ARRANGEMENT AND METHOD FOR THE CHEMICAL EXAMINATION OF A SAMPLE

Description

[0001] The invention relates to an arrangement and a method capable of chemically analyzing a sample. The sample is, in particular, a saliva sample or a nasal or oral swab taken from a human or other living being. The analysis of the sample is intended to determine whether or not the sample contains at least one specified substance. The substance is, in particular, a drug or medication, or even microbes or viruses.

[0002] A drug testing device that can be held in one hand is known as the "Dräger DrugCheck 3000." A configuration with a portable sample collector and a stationary base station is offered under the name "Dräger DrugTest 5000." With both devices, a test subject enters a saliva sample into a portable sample collector. This saliva sample is tested for several different drugs and medications. Such a sample collector is also described in DE 10 2014 001 386 A1. A device capable of testing a saliva sample for a "mind-altering substance" is described in AU 20 2010 0588 A4.

[0003] GB 2483077 A shows a device with which a test subject can be tested for drugs. A sample collector (10) can take a sample, for example from the mouth of a test subject. The sample collector 10 can be inserted into a receiving unit (disposable cartridge 20). A reagent in the receiving unit 20 reacts chemically with the sample. A safety mechanism with an actuation paddle 33 and a trigger 36 prevents the chemical reaction from being triggered unintentionally and prematurely. The color of test strips 28 in the receiving unit 20 can be determined through a viewing window 38. The receiving unit 20 can be inserted into a slot 51 of an optical reader 50. The optical reader 50 can measure the color of the test strips 28 through the viewing window 38 and show the result on a display 53.

[0004] DE 10 2014 001 386 A1 describes a test device 10 with a mixing container 1. In the mixing container 1, a sample to be tested is mixed with a reagent. For this purpose, the test device 10 is shaken. A user can visually evaluate a display element 2 from the outside. The porous display element 2 absorbs an indicator dye. Upon shaking, the indicator dye flows out of the display element 2 and dissolves in a mixture of the sample and the reagent. The dissolution of the indicator dye leads to a decolorization of the display element 2. This is a sign that the test device 10 has been shaken sufficiently. In one embodiment, the indicator dye also functions as a reagent.

[0005] WO 2007 / 016691 A2 describes a device 10 which can receive a sample and detect a substance, for example bacteria or viruses or components thereof, in the sample. The device 10 can be divided into a sample preparation orientation ( Fig. 1) and into a testing orientation (Fig. 3A). In the sample preparation orientation, a sample acquisition device 24 of the device 10 collects the sample, and the sample acquisition device 24 can be inserted into a receiving unit with a housing 14. The sample flows down from the sample collector 24 into a chamber 16 of the receiving unit, where it reacts chemically with a reagent. After a sufficiently long period of time, the device 10 is rotated 90° and is then in the testing orientation. The sample flows from the chamber 16 into a testing device 20 with a viewing window 23. A user can perceive a color inside the testing device 20 through the viewing window 23. The color is an indication of whether the substance is present in the sample or not. US 2021 / 0128060 shows an arrangement with an alcohol meter and a monitoring sensor.

[0006] The invention is based on the object of providing an arrangement and a method which are capable of chemically examining a sample for at least one predetermined substance, whereby it should be possible for the arrangement and the method to be used with a higher operational reliability than known arrangements.

[0007] The object is achieved by an arrangement having the features of claim 1 and by a method having the features of claim 11.

[0008] Advantageous embodiments are specified in the subclaims. Advantageous embodiments of the arrangement according to the invention are, to the extent appropriate, also advantageous embodiments of the method according to the invention, and vice versa.

[0009] The arrangement and method according to the invention are capable of testing a sample for at least one substance, i.e., for the presence of this substance. The sample is, in particular, a saliva sample, a palate sample, or a nasal sample. The substance is, in particular, at least one drug or medicament, or at least one pathogen, or an antibody against a pathogen, or another virus.

[0010] The arrangement according to the invention comprises a sensor unit and a monitoring unit. The sensor unit can be mechanically connected to the monitoring unit, preferably detachably connected. When the sensor unit is connected to the monitoring unit, the sensor unit cannot perform any movements relative to the monitoring unit.

[0011] The sensor unit comprises an input unit. This input unit enables the input of a sample to be examined. The sample could be, for example, a saliva sample taken from the mouth of a human or other living being, a swab taken from the nose, ear, or palate of a human or other living being, or a sample taken from the surface of an object. For example, the purpose of testing is to determine whether a drug was present on the surface of the object or whether the surface is contaminated with certain viruses or microbes. The input unit is capable of receiving the input sample. Preferably, a chamber of the input unit receives the sample.

[0012] The sensor unit further comprises a substance sensor. The substance sensor comprises at least one chemical reagent. The or each chemical reagent is capable of chemically reacting with a sample received by the input unit. In other words: when the sample comes into contact with the or a reagent, a chemical reaction is automatically triggered and then takes place in the sensor unit. The respective result of the or at least one chemical reaction depends on whether the sample contains the or at least one specified substance or not – more precisely: whether the concentration of the substance in the sample is above a detection limit or not. Optionally, the chemical reaction depends on the concentration of the substance in the sample.

[0013] It is possible for the substance sensor to detect multiple substances in the sample. Preferably, each reagent is associated with at least one substance for which the sample is to be analyzed. Therefore, the substance sensor preferably comprises more than one reagent. It is possible for the same reagent to be associated with different predetermined substances for which an input sample is to be analyzed. It is also possible for the same substance to be associated with a first and a second reagent that are different from each other.

[0014] The substance or a substance is, in particular, a drug, for example, cannabis, an amphetamine, an opiate, or cocaine, or a medication, or even a pathogen, or an antibody that indicates the presence of a pathogen in the subject's body. A drug to be detected as a substance is, in particular, from the class of benzodiazepines or the class of synthetic opioids, for example, oxycodone.

[0015] The substance sensor further comprises at least one indicator. The or each indicator is assigned to a substance to be detected and is capable of visually indicating the respective result of a chemical reaction between the reagent assigned to this substance and the sample. For example, the indicator changes color depending on whether the substance, or a substance, to which the reagent is assigned is present in the sample or not. For example, the indicator changes color only when the substance is present, or only when the substance is not present, or changes color differently depending on whether the substance is present or not.

[0016] The monitoring unit comprises at least one monitoring sensor, optionally several monitoring sensors. According to the invention, the monitoring sensor or at least one monitoring sensor is capable of measuring a measure of a movement of the sensor unit in space, at least when this sensor unit is connected to the monitoring unit.

[0017] In many cases, thanks to the monitoring unit, the sensor unit can be implemented without any components that require electrical power. In particular, it is not necessary to equip the sensor unit itself with a monitoring sensor or a communication unit. A monitoring sensor and a communication unit usually require electrical power. Because the sensor unit can be mechanically connected to the monitoring unit and this monitoring unit comprises at least one monitoring sensor, the sensor unit itself is still monitored while connected to the monitoring unit, namely by at least one monitoring sensor of the monitoring unit, optionally by several monitoring sensors. It is possible for the sensor unit to not include any electrical load. In this case, the sensor unit requires neither its own power supply unit nor a connection to a stationary power supply network.This design makes it possible in many cases to provide a relatively small and / or light sensor unit.

[0018] The sensor unit does not need to be approved as an electrical device. This simplifies the design of the sensor unit in many cases.

[0019] The monitoring unit generally consumes relatively little electrical energy, particularly the electrical energy required to operate the monitoring sensors. Because the monitoring unit consumes only a small amount of electrical energy, the monitoring unit's own power supply unit can be relatively small or supply electrical energy for a relatively long time. This feature facilitates mobile use of the inventive arrangement, for example, to check a motor vehicle driver on a road or in a parking lot. It is not necessary to connect the inventive arrangement to a stationary power supply network in order to record and evaluate the sample. In particular, a connection is not required while the sensor unit is chemically reacting with a recorded sample.

[0020] According to the invention, the or at least one monitoring sensor is capable of measuring a measure of a movement of the sensor unit in space when the sensor unit is connected to the monitoring unit. According to the invention, the sensor unit, when connected to the monitoring unit, is unable to execute any movement relative to the monitoring unit. Therefore, it is sufficient if the monitoring sensor measures its own movement in space. Thanks to the mechanical connection, this movement of the monitoring sensor corresponds to the movement of the sensor unit in space. It is possible, but thanks to the mechanical connection, not necessary, to directly measure the movement of the sensor unit in space. A signal from the monitoring sensor therefore correlates with the movement of the sensor unit in space.

[0021] For example, the monitoring sensor measures how long the sensor unit has been moved in the room, how long it has been moved at a minimum speed or minimum acceleration, and / or the maximum acceleration of the sensor unit in the room. Alternatively, the monitoring sensor measures the total distance the sensor unit has traveled while moving in the room or within a specified period of time.

