WO2011042253A1

WO2011042253A1 - Biosensor apparatus having a self-test device

Info

Publication number: WO2011042253A1
Application number: PCT/EP2010/062480
Authority: WO
Inventors: Andreas Helwig; Christoph Heller; Ulrich Reidt; Alois Friedberger; Thorsten Otto
Original assignee: Eads Deutschland Gmbh
Priority date: 2009-10-08
Filing date: 2010-08-26
Publication date: 2011-04-14
Also published as: DE102009048811A1; DE102009048811B4

Abstract

The invention relates to a biosensor apparatus (10) having a self-test device (56) which is designed to detect malfunctions of the individual components of the biosensor apparatus (10). If the self-test device (56) detects a fault in one of the components in the biosensor apparatus (10), said device switches off the biosensor apparatus (10) due to safety reasons.

Description

Biosensor device with self-test device

The invention relates to a biosensor device for detecting biological particles, which has a fluidic device for conducting fluids and has a detection device for detecting the biological particles. The fluidic device has a plurality of fluidic elements and the detection device has a plurality of detector elements.

The detection of biological particles, in particular of living bacteria, has previously been carried out by means of a time-consuming cultivation of the microorganisms. For this purpose, suitable biological laboratory rooms and a certain amount of time were necessary to carry out the detection.

In order to make the detection of biological particles faster, new methods have been developed, with which the detection can be carried out quickly and also independently of location.

Such a detection method is described for example in DE 10 2007 021 387 A1. Here, the biological particles are filtered out by means of a filter from the sample to be examined. Fabrics and chemicals needed for different detection steps, such as marking steps to label the particles, are directed via a fluidic device to and from the filter. By means of a detection device, the radiation of the probes marking the particles is detected, with which the particles can be detected.

With such a method, a rapid and location-independent detection of the biological particles is possible. Preferably, the detection method should be performed automatically. For automatic detection, the individual components of the biosensor device are functional,

The object of the invention is therefore to provide a biosensor device for the detection of biological particles, with which an automatic detection can be performed reliably.

This object is achieved with the device according to the invention according to claim 1.

Advantageous embodiments are the subject of the dependent claims.

Due to the desire for automatic detection, it is preferred according to the invention that the functional test can also be carried out automatically.

Such an automatic test device is not known in the prior art. As a result, biosensor devices known heretofore either have to be manually maintained at regular intervals, or users can not really be sure that the results output from the biosensor device are correct, as malfunctions in the biosensor device can lead to falsification of the results ,

In a biosensor device, especially when it is used for the investigation of drinking water, a functional monitoring is desirable. Furthermore, the drinking water should not be contaminated in case of malfunction. This is achieved in a preferred embodiment of the invention.

The biosensor device according to the invention preferably has a fluidic device, which conducts fluids in the biosensor device and transports them to the intended locations. Next, the biosensor device Advantageously, a detection device in which the biological particles are detected. The fluidic device has at least one fluidic element, preferably a plurality of fluidic elements, and the detection device has at least one detector element, preferably a plurality of detector elements. In order to test whether the fluidic elements and / or the detector elements function correctly, a self-test device is provided which automatically tests these components. The self-test device preferably uses the components already present in the biosensor device in order to monitor the state of the components as well as the overall system by means of specific sequence programs. Thus, a system monitoring is possible, with no significant expansion of the system is required by additional monitoring devices.

Advantageously, the self-test device has at least one test device which is designed for testing the fluidic elements and / or the detector elements. Further preferably, an evaluation device is provided in the self-test device, which receives test signals from the test device and evaluate them, d. H. can judge.

Preferably, at least the test device and / or at least the fluidic element and / or at least the detector element is designed as a USB component (USB = universal serial bus). This has the advantage that the individual components can be connected to each other during operation. In addition, their properties can be automatically detected.

Advantageously, the USB components are connected via USB connections to the evaluation device. Thus, the evaluation device can receive and further process test signals or general signals of the test device and / or the fluidic elements and / or the detector elements.

Further preferably, the evaluation device is formed by software which is to be loaded or loaded in a computer unit. The software can then automatically perform the evaluation of the received test signals from the USB devices by means of the evaluation.

Advantageously, the self-test device is started by an initialization step of the software. Since the biosensor device is preferably designed for recording samples on its own, it is advantageous if the self-test device is initialized prior to each of such sample pick-ups by starting the software of the computer unit. This means, e.g. Before the biosensor device picks up a sample and starts a measurement, the entire system is tested via the software initialization step. During the initialization step, the USB components can be tested for their functionality and confirm their operational readiness. In addition to using USB ports, however, other interfaces may be used.

