WO2026062018A1 - A temperature-control mount and a temperature-control box for receiving a test element and an analytical measurement method - Google Patents

Abstract

The invention relates to a temperature-control mount (10) for receiving a strip-like test element (12) having an optical reagent test zone (22) to which a sample of bodily fluid can be applied by a proband for self-testing, the temperature-control mount (10) comprising a flat base plate (40) adapted to support a single test element (12), a thermal element (16) arranged on the base plate (40) in a stacked configuration and configured for providing heating power and/or cooling power to the test element (12) when mounted thereupon, a positioning unit (18) adapted to ensure a predefined alignment of the test element (12) on the thermal element (16), a controller (20) configured for temperature control at least of the test zone (22) via the thermal element (16) and a power supply (24) to deliver electrical energy to the thermal element (16) and the controller (20).

Description

A temperature-control mount and a temperature-control box for receiving a test element and an analytical measurement method

Description

The present invention relates to a temperature-control mount for receiving a strip-like test element having an optical reagent test zone to which a sample of bodily fluid can be applied by a proband for self-testing and further relates to a temperature-control box and still further to an analytical measurement method making use of the mount and optionally the box.

In analytical measurements evaluating a result from an image of an optical test element, the use of generally available electronics such as smartphones or other mobile devices including a camera has become more and more popular over the recent years. As opposed to laboratory measurements in a standard (clinical) environment, when using mobile devices by laypersons, various additional influences need to be taken into account. For example, one approach to take the temperature of a reaction on a test strip into account is to provide a temperature sensor or a temperature indication area right on the test strip itself. However, in cases lacking any temperature control, only tests without specific temperature requirements regarding the test reaction (i.e. the test chemistry) can be performed.

On this basis, the object of the invention is to further improve the known devices and methods and to provide an easy-to-use design which allows for efficient mobile-based selftests on bodily fluids also performed by laypersons in a home environment with improved accuracy and extended application range. The combination of features stated in the independent claim is proposed to achieve this object. Advantageous embodiments and further developments of the invention are derived from the dependent claims.

The invention is based on the idea of providing a stabilized test element temperature. Specifically, the invention is targeted to simple home tests that are evaluated using a smartphone and adds as an accessory a missing function (temperature control)

Accordingly, in a first aspect of the present invention, it is proposed a temperature-control mount for receiving a test element, the temperaturecontrol mount comprising:

- a flat base plate adapted to support a single test element;

- a thermal element arranged on the base plate in a stacked or layered configuration and configured for providing heating power and/or cooling power to the test element;

- a positioning unit adapted to ensure a predefined alignment of the test element on the thermal element;

- a controller configured for temperature control at least of the test zone via the thermal element;

- a power supply to deliver electrical energy to the thermal element and the controller.

Such an arrangement allows for an active temperature control in a control loop and provides that any optically detectable test which requires some sort of temperature control (e.g. heating/cooling, constant temperature) can be performed. The particular combination of elements proposed above is specifically adapted to the situation of analytical measurements by a smartphone used by a layman for self testing. Said situation requires to take particular aspects into account, and in particular requires to find a balance between an effective temperature control on the one hand and an optical pathway (from the mobile device’s camera to the reagent test field) which is essentially free of obstacles on the other hand. Furthermore, correct alignment of the test element with respect to tempering and image capturing can be achieved. Other benefits are little space requirements and low material/manufacturing expenses.

For a simple application, the mount is configured as a is configured as a hand-held portable unit for handling in home-testing by the proband. In other words, the mount is configured as a separate or standalone unit for temperature control of the test element which can be attached to the mount.

Advantageously, the thermal element comprises a Peltier element for cooling and/or a heating resistor element, thus allowing temperature adjustment in any environment.

In order to guide the user or proband, a feedback element adapted for signaling a set temperature reached and/or a sample application request is proposed.