[0022] In many cases, it is necessary for the sensor unit, together with the sample it has collected, to be moved around the room so that the desired chemical reaction between the sample and the reagent or at least one reagent takes place and so that the result of the reaction reliably indicates whether and / or at what concentration the substance is present in the sample. In particular, it is often necessary to shake the sensor unit. If there is no or insufficient movement, the chemical reaction often does not take place, and then the presence of the substance cannot be ruled out with sufficient certainty. On the other hand, in many cases it is necessary for the sensor unit to be stationary for a certain period of time so that the chemical reaction can proceed at rest. In many cases, both requirements must be met: sufficient movement and sufficient rest for the sensor unit.

[0023] Thanks to the monitoring sensor, the measured movement of the sensor unit can be automatically compared with at least one predefined criterion. This or each criterion specifies, for example, a range for the duration of the movement, the acceleration, or the amplitude to be achieved during the movement of the sensor unit, or the duration of a rest period during which the sensor unit should not be moved, or both. An evaluation unit can then automatically decide whether the sensor unit has been moved correctly in space or not. This allows, in particular, the automatic determination of whether the result provided by the sensor unit when examining the sample is valid or not.

[0024] The invention is particularly advantageous when the assembly is shaken by a human rather than by a vibrator or other machine. The invention eliminates the need for these humans to monitor how the assembly is moved or held.

[0025] According to the invention, the chemical reaction between the sample and the reagent influences the indicator or at least one indicator, and the indicator visually indicates the result of the reaction. In many cases, it is not necessary to move the sensor unit in space throughout the entire duration of the chemical reaction. Rather, in many cases, it is sufficient to move the sensor unit in space for an initial period, in particular to mix the sample with the reagent or each reagent, and then leave it stationary. Thanks to the invention, a user does not need to visually monitor the indicator to know when the movement of the sensor unit can be stopped.

[0026] According to the invention, the sensor unit can be mechanically connected to the monitoring unit. Preferably, after this connection has been established, a portable measuring arrangement consisting of the sensor unit and the monitoring unit is formed. A person can shake this measuring arrangement. Shaking the portable measuring arrangement requires only relatively little mechanical effort, which therefore causes relatively little fatigue for the person. In many cases, this shaking triggers at least one chemical reaction between a reagent in the sensor unit and the sample received by the input unit, optionally several chemical reactions. In many cases, the or each chemical reaction is only triggered if the measuring arrangement, and thus the sensor unit with the sample, is shaken for a sufficiently long time.Because a human can shake this measuring device, in many cases the need for a device comprising a shaker or vibrator to shake the sensor unit is avoided. Such a device must be provided and typically requires significantly more electrical power than the monitoring unit and / or is heavier, which is why the device can only be used briefly or not at all in many applications. In particular, a measuring device that can be shaken by a human can often be used in a mobile manner, for example, to test a motor vehicle driver for drugs on a roadside or in a parking lot.

[0027] Particularly preferred is that a person can hold and shake the measuring device in one hand.

[0028] Preferably, the monitoring unit can be detachably connected to the sensor unit; particularly preferably, the same monitoring unit can be detachably connected to different sensor units one after the other, with each sensor unit used comprising an input unit and a substance sensor. This configuration makes it possible to detach a sensor unit from the monitoring unit and use the same monitoring unit multiple times, namely with different sensor units one after the other. This saves material and, in particular, waste.

[0029] According to the invention, the sensor unit can be connected to the monitoring unit. In one embodiment, a portable computer, in particular a smartphone or a tablet, is used as the monitoring unit. Such a portable computer often already has those sensors which are used or can preferably be used as monitoring sensors according to the invention or according to various embodiments of the invention, as well as its own power supply unit, in particular a rechargeable battery. In particular, such a portable computer often comprises a system clock and an acceleration sensor or other motion sensor capable of measuring a measure of the movement of the computer in space. This portable computer is thus also capable of measuring a measure of the movement of the sensor unit in space.In addition, such a portable computer often includes a camera, which camera is capable of detecting the status of the indicator if the sensor unit is suitably connected to the monitoring unit in the form of the portable computer.

[0030] According to this embodiment, the measuring arrangement further comprises a mechanical adapter. Using this adapter, the sensor unit can be detachably connected to the portable computer or is detachably connected to the portable computer. This provides a portable measuring arrangement that a person can hold and shake. The adapter can be designed as a purely passive mechanical component. It is also possible to use a device other than a portable computer as the monitoring unit and to connect this device to the sensor unit using the adapter, preferably detachably.

[0031] In many cases, the adapter eliminates the need for a dedicated monitoring unit. It is sufficient to provide an adapter that, on one side, fits the dimensions of a standard smartphone or other portable computer or device, and, on the other side, fits the dimensions of the sensor unit.

[0032] The adapter preferably comprises a monitoring-side coupling unit that can be releasably coupled to the monitoring unit in the form of the portable computer, as well as a sensor-side coupling unit that can be releasably coupled to the sensor unit. The same adapter can be used consecutively for different sensor units and preferably also for different monitoring units.

[0033] In one embodiment, a dimension of the adapter's monitoring-side coupling unit can be changed. This makes it possible to adapt the adapter to the dimensions of a portable computer used as the monitoring unit. The same sensor unit can be optionally connected to one of several portable computers as the monitoring unit. The same adapter can be optionally connected to one of several possible portable computers as the monitoring unit. It is not necessary to provide different adapters for different sensor units or monitoring units.

[0034] In one implementation, the adapter is designed so that the distance between the two coupling points can be changed. This also allows the distance between the monitoring unit and the sensor unit to be changed. In general, one coupling point can be shifted or otherwise moved relative to the other coupling point. The feature that one coupling point is movable relative to the other coupling point makes it easier to position the sensor unit relative to the monitoring unit in such a way that the following is achieved: A monitoring sensor of the monitoring unit in the form of a camera on the portable computer is directed at the indicator or at least one indicator of the sensor unit, and this indicator lies in the area that the camera can focus on. An image generated by the camera therefore shows the indicator.In addition, this adapter allows for the following to be achieved with greater reliability: The connected sensor unit cannot move relative to the monitoring unit. Thanks to the adapter, it is often unnecessary to adjust the geometry of the sensor unit to the monitoring unit, or vice versa.

[0035] According to the invention, the or each indicator of the substance sensor visually indicates the result of the chemical reaction between the sample and the associated reagent, whereby the result and thus the visual display depend on whether the sample contains the substance to which the reagent is assigned. For example, the indicator changes color depending on whether the sample contains the substance or not, or takes on a color that depends on the presence or absence of the substance. An image generated by the camera and showing this indicator also shows the visually perceivable result of the chemical reaction. By evaluating this image, it can be determined whether the substance is present in the sample or not.

[0036] It is possible for an image analysis program to automatically evaluate the camera image or at least one image. The image analysis program preferably identifies the image of the indicator or an indicator in the image and determines the status of the identified indicator. This image analysis program can be installed on a remote computer or on the monitoring unit itself. If a portable computer is used as the monitoring unit, this portable computer often already contains the necessary processors and data storage to install an image analysis program. It is also possible for a person to evaluate the image and enter the analysis result or to check the result of an automatic analysis. In all cases, it is possible for the image analysis to be carried out remotely from the sensor unit and the monitoring unit, optionally with a time offset.This allows for a smaller monitoring unit.

[0037] According to the invention, the substance sensor comprises at least one indicator that visually displays the result of a chemical reaction between the reagent to which the indicator is assigned and the sample. In one embodiment, the sensor unit comprises a display surface, for example, a transparent disc. At least part of the or each indicator is visible on or behind this display surface. This makes it possible to visually perceive each indicator at a glance. The optional camera of the monitoring unit can generate at least one image of this display surface when the sensor unit is connected to the monitoring unit, and this image shows the display surface and thus all indicators.

[0038] In one implementation, the camera of the monitoring unit is designed to generate a sequence of images, with this sequence showing how the indicator, or at least one indicator, preferably each indicator, changes visually over time. In some applications, the temporal progression of an indicator's appearance correlates with the concentration of the associated substance in the sample. By evaluating the sequence of images, the concentration of this substance in the sample can therefore be determined at least approximately in many cases.

[0039] The design with the camera makes it possible to record the result of a chemical reaction, even remotely, without the sensor unit having to transmit a test result. This allows the sensor unit to be implemented without a power supply unit and without a communication unit. Furthermore, no wired data connection is required between the sensor unit and the monitoring unit. The sensor unit can be constructed as a passive mechanical component that contains the required reagent(s) but no electrical load. Thanks to the monitoring unit's camera, it is also not necessary for a human to inspect the indicator(s) and note the displayed results and / or manually enter them into the monitoring unit. Rather, it is sufficient to transmit images from the camera to a remote receiver.

[0040] In a further development of the embodiment with the camera, the arrangement comprises a housing. The aforementioned adapter with the two coupling points can be used as this housing. When the sensor unit is connected to the monitoring unit, this housing encloses a space. Preferably, the housing encloses the space in a light-tight manner. The enclosed space is located between the sensor unit and the monitoring unit. The camera of the monitoring unit and the or each indicator of the sensor unit are adjacent to this space.

[0041] The enclosure, which encloses a space, increases the safety of the camera configuration. The enclosure reduces the risk of natural or artificial ambient light falling on an indicator, resulting in an incorrect evaluation of the image generated by the camera and showing this indicator, or of an indicator not being visible in the image due to light incidence. The enclosure facilitates the adjustment of automatic image evaluation. The enclosure ensures consistent lighting conditions in the enclosed space, regardless of the ambient lighting.

