WO2008007280A2

WO2008007280A2 - Assay system and method

Info

Publication number: WO2008007280A2
Application number: PCT/IB2007/052504
Authority: WO
Inventors: Maarten P. Bodlaender; Wilhelmus J. J. Stut
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2006-06-28
Filing date: 2007-06-28
Publication date: 2008-01-17
Also published as: WO2008007280A3

Abstract

Assay system, comprising: -at least one disposable assay device (1), configured to assay one or more samples and configured for transmitting assay data or information to a remote receiving system (20); and -at least one receiving system (20) which is configured to receive the assay data or information; wherein the system comprises at least one interactive user guidance system that is configured to provide user guidance at least before a user applies one or more samples to the device (1). The invention also provides an assay method.

Description

Assay system and method

FIELD OF THE INVENTION

The invention relates to an assay system, comprising: at least one disposable assay device, configured to assay one or more samples and configured for transmitting assay data or information to a remote receiving system; and - at least one receiving system which is configured to receive assay data or information.

The invention also relates to an assay device and an assay method.

BACKGROUND OF THE INVENTION International patent application WO 95/33996 of Zwanziger et al. discloses a home test kit for use in testing for a disease or a physiological condition, with telephone verification of test results. The known home test kit facilitates the delivery of any necessary counseling as a result of the outcome of a test. During use, an individual can obtain a sample of physiological fluid from him or herself. The sample can be introduced into an assay device to produce a coded pattern indicative of the presence or absence of the disease. The individual can transmit the coded pattern to a remote location for interpretation, for example by telephone. Then, the individual can receive, from the remote location, an interpretation of the coded pattern together with any counseling which may be appropriate in view of the interpretation of the coded pattern. In this way, the remote location has to be used for interpretation of the test.

Also, from EP972196B1 a different assessment device is known, where a recording part is detachable from an assay part. This known device is provided with a test- ready indicator. The results of the assay are also not directly available to the user. Consumers are usually not skilled in medical procedures. Therefore, consumers may accidentally deviate from the measurement procedure during self- measurements. When consumers realize that they do not know exactly what to do, this makes them uncomfortable and uncertain. SUMMARY OF THE INVENTION

The present invention aims to provide an improved assay system and assay method.

According to an embodiment, the assay system is characterized by at least one interactive user guidance system that is configured to provide user guidance at least before a user applies one or more samples to the device.

This invention can improve comfort by giving user guidance. Also, by providing user guidance before at least one sample is being applied to the assay device, more accurate and reliable results can be obtained. As an example, the assay device can be substantially provided with the user guidance system, for example by electronically providing the device with such a system. Alternatively, for example, the user guidance system can be located remote from an assay device, for example in the case that the assay device can be a relatively simple and/or cheap device having relatively few components. Also, part of the user guidance system can be integrated with an assay device, and part of the user guidance system can be located remote from that assay device. Besides, the system can comprise different assay devices, for example one or more assay devices that do include a user guidance system, or part thereof, and one or more assay devices that do not include a user guidance system. Preferably, the user guidance system is an interactive system, for example an interactive electronic system, which can communicate with a user, react or respond to user actions and/or, which can control and/or modify a desired assaying of a sample, based on user action.

According to a further embodiment, the user guidance system is configured to ask a user of the assay device one or more questions, for example multiple-choice questions, and to receive respective answers from the user, and the user guidance system is configured to allow or disallow use of a respective assay device, depending on one or more answers received from a user of the device. For example, in case it is an object to determine whether or not a user has pre-diabetes or diabetes, the user guidance can be configured to help a user in obtaining a blood sample, and/or to aid the user in taking the blood sample at a desired assaying time. For example, according to a further embodiment, the user guidance system can be configured to determine whether a user of the assay device is in a fasting state, preferably by asking the user one or more fasting state-related questions and by receiving respective answers from the user, for example a question "did you have breakfast?" or "when was your last meal?". Thus, for example, a pre-diabetes or diabetes test, particularly a Fasting Plasma Glucose Test (FPG), can be performed more reliably.

Also, according to an embodiment, there is provided a disposable assay device, configured for transmitting assay data or information to a remote receiving system, and the assay device is configured to carry out an oral glucose tolerance test (OGTT).

Therefore, it can be determined with high accuracy whether or not a user of the device has (pre-)diabetes. Preferably, a user guidance system is provided, configured to lead the user through the OGTT test, wherein the user is guided to test at least a first blood sample, and a second blood sample precisely after the lapse of a predetermined time interval following the application or testing of the first blood sample (for example a time interval of one or several hours). This assay device can be applied in a system according to the present invention, however, this is not essential to the device. Also, this device can be applied in an assay system that does not comprise an interactive user guidance system to provide guidance to the user of the device. Besides, according to an embodiment, there is provided an assay method, particularly utilizing a system according to the invention, the method at least comprising: providing at least one disposable assay device to at least one user, the assay device being configured for transmitting assay data or information to a remote receiving system; and - providing interactive user guidance to the user of the assay device at least prior to application of one or more samples to the device.

This can provide the above-mentioned advantages. In a further embodiment, the assay device can provide at least part of the user guidance. Also, in an embodiment, at least part of the user guidance can be generated remote from the assay device by an electronic user guidance generator.

According to an embodiment, the user guidance can involve notifying a user of the assay device to use the device, for example generating an alarm at a predetermined time.

In an embodiment, the assay device can be available only for performing an assay in predetermined time-slots, for example only between 6 am and 8 am.

Besides, advantageously, the user guidance may comprise automatically generating speech instructions, for example utilizing a speech generator.

A basic idea is to provide user guidance, particularly interactive user guidance, for example via electronics provided on the assay device and/or via a remotely located guidance system, so that the user can be guided though a test with comfort and reassurance and more reliable test results can be obtained.

BRIEF DESCRIPTION OF THE DRAWINGS Further advantageous embodiments of the invention are described in the dependent claims. These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereafter.

Fig. 1 schematically shows a first embodiment of an assay device according to an embodiment of the invention; Fig. 2 shows a second embodiment of an assay device;

Fig. 3 shows a third embodiment of an assay device;

Fig. 4 shows a system according to an embodiment of the invention;

Fig. 5 shows a flow chart of an assay method; and

Fig. 6 shows a flow chart of an alternative assay method.

DETAILED DESCRIPTION

In the present application, similar or corresponding features are indicated by means of similar or corresponding reference signs.

