the capillary wick that does not contain the liquid sample. In cases where the transport speed of the liquid sample is assumed to be constant for all points on the transport front, the capillary wick of this embodiment is advantageously positioned to interact with the liquid sample receiving interface and the test portion at the first and second boundary lines, respectively, so that all lateral path lengths between any points along the first and second boundary lines are substantially constant. The term "substantially constant" should be understood to mean a constant value within reasonable limits of manufacturing and determination, and in some embodiments, includes a length deviation of up to 5%.

[0099] The test assembly may include a conjugate pad containing a conjugate material configured to release the conjugate material upon contact with a liquid sample. The reactive material of the test portion may be configured to react in a predetermined manner with the combination of the conjugate material and the liquid sample, which combination is considered a specific analyte.

[0100] The absorbent material of the liquid sample receiving unit preferably functions as a sponge and is configured to retain the liquid sample. Upon immersion, a portion of the liquid sample migrates (i.e., is transported, for example, by capillary action) to a conjugate pad containing conjugate material in the form of so-called conjugates, such as a dried form of bioactive particles in a sugar-salt matrix, configured to ensure an optimized chemical reaction between the target analyte (e.g., antigen) expected to be present in the liquid sample and its chemical partner (e.g., antibody). The chemical partner is preferably integrated onto the surface of the bioactive particles. The liquid sample dissolves the sugar-salt matrix, but also the particles. In this way, the target analyte binds to the particles as it moves further through the capillary wick toward the test portion. The test portion of the capillary wick has one or more regions (often in the form of strips) in which a reactive material, often in the form of a third molecule, is present. When the liquid sample-conjugate mixture reaches these strips, the target analyte is bound to the bioactive particles from the conjugate pad, and the reactive material binds the complex. In response, as more liquid sample passes through the strip, particles accumulate and the strip changes color. Typically, there are at least two strips in the test section: a control strip that captures any particles, thereby indicating that the reaction conditions and technology are working properly, and a second strip that contains a specific capture molecule and captures only particles with immobilized analyte molecules.

[0101] The test assembly may further include an absorbent pad at a distal end of the test strip opposite the proximal end of the test strip, with the liquid sample receiving interface coupled to the absorbent pad. The absorbent pad is configured to prevent backflow of the liquid sample. Thus, the absorbent pad is configured to act as a sink for the liquid sample, maintaining the flow of liquid on the capillary wick and preventing the flow of the liquid sample back to or toward the liquid sample receiving unit.

[0102] The test assembly may further comprise at least one solution chamber for accommodating a respective buffer solution and a flow control means configured to control movement of the buffer solution to the liquid sample-receiving interface or to the at least one test strip. The at least one solution chamber is preferably disposed on the support structure. The solution chamber may be provided as a cavity within the support structure.

[0103] Some buffers are advantageously selected to facilitate transfer of the liquid sample to the test zone. Other buffers have reactants configured to react in a predetermined manner with specific analytes. In cases where the test assembly has multiple solution chambers, different solution chambers may contain different buffers, which are transferred individually to the liquid sample receiving unit or to each test strip or group of test strips according to the specific needs of the test assembly.

[0104] The flow control means may be configured to control the movement of buffer to the liquid sample receiving interface or the liquid sample receiving unit either before the liquid sample is received through the liquid sample receiving interface, while the liquid sample is received through the liquid sample receiving interface, after the liquid sample is received through the liquid sample receiving interface, or any combination thereof.

[0105] Alternatively or additionally, the device may be configured to control the transfer of buffer to the at least one test strip before the liquid sample is transferred from the liquid sample receiving interface or the liquid sample receiving unit to the at least one test strip, while the liquid sample is transferred from the liquid sample receiving interface of the liquid sample receiving unit to the at least one test strip, after the liquid sample is transferred from the liquid sample receiving interface or the liquid sample receiving unit to the at least one test strip, or any combination thereof.

[0106] By transferring a buffer to the liquid sample receiving interface, or to the liquid sample receiving unit, or to the capillary wick before the liquid sample is received or transferred, the capillary wick or absorbent material, respectively, is wetted, which in certain embodiments increases the absorption capacity.

[0107] By transferring buffer to the liquid sample receiving interface or liquid sample receiving unit or capillary wick during liquid sample reception or transfer, the volume of liquid present and the flow rate of the liquid sample are increased, thus reducing the time required for the liquid sample to reach the test portion of the test strip.

[0108] Transferring a buffer to the liquid sample receiving interface or liquid sample receiving unit or capillary wick after receiving or transferring the liquid sample is advantageously used in certain embodiments to flush the liquid sample towards the test area.

[0109] The flow control means may comprise a soluble material configured to dissolve in the buffer solution at a predetermined dissolution rate and configured to allow flow of the buffer solution away from each solution chamber after a predetermined time.

[0110] One embodiment includes a microfluidic system having a solution chamber, microfluidic channels for transporting a solution, a body fluid, or both, one or more separation chambers, one or more geometric passive valves, one or more waste channels, an inlet coupled to a liquid sample receiving interface, one or more outlets coupled to a capillary wick, an air vent, and an air inlet. In particular, the microfluidic system is fabricated from a suitable material by 3D printing, particularly digital light projector 3D printing, and then placed on a support structure.

[0111] In another embodiment, the microfluidic system is integrated into the support structure by surface modification thereof, advantageously having hydrophilic surfaces to promote capillary flow in some of the microfluidic channels and chambers and hydrophobic surfaces to stop or reduce flow in other microfluidic channels and other sections of the microfluidic system, thus acting as a hydrophobic passive valve.

[0112] The microfluidic system is preferably designed to be placed or fabricated directly on a support structure having a maximum extension of less than 5 cm, preferably less than 4 cm, more preferably less than 2.5 cm.

[0113] In a preferred embodiment, the microfluidic system is placed or fabricated directly on the support structure, and the optical sensor, conversion unit, transmitter unit and, if present, light source are placed inside the cover unit.

[0114] Optionally, the test assembly may include a reservoir containing a soluble material, e.g., a pharmacologically inactive substance such as lactose monohydrate. The soluble material is configured to dissolve upon contact with a bodily fluid. Dissolution of the soluble material is configured to bring the solution chamber into contact with the puncturing means. The puncturing means is preferably configured to puncture the solution chamber and allow controlled flow of buffer solution from the solution chamber.

[0115] The test assembly may also include a lancet, hollow needle, or catheter, or a microfluidic connection system filled with a soluble material. The lancet, hollow needle, or catheter is configured and arranged to puncture the solution chamber when operated (e.g., by applying pressure or by actuating the test assembly in a predetermined manner). When the solution chamber is punctured, the buffer solution contacts the soluble material. Therefore, by appropriately selecting the soluble material and its amount, as well as the flow control means and the geometric shape of the solution chamber, the time period from puncturing the solution chamber until the buffer solution reaches the test strip or liquid sample receiving unit can be controlled.

[0116] Optionally, the flow control means may comprise a microelectromechanical (MEMS) flow control means connected to the power management unit for controlling the movement of the buffer solution. The microelectromechanical flow control means may comprise a microsensor and / or a microactuator such as a micropump. The microsensor and / or microactuator may be integrated into a microprocessor for controlling the microsensor and / or microactuator.