Advantageously, the self-test device is designed to be able to determine a malfunction of at least one fluidic element and / or at least one detector element. If the self-test device has detected a malfunction in one of the components of the biosensor device, it is advantageously designed to switch off the biosensor device. Thus, further damage or disturbance of the individual components can be avoided and the contamination of the sample source can be prevented.

For performing the detection in the biosensor device and / or for cleaning at least one detection fluid and / or cleaning fluid, but preferably a plurality of detection and / or cleaning fluids is provided. In the detection fluids, for example, the probes for labeling the biological particles may be present, which attach to the biological particles when the detection fluid is passed through the filter on which the biological particles are immobilized. Cleaning fluids are designed to clean the filter after detection by removing the biological particles that have been immobilized there from the pores. Which of the fluids, whether Detetkionsfluid or cleaning fluid, and which of the Detetkionsfluide or which of the cleaning fluids is currently needed, can be advantageously selected by a selection valve. This selection valve is advantageously an eight-way valve with which at least eight different detection and / or cleaning fluids can be selected. Such a selection valve results in a large margin of the available fluids.

Advantageously, the fluids, d. H. the detection and / or cleaning fluids transported via a fluidic element in the fluidic device. This fluidic element, which may advantageously be one of a plurality of fluidic elements, is preferably a pump which pumps the detection and / or cleaning fluids.

Preferably, the pump is a precision micropump. Such a pump is in particular a pump of reduced size, which is used for microsystems, but has similar flow rates as the classical pumps. Especially in portable devices such a micro-pump can be easily integrated in the reduced space available. Since only very small volumes are pumped, it is advantageous if the micropump is a precision micropump to accurately pump very small volumes.

Advantageously, the selection valve, which is preferably a multi-way valve, in particular an eight-way valve, connects the pump with the detection and / or cleaning fluids. With such a connection, the pump can precisely pump the detection and / or cleaning fluid to the filter that is needed, be it for detection or for cleaning.

Advantageously, as a test device in the self-test device or as one of several test devices, a fluid identification device is provided. see. With this fluid identification device, it is possible to detect which detection and / or cleaning fluid is involved. For this purpose, the fluid identification device advantageously has, for example, at least one power measuring device which can measure the power of the pump. If the fluid identification device further advantageously has a rotational speed measuring device of the pump motor axis, and is designed such that it has a rotational speed measurement device.

/ Power consumption characteristic can create and evaluate, it can calculate from this characteristic, which viscosity has the fluid in question. Thereby it can be identified which fluid is being pumped by the detection and / or cleaning fluids just from the pump.

Preferably, the selection valve, d. H. e.g. the multi-way valve such. the eight-way valve, the different process fluids with the pump. For example, depending on the step being performed in the biosensor device, a particular detection and / or cleaning fluid is introduced into the biosensor device. This may be, for example, a buffer solution or a cleaning solution or the like. If the multiway valve, e.g. If the eight-way valve is a USB device, it will cause a software failure if it is not operational or is not powered. Preferably, during software initialization, the selection valve should successfully sequentially connect to all (e.g., eight) input channels.

In the event of a shock or power failure, the selector valve may lose the information as to which channel it is currently dialing; H. the channel number does not correspond to the actual selected channel. Therefore, it is advantageous if it can be determined which fluid has just been selected by the selection valve.

The different process fluids have different physical and chemical properties. Therefore, it is possible to select the actually selected channel via, for example, the viscosity of the process fluid determine. If the viscosity of two or more channels is compared, the correct information of the selected channel can be identified. As described above, the viscosity of a fluid can be calculated from the rotational speed of the pump and its power consumption. The delivery of liquids with higher viscosities requires a higher power consumption at the same rotational speeds. For this viscosity test, the pump already provided in the biosensor device can be used. Additional sensors are not needed for this.

For identification of the pumped fluid, other physical and chemical properties of the process fluid can be used. Advantageously, the conductivity, which is an easily measured quantity, can be used for identification. Further advantageously, therefore, the fluid identification device alternatively or additionally on a conductivity measuring device. Therefore, a conductivity test can be used to identify the selected valve channel, if additionally or alternatively, a conductivity measuring device is provided.

Preferably, the fluid identification device alternatively or additionally has a pH value measuring device for measuring the pH. The pH values of the process fluids differ and the fact that a pH value measuring device is provided allows the selected valve channel to be determined. For this purpose, only the pH of the detection and / or cleaning fluid must be measured.

Preferably, an optical detection unit is alternatively or additionally provided in the fluid identification device. With such an optical detection unit, the optical density of the detection and / or cleaning fluid can be measured. Since the different process fluids have different optical densities due to their chemical composition, an optical detection unit can measure the optical density and thus identify the correct selected channel. Furthermore, at least one vessel is provided as the fluidic element or as one of several fluidic elements. In this vessel or in these vessels, the detection and / or cleaning fluids can be stored so that they are always available for the Detetkionsprozess and / or for the cleaning process.