There are 20.8 million people in the United States, or 7% of the population, who have diabetes. While an estimated 14.6 million have been diagnosed with diabetes, 6.2 million people (or nearly one-third) are unaware that they have the disease.

Today, in order to determine whether or not a person has pre-diabetes or diabetes, health care providers conduct a Fasting Plasma Glucose Test (FPG) or an Oral Glucose Tolerance Test (OGTT). Either test can be used to diagnose pre-diabetes or diabetes. Instead of the person having to go to the care provider, the person can perform the test at home. For example, the person may put a blood sample on a device that is capable of conducting a glucose test.

For a number of medical measurement protocols, it is necessary to perform a sequence of measurements instead of only one measurement. While it is known in the art to include multiple application wells on an assay part of an assay device, the existing technology is not suitable for measurement protocols that require significant amounts of time to pass between each measurement. For example, to have a better quality assessment it may be beneficial to repeat the measurement for 3 consecutive days. In a known device (see EP972196B1), the assay part can only be detached at the end of this period. During this period there is the risk of bio-contamination as the first application well contains biomaterial after the first assessment. This risk can be avoided by independently removable application wells w, as can be seen from the present embodiments.

Fig. 1 schematically shows an embodiment of a disposable assay device 1. The device 1 comprises a carrier or substrate having two first carrier parts 3, 5, with respective sample receiving areas w for receiving samples to be tested, and having a second carrier part 9 comprising a memory device 10 configured to store assay results relating to tested samples. The carriers 3, 5, 9 can be made of various materials, for example a suitable paper or paper- like material, plastic and/or other materials. Also, the first carrier parts 3, 5 are independently removable (i.e. independently with respect to each other) from the second carrier part 9, to independently remove the respective application wells w from the second carrier part 9. Advantageously, the assay device 1 is configured for transmitting assay data or information to a remote receiving system. For example, the device 1 can be configured to store the assay results without disclosing the results to a user of the device 1 (here, a user of the device 1 is generally a person who, during use of the device 1 to assay one or more samples, applies a mentioned sample to an application well w of the device 1). The assay device 1 can be configured to assay one or more samples and to provide at least one assay result based on the assaying of the one or more samples.

For example, the device 1 can be used to assay individual users of an assay system, for screening purposes. Individuals to be tested by the device 1 can be human individuals. However, alternatively, the devices can be configured to assay animals or vegetation.

Besides, assays to be conducted with the device 1 can involve screening of certain other areas or locations, for example screening environments (air, water, soil, etc.) for contamination, for certain substances and/or for organisms.

The assay device 1 can be configured to detect various types of analytes. For example, analytes to be determined can include glucose, pregnancy-related analytes, cholesterol, drugs, biotoxins, diseases, cardiac markers, chemicals, hormones, proteins, and/or other analytes. Other analytes can includes certain substances, toxic matter, environmental contamination and/or different analytes.

The assay device 1 can be configured to assay various types of samples, for example samples of blood, bodily fluid, saliva, urine, plasma, serum and/or other sample types, as will be clear to the skilled person. Also, the different application wells w can be used to receive different samples, for example in a predetermined sequence and/or after predetermined time periods. Alternatively, different application wells w of the device can be used to receive parts of the same sample, if desired.

Besides, advantageously, the assay device 1 is portable, lightweight, and compact, for example having a relatively flat credit card format, or sheet-like configuration. For example, the assay device 1 can be configured to be sent to users in a simple envelope or package, or by or as part of a letter, by regular mail.

The assay devices 1 can each be configured in various ways to conduct an assay on a sample, as will be clear to the skilled person. For example, the assay device 1 can be provided with one or more suitable enzymes, antibodies, binders or binding agents, a labeling substance, and/or microorganisms, which can be responsive to a specific analyte to be searched for. An analyte and/or analyte-dependent modifications can be detected, for example, optically, electrochemically, by electrical resistance measurement, and/or in a different way, by the assay device 1. Testing of the analyte can be conducted, for example, at the respective sample-receiving areas (or sample wells) w, or at other locations of the assay device.

In the present embodiment, the first and/or second carrier parts comprise microelectronics configured to assay the samples, provide respective test results and store the results in the memory 10. To this aim, for example, the microelectronics can cooperate with and/or be electrically connected to the mentioned sample receiving wells w in a suitable manner to carry out the assaying of the samples, as will be clear to the skilled person.

Preferably, the second carrier part 9 is provided with a major part (for example more than 50% and particularly at least 90%) of the microelectronics, for example with substantially all of the microelectronics. The testing can be controlled, for example, by a suitable controller 8 of the device. In a more detailed analysis of the architecture of the device, it can comprise a controller 8, connected to an A/D convertor through a digital connect, that is connected to application wells w through one or more analog connects 18. Preferably, the A/D convertor is provided on the second carrier part 9, for example via integration with the controller 8, for cost saving and to enable re-using the A/D convertor over multiple application wells, and recycling it. A mentioned test result, which is stored in the memory device 10, can include various types of results, for example a numerical value or true-false value (or "positive- negative", 0-1, True-False) relating to a successfully conducted sample assaying. On the other hand, in case an assay is inconclusive or fails, such as due to a certain device failure, a test result can be "assay inconclusive", "assay failed", "device failure" or a similar result. In a further embodiment, the carrier can be provided with a low-cost write-once display, configured to subsequently provide operating steps to be taken by a user of the device 1, during use. Besides, in an embodiment, the device can be provided with a user interface, preferably comprising multiple-choice buttons (also depicted in Fig. 3). Further, the carrier can advantageously be provided with a user guide configured to guide a user in the application of samples to the first carrier parts, the user guide preferably being arranged to indicate a predetermined sequence of use of the first carrier parts. For example, the user guide can be provided in printing, or via audiovisual means such as a display 38 and/or loudspeaker 35 that is/are controllable by the controller 8 to display and/or voice user guidance instructions.

Each sample-receiving area w can be provided to receive a respective sample. Detection areas can be provided for testing the samples that have been received at the receiving area 3 during use. The first carrier parts 3, 5 and/or second carrier part 9 can be provided with such detection areas. For example, an assay device 1 can comprise a plurality of sample-receiving areas w and one respective detection area, the detection area for example being located on the second carrier part 9. Alternatively, on/in the assay device 1, one sample-receiving area w can be associated with several respective detection areas, for example to assay one sample, received on that receiving area w, for different analytes. Besides, an assay device 1 can comprise several sample-receiving areas and several respective detection areas, to test several samples. For example, sample-receiving areas w and detection areas can be integrated with each other, or be spaced apart from each other. In the latter case, for example, sample conductors can be provided, for example capillary channels, to conduct one or more samples, or parts thereof, from one or more receiving areas w to one or more detection areas, for example by capillary action, gravity, or in a different manner. Besides, for example, the assay device can be manipulated, for example via folding or bending, to bring a sample-receiving area into contact with a detection area. Each assay device 1 can also be configured in a different manner.