[0117] Optical sensors and flow control devices may be formed by optical microelectromechanical systems (MOEMS). MOEMS is defined as the combination of MEMS integrated with micro-optics. MOEMS are configured to sense and manipulate optical signals at extremely small size scales using integrated mechanical, optical, and electrical systems. MOEMS include a wide variety of devices, including but not limited to optical switches, optical cross-connects, tunable VCSELs, and microbolometers. These devices are typically fabricated using micro-optics and standard micromachining techniques using materials such as silicon, silicon dioxide, silicon nitride, and gallium arsenide.

[0118] The support structure of the test assembly may have a circular shape with a diameter length of less than 5 cm. Preferably, the liquid sample receiving interface is located at a central position of the support structure. This allows for highly ordered placement of at least one test strip, thus facilitating the manufacture of the test assembly. This is particularly advantageous for test assemblies including multiple spirally arranged test strips.

[0119] Alternatively, the liquid sample receiving interface can be positioned away from the center of the support structure. This is particularly advantageous in test assemblies in which two or more test strips are arranged relative to one another along a direction perpendicular to the plane. In this particular arrangement, the total width of the test strips corresponds to the sum of the individual test strip widths of each test strip. For example, in one exemplary embodiment of the test assembly, the support structure has an elliptical shape, and the liquid sample receiving interface is positioned closer to the apex of the ellipse than the center of the ellipse. This embodiment is advantageously configured to have longer test strips than would be the case for a circular support structure with a centrally located liquid sample receiving unit.

[0120] The test apparatus may include an optional cover unit that is mountable to the support structure.

[0121] Alternatively or additionally, the cover unit of the test device may have an integrated light source. The light source can be powered by a power supply unit, for example a light-emitting diode powered by a battery. Alternatively, the integrated light source comprises a photoluminescent material, preferably a phosphorescent material, by which absorbed radiation is re-emitted at a relatively low intensity for several hours after initial excitation. In yet another alternative, the test device may additionally or alternatively have a luminal in the reservoir.

[0122] Preferably, the support structure of the test assembly and the cover unit are each configured to be attachable. The test apparatus may include attachment means configured to removably couple the test assembly and the cover unit. Suitable attachment means, in certain embodiments, include a bayonet-type attachment structure comprising at least one peg and a corresponding slot on each of the test assembly and the cover unit.

[0123] At least one peg may be arranged on the test assembly, in particular on the support structure, and a corresponding slot is preferably arranged on the cover unit. Alternatively, at least one peg may be arranged on the cover unit, and a corresponding slot is preferably arranged on the test assembly, in particular on the support structure of the test assembly.

[0124] In alternative embodiments, the test fixture may include other attachment means such as, but not limited to, threaded elements, snap-lock elements, or locking tabs.

[0125] Alternatively, the test device may comprise a cover unit permanently coupled to the test assembly. In particular, the cover unit may be permanently snap-fixed to the test assembly. The optical sensor, and preferably also the conversion unit and the transmitter unit, may be arranged inside the cover unit, for example on a circuit board attached to the cover unit.

[0126] The test device may have a substantially cylindrical fitting, even if the cover unit, the support structure, or both the cover unit and the support structure provide recessed or raised areas or holes. The lower base is provided by the support structure, and the height is the extension of the cover unit perpendicular to the support structure. The upper base is also formed by the cover unit. Preferably, the diameter of the base is less than 5 cm, more preferably less than 3 cm, and even more preferably less than 2.5 cm. The height of the test device is preferably between 3 cm and 0.5 cm, more preferably between 2 cm and 1 cm.

[0127] The support structure and the cover unit may comprise thermoplastic polymers suitable for injection molding. The cover unit and the support structure may comprise thermoplastic polymers having different properties. Preferably, the thermoplastic polymer comprised in the cover unit is translucent or transparent.

[0128] The test device may also have a test strip housed within a portion of the inner periphery of the cover unit. Preferably, in a planar state, the length of the test strip measured along the long axis of the test strip is 10 cm or less, more preferably less than 70 mm. The width of the test strip measured along the short axis of the test strip is preferably 6 mm or less, more preferably less than 4 mm. The maximum thickness of the test strip measured along an axis perpendicular to the long and short axes is preferably less than 3 mm, more preferably less than 2 mm. If the test strip has a sample pad and / or a waste pad, the test strip typically has its maximum thickness in the sample pad and / or waste pad section.

[0129] Preferably, the test strip of the test assembly is fixed in place so that it cannot move relative to its designated position. In one embodiment, the support structure comprises fixing means for fixing the test strip to the support structure.

[0130] In some embodiments of a test device having a cover unit, its internal volume, i.e., the internal volume defined by the cover unit and the support structure, has a separation structure that divides the internal volume into two subchambers by a separation structure. Thus, in certain of these embodiments, the separation structure defines a lower chamber and an upper chamber. The lower chamber is defined by the support structure, a lower portion of the peripheral wall of the cover unit, and the separation structure. The upper chamber is defined by an upper portion of the cover unit and the separation structure. The separation structure has at least one opening configured to allow transfer of a liquid sample from the lower chamber to the upper chamber. Preferably, the lower chamber is configured to accommodate a liquid sample providing unit, such as a retractable lancet or needle, which in certain embodiments is a hollow needle. The liquid sample providing unit is not limited to a retractable lancet or needle. Additionally or alternatively, the lower chamber may accommodate one or more solution chambers containing one or more buffer solutions and a microfluidic system configured to deliver the buffer solutions to designated locations within the test assembly. Also preferably, the upper chamber is advantageously configured to accommodate a test strip.It is also possible for the test device to comprise separating structures arranged to define three or more sub-chambers.

[0131] The testing device may include a liquid sample providing module configured to be coupled to a liquid sample receiving interface.

[0132] The test device for lateral flow assays is preferably modular. In particular, interchangeable liquid sample provision modules may be provided. The test device may be configured to be used with one specially designed liquid sample provision module or, alternatively, with a variety of different liquid sample provision modules. This preferred modular nature of the test device allows multiple different test devices to be used in combination with one single liquid sample provision module.

[0133] The liquid sample provision module of the testing device may be or may comprise a needle or lancet, or an array of needles or lancets, fluidly connected to the liquid sample receiving interface. Alternatively, the liquid sample provision module may be a liquid container configured to be fluidly connected to the liquid sample receiving interface.

[0134] Preferably, the liquid sample providing module includes at least one lancing element having a distal end and a proximal end, the proximal end configured to interact with the liquid sample receiving interface. In one embodiment, the lancing element may be a needle or lancet, particularly a blood lancet, having a distal end and a proximal end. The hollow needle further includes a passageway fluidly connecting the distal end and the proximal end. In the lancing element, the proximal end is configured to interact with the liquid sample receiving interface. This allows the at least one lancing element to be used to extract a liquid sample from a container or organism and transfer the liquid sample from the container or organism to a test strip via a liquid sample receiving interface, which in some cases is integrated into the liquid sample receiving unit and in other cases is part of the test strip. Alternatively, in another embodiment, the liquid sample providing module is a catheter or cannula.