If the fluidic identification device preferably has at least one pressure and / or level measuring device, the pressure and / or level in the vessel can be measured. With such a structure, it is possible to determine the selected channel, since the pressure and / or level measuring device indicates a change in pressure and / or level when the selection valve selects the vessel with the pressure and / or level gauge and so fluid is taken from it.

Advantageously, the fluid identification device is designed such that it stores the test signal of the pressure and / or level measuring device. This can be determined from the vessels even at several sampling steps, where just a fluid is removed. It is always selected exactly the vessel in which the pressure and / or level changes. In order to detect a change, the previous state must be known, which is possible via a storage of the previous test signal.

Advantageously, a pump function monitoring device is provided as a test device or as one of several test devices. The precision micropump is responsible for transporting the process fluids through the biosensor device. It is preferably a USB device and then causes a software error if its control can not be initialized and after a certain time issues a signal if the controller does not recognize the pump. Possible errors of the precision micropump are a broken connection or a jammed rotor or other pump actuator. Advantageously, the pump function monitoring device has the flow measuring device or at least one of a plurality of flow measuring devices. If the pump function monitoring device further preferably has the power measuring device, it is possible to detect and evaluate a power consumption / flow rate characteristic. Thus, the precision micropump carries its own self-test procedure in its functionality.

Further advantageously, the pump function monitoring device has a rotational speed measuring device of the motor axis, so that it is designed for detecting and evaluating a rotational speed / flow rate characteristic. Alternatively, it may also evaluate a rotational speed / power consumption characteristic.

Further advantageously, the pump function monitoring device has at least one pressure measuring device. Thus, it is designed to detect and evaluate a power consumption / pressure characteristic and / or a rotational speed / pressure characteristic. By observing these characteristics, it is possible to check the functionality of the micropump. Since the flow rate measuring device and the pressure measuring device are both part of the biosensor device, no additional sensors are needed. Advantageously, a combination of the characteristics, for example, rotational speed against flow and pressure for better monitoring of the pump can be used.

The flow meter generates information about the flow rate (volume per time) of the process fluid. During initialization of the software, the value of the flow meter must be 0. If this is not the case, the flow measuring device does not work correctly. Possible errors can be a damaged cable or a missing power supply. The flow changes its value depending on the following parameters: rotational speed of the pump, power consumption of the pump, viscosity of the process fluid at a predetermined pump rotational speed, pressure in the system at a given pump rotational speed. The functionality test of the flow measuring device is advantageously designed such that the dependence of one of the mentioned parameters with the signal of the flow measuring device is set in dependence, ie, for example, the rotational speed of the pump relative to the flow rate. The functionality of the flow measuring device can be determined in this way. A combination of the mentioned test values is advantageous.

The detection device has at least one inlet channel, by means of which advantageously the process fluids, ie the detection and / or cleaning fluids, can be introduced into the detection device. Particularly preferably, the detection device has two inlet channels for this purpose. Further preferably, at least one outlet channel is provided at the detection device, in particular a plurality, eg four outlet channels are provided. Preferably, a selection valve for connecting the at least one outlet channel to the at least one inlet channel is provided as the detector element or as one of a plurality of detector elements; In particular, a multi-way selector valve, in particular a four-way double selection valve is provided, which is designed to connect the plurality, eg two, inlet channels to the plurality, eg four, outlet channels. Depending on the position of the selection valve, one of the (eg two) inlet channels and one of the (eg four) outlet channels are selected. Depending on the position of the selection valve, the penetrating fluid is passed through the detection device in different ways. The selection valve, eg, the four-way dual-port valve, is preferably a USB device and causes a software error when it is not operational or when it has no power supply. During initialization of the software, the selection valve must sequentially successfully connect to all (eg four) exhaust ports and all (eg two) intake ports. In the event of a shock or power failure, it may be possible for the selector valve to lose its channel information, ie the number of the inlet channel or the outlet channel will no longer coincide with the number of the channel that is selected. Therefore, it is advantageous if it can be identified in which position the selection valve, for example the four-way double selection valve, is currently located. For this purpose, a position identification device is preferably provided as a test device or as one of a plurality of test devices. It can identify the position of the selection valve, eg the four-way double selection valve.

As a detector element or as one of a plurality of detector elements, a filter is preferably provided which filters out the biological particles from the sample for the purpose of detection. Thus, the biological particles are immobilized and provided for detection.

Advantageously, the self-test device has a filter function monitoring device which monitors the filter. For this purpose, the self-test device advantageously has at least one differential pressure device which measures the differential pressure in front of and behind an element to be monitored, such as the filter.