A further improvement also with respect to alignment of thermal and optical pathways can be achieved when the positioning unit comprises at least one of a guidance element, a stop element, a fixture element, the at least one guidance, stop and/or fixture element having a contour for positive engagement with the test element. In order to ensure a reliable and reproducible thermal conductance to the thermal element, it is advantageous when the positioning unit is configured to press the test element flat against a surface.

To evenly distribute the heat at least on the test zone, it is further advantageous when a thermal conductor element is arranged on the thermal element and provides a thermal contact region for the test element.

For a mobile independent use it is favorable when the power supply comprises a battery, specifically a rechargeable battery.

A particular advantageous embodiment further provides an unobstructed optical pathway to an image detection area for image detection of the test element by means of a camera of an external handheld mobile device, preferably a smartphone.

A further improvement in this connection provides image alignment markers for aiding in image capture.

In a further aspect of the present invention, it is proposed an arrangement comprising a mount according to the invention, a single strip-like test element having an optical reagent test zone to which a sample of bodily fluid can be applied for self-testing by a proband and a separate mobile device including a camera, preferably a smartphone, which can be handled by the proband for image detection of the test element and evaluation of a test result. In this way, a system for smartphone-based tests is completed for a missing function, namely temperature control of the test strip. In a still further aspect of the present invention, it is proposed a temperature-control box for receiving a test element, the box defining an internal space, wherein the internal space is configured to removably receive a temperature-control mount according to the invention or wherein a temperature-control mount according to the invention is fixedly arranged in the internal space. Such a more closed arrangement allows for even better temperature control due to housing and in addition for ambient light shielding.

Advantageously, an optical pathway or a window is provided for taking an image at least of the test zone by means of a camera of an external mobile device, preferably a smartphone.

For a hands-free handling it is further advantageous when a support structure for positioning of a mobile device having a camera externally of the box is provided, where a still further advantage can be achieved when the support structure provides for a defined distance of the camera to the test element in order to enable focused image recording at least of the test zone.

Advantageously, a shielding element, specifically a flexible or a moveable lid, is configured to provide alignment of a mobile device having a camera and/or protection of the internal space from ambient light.

To improve test handling and sample dosing, it is advantageous when a port for inserting the mount and/or test element is provided. In a particular embodiment, the port is configured such that a sample application site is accessible by the proband from external of the box. A further aspect of the invention concerns an analytical measurement selftesting method for determining an analyte in a sample of a bodily fluid by using a mobile device having a camera, preferably a smartphone as mobile device, the method comprising determining the analyte from an image of an optical strip-like test element captured by the camera of the mobile device, wherein the image comprises at least a part of the optical test element, wherein the sample of the proband’s bodily fluid is applied by the proband to a reagent test zone of the optical test element, the reagent test zone being adapted to provide an optically detectable change upon sample application, wherein the image comprises at least a part of the reagent test zone having the sample of the bodily fluid applied thereto. In order to achieve the above explained improvements and beneficial effects, it is proposed that the method makes use of the temperature-control mount and optionally of the temperature-control box according to the invention.

Advantageously, a request for sample application is signaled to the proband upon reaching a target temperature.

For simplifying handling, the image is taken by the proband after sample application by handling the mobile device.

A still further improvement provides that the analyte, particularly an analyte concentration, is evaluated from a color of a color formation reaction on the reagent test zone by means of a mobile app as a software running on the mobile device. Advantageously, the test result is communicated to the proband by the mobile app.

According to the invention, various control options may be realized:

Unidirectional communication between the mobile device (specifically smartphone) and the controller on the mount, where the mobile device recognizes the test type and sends the set temperature value to the controller;

Bidirectional mobile device - controller communication e.g. via Bluetooth. In addition, the controller may send other optional data such as battery status to the mobile device for e.g. user feedback or holistic measurement data collection.

No mobile device - controller communication. In this case, both the mobile device and the controller recognize the test type, the latter for example by use of mechanical interlocking or other identifiers on the test element.