In an embodiment, as an example, the two first carrier parts 3, 5 can be configured to carry out the same assay test, particularly to test a sample for the same analyte. Alternatively, the first carrier parts 3, 5 can be configured to carry out different assay tests, particularly to test samples for different analytes.

Also, each of the assay devices 1 can be configured to provide at least one assay result based on the assaying of the one or more samples. The mentioned controller 8 of the device 1, for example a microelectronic processor or CPU (Central Processing Unit) 8, can be configured to control and process the assaying of samples, which are received at the receiving areas w. In this case, the memory 10 is controllable by the controller or processor 8 to store the test results. As an example, the controller 8 and memory 10 can be integrated with each other, or be separate components. Also, for example, the embodiment of Fig. 1 can comprise a so called lab-on-a-chip system, and, for example, the controller 8 can comprise a lab-on-chip processor which can at least partly include a mentioned detection area.

Besides, the assay device can be provided with a test result transmitter 19 configured to transmit a test result to an external test result receiver 16. Here, for example, data transmission between the transmitter 19 and receiver 16 (which data transmission is schematically indicated by a dashed line D2) can take place via suitable wiring and/or wirelessly, for example using electric, electromagnetic and/or optical signals, a network interface or digital output, or differently.

Advantageously, the memory 10 can be read by an external memory reading device 15 for obtaining the test result from the assay device 1. For example, data transmission between the memory 10 and reading device 15 (schematically indicated by a dashed line Dl) can take place via suitable wiring and/or wirelessly, for example using electric, electromagnetic and/or optical signals, a mentioned test result transmitter 19, or differently.

A mentioned external test result receiver 16 and memory reader 15 can be configured in various ways, and can include a dedicated docking station for docking the assay device 1C, a computer, a personal digital assistant (PDA), a mobile phone, and/or can be part of a remote receiving system 20 (schematically depicted in Fig. 1) and/or can be configured differently. For example, in an embodiment, the external test result receiver 16 and memory reader 15 can be integrated with each other. Components of the assay device 1 can be powered in various ways, for example by a solar cell, a battery, by charging, by inductance, by self-powering or capillary action, by a storage capacitor, by power storage via motion and/or a winding mechanism, or differently.

In the present embodiment, the test result storage part 9 of the device 1, for example comprising the mentioned memory 10, and preferably comprising the processor 8 and transmitter 19, might be separable from each respective sample receiving area w. Also, as an option, an assay device 1 can be provided with a test ready indicator 6, for example a LED (light emitting diode) or speaker or otherwise, to indicate when an assay of a sample is completed. In the present embodiment (see Fig. 1), the second carrier part 9 comprises the test ready indicator 6.

For example, the assay device 1 provides assay data or information, the assay data or information relating to, being based on and/or comprising one or more assay results of the assays carried out by the device 1. Advantageously, the device 1 is configured to keep the test result secret to the user of the device, similar to devices known from WO 95/33996. For example, the device 1 can be configured to provide the user with a code to be sent to a central receiving system 20.

The skilled person will appreciate that the receiving system 20 can be configured in various ways. As an example, the receiving system can be configured to receive assay data or information (which can comprise the afore-mentioned code), the assay data or information relating to, being based on and/or comprising one or more assay results of the assay devices 1 and/or comprising information that the assaying has failed. Transmission of the mentioned assay data or information (or code) to the central receiving system can comprise, for example, electronic transmission, transmission via a computer and/or telephone network, transmission via a communication connection between a user communication terminal and a communication terminal of the receiving system, transmission via regular mail and or transmission via locally available test result collection facilities, depending for example on the configuration of the respective assay device 1. Also, for example, the user can send the whole assay device 1, or preferably only the memory-comprising part 9 thereof, containing assay data or information, to a remote receiving system 20.

For example, the receiving system 20 can be provided with a computerized call-receiving system, and/or voice response system, configured to receive calls from the users, for example to receive the assay data from the users, communicate with users and/or return test result-related information back to the users. Besides, in an embodiment, the receiving system 20 can be configured to cooperate with or be provided with an assay device distribution system, to distribute one or more assay devices 1 to a user, for example depending on received assay data or information of an assay device 1 used earlier by that user. Also, for example, the receiving system 20 can at least be configured to determine, using received assay data or information, whether a respective assay result of an assay device 1 is a negative or positive assay result, and/or whether the result is inconclusive, and/or whether the assaying has failed and optionally a/the reason(s) why the assaying has failed. Then, in a further elaboration, a distribution system/receiving system 20 can be configured to distribute at least one further assay device to a user U of a prior assay device, in case the receiving system 20 has determined that a respective assay result of the prior assay device 1 is a positive assay result, and/or an inconclusive result. For example, a more accurate assay device can be sent to the user, who provided a positive or inconclusive test result using a prior assay device, to confirm the positive test result or to redo the assay, respectively, with higher accuracy.

Besides, in an embodiment, the receiving system 20 can at least be configured to determine, using received assay data or information, at least one type of deviation concerning received assay data or information with respect to threshold data or information, estimated data or information, and/or expected data or information. Also, in an embodiment, the receiving system 20 can be configured to receive at least removed parts 3, 5 of used assay devices 1, and to perform at least one of the following: detect damage and/or malfunction of received assay devices or of parts thereof, read data or information from received assay devices or parts thereof, recycle received assay devices 1 or parts thereof. For example, to detect damage and/or malfunction of received assay devices or of parts thereof, the receiving system can be provided with suitable sensors and/or detectors, as will be clear to the skilled person. The receiving system 20 can be configured, for example, to detect a color and/or optically detectable test result indicators of a received assay device or part thereof.

In the embodiment of Fig. 1, the device 1 is provided with a central second part 9 having first parts 3, 5 extending on opposite sides of the second part 9. Both first carrier parts 3, 5 can be detachably coupled to the second carrier part 9. Such detachable coupling can be configured in various ways. For example, the carrier can be provided with weakening lines or perforation lines L, extending between the first and second carrier parts 3, 5, 9 for independently removing the first carrier parts from the second carrier part. The weakening lines or perforation lines L are such that a user can tear off or break off each first carrier part 3, 5 from the second memory comprising part 9 via those lines.