[0042] In a further development of the embodiment with the camera, the monitoring unit comprises a light source. This light source is capable of emitting light in the visible range or also in the infrared range or in the ultraviolet range. When the sensor unit is connected to the monitoring unit, at least part of the light emitted by the light source falls on the indicator or at least one indicator. Preferably, the sensor unit comprises a display surface, wherein the or each indicator is at least partially visible on or behind the display surface. The emitted light falls on this display surface. Thanks to the embodiment with the light source, the camera is capable of generating an image showing the indicator or at least one indicator even when there is little ambient light, for example at night or in a dark room.

[0043] The housing design and the light source design can be combined. The light source illuminates the space enclosed by the housing. With this combination, the enclosed space always has the same or at least adjustable lighting conditions. The housing design can also be combined with the adapter design.

[0044] In one embodiment, the camera is designed to generate a sequence of images upon receiving a trigger signal. This sequence preferably shows how the indicator, or at least one indicator, visually changes over time. The camera preferably generates the images at a predetermined image recording frequency. A signal-processing control unit of the monitoring unit preferably generates the trigger signal. The camera terminates the process of generating the images when a predetermined period of time has elapsed or when the camera has received a termination signal from the control unit of the monitoring unit. As a result, in many cases, no more images are generated than necessary, which saves storage space and electrical energy.

[0045] According to the invention, the or at least one monitoring sensor is capable of measuring a measure of the movement of the sensor unit in space, for example, acceleration. In one embodiment, a signal-processing evaluation unit automatically compares a signal from this monitoring sensor with at least one predetermined criterion, wherein the or each criterion is stored in a computer-analyzable form. The criterion specifies a requirement for the movement, for example, the smallest or largest maximum duration or the minimum or maximum acceleration. In one embodiment, the evaluation unit generates an instruction for a user depending on the comparison between the signal from the monitoring sensor and the criterion, wherein this instruction specifies future handling of the sensor unit. For example, this instruction specifies that the sensor unit is to be moved further or that the movement of the sensor unit is to be stopped now.Preferably, this instruction is issued in a form perceivable by a human. This design supports the user in moving the sensor unit correctly. In many cases, the error of moving the sensor unit too briefly can still be corrected by giving the user a corresponding instruction. Without such an instruction, however, the sample analysis might produce an invalid result.

[0046] It is also possible for a special device, such as a backlash or a shaker, to move the assembly with the sensor unit and the monitoring unit in space. A control unit controls this special device. The control unit receives a signal from the monitoring unit and compares this signal with the specified criterion, or at least one specified criterion, that specifies a requirement for the movement of the sensor unit. Depending on the result of this comparison, the control unit controls the special device and, in particular, causes the device to continue or stop the movement of the assembly.

[0047] In one embodiment, the monitoring sensor or a monitoring sensor comprises an acceleration sensor or is designed as an acceleration sensor. A portable computer used as a monitoring unit often already includes such an acceleration sensor. The acceleration sensor is capable of measuring the temporal progression of an acceleration in space that acts on the monitoring unit, for example because the monitoring unit is shaken or held still. At each sampling time, the acceleration sensor therefore delivers three measured values, which together define a vector in three-dimensional space. It is of course possible for the monitoring sensor to determine at at least one sampling time that no acceleration is acting on the monitoring unit, i.e., the monitoring sensor measures the absence of acceleration. The acceleration functions as a measure of movement in space.The sequence of three measured values ​​acts as a signal from the monitoring sensor.

[0048] According to the invention, at least one monitoring sensor is capable of measuring a measure of the sensor unit's movement in space. This monitoring sensor is referred to below as a motion sensor. An acceleration sensor is one embodiment of a motion sensor.

[0049] According to the invention, the sensor unit can be connected to the monitoring unit, preferably detachably. Once this connection is established, the sensor unit ideally cannot execute any movement relative to the monitoring unit. At the very least, the sensor unit connected to the monitoring unit cannot execute any movements relative to the monitoring unit such that a movement signal from the motion sensor is valid for the monitoring unit but not for the sensor unit. Due to the mechanical connection, the motion sensor measures the temporal progression of a movement of the sensor unit, e.g., an acceleration acting on the sensor unit.

[0050] The design with the motion sensor is particularly advantageous when the sensor unit with a recorded sample must be shaken so that the chemical reaction of a reagent in the sensor with the sample is triggered and proceeds correctly. This shaking mixes the sample with the reagent. Only if the sensor unit has been shaken sufficiently vigorously and / or for a sufficiently long time can it deliver a valid result. Thanks to the motion sensor, it is not necessary for a human to monitor and record the shaking of the sensor unit. Because the motion sensor is a component of the monitoring unit according to this design and the sensor unit can be connected to the monitoring unit, it is not necessary to equip the sensor unit itself with a motion sensor. Therefore, the sensor unit does not need to have a power supply unit.This feature is particularly advantageous when the same monitoring unit is connected to multiple sensor units in succession to examine multiple samples one after the other.

[0051] The actual temporal progression of the movement in space performed by the sensor unit can be saved and / or compared with a predefined target temporal progression. This makes it possible to check whether the sensor unit has been shaken correctly or not. This check can also be carried out retrospectively and / or remotely. Such a check is particularly advantageous or even necessary in many cases when it is necessary to prove that a test subject has consumed an illegal drug or abused a medication, or when it is necessary to ensure that a test subject has not actually taken an illicit drug and / or abused a medication, and it must be ensured that a corresponding positive or negative test result is actually valid and correct. The same applies to testing whether a test subject is infected with a virus.

[0052] In one embodiment, the measured actual temporal progression of the movement, e.g., the acceleration, as well as the result obtained by the sensor unit during the sample analysis are stored in a tamper-proof manner, i.e., in such a way that subsequent modification is no longer possible, or at least no longer possible undetected. This makes the sensor unit's result admissible in court.

[0053] In a further development of the embodiment with the motion sensor, the signal from the motion sensor is used to trigger the process described above, whereby the camera generates a sequence of images. The process by which the camera generates the sequence is triggered depending on the signal from the motion sensor. In one implementation, the process by which the camera generates the sequence is triggered after the measuring arrangement comprising the sensor unit and the monitoring unit has been moved and the measuring arrangement has subsequently not been moved for a predetermined period of time. In many cases, after this period of time, a chemical reaction begins, which leads to a gradual and visually perceptible change in the indicator or at least one indicator. This chemical reaction can depend on the concentration of a substance in the sample.In many cases, the sequence of images better illustrates the progress of this chemical reaction than a single image. On the other hand, the design that uses the motion sensor signal to generate the trigger signal and / or the termination signal often results in the camera only generating images when a chemical reaction is actually taking place and is visible. This saves electrical power for operating the camera and saves storage space for the generated images.

[0054] In a further development of the embodiment with the motion sensor, the arrangement comprises an evaluation program, i.e. software, for example an app for a portable computer that is used as the monitoring unit. This evaluation program can evaluate the signal from the motion sensor. Based on this evaluation, the evaluation program can automatically decide whether the actual temporal course of a movement in the room that acts on the sensor unit meets a predetermined criterion or not. This criterion is preferably specified as follows: If the actual temporal course of the movement performed by the sensor unit in the room meets the criterion, the sample is sufficiently mixed with the or each reagent, and the sensor unit delivers valid results. The criterion is preferably whether the actual temporal course is equal to a predetermined target temporal course or not, up to a predetermined tolerance.The criterion may further specify the duration of a rest period, which must be observed after a movement, particularly after shaking, of the sensor unit. The or each criterion is stored in a computer-analyzable form in a data memory to which the evaluation program has at least temporary read access.

[0055] Thanks to the evaluation program, it is possible to automatically determine whether the sensor unit was shaken correctly or whether it was shaken too weakly / too vigorously and / or too briefly / too long. This can often determine whether a test result from the sensor unit is valid or not.

[0056] In many cases, it is necessary to first shake the sensor unit in a specific manner and then hold the sensor unit still for a specific period of time. Shaking mixes the sample with the sensor's reagent(s). The chemical reaction takes place during this rest phase and / or comes to an end during the pause. By automatically evaluating the actual temporal progression of the movement in space, the evaluation program can automatically decide whether a rest period of the required duration has been observed or not. Optionally, the monitoring unit can also include a clock that can measure the duration of the rest phase. A portable computer usually includes a suitable system clock for this purpose.

[0057] In an application already described, the results of the evaluation program can be used to subsequently determine whether the sensor unit was moved correctly or not. In another embodiment, the results of the evaluation program can be used to determine during use whether the sensor unit has already been moved sufficiently and / or held still for a sufficient length of time, or whether it needs to be moved further and / or held still for a longer period.

[0058] Preferably, the evaluation program is capable of controlling an output unit. The controlled output unit is capable of outputting information in a form perceivable by a human, in particular visually. The output unit can belong to the monitoring unit or to a spatially distant portable or stationary computer. The evaluation program is capable of evaluating the signal from the motion sensor and generating a message based on this evaluation. In one embodiment, this message includes information as to whether or not the sensor unit is capable of delivering a valid result. In another embodiment, this message specifies how long and / or how strongly the sensor unit still needs to be moved in order to reliably examine the sample, and / or stipulates that the sensor unit should not be moved any further, and / or specifies how long it still needs to be held still.The evaluation program triggers the step that this message is output on the output unit.