By measuring the differential pressure between the area in front of the filter and the area behind the filter, which are separated from each other by the filter, the position of the selection valve can advantageously be identified via the differential pressure measuring device.

For this purpose, the differential pressure measuring device preferably has at least one first pressure sensor which is designed to measure a pressure P1 above the filter, more preferably the differential pressure measuring device has two pressure sensors, wherein the second pressure sensor is designed to measure a second pressure P2 over the filter. It is the Pressure sensor P1 arranged in the fluidic system in front of the filter and the pressure sensor P2 in the fluidic system after the filter.

Advantageously, the position identification device comprises the pressure P1 of the first pressure sensor and / or the pressure of the second pressure sensor and can advantageously calculate therefrom the differential pressure across the filter and store this differential pressure.

If the four-way dual-port valve is used, e.g. following four ways of fluid transport are possible:

1 . The transfer of the fluid directly into a waste, for example via a bypass.

2. Transport of the fluid to the filter via pressure sensor 1, via the filter, via pressure sensor 2, into the waste.

3. Transport the fluid to the filter via pressure sensor 1, tangential to the filter and into the waste.

4. Transport of the fluid to the filter via pressure sensor 2, over the filter in the opposite direction as under 2. and via pressure sensor 1 in the waste.

Depending on the selected selection valve position, different pressure values result at the first and the second pressure sensor.

Since the evaluation device is preferably designed for detecting and evaluating a differential pressure / valve position characteristic, it is possible to determine from the pressure difference between the first and the second pressure sensor in which position the selection valve is currently located. In order for the two pressure sensors to be located particularly close to the filter, it is advantageous if they are integrated in a detection chamber in which the filter is located. During initialization of the software, the value of the pressure sensors should be 0. If this is not the case, they will not work correctly. A potential error could be a missing power supply or a faulty cable.

Depending on the position of the selection valve, different pressures may be applied to the two pressure sensors. The functionality of the pressure sensors can be monitored by comparing the values while changing the position of the selection valve and pumping fluids through the biosensor device. It is also possible to record the flow rate as a function of the pressure, or to set it with different viscosities and selection valve positions depending on. The results show if the pressure sensors are working properly.

Advantageously, at least one optical detection device is provided as the detector element or as one of a plurality of detector elements. This preferably has a light source, in particular a light emitting diode (LED). A possible fault of the light emitting diode may be due to a missing power supply or a defective cable. Therefore, as a test device or as one of a plurality of test devices, it is preferable to provide a light function monitor for testing the light source on function.

This light-function monitoring device advantageously has an energy meter that measures the energy consumption of the light source. This can be used to monitor whether the LED is working electrically. If the LED is off or defective, its energy consumption is zero. If the LED is working, the energy consumption must be within the range specified by the manufacturer. However, it is also of interest how the light characteristics of the LED are. Therefore, the light-function monitoring device advantageously has at least one light-detecting device, which is configured in particular as a photomultiplier (PMT).

The light-function monitoring device is advantageously designed such that it sets the energy consumption of the light source with a test signal of the light-detecting device in dependence and / or can store the determined data.

In a self-test, e.g. compared the detected by the light detection device test signals when the LED is turned on and off. If the LED is on, the light detector should be illuminated, if it is off, it should be in the dark. These values of the light signals can be used to determine the functionality of the LED. If the determined data are stored and thus a history is created, the sensitivity properties of the light detection device can also be observed. This information can be further used for other self-tests or for statistical evaluations.

An error of the light detecting device, in particular of the photomultiplier, may be a missing power supply or a broken cable. Its functionality is tested in the same way as the functionality of the LED.

Advantageously, the biosensor device has at least one sample receiving device, with which samples can be taken from drinking water pipes. In order to avoid contamination of the drinking water, this sample receiving device advantageously has at least one safety device. This safety device is preferably a check valve. This prevents that already taken drinking water can return to the drinking water pipe and thus pollutes the drinking water with possibly already used process fluids. Further advantageously, the self-test device has at least one temperature monitoring device. Thus, the temperature in the biosensor device can be monitored. It is particularly advantageous because the detection of biological articles in only a fairly narrow temperature range is feasible. If the temperatures are too low or too high, the functional groups on which the probes attach to the marking can degenerate and no longer exist. Then a detection of the biological particles is no longer possible.

Therefore, it is also preferable to provide a temperature regulating means which regulates the temperature in the biosensor device. If the temperature monitoring device measures too low a temperature in the biosensor device, it is advantageous if the temperature regulating device has a heating device which heats the biosensor device to the desired temperature. If, on the other hand, the biosensor device has too high a temperature, it is advantageous if the temperature regulating device also has a cooling device which cools the biosensor device to the desired temperature.