[0135] In operation of the exemplary test device, a liquid sample is transported from the distal end to the proximal end of the lancing element, preferably by capillary action, although this action is not limited to capillary action. The liquid sample is transported to the test strip through a liquid sample receiving interface. When a predetermined volume of the liquid sample reaches the liquid sample receiving interface, the liquid sample contacts one or more test strips. The predetermined volume of the liquid sample is related to the geometric shape of the liquid sample receiving interface and its physical properties, such as the materials contained therein, their porosity, etc. The capillary wick of the test strip allows the liquid sample to be transported from the liquid sample receiving interface to the test portion by capillary action. The test portion includes a reactive material configured to react with at least one analyte in a predetermined manner, particularly by changing the color of the reactive material when the analyte is present in the test portion of the test strip.

[0136] Alternatively or additionally, the soluble material configured to dissolve upon contact with bodily fluid may be configured to activate a detachment mechanism that, when activated, moves the liquid sample providing module away from the container or organism from which the liquid sample is to be extracted, thereby detaching the testing device. The soluble material may include a soluble inorganic salt. Alternatively, the soluble material may be a complex of a soluble salt and a polymer.

[0137] The detachment mechanism may include a biased spring attached to the liquid sample provide module. Dissolution of a soluble material in contact with the liquid sample releases the biased spring, causing it to return to an unstressed state, thereby driving the detachment motion. In embodiments where the liquid sample provide module includes a lancing element, preferably, dissolution of the soluble material drives the detachment motion of the lancing element, which then moves out of the container or organism, thereby allowing liquid sample extraction to conclude.

[0138] The separation mechanism may be integrated into the support structure. For example, the separation mechanism may be a portion of the support structure on which the liquid sample-receiving interface is disposed. This portion of the support structure is configured to be in a biased state when the soluble material is not yet in contact with the liquid sample. Once the soluble material is at least partially dissolved, the biased portion of the support structure returns to a non-biased or unstressed state, thereby driving the separation motion. Certain embodiments include a bistable snap dome forming part of the separation mechanism. Another embodiment includes a snap dome configured to have two or more actuation states, each actuated by a respective amount of force or in a respective predetermined sequence. One of the actuation states may be configured to cause puncturing of a solution chamber in which a buffer solution is stored. The puncturing of the solution chamber may be performed upon activation of another actuator or upon receipt of a predetermined output signal provided by a sensing unit included in the testing device.

[0139] Alternatively, the separation mechanism may be configured to be directly operable by a user, and the operation does not involve dissolving the soluble material. For example, the separation mechanism may be a monostable snap dome trigger that is actuated by applying a predetermined amount of pressure. Upon actuation, the monostable snap dome trigger is configured to assume an unstable state and return to a stable state after a predetermined time period related to the geometry and material of the snap dome trigger. In some embodiments, the snap dome trigger is configured to drive a retractable liquid sample delivery module (e.g., a lancet or needle) into an outward movement configured to initiate bodily fluid extraction and an inward movement configured to terminate bodily fluid extraction when the snap dome trigger is operated by a user.

[0140] The separation mechanism may be implemented as a double-push bistable actuator. A first push by the user is configured to drive outward movement of the liquid sample providing module (e.g., a lancet or needle), and a second push by the user is configured to drive inward movement of the liquid sample providing module, thereby terminating the extraction of the bodily fluid. Preferably, the separation mechanism implemented as a double-push bistable actuator is configured such that the first push or the second push causes a buffer solution contained in the solution chamber to be released from the solution chamber and move toward the liquid sample receiving interface or at least one test strip. Thus, the separation mechanism implemented as a double-push bistable actuator may be configured to automatically release the buffer solution from the solution chamber in response to the first push or the second push. For example, the separation mechanism may be configured such that the solution chamber is punctured, cut, or excised by the separation mechanism in response to the first push or the second push.

[0141] It should be noted that the presence of a liquid sample delivery module is not required. One embodiment of the test assembly may comprise a soluble material and a detachment mechanism, where the detachment mechanism is connectable to an external liquid sample delivery module.

[0142] In some embodiments of the test device, the timing function of the liquid sample extraction is appropriately controlled by the type of soluble material and the amount of soluble material, taking into account the properties of the liquid sample. The type and amount of soluble material affect the period between the start time when the liquid sample begins to react with the soluble material and the end time when the pulling-off movement occurs. Therefore, this period can be adjusted by selecting the type and amount of soluble material.

[0143] Additionally, the separating mechanism may be constructed and arranged so that the separating motion causes puncturing of a container containing a buffer solution. Puncturing the container allows the buffer solution to flow out of the container. The container is suitably arranged so that the flow of the buffer solution away from the container carries the extracted liquid sample, along with any dissolved soluble materials, to the test strip. Alternatively or additionally, the buffer solution can be provided directly to the test strip. In this case, the buffer solution contacts the liquid sample, and both move toward the conjugate pad. The buffer solution is preferably configured to chemically react with at least one analyte of the liquid sample in a pre-specified manner.

[0144] At least one of the test strips in the test assembly is preferably arranged so that the shortest distance between two longitudinal ends opposite each other of the test strip centerline is shorter than the test strip centerline length in a planar state. This spatial arrangement of the test strips within the test device preferably results in a curved test strip or a strip having a centerline with a centerline length longer than the effective extension in any coordinate direction of the test strip in the curved state. Thus, the centerline length indicates the length of the test strip, and thus the longitudinal extension of the curved test strip or the test strip in the curved state, measured along the centerline, taking into account the curvature of the test strip. The shortest distance is the shortest distance between the proximal end of the test strip, i.e., the section of the test strip that is in contact with or near the liquid sample receiving unit, or the section of the test strip that has a liquid sample receiving interface, and the distal end of the test strip where the test portion is located or is adjacent to the test portion. Thus, providing a test strip with a curved geometry, or arranging it in a curved state, or a combination of both, allows for a reduction in the size of the test device for a given centerline length of the test strip. Preferably, the test device is configured to have a maximum extension in any spatial direction of less than 5 cm.