[0059] In some cases, this configuration results in the sensor unit still being moved and / or held still correctly due to the output message, even though it was not moving correctly before the message was output, in particular, it was not moving for long or not moving strongly enough, or was not held still long enough. Therefore, this configuration can reduce the consumption of sensor units in some cases.

[0060] In one embodiment, the evaluation program is installed on the monitoring unit itself and is executed by the monitoring unit. When executed, the evaluation program controls components of the monitoring unit. If a portable computer is used as the monitoring unit, this portable computer often already includes the necessary processors and data memory to execute the evaluation program. The evaluation program can run on a standard operating system. The embodiment in which the evaluation program is installed on the monitoring unit itself makes it easier to make a signal from the monitoring sensor(s) available to the evaluation program. This eliminates the need for a wireless or wired data connection between the monitoring unit and a remote computer on which the evaluation program is installed.

[0061] In another embodiment, a special monitoring unit is used, which comprises the or each monitoring sensor and optionally a light source. This monitoring unit is at least temporarily in a data connection with a separate, in particular spatially remote, computer. The evaluation program is installed on this computer, receives the signal from the motion sensor, and preferably controls components of this computer during execution. The data connection can be a wireless or wired connection and uses a communication unit of the transmission unit and a communication unit of the spatially remote computer. The computer can be a portable computer, in particular a smartphone or a tablet, or a stationary computer.

[0062] The feature of using a dedicated monitoring unit with the motion sensor and a separate computer with the evaluation program eliminates the need for the evaluation program to run on this monitoring unit. The monitoring unit then requires neither a processor capable of executing the evaluation program, nor a data memory, nor a power supply unit for the processor. As a result, the monitoring unit consumes less electrical energy, namely only the electrical energy required to operate the monitoring sensors and, optionally, the light source. In many cases, a dedicated monitoring unit can therefore be implemented relatively easily (lower weight). The separate computer does not need to be connected to the sensor unit and optionally shaken; only the monitoring unit needs to be.The separate computer does not need to be able to withstand the movements of the sensor unit. If a dedicated monitoring unit is used, this monitoring unit can often be more easily adapted to the sensor unit in terms of its dimensions and geometry. This easier adaptability is particularly advantageous if an existing sensor unit, for example, a specific series, is to be reused. In many cases, the sensor unit does not need to be modified, and the dedicated monitoring unit is adapted to the existing sensor unit.

[0063] In one embodiment, the monitoring sensor or a monitoring sensor comprises a thermometer. The thermometer is capable of measuring the temperature in the environment surrounding the monitoring unit. If the sensor unit is connected to the monitoring unit, this thermometer also measures the temperature in the environment surrounding the sensor unit. This ambient temperature can influence the chemical reaction or at least one chemical reaction taking place in the sensor unit and therefore also the duration and / or intensity of the required movement. At some ambient temperatures, it may be impossible for the sensor unit to provide valid results.

[0064] In one embodiment, the monitoring unit comprises an output unit, in particular a screen. The monitoring unit can output messages on this output unit in a form perceivable by a human. In one embodiment, this message specifies a required treatment of the sensor unit. For example, the message specifies how long the sensor unit should be shaken and / or subsequently held still. The message can also describe a result of the sensor unit.

[0065] The design with the thermometer and the design with the output unit can be combined. According to this combination, the monitoring unit can generate a message that depends on the ambient temperature measured by the thermometer.

[0066] The duration of the shaking may depend on the ambient temperature, in particular in such a way that the higher the ambient temperature, the shorter the required shaking duration. It is possible that a message is output on the output unit to stop shaking now. In some cases, outputting the message thus prevents the sensor unit from being shaken longer than necessary. This saves time. Alternatively, the message specifies whether or not the sensor unit can even achieve a valid result at the measured ambient temperature. The monitoring unit can output the generated message on the output unit.

[0067] According to the invention, the sensor unit can be mechanically connected to the monitoring unit. In one embodiment, the monitoring unit comprises a base body and a holding plate. The holding plate is mechanically connected to the base body. The sensor unit can be placed on the holding plate. The sensor unit is then located next to the base body. The holding plate supports the sensor unit. In many cases, thanks to this embodiment, the sensor unit can be connected particularly securely to a monitoring unit designed in this way, and the risk is reduced that the sensor unit can move relative to the monitoring unit when it is connected to the monitoring unit and both are moved. Preferably, the sensor unit can be detachably connected to the base body, in particular by means of a snap connection or locking connection or a magnetic connection or at least one hook.

[0068] Preferably, the mounting plate comprises a peripheral edge that defines a basin into which the sensor unit can be placed. According to this embodiment, the sensor unit is held particularly securely on the mounting plate.

[0069] Preferably, the holding plate can be pivoted relative to the base body, in particular rotated, when the monitoring unit is not connected to the sensor unit. This configuration makes it possible to move the monitoring unit into a space-saving transport position in which the holding plate rests against the base body. When the holding plate is rotated away from the base body, the sensor unit can be placed on the holding plate. It is possible for the monitoring unit to be automatically switched on when the holding plate is moved away from the base body and switched off when the holding plate is moved towards the base body and into the transport position. This configuration often saves electrical energy because it prevents the monitoring unit from remaining switched on during a rest period.

[0070] In one embodiment, the monitoring unit comprises an output unit, in particular a screen. The monitoring unit is capable of displaying on this output unit, in a form perceivable by a human, instructions for use of the sensor unit, in particular instructions on how to input a sample into the input unit and / or how to move a measuring arrangement consisting of the monitoring unit and the sensor unit connected to the monitoring unit so that a reagent of the sensor can be mixed with the sample and the indicator can display the result of the chemical reaction. By displaying these instructions for use on the output unit, the risk of the sensor unit being used incorrectly is reduced. For example, a message is displayed prompting you to start and / or stop shaking now.

[0071] In one embodiment, the monitoring unit generates the operating instructions based on a measurement result from the optional thermometer, which measures the ambient temperature in the area surrounding the monitoring unit. For example, the monitoring unit uses a computer-available template (pattern) for the operating instructions and inserts at least one parameter into this template that depends on the measured ambient temperature. This parameter specifies, in particular, how long the measuring arrangement should be moved and / or held still. In this way, the operating instructions are adapted to the current ambient temperature.

[0072] In one embodiment, the monitoring unit can be operated in one of two different modes: monitoring mode or documentation mode. When the monitoring unit is operated in monitoring mode, the sensor unit is connected to the monitoring unit after the sample has been inserted, and the resulting measuring arrangement is moved. A motion sensor in the monitoring unit measures the movement of the measuring arrangement and generates a signal.

[0073] When the monitoring unit is operated in documentation mode, the connection between the sensor unit and the monitoring unit is established when the indicator or at least one indicator visually displays or begins to display the result of a chemical reaction. A camera on the monitoring unit generates at least one image showing the indicator or at least one, preferably each, indicator. The indicator image or each image can be saved, thereby allowing the result of the test to be documented. In one embodiment, the indicator image or each image is saved in a tamper-proof manner, and the result of the chemical reaction can be documented in a legally admissible manner if necessary. When operating in documentation mode, the monitoring unit is preferably connected to the sensor unit for a shorter period.This allows the same monitoring unit to be connected to a larger number of different sensor units in succession than when operating in monitoring mode. A larger number of samples can be analyzed in the same amount of time. Even when operating in monitoring mode, the sensor unit does not require any electrical load and therefore does not require a power supply unit.

[0074] In one application, the arrangement according to the invention is used to examine a saliva sample or a swab from the nose, ear, or palate of a human or other living being for at least one substance. This substance is, in particular, a drug or a medicament. In another application, the arrangement according to the invention is used to examine a sample taken from the nose, ear, or mouth of a human or other living being for microbes or viruses. It is also possible that the sample to be examined was taken from the surface of an object, and it is to be determined whether a drug or medicament was present on this surface.

[0075] In the following, the invention is described using an exemplary embodiment. Figure 1 shows two perspective views, on the left a collection unit and on the right a stationary base station in which the collection unit is shaken and a saliva sample is evaluated; Figure 2 shows a perspective view of the sensor unit and a front view of the display area of ​​the sensor unit; Figure 3 shows a schematic side view of the arrangement according to the invention with sensor unit, monitoring unit and evaluation unit, wherein the sensor unit is positioned next to the monitoring unit; Figure 4 shows the sensor unit and the monitoring unit of Figure 3 with the sensor unit behind the monitoring unit; Figure 5 the arrangement of Figure 4in a user's hand; Figure 6 shows a different embodiment of a monitoring unit according to the invention, which has its own screen; Figure 7 shows a further embodiment in which a smartphone additionally functions as a monitoring unit and is connected to the sensor unit by means of an adapter.

[0076] Figure 1 shows a prior art device with a collection unit 20 and a stationary base station 30. Such a device has become known under the designation "Dräger DrugTest 5000 System." The collection unit 20 is called the "Test Kit," and the base station 30 is called the "Analyzer." Naturally, the collection unit 20 is used only to test a single sample for drugs or medications.