Preferably, the assay device 1 is configured to detect the removal of a first carrier part 3, 5 from the second part 9. Also, preferably, the device 1 is configured to record a time of the removal of the first assay part in the memory device 10. Such detection and/or time recording can be carried out, for example, by the controller 8. Detection of removal of a first carrier part 3, 5 can be achieved using, for example, tear off detectors 33, for example respective electrically conducting detection lines or loops that are coupled to the controller 8, and that are interrupted or broken when a respective first carrier part 3, 5 is removed from the second part 9. In a further embodiment, the device 1 can be configured to record each assay result in combination with identification information of a respective first carrier part 3, 5, leading to that assay result (i.e., the first carrier part 3, 5 which received a respective sample), in the memory device 10. Also, the device 1 can be configured to record each assay result in combination with time information concerning a respective assay, leading to that assay result, in the memory device 10. Other types of information can also be stored in the memory device 10, for example assay context information. For example, the assay device 1 can be configured to monitor assay context before, during and/or after assaying a mentioned sample, and preferably to store the results of such monitoring in the memory device 10. For example, the assay device 1 can be provided with one or more assay context sensors to detect temperature, humidity, contamination and/or other assay context factors. As an example, one or more such sensors can be integrated in the controller 8, or can be connected thereto in a suitable manner.

During use of the embodiment of Fig. 1, the device 1 can be provided to a user, for example by postal delivery, by handing-out or in a different manner. The user can use the device 1 (for example at home or in another suitable location) in an assay method by applying one or more samples to the application wells w of the first carrier parts 3, 5 of the device 1 to test the samples for the presence of one or more analytes. Test results, relating to the testing of the samples, are stored in the memory 10 of the device, without displaying or otherwise disclosing the results to the user. Preferably, the user removes each first carrier part 3, 5 from a remaining device part after having used that first carrier part. Thus, cross- contamination can be avoided, and all assay results can be stored in the same memory 10. After both first carrier parts 3, 5 have been used and removed, the remaining second part 9 can be returned to a central receiving/processing facility to deliver the memory 10 and its results. Alternatively, such results can be sent using suitable communication means, as mentioned above. Thus, a sequence of measurements can be performed, instead of only one measurement, in a safe, efficient and accurate manner. For example, an improved assessment can be obtained when the measurement is repeated after a predetermined time period of 1 day (circa 24h). For example, the first carrier parts 3, 5 of the device can be used sequentially, with a predetermined intermediate time period. The device 1 can be configured to indicate this time period, for example via a suitable display. Also, the device 1 can be provided with a timer, for timing the lapsing of the predetermined time period. The device can be configured to indicate to the user when the predetermined time period has lapsed to encourage the user to use the next first carrier part for a subsequent assay.

The embodiment of Fig. 1 provides the advantage that the user can use any application wells w first, as they can be independently detached. If the different assay parts contain different tests, this allows freedom in the order in which tests are taken. Besides, all first carrier parts can be the same in set-up, and wiring of electronic parts can be relatively straightforward. This simplifies the card design and lowers material costs.

Fig. 2 shows another embodiment of an assay device 101, being provided with a user interface, for example multiple-choice buttons B1-B4. The multiple choice buttons Bl- B4 can be associated with respective questions Q1-Q2, for example printed next to the buttons and/or on the buttons. The device can be provided with a specific dedicated carrier part 15, comprising the questions Q and/or buttons B, which dedicated carrier part 15 can be removably connected to the second carrier part 9, which has been provided with a controller 8 and memory 10. Alternatively, the dedicated carrier part 15 and second part 9 may be integrated with each other. The Fig. 2 embodiment is provided with only one first carrier part 3 having a single sample application well w. In the present embodiments, the first carrier part 3 is removably connected to the dedicated user interface carrier part 15. For example, the second carrier part 9 can be provided with a user interaction means 6, for example a test ready indicator. Thus, detaching the first carrier part 3 results in a minimal loss of functionality for the device 101. As the first carrier part 3 is disposed of (it is potentially contaminated), the embodiment of Fig. 2 provides a design where functionality is placed on the recording part when possible. Specifically, any user interaction means, like the test-ready indicator 6 (or the multiple-choice buttons), are placed on the second carrier part 9. In this way, these user interaction means can be used to continue an interaction with the user, even after the action of the detach mechanism . For example: the second carrier part 9 needs to be returned to a central processing facility, and the user can be reminded of this aspect by causing the test-ready indicator 6 to blink at intervals, thus focusing attention of the user on the device 101 to be sent in. Fig. 3 depicts an embodiment of an assay device 201 which differs from the embodiment shown in Fig. 1, in that a first carrier part 3 is provided with controller parts 8', 8", for example an application well controller part 8' for controlling application wells w, and a sample analysis part 8" to analyze tests performed in the application wells w. Another controller part 8, for example comprising a process guidance module, is provided on the second carrier part 9. Such various controller parts 8, 8', 8" can also be integrated with each other. For example, the application well controller 8' can be configured to enable / disable the application wells w, until the process guidance module 8 has determined that a user has completed the right preparation steps.

A tear-off detector 33 is provided between the first carrier part 3 and the second carrier part 9 to detect separation of these carrier parts 3, 9. Besides, the device 201 can be provided with a display 38, a speaker 35, a microphone 36, a speech analysis/recognition processing unit 37 and a clock and/or alarm unit 34. As an example, the device 201 can be configured to communicate with a user thereof, through speech and speech recognition, utilizing the speaker 35, microphone 36, and speech analysis processing unit 37. Also, the display 38 can be used to communicate questions and/or information to the user. In Fig. 3, arrows indicate possible communication interconnections between the various device components, for transferring signals, data and/or information between the various device components. For example, the process guidance controller part 8 can be a main controller which communicates with other units, such that the device can carry out the assaying of one or more samples, for example in conformity with a method according to the invention.

Besides, in the embodiment of Fig. 3, the assay device 201 as such can be provided with a user guidance system, configured to interactively provide user guidance to the user of the device 201. For example, an integrated user guidance system can comprise the mentioned process guidance controller part 8, speaker 35, microphone 36, speech recognition processor 37, clock and/or alarm unit 34 and/or display 38. The role of the process guidance controller can be to interpret certain user answers, and to determine a next step (e.g. next message to be rendered, or enabling of application well) of use of the assay device 1. In the present embodiment, the process guidance controller is integrated with the device controller 8. Alternatively, a dedicated process guidance controller can be provided. The user guidance can include, for example, an alarm or wake-up call, and/or questions relating to the condition of the user of the assay device 1, as will be explained below.