[0145] Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. [Brief explanation of the drawings]

[0146] [Figure 1A] FIG. 1 shows a cross-sectional view of a test device comprising a lancing element, a test assembly and a cover unit. [Figure 1B] FIG. 1 shows a plan view (top view) of one embodiment of a test assembly for a lateral flow assay. [Figure 2A]1A and 1B are schematic diagrams showing top and cross-sectional views of a set of four test strips of a test assembly for a lateral flow assay, with the test strips in a planar position. [Figure 2B] 1A and 1B are schematic diagrams showing top and cross-sectional views of a set of four test strips of a test assembly for a lateral flow assay, the test strips being in a curved position. [Figure 3] FIG. 1 is a diagram illustrating a schematic of one embodiment of a test assembly for a lateral flow assay. [Figure 4] FIG. 10 is a schematic diagram of another embodiment of a test assembly for a lateral flow assay, including a solution chamber and a flow control means. [Figure 5] FIG. 1 is a schematic diagram illustrating one embodiment of a test apparatus. [Figure 6A] FIG. 1 shows a top view of a test strip having curved longitudinal edges in a planar state. [Figure 6B] FIG. 1 shows a side view of a test strip having curved longitudinal edges in a planar state. [Figure 7A] FIG. 10 illustrates an exemplary distancing mechanism in a biased state. [Figure 7B] FIG. 7B shows the separation mechanism of FIG. 7A in an unstressed state. [Figure 8A] FIG. 1 shows a diagram of an exemplary support structure on which a microfluidic system is disposed. [Figure 8B] FIG. 8B shows an enlarged view of a portion of the microfluidic system shown in FIG. 8A. [Figure 9] FIG. 1 shows an illustration of an exemplary support structure into which a microfluidic system is engraved. [Figure 10] 1 shows a schematic diagram of a test system according to the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0147] 1A shows a cross-sectional view of an embodiment of a test device 160. The test device 160 includes a lancet 128. The test device includes a test assembly 170 and a cover unit 103. The lancet is a specific, non-limiting example of a lancing element of a liquid sample delivery module, and is coupled to a liquid sample receiving interface 106 of the test assembly 170. Other suitable liquid sample delivery modules include, but are not limited to, a needle, a hollow needle, or a cannula. The test assembly further includes a support structure 104, a liquid sample receiving unit 102, and two test strips 108.1 and 108.2, each having a respective test portion 112.1 and 112.2.

[0148] The test apparatus 160 also includes a power management unit 105 having a voltage stabilization circuit. The test apparatus further includes an optical sensor 111 configured to detect incident light reflected by the test portions 112.1 and 112.2 and convert the detected light into an electrical signal representative of the intensity and / or color of the incident light. The optical sensor 111 is connected to a conversion unit 116. The conversion unit is configured to convert the electrical signal into digital data representative of the intensity and / or color of the detected light. The conversion unit 116 is an analog-to-digital converter and is included in the optical sensor 111. Alternatively, the conversion unit may be a separate component disposed on the support structure 104 and operably connected to the optical sensor 111. For example, the optical sensor 111, the power management unit 105, and a transmitter unit having an RF interface may be disposed on the support structure 104. The light reflected from the test portions 112.1 and 112.2 may be directed to the optical sensor using one or more mirrors also disposed on the support structure 104. A mirror can be used to form an optical path connecting the test portions 112.1 and 112.2 to the optical sensor 111. The optical sensor 111, the power management unit 105, and the transmitter unit with the RF interface can also be disposed on a circuit board, such as a flexible PCB. The circuit board can be disposed on the support structure 104. An optical element, such as a mirror, can be used to form an optical path from the test portions 112.1 and 112.2 to the optical sensor 111 disposed on the circuit board. The circuit board can also be attached to the inner surface of the cover unit 103 facing the support structure. Preferably, the optical sensor is positioned such that when the circuit board is attached to the inner surface of the cover unit 103, the optical sensor also faces the support structure. Because the test portions 112.1 and 112.2 face the sidewall of the test apparatus, the optical element is preferably positioned and configured to redirect light reflected from the test portions 112.1 and 112.2 by approximately 90° toward the optical sensor 111.Additionally, one or more light sources, e.g., LEDs, positioned and configured to illuminate the test portions 112.1 and 112.2 may be included. The one or more light sources may be located on the support structure 104, on the circuit board, or directly on the inner surface of the cover unit 103.

[0149] The test device 160 also comprises a transmitter unit 113 connected to the power management unit 105 and the conversion unit 116. The transmitter unit 113 is configured to wirelessly transmit digital data representing the detected light intensity and / or color, for example according to a predetermined wireless communication protocol.

[0150] Figure 1B shows a plan view (top view) of an exemplary embodiment of a test device 101 having a test assembly 100 for a lateral flow assay. In the following description, features common to the test device 160 of Figure 1A and the test device 101 of Figure 1B will be referenced using the same numerals.

[0151] Test device 101 of FIG. 1B includes a liquid sample receiving unit 102 disposed on a support structure 104. In an alternative and preferred test device, the liquid sample receiving unit is located at a central position on the support. In other test devices (not shown), the liquid sample receiving interface may be located directly on the test strip; therefore, these alternative test devices, like test device 101, do not have a dedicated liquid sample receiving unit. Support structure 104 is a flat structure that defines a plane XY defined by the axes shown in FIGS. 1A and 1B. Support structure 104 has a maximum linear extension L of less than 5 cm, preferably less than 3 cm, and more preferably less than 2.5 cm. MaxThe liquid sample receiving unit 102 has a liquid sample receiving interface 106 in the form of an opening in the support structure 104. The liquid sample receiving unit 102 is configured to receive a liquid sample via the liquid sample receiving interface 106. The liquid sample receiving unit has an absorbent material (not shown), preferably a porous hydrophilic material, which preferably comprises nitrocellulose or a similar material.

[0152] The test assembly 100 also includes two test strips 108.1 and 108.2. Each test strip 108.1, 108.2 is fluidly connected to the liquid sample receiving unit 102, and each test strip includes a capillary wick (110.1, 110.2) coupled to the liquid sample receiving unit 102. Preferably, the capillary wick also includes a porous, hydrophilic material, such as nitrocellulose or a similar material. Each test strip 108.1, 108.2 includes a respective test portion 112.1, 112.2 as part of the capillary wick 110.1, 110.2. The test portion includes a respective reactive material (not shown) configured to react in a predetermined manner with at least one respective analyte. In some test assemblies, the test portions 112.1 and 112.2 may include different reactive materials configured to react with different analytes. In other test assemblies, the test portions have a single reactive material configured to react with a given analyte with the same or different sensitivity to improve the accuracy of the test assembly or to allow semi-quantitative assessment of the given analyte. Other alternative test assemblies may have multiple test portions having a given material and, additionally, at least one test portion having a different reactive material.

[0153] In this particular test assembly 100, the two test strips 108.1 and 108.2 are arranged so that the angle formed between the width direction of the test strip (Z in the particular embodiment of FIGS. 1A and 1B) and the normal N to the plane (XY) at each longitudinal position along the length of the test strip is substantially constant, within the practical limits of manufacturing and angle determination, at an angle value of substantially 0°. This means that the width direction of the test strip is perpendicular to the support structure 104.

[0154] Additionally, the test assembly may further include a first window section 114 (dashed line) disposed around the periphery of the liquid sample receiving unit 102. The first window section 114 is at least partially transparent in the visible wavelength range and is positioned to allow control of the positioning of the liquid sample receiving unit relative to the exterior surface. By allowing a user to partially view the exterior surface where the test assembly is to be positioned, the precise position of the liquid sample receiving unit can be advantageously controlled.

[0155] The test device 101 also includes a power management unit 105 having an energy storage unit for storing and supplying electrical energy, and an optical sensor 111. The optical sensor 111 is configured and arranged to detect incident light reflected from the test portions 112.1 and 112.2. The optical sensor 111 is configured to convert the detected light into an electrical signal representative of the intensity or color of the incident light.