[0077] The collection unit 20 comprises a sample collector 21, a cap 24 for the sample collector 21, a receptacle 22, and a housing 23. A test subject provides a saliva sample by placing the sample collector 21 in their mouth and moving it. The provided saliva sample flows into a chamber inside the housing 23. The sample collector 21 is fixedly or detachably connected to the housing 23 via a receptacle unit 22.

[0078] A tester pushes the collection unit 20 with the delivered saliva sample through the sealable opening 31 into the interior of the base station 30. A sensor (not shown) is located inside the base station 30 and examines the saliva sample for various drugs and / or medications. The display unit 36 ​​then displays the result. The base station 30 includes several control elements 32 in the form of buttons.

[0079] Figure 2shows, on the left, a perspective view of an exemplary portable sensor unit, which is a component of the exemplary embodiment of the arrangement according to the invention, and, on the right, an enlarged front view of a display surface of this sensor unit. Two such sensor units are known under the names "Dräger DrugCheck 3000" and "Dräger Antigen Test SARS-CoV-2." Such a sensor unit is also described in DE 10 2014 001 386 A1. The entire sensor unit is used for a single sample for drugs and / or medications. Another portable sensor unit can also be used for the invention.

[0080] Note: The same substance can be a medication that improves a person's health in some applications, and a drug that harms a person and causes addiction in other cases. Therefore, the general term "substance" is used below. The sensor unit 10 is capable of detecting at least one substance, wherein the or each substance is in particular a drug or medication.

[0081] The sensor unit 10 of Figure 2 includes a cassette 5 with a measuring chamber and an ampoule made of a fragile material, e.g. glass, wherein the ampoule contains at least one reagent, several paper strips in the cassette 5, a transparent display surface 6 on the cassette 5, a unique identifier 8 in the form of a QR code, wherein the identifier 8 distinguishes this sensor unit 10 from any other sensor unit, a housing 3 surrounding the cassette 5, a receiving pocket 9 on the housing 3, a cover 4 for the display surface 6, wherein the cover 4 belongs to the housing 3, a tubular receiving unit 2 which is firmly connected to the cassette 5, and a hollow sample collector 1 which can be inserted into the receiving unit 2.

[0082] Antibodies are applied to each paper strip in cassette 5. Proteins are preferably used as antibodies, with these proteins being produced in vertebrates by the vertebrate's body cells producing reaction products. The body cells produce these proteins by reacting to certain substances administered to the vertebrates. These administered substances are often referred to as antigens.

[0083] In the exemplary embodiment, these antibodies are applied to the paper strips and each function as a reagent per paper strip. Each reagent reacts chemically with a substance that may be contained in the saliva sample. Each paper strip is therefore assigned to at least one substance. The course of the chemical reaction on the paper strip depends on whether this substance is actually contained in the saliva sample or not, and in one embodiment also on the concentration of this substance in the saliva sample. After the chemical reaction is complete, the paper strip has taken on a color, whereby this color depends on whether the assigned substance is contained in the saliva sample or not. At least a part of each paper strip is located behind the display surface 6, so that the respective result of each chemical reaction is visible on or behind the display surface 6.Each paper strip acts as an indicator for the assigned substance.

[0084] In the exemplary embodiment, the sensor unit 10 is capable of automatically detecting up to six different substances in a single saliva sample from a test subject. In the exemplary embodiment, these are meta-amphetamines (MET), cannabis (THC), benzodiazepines (BZO), amphetamine (AMP), opiates (OPI), and cocaine (COC). The sensor unit 10 has no electrical load and requires no electrical power. The reagent in the ampoule and the reagent on a paper strip together form a reagent for the assigned substance. Therefore, six indicators in the form of six paper strips are visible on the display surface 6.

[0085] Before use, the sample collector 1 is inserted into the receiving pocket 9. The entire sensor unit 10 is fluid-tight and is preferably sealed with a vacuum in a bag made of metal foil (not shown).

[0086] To test a test person for the six possible substances, the sensor unit 10 is removed from the bag. The test person enters a saliva sample into the sample collector 1. In doing so, he takes the thicker part of the sample collector 1, which is in Figure 2 The patient holds the sample collector 1 in his hand, as shown on the right, and places the thinner end in his mouth. A colored ring on the thinner end of the sample collector 1 disappears when the sample collector 1 has collected enough saliva.

[0087] In a variation not shown, the test subject inserts the thinner end into each nostril, one after the other, and moves the sample collector inside the nose. This variation is used specifically to test the test subject for a virus, especially the coronavirus.

[0088] The following description refers to a sample in the form of a liquid saliva sample. It also applies to other samples. After the test subject has provided the saliva sample, the sample collector 1 containing the collected saliva sample is inserted from above into the collection unit 2, with the thin end pointing toward the cassette 5. Upon insertion, the ampoule in the cassette 5 breaks. The saliva flows from the sample collector 1 into the measuring chamber in the cassette 5. The reagent flows from the broken ampoule into the measuring chamber.

[0089] A tester shakes the entire sensor unit 10. The shaking creates a mixture of the saliva sample and the reagent from the ampoule in the measuring chamber. The tester then holds the sensor unit 10 still. The shaking and subsequent rest complete the chemical reaction between the saliva sample and the reagent in the measuring chamber. The tester is a human and can be the test subject or another human.

[0090] After this rest period, the tester breaks off the cover 4 from the housing 3 and pushes the cassette 5 into the housing 3 from above. This brings the mixture of the saliva sample and the reagent into contact with the six indicator paper strips. Each indicator paper strip changes color depending on whether the assigned substance is present in the saliva sample or not. After a certain time, the test results become visible on the display 6.

[0091] In the illustrated embodiment, if the cassette 5 was able to test the saliva sample, a horizontal line appears next to each of the two Cs (control area) on the display area 6. If these two lines do not appear, the test does not produce a valid, usable test result. One possible reason for these two lines not appearing is the following: The cassette 5 was not pushed far enough or otherwise incorrectly into the housing 3.

[0092] If none of the six substances is present in the saliva sample at a concentration above the respective detection limit, a horizontal line appears next to each substance abbreviation in the two columns of display area 6, for a total of six additional lines. If there is no horizontal line next to an abbreviation, the corresponding substance has been detected in the saliva sample.

[0093] In order for the sensor unit 10 to Figure 2 To provide reliable results, it must be moved in a specific manner after the sample has been deposited. Otherwise, no valid test result will be provided. The system according to Figure 1 requires the stationary monitoring unit 30, which requires a connection to a stationary power supply network or a dedicated power supply unit and takes up a certain amount of space. In the exemplary embodiment, no stationary base station is required.

[0094] Figure 3 shows a side view of a first embodiment of the arrangement according to the invention, which does not require a stationary base station and nevertheless reduces the risk of the sensor unit 10 being moved incorrectly after sample delivery. The same reference numerals have the same meaning as in Figure 2 .

[0095] The arrangement according to the invention according to Figure 3 includes the sensor unit 10, which in the embodiment is the same as the sensor unit 10 of Figure 2 is designed, a mobile monitoring unit 40 and a signal processing evaluation unit 70.

[0096] Figure 4 shows the sensor unit and the monitoring unit of Figure 3 with the sensor unit 10 behind the monitoring unit 40. The sensor unit 10 is in Figure 3 right next to and in Figure 4 arranged in front of the monitoring unit 40.

[0097] In the exemplary embodiment, the mobile monitoring unit 40 has the shape of an L and comprises a housing 41, a camera 42 mounted on the housing 41, an optional light source 52 also mounted on the housing 41, an acceleration sensor 43, optionally a thermometer 49, a base-side communication unit 45, a control unit 46 and its own power supply unit 47.

[0098] The housing 41 encloses a base body of the monitoring unit 40. A pivotable rectangular support plate 51, which can support a sensor unit 10, is attached to this base body. The support plate 51 preferably has a circumferential, upstanding edge, so that the support plate 51 forms a basin into which the sensor unit 10 can be placed. This support plate 51 can be folded upwards about the rotation axis DA in order to transport the monitoring unit 40 when no sensor unit is in the basin.

[0099] The monitoring unit 40 may also have the shape of a tube or column that is open at the top.

[0100] The acceleration sensor 43, the control unit 46, the thermometer 49, and the power supply unit 47 are arranged inside the housing 41. Preferably, the base-side communication unit 45 is also arranged inside the housing 41.

[0101] In the exemplary embodiment, the evaluation unit 70 is implemented on a smartphone. It can also be implemented on another portable or stationary computer. The evaluation unit 70 comprises a housing 75, evaluation software 71 that can be executed on a computer, e.g. an app, a data memory 76, a screen 77, an evaluation-side communication unit 72, a clock 44, a signal-processing control unit 73 and its own power supply unit 74 and / or a connection to a stationary power supply network.

[0102] The evaluation unit 70 can be a commercially available smartphone or other portable or stationary computer. The evaluation software 71, which runs on a processor of the evaluation unit 70 and preferably takes the form of a computer app, is special.