Further advantageously, the self-test device has a leak detection device. Thus, damage in the fluidic device can be detected directly, and the necessary repair can be indicated by a signal. It is advantageous if the leak detection device has a conductivity device. By measuring the conductivity of the exiting fluids, it is possible to detect exactly where a leak is located.

The overall fluidic device may have two possible failures, either it has a leak or it is clogged. If it has a leak, fluid will escape, which can be detected by the leak detection device. A blockage, on the other hand, can, depending on the position of the blockage in the Fluidic device, are recognized by the self-tests and the comparison of all self-tests of the individual components of the biosensor device.

The self-test device preferably has a data acquisition, in particular electronic data acquisition, which records all data and test signals that are regenerated in the self-test. Data acquisition is the heart of electronic signal processing. It preferably collects all the information of the individual components and delivers them to a process unit (CPU). The data acquisition is preferably a USB device and will cause a software error if it is not ready or if power is not available during initialization. If the data acquisition is not working properly, the biosensor device will not be ready.

Before commissioning the septum, a self-test run is performed. After all the test signals have been collected in a self-test matrix, the biosensor device is capable of self-detecting blockage in the fluidic device as well as the position of the blockage.

In the following the invention is explained in more detail with reference to the attached drawing:

FIG. 1 shows an embodiment of a biosensor device indicated generally by reference numeral 10.

The biosensor device 10 has a fluidic device 12 and a detection device 14. The fluidic device 12 is provided for transporting fluids such as detection fluids and / or cleaning fluids and / or a fluid sample through the biosensor device 10. In the detection device 14, biological particles present in the sample are detected. For detection, a sample is first taken from a line 16. A check valve 18 prevents the already taken sample from flowing back into the conduit, thus contaminating the contents of the conduit.

The sample is pumped by a pump 20 via a here in the form of a multi-way valve, namely a eight-way valve 22 first selector valve in the fluidic device 12 to the detection device 4. The eight-way valve 22 is further configured to select one of seven vessels 24. In these vessels detection and / or cleaning fluids are stored. Depending on which of the fluids is needed, the eight-way valve 22 selects the respective vessel 24, and since the eight-way valve 22 is connected to the pump 20, the selected fluid in the fluidic device 12 can also be pumped towards the detection device 14.

So that the detection of the biological particles can also be quantitative, a flow measuring device 26 is provided in the fluidic device 12. With this flow measuring device 26, it is possible to determine which sample volume or volume of the detection fluid has been pumped to the detection device 14.

In order to ensure a more accurate quantitative analysis, an air bubble sensor 28 is further provided which detects the presence of air bubbles in the fluidic device 12 and outputs a message to remove these bubbles as they interfere with a quantitative analysis of the sample.

By the pump 20, the sample and / or the detection and / or cleaning fluids to a second selection valve, which is advantageously designed as a multi-way valve and is formed here by a four-way double selection valve 30, pumped. Here the fluids can take different routes. You can take the path to a filter 38 via a differential pressure measuring device 32 having two pressure sensors 34, 36. The filter 38 is a micromechanical filter, which is used for the detection of particles, in particular of bacteria. This microfilter has or consists of a thin, for example, 1 μητι thick membrane, for example of monocrystalline silicon or diamond or has a diamond layer. The membrane is perforated, the holes have a diameter of eg 450 nm, ie the membrane or the microfilter forms a sieve. If, for example, a water sample is pumped through the filter, bacteria of, for example, about 1 μm in diameter are retained on the filter surface, where they can subsequently be detected.

For detecting the biological particles, an optical detection device 40 is provided in the detection device 4, which has a light source 42 and a light detection device 44. Upon detection of the fluorescence of the particles, the particles immobilized on the filter 38 are marked. As a result of the fact that the light source 42 illuminates the marking probes, they are activated and emit photons in accordance with a fluorescence process during excitation decay. These photons are emitted by the light detector 44, e.g. a photomultiplier is numbered.

The fluids may also make their way to a waste 46 in the four-way dual port valve 30.

Since the reaction of the labeling probe with the biological particles preferably takes place at a very specific temperature, the biosensor device 10 also has a temperature regulating device 48. This comprises a heating device 50 and / or a cooling device 52, which can heat or cool the fluids.

Furthermore, a data acquisition 54 is provided in the biosensor device 10.

In order to monitor whether the individual components of the biosensor device 10 function correctly, the biosensor device 10 has a self-test function. device 56 on. This is designed for testing the various elements of the fluidic device 12 and / or detection device 14. It has an evaluation device 58, which can evaluate the various test signals. All components of the biosensor device 10 are designed as USB components, and connected via USB connections to the evaluation device 58.