[0156] The test apparatus 101 of FIG. 1B also includes a light source 109 positioned and configured to illuminate the test portion 112.1. Furthermore, an optical element 107 is positioned and configured to direct light provided by the light source 109 and reflected from the test portion 112.1 to the optical sensor 111. Preferably, the optical sensor 111, the conversion unit 116, and the transmitter unit 113 are disposed inside a cover unit (not shown) of the test apparatus. The light source 109 and the optical element are also preferably disposed inside the cover unit. Alternatively, the optical sensor 111, the conversion unit 116, and the transmitter unit 113 can be disposed on the support structure 104 or on a circuit board disposed on the support structure 104. It is also possible to dispose at least one of the optical sensor 111, the conversion unit 116, and the transmitter unit 113 outside the cover unit of the test apparatus.

[0157] The optical sensor 111 is operatively connected to a conversion unit 116 configured to convert the electrical signal into digital data. The transmitter unit 113 is part of a transceiver unit 117 connected to the power management unit 105 and the conversion unit 116.

[0158] The conversion unit 116 is connected to the transceiver unit 117 via a data bus for providing digital data to the transmitter unit 113 of the transceiver unit.

[0159] The transceiver unit 117 is configured to receive control commands and transmit digital data according to a predetermined wireless communication protocol. The transceiver unit 117 is configured to harvest energy from an external device. Therefore, the transceiver unit 117 has energy harvesting capabilities and is configured to harvest energy from the external device via electromagnetic induction. For this purpose, the transmitter unit of the transceiver unit includes an NFC coil and an NFC chip for short-range wireless communication with the external device. The power management unit 105 includes a capacitor, preferably a supercapacitor, for storing the harvested energy. In an alternative embodiment, the energy storage unit is not present, and the harvested energy is used directly to power the components of the test device 101.

[0160] Alternatively or additionally, the test device 101 may include one or more solution chambers 124.1, 124.2 (dashed lines), each containing a respective buffer solution. The test device 101 may also include optional flow control means (not shown in FIG. 1 , see description of FIG. 4 ) advantageously configured to control the movement of buffer solution to the test strips 108.1, 108.2. In some test assemblies, each solution chamber is associated with all test strips. However, in alternative test assemblies, some solution chambers are associated with only one test strip or a subset of the multiple test strips.

[0161] In some embodiments of the test device (not shown), the flow control means may be configured to control the movement of buffer to the liquid sample receiving interface or the liquid sample receiving unit. In some test devices with two or more solution chambers, at least one solution chamber of the plurality of solution chambers is coupled to the liquid sample receiving interface and at least one solution chamber of the plurality of solution chambers is coupled to at least one test strip of the plurality of test strips.

[0162] In any of the above-described test devices, the capillary wick of the test strip may be disposed on a test strip carrier configured to confine at least a portion of incident light within a light-guiding layer of the carrier by total internal reflection, achieved, for example, by appropriate selection of materials having appropriate respective refractive indices or position-related refractive index profiles. The test strip carrier also has a light output section in which the test portion of the test strip is appropriately positioned. The light output section is configured to allow the trapped light to exit the test strip carrier. These particular test strip carriers are therefore appropriately configured to illuminate the test portion disposed thereon from its rear. Advantageously, in some embodiments, the capillary wick is thin enough to guide at least a portion of light incident on the rear of the test portion to the front.

[0163] The geometry of an exemplary set of test strips 208 is described with reference to FIGS. 2A and 2B. In FIG. 2A, four test strips form the set of test strips. Each individual test strip has a respective test portion 212. In a planar state, each test strip has a test strip centerline length L in the longitudinal direction, a test strip width W in the width direction perpendicular to the longitudinal direction, and a test strip thickness d in the thickness direction perpendicular to both the longitudinal and width directions, where the test strip thickness d is smaller than the test strip centerline length L and the test strip width W, i.e., has an extension shorter than the test strip centerline length L and the test strip width W. FIG. 2B shows the same set of test strips 208 in a curved state, where the shortest distance between the two opposite longitudinal ends of the test strip centerline, or in other words, the effective extension R, is shorter than the test strip centerline length L in the planar state shown in FIG. 2A. In this particular example, the shortest distance between the two opposite longitudinal ends of the test strip corresponds to the effective extension R. In another exemplary configuration (not shown), where the test strip is bent, for example, into a circle, the shortest distance between the two opposite longitudinal ends disappears, while the effective extension corresponds to the diameter of the formed circle, which is π / L. In both cases, the shortest distance and the effective extension are shorter than the test strip centerline length.

[0164] Figure 3 illustrates a schematic diagram of another embodiment of a test apparatus 301 having a test assembly 300. Test assembly 300 shares many features with test assembly 100 described with respect to Figure 1B. These common features are referenced by using the same reference numerals, with only the first digit being changed, which is "1" when referring to Figure 1 and "3" when referring to Figure 3.

[0165] Test assembly 300 includes a support structure 304 having an opening 306, which in this particular test assembly is coupled to a liquid sample receiving unit 302. In an alternative embodiment of the test assembly, the opening is coupled directly to a section of the test strip that functions as the liquid sample receiving interface. The liquid sample receiving interface is advantageously configured to interact with an external liquid sample providing module (not shown). The liquid sample providing module that may be coupled to liquid sample receiving interface 306 may include, for example, a lancet, needle, cannula, or liquid container with means for transporting the liquid sample contained therein through liquid sample receiving interface 306 to liquid sample receiving unit 302. Alternatively, the liquid sample may be provided directly to the liquid sample receiving interface, in which case a liquid sample providing module is not required.

[0166] The test assembly 300 includes a test strip 308 in a curved state (not shown) that is fluidly connected to a liquid sample receiving unit 320. The test strip 308 includes a capillary wick 310. The test strip also includes a conjugate pad 320 containing immobilized conjugate material. The conjugate pad 320 is configured to release the immobilized conjugate material upon contact with a liquid sample. The conjugate material is contained in the conjugate pad, i.e., as colloidal gold particles or colored, fluorescent, or paramagnetic monodisperse latex particles. These are conjugated to a specific biological component that is expected to be identified in the liquid sample. In some test devices, this biological component is an antigen, and in other test devices, it is an antibody. The test strip 308 also includes a test portion 312 having a test line 312.1 and a control line 312.2 that form a so-called reaction matrix.

[0167] The liquid sample received through the liquid sample receiving interface 306 is transported by capillary action from the liquid sample receiving unit 302 along the capillary wick 310. At the conjugate pad 320, the liquid sample releases conjugate material, and the combination of the two is further transported toward an absorbent pad 322 located at the distal end of the test strip 308, opposite the proximal end to which the liquid sample receiving unit 302 is attached. The absorbent pad 322 of this (and similar) test strips is configured to act as a sink for the liquid sample, maintaining the flow of liquid on the capillary wick and preventing the flow of the liquid sample back toward or toward the liquid sample receiving unit 302.

[0168] The test device 301 also includes an optical sensor (not shown) positioned and configured to detect light reflected from the test portion 312 of the test strip 308. The optical sensor is further configured to convert the incident light into an electrical signal representative of the intensity and / or color of the detected light. The test device 301 includes a conversion unit that converts the electrical signal into digital data and a transmitter unit that wirelessly transmits the digital data upon activation by an external initiator device 1020.