[0103] The control unit 73, the clock 44, and the power supply unit 74 are arranged inside the housing 75, while the communication unit 72 and the screen 57 are arranged outside on or in the housing 75. The evaluation unit 70 is capable of visually outputting messages on the screen 77 in a form perceivable by a human and, if the screen 77 is configured as a touchscreen, of detecting user inputs. Optionally, the evaluation unit 70 is also capable of outputting acoustic messages and / or causing the evaluation unit 70 to vibrate, thus outputting messages in a haptic form.

[0104] As already mentioned, the sensor unit 10 does not require an electrical power supply. The monitoring unit 40 has its own power supply unit 47. Therefore, the sensor unit 10 and the monitoring unit 40 are suitable for mobile use, for example, by emergency services checking road users for specified substances. The evaluation unit 70 can be spatially separated from the sensor unit 10 and the monitoring unit 40.

[0105] The sensor unit 10 can be detachably connected to the monitoring unit 40. In the exemplary embodiment, the sensor unit 10 can be placed on the folded-down support plate 51. The detachable connection can be established, for example, with clamps, a locking connection, a snap connection, a press fit, and / or magnets. If the monitoring unit 40 is in the form of a tube or column open at the top, the sensor unit 10 can be inserted from above. In this embodiment, too, the sensor unit 10 is preferably additionally detachably attached to the monitoring unit 40 with clamps, a locking connection, a snap connection, a press fit, hooks, and / or magnets.

[0106] Once the detachable connection is established, the sensor unit 10 is ideally unable to perform any movements relative to the monitoring unit 40. Hereinafter, the arrangement consisting of the monitoring unit 40 and the sensor unit 10, with the sensor unit 10 connected to the monitoring unit 40, is referred to as the "measuring arrangement 10, 40."

[0107] The sensor unit 10 is used for a single sample input, while the monitoring unit 40 can be used successively for multiple sample inputs, each with a sensor unit 10. It is possible to use the same monitoring unit 40 successively with different sensor units 10, for example for different substances.

[0108] In one embodiment (not shown), the cover 4 is transparent. In another embodiment, which is shown in Figure 2As shown, the cover 4 is not transparent. To expose the display surface 6, the tester removes the cover 4 from the housing 2. If necessary, the tester slides the sensor unit 10 slightly upward relative to the monitoring unit 40. After the cover 4 is removed, the tester presses the cassette 5 downward into the housing 3 as described above, and the step in which the six indicator paper strips come into contact with the mixture of saliva sample and reagent is automatically triggered. The evaluation results appear on the display surface 6 of the sensor unit 10 as described above.

[0109] The acceleration sensor 43 measures a measure of the temporal progression of the acceleration, which the monitoring unit 40 executes in a stationary three-dimensional coordinate system. At each sampling time, a measured value with three coordinates is generated. In conjunction with optional measured value processing, the acceleration sensor 43 thereby generates a movement signal. If the sensor unit 10 is connected to the monitoring unit 40, the movement signal from the acceleration sensor 43 contains information about the direction, strength, and duration in which the sensor unit 10 was shaken. The movement signal also contains information about how long the sensor unit 10 was subsequently held still.

[0110] The thermometer 49 is in thermal contact with the environment and is capable of measuring the ambient temperature. In one embodiment, the measured ambient temperature is used to decide whether the test results of the sensor unit 10 can be valid or are fundamentally invalid at this ambient temperature. In another embodiment, the control unit 46 receives measured values ​​from the thermometer 49 and controls a heating and / or cooling unit to increase or decrease the temperature near the cassette 5. In a third embodiment, a message containing the measured ambient temperature is transmitted to the evaluation unit 70, and the use of this message is described further below.

[0111] Once the connection between the sensor unit 10 and the monitoring unit 40 is established, the optional light source 52 can illuminate the display surface 6. The light emitted by the light source 52 can be in the visible range and / or the infrared range and / or the ultraviolet range. In one implementation, the light source 52 can change the wavelength of the emitted light.

[0112] When the connection is established, the camera 42 is directed at the display surface 6 and is therefore capable of recording images of the displayed test results. These images show, in particular, the QR code 8 and the above-described up to six horizontal lines next to the six abbreviations for six possible substances on the display surface 6. Preferably, the images also show whether a valid test result was obtained (two horizontal lines next to the C) or not.

[0113] In one embodiment, the camera 42 automatically focuses on the display surface 6. In another embodiment, a user can manually adjust the focus or focal plane of the camera 42. For example, a corresponding actuating unit 53 for manual focusing, in particular a rotary wheel, is embedded in the housing 41. Or a corresponding actuating unit and a software application for manual focusing are installed on the monitoring unit 70. It is also possible for a software application on the evaluation unit 70 to assist a user in focusing the camera 42 on the display surface 6 using the actuating unit 53.

[0114] A wireless communication connection can be established between communication units 45 and 72, for example, via Bluetooth Low Energy or a mobile radio standard. Preferably, evaluation unit 70 requests test results from monitoring unit 40, and monitoring unit 40 transmits the requested test results to evaluation unit 70. Evaluation software 71 is capable of automatically evaluating transmitted test results.

[0115] As already explained, the evaluation unit 70 comprises a screen 77. In a preferred embodiment, the control unit 73 of the evaluation unit 70 automatically generates operating instructions for the measuring arrangement 10, 40 and causes these operating instructions to be displayed on the screen 77. These operating instructions specify, in particular, how strongly and for how long the measuring arrangement 10, 40 should be shaken and how long it should subsequently be held still. In one embodiment, these operating instructions depend on the measured temperature in the environment of the sensor unit 10. As already mentioned above, the thermometer 49 measures this ambient temperature. The control unit 73 therefore generates the operating instructions depending on the measured ambient temperature.For this purpose, the control unit 73 preferably uses a scheme (a template) of a user manual and inserts into this scheme at least one value that depends on the measured ambient temperature, in particular a time period. The scheme can include at least one calculation rule that depends on the ambient temperature.

[0116] In one embodiment, the examiner can choose whether they want a quick or more reliable test result. The more reliable test result requires more time. The control unit 73 uses this specification to generate the user instructions accordingly.

[0117] The evaluation software 71 compares the transmitted information about the measured accelerations acting on the sensor unit 10, in particular directions, duration, and strength, and the measured duration of the subsequent rest period with a predefined target shaking pattern and a predefined target duration of a subsequent rest period. The measuring arrangement 10, 40 is shaken so that the saliva sample is mixed with the reagent, and then held still so that the indicator paper strips react chemically with the mixture. The evaluation software 71 automatically decides whether the sensor unit 10 was shaken correctly and then held correctly still or not. For this purpose, the evaluation software 71 uses the movement signal from the acceleration sensor 43.For example, the evaluation software 71 decides whether the actual temporal progression of the acceleration lies within a predetermined tolerance band around the predetermined target progression or not.

[0118] Preferably, the tester is then shown whether or not they have shaken the measuring assembly 10, 40 correctly and then held it still. Optionally, the tester is shown whether and for how long they should continue shaking the measuring assembly 10, 40. To indicate the need to shake for a longer time, the evaluation software 71 uses the movement signal from the acceleration sensor 43.

[0119] The sensor unit 10 displays the test results on the display surface 6 after the tester has pushed the cassette 5 into the housing 3 as described above, thereby starting the analysis of the saliva sample, and after a predetermined analysis period has elapsed. The time at which the analysis of the saliva sample begins is transmitted to the evaluation software 71. At the beginning and after the end of the analysis period, the evaluation software 71 causes the evaluation unit 70 to transmit a corresponding command to the monitoring unit 40.

[0120] In one embodiment, the camera 42 generates images of the display surface 6 at a predetermined image recording frequency after the evaluation of a saliva sample has begun. In another embodiment, the monitoring unit 40, upon receiving a corresponding command from the evaluation unit 70, causes the camera 42 to generate at least one image of the display surface 6.

[0121] In one embodiment, the control unit 46 of the monitoring unit 40 or the control unit 73 of the monitoring unit 70 generates a trigger signal and subsequently a termination signal for the camera 42. The camera 42 generates images at the predetermined image recording frequency after it has received the trigger signal and until it receives the termination signal. The control unit 46, 73 generates the trigger signal after it has been determined by evaluation of the movement signal from the acceleration sensor 43 that the measuring arrangement 10, 40 has been moved and subsequently not moved for a predetermined period of time. For example, the evaluation program 71 performs this evaluation. After this period of time with the rest period has elapsed, the indicator paper strips 5 behind the display surface 6 begin to visibly change. The generated sequence of images shows this change.In many cases, this change correlates with the concentration of a substance in the saliva sample. The control unit 46, 73 generates the termination signal, for example, after a predetermined period of time has elapsed since the trigger signal was generated.

[0122] In a previously mentioned implementation, the light source 52 is capable of emitting light at different wavelengths. According to this implementation, the light source 52 varies the wavelength of the emitted light, while the camera 42 generates images of the display surface 6. In many cases, these varied wavelengths allow for even better detection of changes in the display surface 6 and thus changes in the indicator paper strips 5, including through automatic image analysis.