For example, controllers of embodiments 1, 101, 201 shown in Figs. 1-3 can be configured to provide desired user guidance. In each case, for example, the controller can be coupled to one or more audio and/or visual information generators (for example display and/or speaker), to provide a user with the user guidance. User feedback can be received, for example, using a microphone 36 and speech recognition processor 37 to receive and recognize speech from the user (see Fig. 3), and/or via one or more buttons (see Fig. 2). Also, the controller 8 can be configured to provide a speech generator to automatically generate user guidance speech instructions, which can be played via the loudspeaker. A separate, dedicated, speech generator can also be provided to that aim.

The skilled person will appreciate that the embodiments shown in Figs. 1, 2 and 3 can be combined in various ways with each other. For example, the embodiment shown in Fig. 3 can also be provided with multiple-choice buttons (see Fig. 2) and/or with at least two first carrier parts. For example, in the Fig. 3 embodiment, the microphone and speech analysis are optional, and can be replaced by multiple-choice buttons.

In a further embodiment, there is provided at least one remote interactive user guidance system to provide guidance to the user of the device 1. Fig. 4 schematically shows an assay system, wherein a user guidance system 60 is located substantially remote from a user location of an assay device 1. Optionally, the remote user guidance system 60 and a mentioned remote receiving system 20 may be integrated with each other.

For example, the assay system can be provided with at least one communication network N to communicate user guidance from the remote user guidance system part 60 to a user or the assay device 1. As an example, the communication network N can be a computer and/or telephone network. A remote user guidance system 60 can be, for example, an automated and/or computerized call center, using voice recognition and speech processing to communicate with the user of the assay device 1. Besides, the remote user guidance system 60 can include a computer network server, for example an Internet server, which can provide user guidance via interactive webpages or digital response forms. Also, the user can be provided locally with a suitable terminal, personal computer, telephone and/or other communication device 61, to communicate with the remote user guidance part 60 in order to receive the user guidance therefrom. For example, the communication device 61 can provide a user interface, operable by a user of the assay device 1, to communicate with the user guidance system. Also, preferably, communication between the user and the user guidance system 60 is two-way communication, allowing the guidance system 60 to send questions and/or instructions to the user of the assay device 1, and the user to send information and/or respond back to the guidance system 60. In an embodiment, the user guidance system 60 can be configured to ask a user of the assay device one or more questions, for example multiple-choice questions, and to receive respective answers from the user. The user guidance system 60 can also be configured to allow or disallow use of a respective assay device 1 , depending on one or more answers received from a user of the device 1. This will be explained below, with respect to Figs. 5-6.

In an embodiment, the user guidance system can be configured to determine whether a user of the assay device 1 is in a fasting state, preferably by asking the user one or more fasting state-related questions and by receiving respective answers from the user, for example a question "did you have breakfast?" or "when was your last meal?". This is particularly advantageous in the case that the device 1 is used to test a blood sample, of a user, for glucose to determine whether the user has (pre-)diabetes. Then, preferably, the user guidance system 60 disallows the user to use the device 1 , in the case that it is determined that the user is not in a desired fasting state.

Also, in an embodiment, the user guidance system can be configured to ask questions regarding a current context and recent user behavior that might influence the test results, and/or questions regarding the long-term health status of the user that might influence the interpretation of the results. Also, in an embodiment, the user guidance system 60 can be configured to send a notification to a user of an assay device 1 at a predetermined time, for example a wake-up call, to notify the user to use the assay device 1 at a desired assaying time. In the embodiment of Fig. 4, the notification can be sent via the communication network N.

Fig. 5 shows a flow chart of the use of an above-mentioned assay system. For example, during use, interactive user guidance can be provided by the assay device 1 as such, provided that the assay device 1 has a user guidance system. Alternatively, a remote user guidance system 60 can be available to provide the user guidance. As an example, in the following, the case will be described wherein the assay device 1 is provided with the user guidance system. Here, for example, the user guidance can be communicated via mentioned communication means, for example a display 38, microphone 36, buttons B, speech recognition, and the-like.

Following from Fig. 5, there can be provided a user-testing phase, wherein the user of the assay device is required to answer a number of questions, and an optional subsequent assaying phase of using the assay device 1 to assay at least one sample. Here, one or more user answers, following from the user testing phase, may determine whether or not the assaying phase can be entered, and/or determine one or more assaying parameters of a respective assay.

For example, the assay device 1 can start with a pre-test and/or stand-by state (step 81). If a user of the assay device 1 wants to start measuring, he can perform a step 82, for example pressing a specific "start test button" S, or giving a command in any other way to the assay device 1, possibly by answering a first multiple-choice question; in the latter case a step 82 and decision 83 are skipped.

The device 1 can decide, in an optional step 83, whether the user can continue the test, after having performed the step 82. For example, continuation can depend on a date/time and on previous attempts by the user to perform the test. Such a date/time can have been stored in the device 1 by the controller 8. If the device does not allow the user to perform the test, this can be indicated to the user in a step 84, and the device can return to state 81. For example, the user can be instructed that the test has to be performed at a later time or date, for example a next day ("please try to test tomorrow"). If the device 1 allows the user to continue, a next step 86 can be carried out.

In step 86, the interactive user guidance system can ask the user a number of multiple-choice questions. As an example, the user can simply answer each question by pressing a button B (see Fig. 2). Also, an above-described speech recognition processing can be used, so that the user can simply answer a question by speech. The user guidance system can be configured to make the testing process dependent on the answers provided by the user.

As follows from the above, one or more of the questions can relate to the fasting state of the user. For example, it can be determined interactively whether or not the user of the assay device 1 is in a fasting state, for example by determining a time period that has passed since the user had a last meal, wherein the user guidance prevents the user from using the assay device, and/or requests the user to wait until a desired fasting state is reached, in case the user is found not to be in a desired fasting state.

Also, one or more of the questions can relate to certain medical conditions which might make the test unsuitable to the user, for example medical conditions which are incompatible with the user of the assay device, for example allergies, problems with stopping blood flowing from wounds, or other conditions. The user guidance can be configured to prevent the user from using the assay device 1 in case it is found that the user has at least one of the specific medical conditions.