[0169] The features that distinguish test assembly 300 from test assembly 100 can be advantageously used in combination with any of the alternatives to test device 100 described above. For example, some test devices may include a reflector element with each flow control means or at least one solution chamber, or preferably both a reflector element with each flow control means and at least one solution chamber, in addition to the features described with reference to Figure 3. Some of these test assemblies also have a test strip carrier in which a capillary wick is disposed.

[0170] Figure 4 illustrates schematically another embodiment of a test fixture 401 of a test assembly 400. Again, test assembly 400 shares several features with test assemblies 100 and 300 described with respect to Figures 1B and 3. These common features are referenced using the same reference numerals, with only the first digit changing, which is "1" when referring to Figure 1, "3" when referring to Figure 3, and "4" when referring to Figure 4.

[0171] The test device 401 comprises a solution chamber 424 containing a buffer solution and flow control means 426.1 configured to control the movement of the buffer solution to the liquid sample receiving unit 402. Alternatively or additionally, some test devices comprise flow control means 426.2 (as indicated by the dashed line) that controls the movement of the buffer solution directly to the test strip 408. Some test devices comprise multiple solution chambers and controlled flow means that control the movement of each solution (which may be the same, different, or a combination thereof) to the liquid sample receiving interface or to one or more test strips. The buffer solution is advantageously selected to facilitate transport of the liquid sample along the capillary wick of the test strip.

[0172] The flow control means 426.1 and 426.2 preferably comprise microelectromechanical (MEMS) flow control means for controlling the movement of the buffer solution. The microelectromechanical flow control means is preferably connected to a microcontroller via a data bus. Control commands can be received via the transceiver unit by the microcontroller for controlling the microelectromechanical flow control means. The microelectromechanical flow control means may comprise microsensors and / or microactuators, such as micropumps, in various test assemblies. In certain test devices, the microsensors and / or microactuators are also integrated into a microprocessor for controlling the microsensors and / or microactuators.

[0173] The test device 401 includes an optical sensor (not shown) for detecting light reflected from the test portion 412 of the test strip 408 and converting the light into an electrical signal representative of the light intensity and / or color. The test device 401 includes a conversion unit (not shown) for converting the electrical signal into digital data and a transmitter unit (not shown) operatively connected to the conversion unit for transmitting the digital data to an external receiving device, for example, via a near field communication (NFC) link. The transmitter unit may include an NFC chip or an RFID tag. Alternatively, the transmitter unit may be configured to transmit the digital data via Bluetooth or Wi-Fi.

[0174] Energy drawn from an external device may power electronic and / or electromechanical components of the test device.

[0175] In particular, the energy supply for such a micropump or microactuator is preferably performed wirelessly, for example when reading out the transmitter unit via an NFC link.

[0176] The capillary wick of some test assemblies is disposed on a test strip carrier configured to confine at least a portion of incoming light within a light guiding layer of the carrier by total internal reflection, and the test portion of the test strip is disposed in a light output section of the test strip carrier such that light trapped within the light guiding layer exits the light guiding layer, thereby illuminating the test portion.

[0177] Any of the test assemblies described above may form part of a test apparatus as described with reference to FIG.

[0178] Figure 5 shows a schematic diagram of one embodiment of a test device 500 for a lateral flow assay. The test device 500 includes a liquid sample provision module in the form of a lancet 528 that is configured to couple to a liquid sample receiving interface 506 of a liquid sample receiving unit 502. Again, the test device 500 includes a test assembly that shares features with the test assemblies 100, 400 described with reference to Figures 1-4. These features share the same reference numerals, except for the first digit, which is "1" when referring to Figure 1, "4" when referring to Figure 4, and "5" when referring to Figure 5.

[0179] The test device 500 includes three separate solution chambers 524.1, 524.2, and 524.3, which also include flow control means including microelectromechanical flow means 526.1, 526.2, and 526.3 configured to control the flow of buffer solution to the test strips 510.1, 510.2, or the liquid sample receiving unit 502.

[0180] In some embodiments of the test device, the test device alternatively or additionally comprises a flow control means configured to control the movement of buffer solution while the liquid sample is moving through the liquid sample providing module to the liquid sample receiving interface.

[0181] Still other test devices may alternatively or additionally comprise flow control means configured to control the movement of buffer after the liquid sample has been transferred to the liquid sample receiving interface via the piercing element.

[0182] Figure 6A shows a top view of a test strip 601 in an alternative geometric configuration used in some embodiments of the test assembly described with reference to Figures 1A, 1B, 3, and 4. Figure 6A shows a top view of test strip 601 with curved longitudinal edges, having a width W and a test strip centerline length L obtained by measuring the length of the centerline (dashed line), and test strip 602 with straight longitudinal edges, having the same width W and test strip centerline length L as test strip 601. Figure 6B shows the corresponding side views of test strips 601 and 602. The thickness of the test width is indicated by d.

[0183] Test strip 601 already has, in a planar state, an effective extension R that is shorter than the maximum longitudinal extension L of the test strip in the planar state. The effective extension of the test strip length in the planar state is equal to the test strip centerline length (dashed line) in the case shown in Figure 6A. In order to achieve an effective extension shorter than L for test strip 602, test strip 602 must be arranged in a curved state, for example by folding, curving or winding test strip 602.

[0184] 7A and 7B illustrate an exemplary detachment mechanism 700 that can be used in combination with any of the testing devices described above. FIG. 7A illustrates the detachment mechanism 700 with a spring 702 in a biased state, and FIG. 7B illustrates the same detachment mechanism 700 with the spring 702 in a non-stressed or unbiased state. The distal end of the spring 702 is coupled to a lancet 704, which in this particular case forms the liquid sample delivery module of the testing device. Alternatively, other detachment mechanisms in accordance with the present invention may be attached to other liquid sample delivery modules, such as flexible catheters or other fluid systems. The proximal end of the spring 702 is coupled to a support structure 706 of the testing device at a fixed point. The lancet 704 is also in fluid communication with a soluble material 708 that is configured to remain attached to the support structure as long as a predetermined percentage of the soluble material remains in a solid state. When the liquid comes into contact with the soluble material, it causes the soluble material to dissolve, thereby allowing the spring 702 to separate from the support structure 706. The spring can then be brought to an unbiased state, as shown in FIG. 7B , forcing the lancet 704 to move in the Z direction. This separation movement separates the lancet from the container or organism from which the liquid sample is to be extracted into the internal volume of the testing device. This separation movement is configured to terminate an ongoing liquid sample extraction process. Alternatively, another separation mechanism may include a bistable snap dome coupled to the liquid sample providing unit, where dissolution of at least a portion of the soluble material initiates a transition from a first stable state to a second stable state.