[0123] In both embodiments, the or each image is transmitted from the display surface 6 to the evaluation unit 70. If the camera 42 only generates an image when it has received a command from the evaluation unit 70, the camera 42 only needs to generate as many images as needed, and only as many images as needed need to be transmitted to the evaluation unit 70. This saves energy and storage space, and sometimes also bandwidth.

[0124] The evaluation software 71 automatically evaluates transmitted images generated by the camera 42. The evaluation software 71 uses the QR code 8 to determine the unique identifier for the sensor unit 10. By evaluating the transmitted images, the evaluation software 71 automatically decides whether a sufficient amount of a saliva sample was entered into the sample collector 1, whether the sample unit 10 achieved a valid and usable evaluation result, and whether or not the saliva sample contains at least one of the six substances mentioned above in a concentration above the detection limit. In one embodiment, the evaluation software 71 uses image analysis to check how quickly stripes appear or disappear on the display surface 6. Preferably, a sequence of images is evaluated. The speed of the change correlates with a concentration of a dose to be detected.

[0125] Preferably, the results obtained by the evaluation software 71 are displayed on the screen 77.

[0126] In one embodiment, the evaluation unit 70 stores the test results for a test subject in the data memory 76, preferably together with the identifier (QR code) 8 for the sensor unit 10 and a timestamp indicating when the sensor unit 10 examined the test subject's saliva sample. Preferably, the evaluation unit 70 also stores the received temporal progression of the acceleration and the duration of the rest phase in the data memory 76 so that, if necessary, it can be later verified that the test results of the sensor unit 10 are valid. In one embodiment, the communication unit 72 transmits the test results to a remote receiver.

[0127] Figure 5shows the measuring arrangement 10, 40 in a user's hand (Hd). The display surface 6 of the sample unit 10 and the camera 42 of the monitoring unit 40 face the viewer. The cover 4 in front of the display surface 6 has been removed. The sample collector 1 is located behind the recording unit 2.

[0128] In the design that Figure 3 , Figure 4 and in Figure 5As shown, the monitoring unit 40 includes an on / off switch and an indicator light for indicating whether the monitoring unit 40 is switched on or off. It is also possible for the monitoring unit 40 to be switched on by folding the holding plate 51 away from the base body 41 about the rotation axis DA, and to be switched off again by rotating the holding plate 51 toward the base body 41 (into the transport position). Furthermore, the monitoring unit 40 has no display surface and thus can neither output messages to a person nor receive user inputs. In many cases, this design saves space, weight, and electrical energy. The monitoring unit 40 can be relatively easily disinfected after use.

[0129] In a modification not shown, the monitoring unit 40 additionally comprises a display unit that indicates whether the connected sensor unit 10 has obtained a valid test result and whether this test result is positive (at least one specified substance is present) or negative. Optionally, the monitoring unit 40 comprises an indicator light that indicates whether a communication connection with the evaluation unit 70 is currently possible or not.

[0130] Figure 6 shows a different embodiment of a monitoring unit according to the invention, which is referred to as monitoring unit 40.1 and which has its own screen 48. The same reference numerals have the same meaning as in Figure 3 to Figure 5 .

[0131] The monitoring unit 40.1 is slightly higher than the monitoring unit 40 of Figure 3 to Figure 5 . The viewer of Figure 6looks at the screen 48 of the monitoring unit 40.1 as well as at the display surface 6 of the sensor unit 10. In the viewing direction of Figure 6 The sensor unit 10 is located behind the monitoring unit 40.1. The evaluation software 71 can be installed on the monitoring unit 40.1 or on the separate evaluation unit 70 of Figure 3 and Figure 6 . When designing according to Figure 6 The tester can read on the screen 48 of the monitoring unit 40.1 whether or not he has shaken the measuring arrangement 10, 40.1 correctly and then held it properly still. Preferably, a wireless communication connection is established between the monitoring unit 40.1 and the spatially remote evaluation unit 70 using the communication units 45 and 72.

[0132] In the case of the designs according to Figure 3 to Figure 6A monitoring unit 40, 40.1 with a camera 42 and an acceleration sensor 43, as well as a spatially remote evaluation unit 70 with the evaluation software 71, are used. The tester holds the measuring arrangement 40, 10 or 40.1, 10 in his hand and shakes it. It is also possible for the monitoring unit with the camera and acceleration sensor 43 to be worn on the wrist like a wristwatch or smartwatch. Such monitoring units are known, for example, for athletes.

[0133] The examiner takes the sensor unit 10 containing the saliva sample in one hand and shakes it. The examiner wears the monitoring unit in the form of a wristwatch on this hand. After shaking and resting, the examiner brings the hand containing the monitoring unit close to the sensor unit 10 so that the camera of the monitoring unit is directed at the display surface 6 of the sensor unit 10. In this case, too, the monitoring unit is connected to the remote evaluation unit 70 via a wireless communication link, e.g., via Bluetooth Low Energy.

[0134] Figure 7 shows a different embodiment in which the evaluation unit 70 is also used as a monitoring unit. In the example shown, the evaluation unit 70 has the form of a smartphone. The same reference numerals have the same meaning as in Figure 3 to Figure 5 . The evaluation unit 70 of Figure 7 has just like the evaluation unit 70 of Figure 3a screen 77 and a communication unit 72 on the housing 75 as well as a data memory 76, a control unit 73 and a power supply unit 74 in the housing 75. Again, the evaluation software 71 is implemented on a processor with data memory of the evaluation unit 70 and is executed by this processor or is executable on the processor. In Figure 7 the evaluation unit 70 is shown from the side, with the screen 77 pointing to the left and the surface of the screen 77 perpendicular to the plane of the drawing of Figure 7 In addition, the evaluation unit includes 70 of Figure 7 other components that a typical smartphone often has, namely a camera 80, a light source 81, an acceleration sensor 78 and a clock 79. Optionally, the monitoring unit 70 of Figure 7 a thermometer 82.

[0135] The sensor unit 10 can be detachably connected to the evaluation unit 70 using a tubular adapter 90. The adapter 90 comprises a sensor-side coupling point 92 and a monitoring-side coupling point 91. The sensor unit 10 can be detachably connected to the sensor-side coupling point 92, and the evaluation unit 70 can be detachably connected to the monitoring-side coupling point 91.

[0136] If the sensor unit 10 with the saliva sample is connected to the evaluation unit 70 using the adapter 90, a measuring arrangement 10, 70, 90 is formed, which the tester can shake. The adapter 90 holds the sensor unit 10 to the evaluation unit 70 so that the tester can shake the evaluation unit 70 without the sensor unit 10 falling off or moving relative to the evaluation unit 70. The camera 80 of the evaluation unit 70 is directed at the display surface 6 of the sensor unit 10. The adapter 90 encloses a light-tight space between the camera 80 and the display surface 6 and prevents any significant amount of light from outside from entering this space. The optional light source 81 of the evaluation unit 70 illuminates this space from the inside. As a result, the evaluation software 71 is able to evaluate the images from the camera 80 even under changing lighting conditions and thereby determine the examination results of the sensor unit 10.

[0137] Preferably, the adapter 90 can be placed selectively in a setting mode and an operating mode. In the setting mode, the sensor-side coupling point 92 can be moved relative to the monitoring-side coupling point 91. This allows the adapter 90 to be configured such that the camera 80 of the monitoring unit 70 is directed toward the display surface 6 of the sensor unit 10. This configuration makes it possible to use the same adapter 90 for different monitoring units 70. In the operating mode, the two coupling points 91 and 92 are fixed relative to one another, so that the sensor unit 10 is held in a specific position and orientation relative to the monitoring unit 70 by means of the adapter 90.

[0138] Such an adapter 90, which encloses a space in a light-tight manner, can also be used for the design according to Figure 3 and Figure 4 use.

[0139] The design that the evaluation unit 70 also functions as a monitoring unit eliminates the need to establish a data connection between the monitoring unit and the evaluation unit. List of reference symbols