The evaluation device 58 is formed by a software 60 processed in a data processing system, which is initialized before each sampling. In this initialization step, all components are tested for functionality. If the self-test device 56 detects a malfunction on one of the components, the biosensor device 10 is switched off.

With a fluid identification device 62, the self-timer 56 is able to detect whether the eight-way valve 22 has selected the correct vessel 24. For this purpose, a power measuring device 64 and a rotational speed measuring device 66 are provided on the pump. From the power and the rotational speed of the pump 20, the viscosity of the pumped fluid can be determined. Since each detection and / or cleaning fluid has a very characteristic viscosity, then it can be recognized from which vessel 24 was selected by the eight-way valve 22.

A conductivity meter 68 additionally measures the conductivity of the detection and / or cleaning fluid and can identify it with it.

Furthermore, a pH-value measuring device 70 is provided which measures the pH value of the detection and / or cleaning fluid. Due to the characteristic pH values of the fluids can also be identified so which vessel 24 is currently selected. An optical detection unit 72 additionally determines the optical density of the pumped fluid, and can thus identify it. Furthermore, a pressure measuring device 74 and / or a fill level measuring device 76 is provided in each vessel 24, which measures the pressure or the level in the vessel 24. Now, if the corresponding vessel 24 is selected by the eight-way valve 22, and the pump 20 pumps the fluid out of the vessel 24, the value of the pressure measuring device 74 and the fill level measuring device 76 changes a subsequent removal by the pump 20 are closed on which of the vessels 24 is currently selected by the eight-way valve 22.

Via various measuring devices, which form a pump function monitoring device 78, the pump 20 is checked for its function. In addition to the power measuring device 64, a flow measuring device 80, the aforementioned rotational speed measuring device 66 and a pressure measuring device 82 are also provided. These measurement devices pass their test signals to the pump function monitor 78, which is connected to the self-test device 56. In the self-test device 56, various characteristics are determined from the test signals via the evaluation device 58, and thus it is concluded whether the pump 20 is functioning. At the same time it can also be concluded from these data whether the flow measuring device 80 is functional. At a high rotational speed of the pump 20, a high flow rate should also be measured. If this is not the case, the flow measuring device 80 does not work correctly.

It is also possible to identify the position of the four-way double-selection valve via a position identification device 84. This can be done in the measurement of the differential pressure via the filter 38, which simultaneously acts as a filter function monitoring device 86.

The test method for identifying the position of the four-way dual selection valve 30 is as follows: Four possible transport routes for the fluids are possible:

1. The fluid is passed directly into the waste 46.

2. The fluid is passed via the first pressure sensor 34 (P1) into a detection chamber 88 having the filter 38 and differential pressure measuring device 32, then flows via the filter 38, and finally into the waste 46 via the second pressure sensor 36 (P2).

3. The fluid is passed via the first pressure sensor 34 (P1) in the detection chamber 88, flows tangentially through the filter 38 and then into the waste 46th

4. The fluid is passed via the second pressure sensor 36 (P2) into the detection chamber 88, flows through the filter 38 in the opposite direction to 2 and then via the first pressure sensor 34 (P1) in the waste 46th

Depending on the selected position of the four-way double selection valve 30 different pressures at the pressure sensors 34, 36 are measured. The following table shows the pressures at the two pressure sensors 34 and 36 in dependence on the position of the four-way double selection valve 30, wherein the maximum absolute pressure and the differential pressure are limited to predetermined limits. If these limits are exceeded, an alarm is triggered.

If the position of the four-way dual selection valve 30 is changed and the pressures P1 and P2 of the first pressure sensor 34 and the second pressure sensor 36 compared, while through the pump 20 fluids through the system can be pumped, the correct position information of the four-way dual selection valve 30 can be identified.

At the same time, the functionality of the first pressure sensor 34 and the second pressure sensor 36 can be checked via such a pressure comparison.

The light source 42 is monitored by a light function monitoring device 90 for their functionality. This is done on the one hand via an energy metering device 92, which indicates whether the light source 42 works in principle. At the same time, the light-detecting device 44 outputs data on how much it is illuminated. It can be deduced from these data how many photons the light source 42 emits. It can be concluded that the functionality of the light source 42. Conversely, of course, the light detection device 44 can be checked from the same time.

In order to generally monitor the temperature in the biosensor device 10, the self-test device 56 also includes a temperature monitor 94. Furthermore, a leak detection device 96 is provided which detects whether there are defects in the fluidic device 12 at which the fluids escape.

The fluidic device 12 as a whole can be tested for functionality by comparing and using all other data generated on all other components. From this it can be concluded whether and at which point the fluidic device 12 may possibly have a blockage. The following two tables show two examples of how to detect a clogged fluidic device 12, and thereby identify the position of clogging. Table 1: Case where the fluidic device 12 between the detection chamber 88 and the waste 46 is clogged.