If at any time, in step 86, one or more of the user answers are such that the device 1 decides that the test has to be postponed, the device can perform an action 87, and can indicate to the user that the test has to be delayed. If at any time, in step 86, one or more of the user answers are such that the device 1 decides that the test is not suitable for the user, the device can perform an action 91, and can indicate to the user that the test cannot be carried out at all. Then, the card 1 can be returned to a remote processing facility 20 without any test measurement having been taken, or the card can send information to the processing facility that the test could not be taken.

On the other hand, in step 86, after answering sufficient questions, the device 1 can also determine that the test can be taken. This can be indicated to the user in an action 88, and the user can start the test in a subsequent step 89. Following from the test, the device 1 can subsequently provide assay data or information relating to, being based on and/or comprising one or more assay results of the assay device 1 and/or comprising information that the assaying has failed, without disclosing the assay result to the user of the device 1 (see above). Following from Fig. 5, there is provided interactive user guidance to the user of the assay device 1 prior to and/or during the user using the device 1, such that the user can use the assay device 1 correctly. Alternatively, at least part of the user guidance can be generated remote from the assay device, for example by a remote electronic user guidance generator 60 (as in Fig. 4). In that case, for example, an automated call center or Internet server can ask the questions to the user, and can guide the user through the various steps (similar to the flow chart of Fig. 5), depending on answers received by the user.

In an embodiment, the user guidance can involve notifying a user of the assay device to use the device, for example by generating an alarm at a predetermined time. Also, in an embodiment, the assay device 1 can only be available for performing an assay in predetermined time slots, for example only between 6 am and 8 am. Also, the assay device 1 can be held disabled for assaying a sample, until the user has followed at least part of the user guidance. For example, to prevent that a user applies a sample to an application well w at a wrong moment, the application well w can be temporarily disabled until the user has completed the right preparation steps (for example, has answered questions and has provided the correct answers).

As an example, the present system and method can be used to accurately determine whether or not a person has pre-diabetes or diabetes. This will be explained in more detail in the following.

For example, a Fasting Plasma Glucose Test (FPG) can be performed, wherein a user's blood glucose level should be measured before the person has had breakfast. The above-described user guidance system can provide means to inform, (e.g. by reminding), or support the user about this, in a simple manner. Also, performing a whole test may involve the user executing a number of interactive steps in a pre-defined order, for example to ensure that a number of conditions are met (e.g. first check that no breakfast has been had, then apply blood sample, then wait sufficient time, and finally transmit an assay result to a receiving system 20). The present embodiments can provide means to really guide the user in this process, by requesting the user to answer questions and by the system responding to the answers by taking appropriate actions. For example, as follows from the above, an assay device 1 or remote user guidance system 60 can ensure that a user is in a fasting state before indicating that the measurement can begin. Also, an assay device 1 or remote user guidance system 60 can ensure that the respective test, of the respective assay device 1, is suitable for the user before prompting the user to start the test. Also, in an embodiment, a multiple-choice question is included on the device

1, such as: "have you eaten in the last 6 hours?" If the user answers affirmatively to the question, the device 1 can signal to the user that the test will be delayed until a later moment (when the user is in a fasting state). This can for example be indicated to the user by means of a first indicator 26 (see Fig. 1), for example a LED that lights up next to a printed text "test must be taken while in fasting state, delay test until tomorrow". If the user answers that he is in a fasting state, and if other conditions are met, the device can indicate that the user can commence the test, for example via a respective second indicator 27 (see Fig. 1, e.g. using a LED that lights up to a printed text "commence test now"). The device 1 can also include other questions to ensure that the right measurement conditions are met, and that the test is suitable for the user.

Besides, as follows from the above, the device 1 or remote user guidance system 60 can contain a wake-up/alarm clock mechanism 34 (as in Fig. 3). For example, when the device 1 wakes the user up, it is more likely that the user is in a fasting state, allowing a glucose test to be done before the user has had breakfast. Also, in an embodiment, a clock or timer is included next to the embedded processor 8 as well as a speaker 35 to wake the user with sound. Since the waking device is the first device that the user interacts with in the morning, the user is automatically reminded of the need to take a glucose test.

Besides, the device 1 can be configured to allow measurements to be taken only in selected time slots. Time slots can be periodical and related to each other. For example, measurements can only be taken between 6 a.m. and 8 a.m.

Since the time at which a user takes a blood glucose measurement can influence the result, the device can be configured to only allow (certain types of) measurements to be taken in specific time slots. These time slots can be relative to the time of day, relative to the time at which previous measurements were done (if a series of measurements needs to be conducted), and relative to the moment the wake-up mechanism is scheduled (provided a wake-up mechanism is used). A simple algorithm, which can be carried out by a processor 8 of the device 1, is the following: user indicates he wants to perform a test T (time=X); - if time X is in interval [a,b] where test T is allowed to be taken, indicate to the user he can continue (here, time can also include date for multi-day measurements); or else indicate to the user the test is currently not scheduled. Besides, in blood glucose testing, a device speaker 35 can be used for audible feedback and process guidance, and optionally a microphone 36 can be used for speech input. For example, when the user has started a test, the device 1 can play a message like

"welcome! Before we start, did you have breakfast today?" If the user answers "yes", the system plays the message "delay this test to tomorrow", otherwise it says "good, now sit down, and put a small blood sample at the yellow circle of the card". Therefore, the user can be made to feel more comfortable, simply by being spoken to by a re-assuring voice. Also, the device 1 can generate spoken feedback at runtime, so that it can react to previous user actions and measurements and tailor the feedback to a specific user. For example, if a first measurement went wrong, the device 1 can elaborate on the steps the user has to take to do it right. Another example is where the device, based on timeouts, can remind the user where he is in the measurement protocol. Also, speech is necessarily linear by nature, and a spoken narrative makes it easier to guide the user through a number of steps than a written sequence of steps, where the user can easily accidentally skip a step. Using speech is also advantageous in case of illiterate users. Besides, audible feedback can be combined with written feedback, and/or indicators, for example LEDs 6, 26, 27 on the device 1, for a more effective guidance mechanism. Also, in an embodiment, an application well w can activate a spring-loaded needle (not shown) when the user puts a body part on top of the well, to automatically draw blood. For example, the needle mechanism can only be unlocked through an electromechanical mechanism (e.g. magnetism) after the right conditions are met. Another embodiment is where the application of electrical currents is necessary to activate a chemical sensor part of the application well. This current is only applied when the device has determined that the test has started. This can be important, as the application well might only be able to accurately test for a limited period of time once the test has started.