In the following, the invention is further elucidated on the basis of embodiment examples shown schematically in the drawings, where:

Fig. 1 shows a temperature-control mount for a test element in connection with a smartphone as detector in a perspective view;

Fig. 2 shows a temperature-control box including the temperature-control mount and a smartphone as a detector in a perspective view;

Fig. 3 is a flow chart of a test handling in a temperature-control mount or box. The temperature-control mount 10 shown in Fig. 1 is configured as a temperature regulating means in an analytical measurement method in particular for home/self-testing by lay men, where a sample of body-fluid is applied by the user to a test element 12 and the test result is optically evaluated by means of a mobile device including a camera, preferably by a smartphone 14.

For this purpose the mount 10 comprises a thermal element 16 configured for providing heating power and/or cooling power to the test element 12, a positioning unit 18 adapted to ensure a predefined alignment of the test element 12 at least with respect to the thermal element 16, a controller 20 that is able to provide defined temperatures at least of a test zone 22 of the test element 12 via the thermal element 16 and a power supply 24 to deliver electrical energy to the thermal element 16 and the controller 20.

The smartphone 14 includes a camera 26 which can be used to capture images of the test zone 22. From optically detectable changes within the test zone 22, e.g. graphical elements like bars or color formation, an analyte or an analyte concentration may be determined advantageously by help of a software application running on the smartphone 14. Examples of such tests are blood glucose tests or LFA tests like rapid antigen tests (such as for SARS-CoV-2).

Such tests may require some sort of temperature control, e.g. heating/cooling, constant temperature at least of the test zone 22. To this end, the thermal element 16 can be configured as a Peltier element or a heating resistor. In order to evenly distribute the heat at least on the test zone 22, a thermal conductor element 28 is arranged on the thermal element 16 and with its upper surface provides a thermal contact region 30 for the test element 12.

The positioning unit 18 comprises two guide rails 32 for lateral guidance and a front stop 34 for positive engagement with the strip-shaped test element 22. The guide rails may have an undercut profile which is configured as a fixture element 36 to press the test element 12 flat against the thermal contact region 30 to ensure a reliable and reproducible thermal conductance to the thermal element 16.

As illustrated only symbolically in Fig. 1 , the power supply 24 includes a battery 38, specifically a rechargeable battery and a solar cell, that powers the thermal element 16 as well as its controller 20 formed by a microprocessor and adapted to record an actual temperature of the test element 12 and to adjust a setpoint temperature in a control loop. Thus, a fast temperature control can be realized directly on the mount 10 without the need of a constant connection to the smartphone 14.

The mount 10 comprises a base plate 40 to support the thermal element 16 and the positioning unit 18 thereupon. In this way, the arrangement can be provided as a hand-held portable unit for a simplified handling in hometesting by a user.

As mentioned above, the test evaluation is based on the use of the smartphone 14, and hence the mount 10 provides an image detection area 41 which is freely visible to the smartphone camera 26 in order to capture an image of the test zone 22 arranged in the detection area 41 . To facilitate image detection by means of the camera 26, image alignment markers 42 are provided on all four comers of the rectangular base plate 40. Such markers 42 may be designed as so-called Arllco-markers comprising a black border and an inner binary matrix. The black border facilitates its fast detection in the image and the binary matrix allows its identification and the application of error detection and correction techniques.

A feedback element 43 is adapted for further user guidance, e.g. for signaling a set temperature reached and/or a sample application request to the user. Such feedback may be provided optically, e.g. by a thermochromic indicator or an LED.

Fig. 2 shows a temperature-control box 100 defining an internal space 102 for the temperature-control mount 10 described above. The internal space 102 is either configured to receive the mount 10 as a separate device or to have the mount 10 fixedly included in the bottom of the internal space 102. While the mount in Fig. 2 is only designated by reference numeral 10 for sake of clarity, it is understood that the parts described above are included in the mount 10.