Table 2: Case when the fluidic device 12 between the four-way dual selection valve 30 and the detection chamber 88 is clogged. Device test status

Eight-way valve 22 Initialization OK,

Viscosity measurement OK

pH measurement OK

Pressure measurement / OK

level measurement

Pump 20 Flow measurement / OK

pressure measurement

Power measurement OK

Flow measurement - flow measurement / OK

Direction 26 Viscosity measurement

Flow measurement / pressure measurement error

Four-way initialization OK

Dual selection valve 30 channel / pressure measurement error

Pressure sensors 34, 36 pressure measurement error, absolute

Pressure P1 too low

Leak detection, no warning signal OK

direction 96

Light source 42 Photon count in darkness OK

Light capture photon number at dark OK

direction 44

Data acquisition 54 Initialisation, pump 20 OK

LIST OF REFERENCE NUMBERS

biosensor

fluidic

detection device

management

check valve

pump

Eight-way valve

vessels

Flow meter

Bubble sensor

Four-way double valve selection

Differential pressure measuring device

first pressure sensor

second pressure sensor

filter

optical detection device

light source

Light detecting means

waste

temperature regulating

heater

cooling device

data collection

Self-testing device

evaluation

software

Fluid identification device

Power measurement device

Rotation speed measuring device

Conductivity measuring device

pH measuring device optical detection unit

Pressure measuring device

Level measuring device

Pumpenfunktionsüberwachungseinrichtun

Flow meter

Pressure measuring device

Position identification device

Filter function monitoring device

detection chamber

Light function monitoring device

Energy consumption measuring device

Temperature monitoring device

Leak detection device

Claims

claims

1 . A biosensor device (10) for detecting biological particles comprising a fluidic device (12) for conducting fluids in the biosensor device (0) and a detection device (14) for detecting the biological particles, the fluidic device (12) comprising at least one fluidic element and the detection device (12). 4) has at least one detector element, characterized in that a self-test device (56) is provided for automatically testing the at least one fluidic element and / or the at least one detector element for functionality.

2. Biosensing device (10) according to claim 1,

characterized in that the self-test device (56) comprises at least one test device for testing the at least one fluidic element and / or the at least one detector element and an evaluation device (58), wherein the evaluation device (58) is designed to receive test signals of the test device.

3. biosensor device (10) according to claim 2,

characterized in that the at least one test device and / or the at least one fluid element and / or the at least one detector element are designed as USB components and / or USB connections are provided, via which the USB component is connected to the evaluation device (58). connected is.

4. Biosensor device (10) according to one of claims 2 or 3, characterized in that the evaluation device (58) is formed by a software to be loaded or loaded in a computer unit and / or that the self-test device (56) for starting by an initialization step of Software, in particular before each sample recording, is formed.

5. biosensor device (10) according to any one of the preceding claims,

characterized in that the self-test device (56) is designed to detect a malfunction of the at least one fluidic element and / or the at least one detector element and / or that the self-test device (56) is designed to switch off the biosensor device (10) when a malfunction is detected.

6. biosensor device (10) according to any one of the preceding claims,

characterized in that at least one detection fluid and / or cleaning fluid for carrying out the detection in the biosensor device (10) and / or for cleaning, in particular a plurality of detection and / or cleaning fluid, are provided and / or that the at least one fluid - Lement is a selection valve, preferably a eight-way valve (22), for selecting at least one of the detection and / or cleaning fluid.

7. Biosensing device (10) according to claim 6,

characterized in that as the fluidic element or as one of a plurality of fluidic elements at least one pump (20), in particular a precision micropump, for pumping the detection and / or cleaning fluids is provided and / or that the selection valve (22) the pump (20) with the Detection and / or cleaning fluids connects and / or that as a test device or as one of a plurality of test devices a fluid identification device (62) is provided for identifying a present in a monitored area detection and / or cleaning fluid.

8. biosensor device (10) according to claim 7,

characterized in that the fluid identification device (62) comprises at least one power measuring device (64) for measuring the power of the pump (20) and / or at least one rotational speed measuring device (66) for a pump axis and / or for detecting and evaluating a rotational speed / power consumption characteristic and / or or for calculating a viscosity of the detection and / or cleaning fluid pumped by the pump (20) from the rotational speed / power consumption characteristic and / or the fluid identification device (62) at least one conductivity measuring device (68) for measuring the conductivity of the detection and / or or cleaning fluid and / or at least one pH value measuring device (70) for measuring the pH value of the detection and / or cleaning fluid and / or at least one optical detection unit (72) for measuring the optical density of the detection and / or cleaning fluid having.