[0140] 1 hollow sample collector of the sensor unit 10, takes a sample from a test subject, can be inserted into the receiving unit 2 2 tubular receiving unit for the sample collector 1, connected to the cassette 5 3 Housing of the sensor unit 10, includes the cover 4 4 Cover for the display area 6, belongs to the housing 3 5 Cassette of the sensor unit 10, holds a mixture of the sample and the reagent as well as six indicator paper strips 6 Display area of ​​the cassette 5, behind which test results (discolorations) of the indicator paper strips 5 are visible 8 individual identification of the sensor unit 10, has the form of a QR code 9 Receiving pocket on the housing 3, holds the sample collector 1 before use 10 Sensor unit, comprises the cassette 5 with the display surface 6, the housing 3, the receiving unit 2, the sample collector 1 and the receiving pocket 9 20 Collection unit, includes the sample collector 21, the receiving unit 22 and the housing 23 21 Sample collector of collection unit 20 22 Receiving unit of the collection unit 20, receives the sample collector 21 23 Housing of the collection unit 20, contains a chamber for a saliva sample 24 Cap on the sample collector 21 30 stationary base station, can accommodate the collecting unit 20, comprises the opening 31, the display unit 36, the operating elements 32 and inside a sensor not shown 31 closable opening of the base station 30 through which the collection unit 20 with a saliva sample can be inserted 32 Base station controls 30 36 Base station display unit 30 40 mobile monitoring unit, comprises the housing 41, the camera 42, the actuating element 53, the acceleration sensor 43, the communication unit 45, the thermometer 49, the control unit 46 and the power supply unit 47 40.1 mobile monitoring unit, includes the same components as the monitoring unit 40 and additionally the screen 48 41 Housing of the monitoring unit 40, encloses the base body 42 Camera of the monitoring unit 40, 40.1, inserted into the housing 41, directed towards the display surface 6 of the sensor unit 10 43 Acceleration sensor of the monitoring unit 40, 40.1 44 Clock of the evaluation unit 45 Communication unit of the monitoring unit 40, 40.1 46 Control unit of the monitoring unit 40, 40.1 47 Power supply unit of the monitoring unit 40, 40.1 48 Screen of the monitoring unit 40.1 49 optional thermometer of the monitoring unit 40, 40.1 51 pivotable rectangular support plate of the monitoring unit 40, carries the sensor unit 10 52 optional light source of the monitoring unit 40, 40.1, illuminates the display area 6 53 optional actuator for manual focusing of the camera 42 70 Evaluation unit, implemented on a smartphone, includes the evaluation software 71, the communication unit 72, the data memory 76, the clock 44, the control unit 73 and the power supply unit 74 71 Evaluation software of the evaluation unit 70, which can be executed on a computer, receives a movement signal from the acceleration sensor 43, 78 and automatically decides whether the sensor unit 10 has been moved and held correctly 72 Communication unit of the evaluation unit 70 73 Control unit of the evaluation unit 70 74 Power supply unit of the evaluation unit 70 75 Housing of the evaluation unit 70 76 Data memory of the evaluation unit 70 77 Screen of the evaluation unit 70, embedded in the housing 75 78 Acceleration sensor of the evaluation unit 70, generates a movement signal 79 Clock of the evaluation unit 70 80 Camera of the evaluation unit 70, embedded in the housing 75 81 Light source of the evaluation unit 70, illuminates the display area 6 82 optional thermometer of the evaluation unit 70 90 Adapter, with which the sensor unit 10 can be connected to the monitoring unit 70 in such a way that the camera 60 is directed towards the display surface 6, comprises the coupling points 91 and 92 91 Monitoring-side coupling point of the adapter 90, can be detachably connected to the monitoring unit 70 92 sensor-side coupling point of the adapter 90, can be detachably connected to the sensor unit 10 THERE Rotation axis around which the holding plate 51 can be rotated relative to the base body with the housing 41 HD Hand of a user holding the measuring arrangement 10, 40

Claims

1. Arrangement for testing a sample for at least one substance, wherein the arrangement comprises - a sensor unit (10), - a monitoring unit (40, 40.1, 70) having a first monitoring sensor (43, 78), and - an evaluation program that can be run on a computer (71), wherein the sensor unit (10) comprises - an input unit (1) and - a substance sensor (5), wherein the input unit (1) - allows the input of a sample to be tested and - is capable of accepting a submitted sample, wherein the substance sensor (5) comprises - at least one chemical reagent and - at least one indicator (6), wherein the or each reagent - is assigned to at least one substance and - is capable of chemically reacting with a sample taken up by the input unit (1), wherein the chemical reaction of the or each reagent depends upon the presence and / or concentration of the or each assigned substance in a sample taken up by the input unit (1), wherein the or each indicator (6) is designed to visually display the corresponding result of a chemical reaction, wherein the sensor unit (10) can be connected to the monitoring unit (40, 40.1, 70) in such a way that, after the connection has been established, the sensor unit (10) is unable to perform any movement relative to the monitoring unit (40, 40.1, 70), and wherein the first monitoring sensor (43, 78) is designed to automatically measure a degree of a movement of the sensor unit (10) connected to the monitoring unit (40, 40.1, 70) in space, and wherein the evaluation program (71) is designed to automatically decide, by evaluating measured values of the first monitoring sensor (43, 78), whether the actual temporal course of the movement of the sensor unit (10) in space is equal to a predetermined temporal target course up to a predetermined tolerance.

2. Arrangement according to claim 1, characterized in that, after establishing the connection between the sensor unit (10) and the monitoring unit (40, 40.1, 70), a portable measuring arrangement is formed which a person can shake, preferably a measuring arrangement that a person can hold and shake in one hand (Hd).

3. Arrangement according to any of the preceding claims, characterized in that the arrangement comprises a mechanical adapter (90), wherein the sensor unit (10) is detachably connected or connectable to the monitoring unit (40, 40.1, 70) by means of the adapter (90) and wherein a portable computer (70), in particular a smartphone, is preferably used as the monitoring unit (40, 40.1, 70).

4. Arrangement according to claim 3, characterized in that the adapter (90) comprises - a monitoring-side coupling point (91) which can be detachably connected to the portable computer (70), and - a sensor-side coupling point (92) which can be detachably connected to the sensor unit (10), wherein the adapter (90) is designed such that, - in one setting mode, one coupling point (92) is movable relative to the other coupling point (91), and, - in one operating mode, one coupling point (92) is fixed relative to the other coupling point (91).

5. Arrangement according to any of the preceding claims, characterized in that the first monitoring sensor comprises an acceleration sensor (43, 78), wherein the acceleration sensor (43, 78) is capable of measuring the temporal course of an acceleration in space acting upon the monitoring unit (40, 40.1, 70).

6. Arrangement according to any of the preceding claims, characterized in that the evaluation program (71) is designed to control an output unit (48, 77) in such a way that the controlled output unit (48, 77) is able to output information in a form perceptible by a human, wherein the evaluation program (71) is designed, - depending upon measured values of the first monitoring sensor (43, 78), to generate information about a required further movement or termination of a further movement of the sensor unit (10) and - to control the output unit (48, 77) such that the controlled output unit (48, 77) outputs the generated information.

7. Arrangement according to any of the preceding claims, characterized in that the or a monitoring sensor comprises a thermometer (49), wherein the thermometer (49) is designed to measure a degree of the temperature in the surroundings of the monitoring unit (40, 40.1, 70).

8. Arrangement according to claim 7, characterized in that the monitoring unit (40.1, 70) comprises an output unit (48), in particular a screen, wherein the monitoring unit (40.1, 70) is designed - to generate a message depending upon the measured temperature of the surroundings and - to output the generated message on the output unit (48) in a form perceptible by a human, and wherein the generated message specifies a required treatment of the sensor unit (10) or a validity of a result of the sensor unit (10).

9. Arrangement according to any of the preceding claims, characterized in that the monitoring unit (40, 40.1) comprises - a base body (41) and - a holding plate (51) mechanically connected to the base body (41), wherein the sensor unit (10) can be placed on the holding plate (51) and is then located next to the base body (41) and wherein the holding plate (51) is preferably pivotally connected to the base body (41).

10. Use of an arrangement according to any of the preceding claims for testing a saliva sample for at least one drug or medication or for at least one pathogen or antibody against a pathogen.

11. Method for testing a sample for at least one substance, wherein the method is carried out using an arrangement which comprises - a sensor unit (10), - a monitoring unit (40, 40.1, 70) having a first monitoring sensor (43, 78), and - an evaluation program that can be run on a computer (71), wherein the sensor unit (10) comprises - an input unit (1) and - a substance sensor (5), wherein the substance sensor (5) comprises - at least one chemical reagent and - at least one indicator (6), wherein the or each reagent is assigned to at least one substance and wherein the method comprises the steps whereby - the input unit (1) receives a sample submitted to the input unit (1), - the sensor unit (10) having the taken-up sample is connected to the monitoring unit (40, 40.1, 70) in such a way that, after the connection has been established, the sensor unit (10) is unable to perform any movement relative to the monitoring unit (40, 40.1, 70), - the sensor unit (10) is moved, in particular shaken, - the or at least one, preferably each, reagent reacts chemically with the sample taken up by the input unit (1), wherein the chemical reaction of the or each reagent depends upon the presence and / or concentration of the or each assigned substance in the sample taken up by the input unit (1), - the or each indicator (6) visually displays the corresponding result of a chemical reaction, - the first monitoring sensor (43, 78) automatically measures a degree of a movement of the sensor unit (10) connected to the monitoring unit (40, 40.1, 70) in space and - the evaluation program (71) automatically decides, by evaluating measured values of the first monitoring sensor (43, 78), whether the actual temporal course of the movement of the sensor unit (10) in space is equal to a predetermined temporal target course up to a predetermined tolerance.

12. Method according to claim 11, characterized in that the step of connecting the sensor unit (10) to the monitoring unit (40, 40.1, 70) is carried out before the sensor unit (10) is moved, wherein the monitoring unit (40, 40.1, 70) and the sensor unit (10) connected to the monitoring unit (40, 40.1, 70) are moved together and wherein the step of the first monitoring sensor (43, 78) detecting a measure of a movement of the sensor unit (10) comprises the step whereby the motion sensor (43, 78) measures the temporal course of a movement of the monitoring unit (40, 40.1, 70), in particular an acceleration acting upon the monitoring unit (40, 40.1, 70), in space, while the sensor unit (10) is connected to the monitoring unit (40, 40.1, 70).