On the upper side wall of the cubic box 100, a window 104 is provided for capturing an image at least of the test zone 22 of the test element 12 by means of the rear camera 26 of the smartphone 14. The window 104 is essentially a clear opening, so that no glass or any other window material obstructs the optical pathway between the camera 26 and the test zone 22. Expediently, the box 100 comprises a support structure 106 for external positioning of the smartphone 14. The support structure 106 e.g. a friction pad, holds the smartphone 14 (of any reasonable size) in place with the rear camera 26 reaching into the window 104.

The dimension height of the box 100 is set to ensure a focused image recording of the test zone 22 by means of the camera 26. Here, a distance in the range of approx. 10 to 15 cm may be chosen in order to focus appropriately.

While the walls of the box 100 shield the internal space 102 from ambient light and ambient temperature, an additional shielding element 108 may be attached at the rim of the window 104. Specifically, the shielding element 108 may be in the form of a flexible or moveable lid covering the camera end of the smartphone 14, thus providing correct alignment of the smartphone 14 and/or screening of ambient light.

The dimension length of the box 100 is appropriately set so that a sample dosing point of a standard test element 12, e.g. of a lateral flow test (LFT) is accessible from the outside. To this end, the box may have a port 110 for reach- or feed-through of the test element 12. A hinged flap 112 at a side wall of the box 100 may allow to dose shorter than standard LFTs from the outside. It is also conceivable that the complete mount 10 is inserted through the flap 112 into the box 100.

A temperature and/or humidity sensing 114 can be arranged in the box 100 to provide high-precision temperature/environmental control. A further option is a controlled lighting 116 in the box 100 to either extend fluorescent testing possibilities or to provide even better standard illumination than given with the smartphone14 for high precision measurements. The lighting 116 may be placed underneath the smartphone support area to ensure homogeneous lighting.

The above-described mount 10 and optionally the box 100 can be employed in an analytical measurement method for determining an analyte in a sample of a bodily fluid by using a mobile device having a camera, which method is specifically configured for home-testing by laypersons.

In such a self-testing schemes, the sample of the bodily fluid is applied to a reagent test zone of the optical test element. The reagent test zone is adapted to provide an optically detectable change upon sample application. Then, using the camera of the mobile device, an image is captured of the test zone and further processed via an App on the mobile device to determine the test result.

Fig. 3 illustrates a handling sequence in the test scheme. Initially, the user is prompted to insert the test element 12 into the mount 10. As a next step, the test element 12 is identified and an assigned set temperature is chosen. Here, various control options may be realized:

Unidirectional communication between smartphone 14 and the controller 20 on the mount 10, where the smartphone recognizes the test type and sends the set temperature value to the controller;

Bidirectional smartphone - controller communication e.g. via Bluetooth. In addition, the controller may send other optional data such as battery status to the smartphone for e.g. user feedback or holistic measurement data collection.

No smartphone - controller communication. In this case, both the smartphone and the controller recognize the test type, the latter for example by use of mechanical interlocking or other identifiers on the test element 12.

Thereafter, a waiting timer is applied accounting for a typical/safe heating or cooling time. When the target temperature is reached, a sample application request is signaled to the user. Finally, after recording an image of the test zone 22, the test readout or result is communicated to the user by the smartphone App.

Claims

Patent Claims

1. A temperature-control mount (10) for receiving a strip-like test element (12) having an optical reagent test zone (22) to which a sample of bodily fluid can be applied for self-testing by a proband, the temperature-control mount (10) comprising: a) a flat base plate (40) adapted to support a single test element (12), b) a thermal element (16) arranged on the base plate (40) in a stacked configuration and configured for providing heating power and/or cooling power to the test element (12) when mounted thereupon; c) a positioning unit (18) adapted to ensure a predefined alignment of the test element (12) on the thermal element (16); d) a controller (20) configured for temperature control at least of the test zone (22) via the thermal element (16); e) a power supply (24) to deliver electrical energy to the thermal element (16) and the controller (20).

2. The mount of claim 1 , wherein the mount (10) is configured as a handheld portable unit for handling in home-testing by the proband.

3. The mount of claim 1 or 2, wherein the thermal element (16) comprises at least one of a Peltier element and a heating resistor element.