[0185] FIG. 8A shows a diagram of a support structure 800 on which a passive microfluidic system 802 is disposed, and FIG. 8B shows an enlarged view of a portion 802.1 of the microfluidic system shown in FIG. 8A. The microfluidic system 802 has an inlet 804 coupled to a liquid sample-receiving interface for receiving a liquid sample. The microfluidic system also has an outlet coupled to a test strip 808, only a portion of which is shown in FIG. 8. The inlet 804 is coupled to an air vent 805 via a waste channel 818. The inlet 804 and waste channel are further fluidly connected to an outlet 806 via a passive valve 812 and a separation chamber 810. An air reservoir 814 is coupled to an air inlet 816, which is disposed between the passive valve 812 and the separation chamber, via a dedicated connection 820. The passive microfluidic system 802 with a geometric passive valve can be fabricated separately from the support structure 800 and then disposed on the support structure 800. It may also be coupled to a reservoir containing a buffer solution (not shown). Suitable manufacturing methods for the microfluidic system 802 include 3D printing, in particular digital light projector 3D printing (DLP 3D printing).

[0186] FIG. 9 shows an illustration of an exemplary support structure 900 into which a microfluidic system 902 is engraved. Features corresponding to those in FIGS. 8A and 8B are referenced using the same numerals except for the first digit, which is an "8" in the microfluidic systems of FIGS. 8A and 8B and a "9" in the microfluidic system of FIG. 9. Passive valve 912, in this particular exemplary microfluidic system, is not a geometrically passive valve like valve 812 but a hydrophobic valve, i.e., a portion of the microfluidic system coated with a hydrophobic surface, particularly a nanocoating, to restrict liquid flow. A similar hydrophobic surface is also located in close proximity to outlet 908, as indicated by the open square in FIG. 9. A dedicated junction 920 between air reservoir 914 and air inlet 916 is also optionally coated with a hydrophobic surface. Preferably, the remaining surfaces, including the waste channel 918, the junction connecting the waste channel with the inlet 916, and the separation chamber, are coated with a hydrophilic material that forms a hydrophilic surface suitable for promoting capillary flow in each section of the microfluidic system 902.

[0187] In summary, the present invention relates to a device having a test assembly for a lateral flow assay. The test assembly has a liquid sample receiving interface disposed on a support structure defining a plane. The liquid sample receiving interface is configured to receive a liquid sample. The test assembly includes at least one test strip fluidly connected to the liquid sample receiving interface. The test strip includes a capillary wick fluidly connected to the liquid sample receiving interface, the capillary wick having at least one test portion. The test portion includes at least one reactive material configured to react with at least one analyte in a predetermined manner. The test device further includes an optical sensor positioned and configured to detect incident light reflected from the at least one test portion and convert the detected light into an electrical signal representative of the intensity or color of the light. The test device also includes a conversion unit that converts the electrical signal into digital data. The test device also includes a transmitter that wirelessly transmits the digital data representative of the detected light intensity and / or color to an external device.

[0188] A test system 1000 according to the present invention includes a test device 1010 and an external device 1020. See FIG.

[0189] The test device 160 includes: a test assembly 170; an optical sensor 111; a conversion unit 116; Transmitter unit 113 and (See Figure 1A.)

[0190] The test assembly 170 is part of the test equipment; a support structure 104; a sample receiving interface 106; at least one test strip 108; and the test strip 108 comprises: The capillary wick 110 includes: · has at least one test portion 112;

[0191] The optical sensor 111, the conversion unit 116 and the transmitter unit 113 are preferably located on the support structure 104 of the test assembly. Alternatively, the optical sensor 111, the conversion unit 116 and the transmitter unit 113 may be attached to the cover unit 103 of the test apparatus.

[0192] The optical sensor 111 of the test device is positioned and configured to detect light reflected from at least one test portion 112 and provide an electrical signal representative of the intensity and / or color of the detected light. The optical sensor 111 may be, for example, a single pixel photodiode or a CMOS sensor or a CCD sensor.

[0193] After converting the detected light into an electrical signal, the electrical signal is provided to a conversion unit 116 .

[0194] The conversion unit 116 is configured to convert the electrical signals into digital data representing the intensity and / or color of the detected light. The conversion unit 116 may be part of the optical sensor 111. The conversion unit 116 may be a separate component of the test device 160. Alternatively, the conversion unit 116 may be part of the transmitter unit 113. Preferably, the conversion unit 116 is or comprises an analog-to-digital converter (ADC) for converting the electrical signals into digital data representing the intensity and / or color of the detected light. The conversion unit may be configured to convert the electrical signals at 8 bits.

[0195] The conversion unit 116 is operatively connected to the transmitter unit 113, for example via a data bus, for providing the digital data to the transmitter unit 113.

[0196] The transmitter unit 113 is configured to wirelessly transmit digital data representing an electrical signal representative of the detected light to a preferably external receiving device 1020 (see FIG. 10 ) using a predetermined wireless communication protocol such as Bluetooth®, Near Field Communication (NFC) or Wi-Fi or RFID. In particular, the transmitter unit 113 may be or have an NFC chip and NFC coil or a Radio Frequency Identification (RFID) tag or transponder or a circuit chip with Wi-Fi embedded or a circuit chip with Bluetooth embedded.

[0197] A transmitter unit 113 based on technologies such as NFC or RFID that do not require a permanent energy supply is preferred: the energy required to power such a transmitter unit is provided by a so-called initiator.

[0198] The transmitter unit 113 configured to transmit data via NFC or RFID preferably has one or more antennas that function as a radio frequency (RF) interface for transmitting electromagnetic signals representing digital data to one or more further antennas of an external device by means of electromagnetic induction. The antennas typically have one or more coils with four or five turns each.

[0199] The initiator may be an external device 1020 that provides a carrier field that is modulated by the transmitter unit 113 for transmitting digital data. Preferably, to power the transmitter unit 113, the transmitter unit 113 draws energy from the external device 1020 via an NFC or RFID link. Thus, the test apparatus 160 itself does not need to include an energy storage unit, e.g., a battery, to power the transmitter unit 113, especially in the case where the transmitter unit is NFC- or RFID-enabled.

[0200] The testing device 160 is a single device that receives a liquid sample, e.g., a bodily fluid such as blood, from a patient, processes the received liquid sample through a microfluidic system that includes a capillary wick with at least one test portion, and enables the received bodily fluid to be analyzed for the presence of a specific analyte. The evaluation of the presence or absence of a specific analyte in the liquid sample is performed externally, e.g., directly on an external device 1020 that receives the digital data. The external device may be a smartphone or tablet, preferably with NFC or RFID capabilities, and configured to function as an initiator device. The external device 1020 can also be used to further transmit the digital data, e.g., to a personal computer or server for evaluation.

[0201] The optical sensor 111, the conversion unit 116, and the transmitter unit 113 may be disposed on the support structure 104 together with the microfluidic components as separate components. The optical sensor 111, the conversion unit 116, and the transmitter unit 113 may be fabricated using electronic packaging, for example, 3D packaging. Thus, using 3D packaging, a compact three-dimensional integrated circuit can be designed by stacking components. After 3D packaging the integrated circuit including the optical sensor, the conversion unit and the transmitter unit can be attached to the support structure or can be attached to a cover unit. Alternatively, a chip including the optical sensor, the conversion unit, and the transmitter can be manufactured using wafer-level packaging (WLP). The optical sensor, the conversion unit, and the transmitter unit may be placed in a protective package for incorporation into a test device.