Also, in an embodiment, interactive user guidance can involve an automated reminder to the user to detach a data-containing part after a test, and/or a periodical reminder to transmit the test results, for example to mail the device or a data-containing device part, wherein the timing of the reminder(s) can be based on timers and recording-part tear-off measurements.

An example embodiment uses voice-feedback to the user. For example, the system can perform the following steps a-d: a) system has completed a blood analysis; b) (Periodically) the user is reminded, using voice-guidance, to remove an assay carrier part 3, 5 and send in a device recording part 9; for example, this reminder continues until the user has removed the first carrier part(s) 3, 5, and is typically sent directly after the measurement, the initial frequency of the reminders being quite high and subsequently decreasing slowly; c) first carrier part(s) has/have been removed: at least one speaker 35 of a second carrier part 9 continues to give guidance to the user; d) (Periodically) the user is reminded to send in the recording part; this reminding preferably continues until the assay part arrives at a remote processing facility 20; optionally, the second carrier part 9 contains a motion sensor; while in motion, the second carrier part 9 assumes it is being transported to the processing facility, and it will delay the reminders.

Typically, reminders can occur only during daytime, directly after the removal of an assay part, and are sent once every X days.

Also, in a further embodiment, the user guidance system is preferably configured to store an interaction pattern, relating to the start and/or end of each user interaction with the user guidance system, together with the test results, for example in the memory 8. This enables the processing facility 20 to determine whether the device 1 has been handled correctly by the user, and also enables the processing facility 20 to improve the design of the device in reaction to identified common interaction problems.

Referring to Fig. 3, in an embodiment, the system could, for example, work as follows:

1. the alarm 34 awakes a user; 2. the process guidance module 8 instructs the speaker 35 to say "good morning, did you have breakfast today?";

3. the speech analysis module converts the answer (e.g. to "no");

4. the process guidance module 8 instructs the application well controller 8' to enable the upper application well w; 5. the process guidance module 8 instructs the speaker 35 to say "put a small blood sample at the upper yellow circle of the first carrier part ";

6. the sample analysis module (or processor part) 31 analyzes the blood, and sends the result to the storage module (memory) 10; 7. the storage module 10 informs the process guidance module 8 about the storage of the result;

8. the process guidance module 8 instructs the speaker 35 to say "the test is ready, please tear-off the first carrier part";

9. the process guidance module 8 repeats the previous step until the tear-off detector 33 has detected that the first carrier part has been torn off;

10. the process guidance module 8 instructs the speaker 35 to say "drop me in a mailbox".

In the above, the use of the device 1 for a Fasting Plasma Glucose Test (FPG) has been described. Advantageously, the assay system is, or is also, configured to carry out a more precise oral glucose tolerance test (OGTT). This will be described in the following, referring to Fig. 6.

For example, at least one eatable and/or drinkable product can be provided. In that case, the user guidance system can be configured to provide user guidance to guide the user to consume the eatable and/or drinkable product before and/or during using the device to assay a sample of the user. In a further embodiment, the eatable and/or drinkable product can contain glucose, and the assay device 1 is configured to test at least one blood sample for glucose. As an example, the product can be a sweet, wine gum, a glucose-containing beverage, or a different product. Besides, in this case, the disposable assay device 1 can be configured to assay at least two blood samples, for example by being provided with at least two application sample wells w. For example, the user guidance system can be configured to provide user guidance to guide the user of the device to test at least a second blood sample after elapse of a predetermined amount of time after testing a first sample. Here, a mentioned clock 34 or timer can be provided to measure the elapse of time after the user has applied a first blood sample to a respective application well. The assay device 1 can be configured to generate a first test result relating to the assaying of the first sample. Also, the user guidance system can be configured to provide guidance to guide the user to assay at least the second sample depending on the first test result. For example, a second test can be carried out in case a first test result is "assay inconclusive", "assay failed", "device failure" or a similar result. However, preferably, a second test is carried out to turn a FPG test into an OGTT test. As an example, in case the first test result indicates that it is likely that the respective user has (pre-) diabetes, a second glucose test can be performed a predetermined time period after the first test, to provide an OGTT test to verify the first test result and to provide a much more conclusive OGTT test result. For example, the assay device can be configured to carry out an oral glucose tolerance test, if desired. Fig. 6 depicts a flow chart of a use of such a device.

In Fig. 6, the assaying of user blood can be started by the user (step 160), for example by pressing a specific "start test button" S, or giving a command in any other way to the assay device 1. A subsequent initialization step 162 can involve asking the user questions (as in the Fig. 5 embodiment). The outcome of this step 162 can be that the test is not suitable to the user. In that case, the device 1 can indicate "test is not suitable" in a fail-step 168, which test result can be transmitted to a data processing system 20 (step 166).

Alternatively (as indicated by broken lines), a result of the initialization step 162 can be that the user has to wait a certain amount of time before he may use the device.

Such a delay is indicated by a delay-step 167. Also, during this step 162 it may be determined whether the user is in a fasting state (see above).

On the other hand, in case the initialization phase succeeds, a first user blood sample can be tested by the device 1 in a first blood test (step 163). Optionally, the user can be guided or instructed (for example by a mentioned user guidance system) to consume a mentioned eatable and/or drinkable product, just before, during or after applying a user blood sample to an application well w of the assay device 1. Preferably, the consumption of the product is at such a time that it does not substantially change the outcome of the first blood test. In case the first test is "negative" (i.e., chance of pre-diabetes or diabetes is unlikely), a "test ready" indication can be provided (for example "FPG ready", see step 165). Also, information or data relating to the test result can be transmitted to a processing facility 20 (step 166). For example, in the case that the user was in a fasting state just before taking his first blood sample, the first test result can be an FPG test result. On the other hand, the device 1, or a user guidance system, may require that a more accurate OGTT be performed. This can be the case, for example, when it was found in the initialization step 162 that the user was not in a fasting state. Also, the OGTT test may be required in case the first test result was positive (i.e., there is a likelihood of pre-diabetes or diabetes). To perform the OGTT test, the device 1 (or user guidance system) can notify the user to wait a predetermined amount of time (step 169; for example 1 hour, 2 hours or a different period). The user can be instructed to take a second blood sample and test the sample, using a second application well w of the device 1, immediately after lapse of the waiting period. Preferably, a reminder is provided by a user guidance system (step 173), for example via an alarm of the device 1 or via a call from a remote call center, that the waiting period is about to lapse and/or has just lapsed. Then, a second blood sample can be applied and tested (step 170), using the device 1. Thus, an oral glucose tolerance test can be carried out. Optionally, after the testing of a second blood sample, one or more blood samples can be tested after predetermined waiting periods (step 172). Preferably, the device 1 measures the amount of time that has lapsed between the application of the various blood samples to respective application wells, and stores the lapsed time period(s), or stores the times that the samples were applied to the device 1.