4. The mount according to any of claims 1 to 3, further comprising a feedback element (43) adapted for signaling a set temperature reached and/or a sample application request to the proband.

5. The mount according to any of claims 1 to 4, wherein the positioning unit (18) comprises at least one of a guidance element (32), a stop element (34), a fixture element (36), the at least one guidance, stop and/or fixture element (36) having a contour for positive engagement with the test element (12).

6. The mount according to any of claims 1 to 5, wherein the positioning unit (18) is configured to press the test element (12) flat against a surface (30) to ensure a reliable and reproducible thermal conductance to the thermal element (16).

7. The mount according to any of claims 1 to 6, further comprising a thermal conductor element (28) arranged on the thermal element (16) and providing a thermal contact region for the test element (12) in order to evenly distribute the heat at least on the test zone (22).

8. The mount according to any of claims 1 to 7, wherein the power supply (24) includes a battery, specifically a rechargeable battery.

9. The mount according to any of claims 1 to 8, further providing an image detection area (41 ) and optionally image alignment markers (42) for image detection of the test element (12) by means of a camera (26) of an external handheld mobile device (14), preferably a smartphone.

10. An arrangement comprising a mount (10) according to any of claims 1 to 9, a single strip-like test element (12) having an optical reagent test zone (22) to which a sample of bodily fluid can be applied for selftesting by a proband and a separate mobile device (14) including a camera (26), preferably a smartphone, which can be handled by the proband for image detection of the test element (12) and evaluation of a test result. - 16 -

11 .A temperature-control box (100) for receiving a test element (12), the box (100) defining an internal space (102), wherein the internal space (102) is configured to receive a mount (10) according to any of claims 1 to 9 or wherein a mount (10) according to any of claims 1 to 9 is arranged in the internal space (102).

12. The box of claim 11 , further comprising an optical pathway or a window (104) for taking an image at least of the test zone (22) by means of a camera (26) of an external mobile device (14), preferably a smartphone.

13. The box of claim 11 or 12, further comprising a support structure (106) for external positioning of a mobile device (14) having a camera (26), preferably a smartphone, wherein the support structure (106) provides for a distance of the camera (26) to the test element (12) in order to enable focused image recording at least of the test zone (22).

14. The box according to any of claims 11 to 13, further comprising a shielding element (108), specifically a flexible or a moveable lid, configured to provide alignment of a mobile device (14) having a camera (26), preferably a smartphone, and/or protection of the internal space (102) from ambient light.

15. The box according to any of claims 11 to 14, further comprising a port (110) for inserting the mount (10) and/or test element (12), preferably wherein the port (110) is configured such that a sample application site is accessible by the proband from external of the box (100).

16. An analytical self-testing method for determining an analyte in a sample of a bodily fluid of a proband by using a mobile device (14) - 17 - having a camera (26), preferably a smartphone, the method comprising determining the analyte from an image of an optical test element (12) captured by the camera (26) of the mobile device (14), wherein the image comprises at least a part of the optical test element (12), wherein the sample of the bodily fluid is applied by the proband to a reagent test zone (22) of the optical test element (12), the reagent test zone (22) being adapted to provide an optically detectable change upon sample application, wherein the image comprises at least a part of the reagent test zone (22) having the sample of the bodily fluid applied thereto, characterized in that the method makes use of the mount (10) according to any one of claims 1 to 9 and optionally of the box (100) according to any one of claims 10 to 15.

17. The method of claim 16, wherein a request for sample application is signaled to the proband upon reaching a target temperature.

18. The method of claim 16 or 17, wherein the image is taken by the proband after sample application by handling the mobile device.

19. The method according to any of claims 16 to 18, wherein the analyte, particularly an analyte concentration, is evaluated from a color of a color formation reaction on the reagent test zone (22) by means of a mobile app running on the mobile device (14).

20. The method according to any of claims 16 to 19, wherein the test result is communicated to the proband by the mobile app.