[0202] In some embodiments, the optical sensor, the conversion unit, and the transmitter unit are mounted on a circuit board that is attached as a module to a support structure or a cover unit. The circuit board may be flexible, for example, a flexible board made of polyimide such as Kapton, polyetheretherketone (PEEK), liquid crystal polymer (LCP), or FR4. Rigid or semi-flexible circuit boards can alternatively be used. In particular, the optical sensor, the conversion unit, and the transmitter can be integrated onto a thin FR4 board. The circuit board may be a printed circuit board (PCB), which is preferably flexible, for example, an FR4 PCB. Alternatively, the printed circuit board may be a rigid or semi-rigid printed circuit board.

[0203] Mounting at least one of the optical sensor, the conversion unit and the transmitter unit on the cover unit of the testing device is advantageous as it leaves more space on the support structure, for example for arranging components of a microfluidic system.

[0204] In particular, the antenna of the transmitter unit can be integrated into the test device using in-molding. In cases where the test device has a cover unit that is attached to a support structure and thus forms a closed housing, the transmitter antenna can be integrated into the housing, for example, attached to the inside of the lid portion of the cover unit by in-molding. Alternatively, the transmitter unit antenna can be integrated into the same chip or circuit as the rest of the transmitter electronics, optical sensor, and conversion unit. For example, the antenna can be integrated into a PCB.

[0205] Because processing of data representing the optical signals acquired by the test device 1010 is performed not on the test device 1010 but on the external device 1020, the test device can be small and does not require a battery to store electrical energy for a relatively long period of time. Rather, as described above in this specification, the test device 1010 can be supplied with energy by the external device 1020. The optical sensor 111, the conversion unit 116, and the transmitter unit only convert the optical signals into electrical signals and digital raw signals, respectively, without further processing of the signals, in particular analysis and evaluation of the signals, because this occurs on the external device or, for example, on a server operably connected to the external device 1020. The digital raw signals provided by the test device 1010 are analyzed and evaluated by the external device 1020 and / or a server 1030 that is at least temporarily connected to the external device 1020. [Explanation of symbols]

[0206] 100 Test Assembly 101 Test Equipment 102 Liquid sample receiving unit 103 Cover unit 104 Support structure 105 Power Management Unit 106 Sample receiving interface 107 Optical elements 108.1, 108.2 Test strips 109 Light source 110.1,110.2 Capillary wick 111 Optical Sensor 112.1, 112.2 Test section 113 Transmitter Unit 114 Window Section 116 Conversion Unit 117 Transceiver Unit 124.1, 124.2 Solution chamber 128 Lancet 160 Test Equipment 170 Test Assembly 208 Test Strips 212 Test Section 300 Test Assembly 301 Test Equipment 302 Liquid sample receiving unit 304 Support Structure 306 Liquid sample receiving interface 308 Test Strips 310 Capillary Wick 312 Test Section 312.1 Test Line 312.2 Control Line 320 Conjugate Pad 322 Absorbent Pad 400 Test Assembly 401 Test Equipment 402 Liquid sample receiving unit 408 Test Strips 412 Test Section 424 Solution Chamber 426, 426.1, 426.2 Flow control measures 500 Test Equipment 502 Liquid sample receiving unit 506 Liquid sample receiving interface 510.1, 510.2 Test strips 524.1, 524.2, 524.3 Separate solution chambers 526.1, 526.2, 526.3 Microelectromechanical flow means 528 Lancet as part of liquid sample delivery module 601,602 Test strips 700 Separation mechanism 702 Spring 704 Lancet 706 Support Structure 708 Soluble materials 800 Support Structure 802 Microfluidic Systems 802.1 Part of a microfluidic system 804 Entrance 805 Air Vent 806 Exit 808 Test Strips 810 Separation Chamber 812 Passive valve 814 Air storage unit 816 Air inlet 818 Waste Channel 820 dedicated connection 900 Support Structure 902 Microfluidic Systems 908 Exit 912 Passive Valve 914 Air storage unit 916 Air inlet 918 Waste Channel 920 Joint 1000 Test System 1010 Test equipment 1020 External device 1030 Server

Claims

1. A test device (160) comprising a test assembly (170) for a lateral flow assay, comprising: The test assembly includes: a liquid sample receiving interface (106) disposed on a support structure (104) defining a plane (XY), said liquid sample receiving interface being configured to receive a liquid sample; at least one test strip (108.1, 108.2) fluidly connected to said liquid sample receiving interface (106) via a microfluidic system (802, 902); wherein the test strip comprises: a capillary wick (110.1, 110.2) fluidly connected to the liquid sample receiving interface and having at least one test portion (112.1, 112.2), the test portion having at least one reactive material configured to react in a predetermined manner with at least one specific analyte; The microfluidic system (802) comprises: an inlet (804) coupled to the liquid sample receiving interface; an outlet (806) coupled to said test strip (808); It is equipped with The inlet (804) is connected to an air vent (805) via a waste channel (818); the inlet (804) and the waste channel (818) are fluidly connected to the outlet (806) via a passive valve (812) and a separation chamber (810); an air reservoir (814) coupled to an air inlet (816) disposed between the passive valve (812) and the separation chamber (810); The test device (160) an optical sensor (111) positioned and configured to detect light reflected from the at least one test portion and convert the detected light into an electrical signal representative of the intensity and / or color of the detected light; a conversion unit (116) for converting said electrical signals into digital data representative of the intensity and / or color of said detected light; a transmitter unit (113) for wirelessly transmitting digital data; Further provided with Test equipment (160).

2. The test device (160) of claim 1, wherein the transmitter unit is configured to transmit the digital data over a short-range wireless communication link.

3. 3. The test device (101) of claim 1 or 2, comprising at least one optical element (107) positioned and configured to direct light reflected from the at least one test portion to the optical sensor.

4. 4. The test device (101) of claim 1, further comprising at least one light source (109) arranged and configured to illuminate the at least one test portion.

5. The testing device (160) of claim 4, further comprising another optical element positioned and configured to direct illumination light emitted by the at least one light source onto the at least one test portion.

6. The test device (160) according to at least one of claims 1 to 5, further comprising a cover unit (103) attachable to the support structure.

7. The testing device (160) of claim 6, wherein the test assembly is permanently coupled to the cover unit.

8. A test device (160) as described in at least one of claims 1 to 7, comprising a liquid sample providing module (528), the liquid sample providing module having at least one piercing element or cannula having a distal end and a proximal end, the proximal end configured to interact with the liquid sample receiving interface.

9. 1. A test system (1000) for testing a liquid sample for the presence of a particular analyte, said test system comprising: a test device (1010) according to at least one of claims 1 to 8; an external device (1020) configured to receive digital data provided by said test device; Equipped with Test system (1000).

10. 10. The test system (1000) of claim 9, further comprising a server (1030), the server (1030) operatively connected to the external device for transmitting digital data received by the external device to the server.

11. The test system (1000) of claim 9 or 10, wherein the test device (1010) is configured to provide to the external device (1020) an unprocessed signal representing a digital signal representing an electrical signal representing an optical signal converted by the optical sensor (111) of the test device (1010).

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