After completion of the testing of the at least first and second blood samples, a test ready signal can be provided (for example "OGTT ready", see step 171), and resulting test information can be transmitted in a suitable manner (step 166).

An advantage of the OGTT test is that it is much more reliable than the FPG test. In this way, for example, the assay device 1 can at least perform, or try to perform, a relatively fast FPG test on a user blood sample. Depending on the outcome of this test, or depending on the user's condition, the test can be changed into the OGTT test. In the latter case, the FPG test can simply be used as part of the OGTT test.

The present invention can provide an assay system, assay devices and an assay method, which can efficiently screen a relatively large group of individuals for one or more diseases or physiological conditions. Also, embodiments of the invention can provide a more economical and more reliable assay system, device and method.

Although the illustrative embodiments of the present invention have been described in greater detail with reference to the accompanying drawings, it will be understood that the invention is not limited to those embodiments. Various changes or modifications may be effected by one skilled in the art without departing from the scope or the spirit of the invention as defined in the claims.

It is to be understood that in the present application, the term "comprising" does not exclude other elements or steps. Also, each of the terms "a" and "an" does not exclude a plurality. Also, a single processor or other unit may fulfill functions of several means recited in the claims. Any reference sign(s) in the claims shall not be construed as limiting the scope of the claims.

The main application of the invention is in determining whether or not a patient has pre-diabetes or diabetes. However, testing for other diseases using body fluid samples or other sensor mechanisms like galvanic skin response or ECG may also benefit from this invention.

Besides, in an embodiment, the user guidance system 20 can comprise a speech processor to communicate with a user of the assay device 1 through speech and speech recognition. Also, as an example, as follows from the above, the user guidance system 20 can be configured to send a notification to a user of an assay device 1 at a predetermined time, for example a wake-up call, to notify the user to use the assay device 1 at a desired assaying time.

In yet a further embodiment, as follows from the above, the disposable assay device 1 can be configured to assay at least two blood samples, wherein the user guidance system 20 is configured to provide user guidance to guide the user of the device to test at least a second blood sample after elapse of a predetermined amount of time after testing a first sample. For example, the user guidance system 20 can be configured to provide user guidance to guide the user to assay at least the second sample, depending on the outcome of the assaying of the first sample.

Claims

CLAIMS:

1. Assay system, comprising: at least one disposable assay device (1), configured to assay one or more samples and configured for transmitting assay data or information to a remote receiving system (20); and - at least one receiving system (20) which is configured to receive the assay data or information; wherein the system is characterized by at least one interactive user guidance system that is configured to provide user guidance at least before a user applies one or more samples to the assay device (1).

2. Assay system according to claim 1, wherein at least part the user guidance system is located substantially remote from a user location of the assay device, the assay system being provided with at least one communication network to communicate user guidance from the remote user guidance system part to a user of the assay device (1).

3. Assay system according to any of the preceding claims, wherein the user guidance system is configured to ask a user of the assay device one or more questions, for example multiple-choice questions, and to receive respective answers from the user, and the user guidance system is configured to allow or disallow use of a respective assay device (1), depending on one or more answers received from a user of the device (1).

4. Assay system according to any of the preceding claims, wherein the user guidance system is configured to determine whether a user of the assay device (1) is in a fasting state, preferably by asking the user one or more fasting state-related questions and by receiving respective answers from the user, for example a question "did you have breakfast?" or "when was your last meal?".

5. Assay system according to any of the preceding claims, wherein the assay device (1) is substantially provided with the user guidance system, and the assay device (1) is provided with a processor configured to control the user guidance, whereby the processor preferably coupled to one or more audio and/or visual information generators, for example a display and/or speaker, to provide a user with the user guidance, and the assay device (1) is optionally provided with a microphone and speech recognition processor to receive and recognize speech from a user of the device (1).

6. Assay system according to any of the preceding claims, comprising at least one eatable and/or drinkable product, wherein the user guidance system is configured to provide user guidance to guide the user to consume the eatable and/or drinkable product before and/or during using the device to assay a sample of the user, which eatable and/or drinkable product preferably contains glucose, and the assay device is preferably configured to test at least one blood sample for glucose.

7. System according to any of the preceding claims, wherein the disposable assay device is configured to carry out an oral glucose tolerance test (OGTT).

8. Assay method, particularly utilizing a system according to any of the preceding claims, the method at least comprising: providing at least one disposable assay device (1) to at least one user, the assay device (1) being configured for transmitting assay data or information to a remote receiving system (20); and providing interactive user guidance to the user of the assay device (1) at least prior to the application of one or more samples to the device.

9. Method according to claim 8, wherein it is determined whether or not a user of an assay device (1) is in a fasting state, for example, by determining a time period that has passed since the user had a last meal, and wherein the user guidance prevents the user from using the assay device and/or requests the user to wait until a desired fasting state is reached, in case the user is found not to be in a desired fasting state.

10. Method according to claim 8 or9, wherein the user guidance includes one or more questions to a user of the assay device, the questions relating to specific medical conditions which are incompatible with the user of the assay device (1), and the user guidance prevents the user from using the assay device (1) in case it is found that the user has at least one of the specific medical conditions.

11. Method according to any of claims 8 to 10, comprising a user testing phase, wherein the user of the assay device is required to answer a number of questions, and an assaying phase of using the assay device (1) to assay at least one sample, wherein one or more user answers, following from the user testing phase, determine whether or not the assaying phase can be entered, and/or determine one or more assaying parameters of a respective assay.

12. Method according to any of claims 8 to 11, wherein the assay device for assaying a sample is disabled until the user has followed at least part of the user guidance.

13. Method according to any of claims 8 to 12, wherein the user guidance instructs a user of an assay device (1) to consume an eatable and/or drinkable product, and to apply at least one user sample to be assayed to the assay device.

14. Method according to claim 13, wherein an oral glucose tolerance test is carried out, utilizing the assay device (1).

15. Method according to any of the claims 8 to 14, wherein the user is guided to test at least a second blood sample after elapse of a predetermined amount of time after testing a first blood sample, and wherein preferably an outcome of the assaying of the first blood sample determines whether or not at least a second blood sample should be tested.