9. biosensor device (10) according to any one of claims 7 or 8, characterized in that at least one vessel (24) for storing the detection and / or cleaning fluids is provided as the fluidic element or as one of a plurality of fluidic elements and / or that the fluididentifica- onseinrichtung (62) at least one pressure and / or level measuring device (74, 76) for measuring the pressure and / or the level in the vessel (24) and / or that the fluid identification means (62) for storing the test signal of the pressure and / or the level measuring device is formed.

10. Biosensor device (10) according to any one of claims 8 or 9, characterized in that as a test device or as one of a plurality of test devices, a pump function monitoring device (78) is provided and / or that the pump function monitoring device (78) comprises a flow meter (80) or at least one of a plurality of flow measuring devices and / or at least one pressure measuring device (82) and / or the power measuring device (64) and / or the rotational speed measuring device (66).

1 1. Biosensing device (10) according to claim 10,

in that the pump function monitoring device (78) detects and evaluates a power consumption / flow rate characteristic and / or a rotational speed / flow rate characteristic and / or a rotational speed / power characteristic and / or a power consumption / pressure characteristic and / or a Drehgeschwindig- keits- / pressure characteristic is formed.

12. Biosensor device (10) according to one of the preceding claims,

characterized in that the detection device (14) has at least one inlet channel, in particular two inlet channels, and at least one outlet channel, in particular four outlet channels per inlet channel and / or that as a detector element or as one of a plurality of detector elements, a selection valve, in particular a four-way double selection valve (30 ), which is designed depending on the position for connecting the two inlet channels with the respective four outlet channels and / or a filter (38) for filtering out the biological particles from the sample for the purpose of detection and / or as a test device or as one of several Test devices, a position identification device (84) for identifying the position of the four-way double selection valve (30) and / or filter function monitoring device (86) for monitoring the filter (38) is provided.

13. Biosensing device (10) according to claim 12,

characterized in that the self-test device (56) comprises at least one differential pressure measuring device (32) for measuring a differential pressure in front of and behind an element to be monitored and / or that the filter function monitoring device (86) comprises the differential pressure measuring device (32) or one of a plurality of differential pressure measuring devices and / or in that the position identification device (84) has the differential pressure measuring device (32) or one of a plurality of differential pressure measuring devices for measuring a differential pressure between the area in front of the filter (38) and the area behind the filter (38) facing each other, and / or the differential pressure measuring device (32) at least one first pressure sensor (34) for measuring a pressure P1 above the filter, in particular a first and a second pressure sensor (36) for measuring two pressures P1 and P2 of the opposing regions of the filter, and / or that the position identification device (84) for detecting the pressure P1 of the first pressure sensor (32) and / or for detecting the pressure P2 of the second pressure sensor (34 ) and / or for calculating the differential pressure from the pressures P1 and P2 and / or for storing the determined data is formed and / or that the evaluation device (58) is designed for detecting and evaluating a differential pressure / valve position characteristic.

14. Biosensor device (10) according to one of claims 2 to 13, characterized in that at least one optical detection device (40) is provided as the detector element or as one of a plurality of detector elements and / or that the optical detection device (40) at least one light source (42 ), in particular a light emitting diode (LED), and / or that a light function monitoring device (90) for testing the light source (42) is provided as a test device or as one of a plurality of test devices and / or that the light function monitoring device (90) comprises an energy meter ( 92) for measuring the energy consumption of the light source (42) and / or at least one light detection device (44), in particular a photomultiplier (PMT), and / or that the light function monitoring device (90) is adapted to the energy consumption of the light source (42) a test signal of the Lichtseinseinseinr (44) depending on set and / or store the data obtained.

15. Biosensing device (10) according to one of the preceding claims,

characterized in that the biosensor device (10) has at least one sample receiving device for sample intake from drinking water pipes and / or that the sample receiving device has at least one safety device for preventing the contamination of drinking water and / or a check valve, which is formed as a safety device.

16. Biosensing device (10) according to one of the preceding claims,

characterized in that the self-test device (56) has at least one temperature monitor (94) for monitoring the temperature in the biosensor device (10) and / or at least one temperature regulator (48) is provided for regulating the temperature in the biosensor device (10) and / or that the temperature regulating device (48) is formed with a heating (50) and / or a cooling device (52) for heating and / or cooling the biosensor device (10).

17. Biosensing device (10) according to one of the preceding claims,

characterized in that the self-test device (56) has at least one leak detection device (96) for detecting damage to the fluidic device (12) and / or a conductivity measuring device which is designed as a leak detection device.

18. Biosensor device (10) according to one of the preceding claims,

characterized in that the self-test device (56) at least one data acquisition (54), in particular an electronic data acquisition (54), for detecting all data and signals, in particular test signals, which are generated in the self-test device (56).