IVD system and method of using an IVD consumable device susceptible to environmental conditions

Abstract

An IVD system comprising an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer in order to carry out an IVD test that enables to obtain reliable test results by more reliably determining whether the IVD consumable device is within or outside of an out-of-package usability time period. In particular, the IVD analyzer comprises an optical detector for determining an optically detectable property of at least one indicator, at least one environmental sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property over time and a controller configured to correlate the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter.

Description

[0001] IVD system and method of using an IVD consumable device susceptible to environmental conditions

[0002] FIELD OF THE INVENTION

[0003] The present invention refers to an in-vitro diagnostic (IVD) system comprising an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer in order to carry out an IVD test, and to a respective method, including determining a pigment color in order to determine whether the IVD consumable device is within or outside of an out-of-package usability time period before use, because of susceptibility of the IVD consumable device to environmental conditions out of package.

[0004] BACKGROUND

[0005] Diagnosis of a medical condition and patient treatment often relies on in-vitro diagnostic (IVD) tests carried out on a patient sample by IVD analyzers, sometimes using a consumable IVD device.

[0006] It is important that the analyzers perform correctly by providing precise and reliable measurements. Thus, it is a general requirement for IVD analyzers to implement workflows that ensure analytical performance.

[0007] Some IVD consumable devices are provided in an environmentally sealed package, due to their susceptibility to environmental conditions such as light, humidity, and other air components such as Oxygen or Carbon Dioxide. Once the package is opened, in order to use the IVD consumable device together with an IVD analyzer, there is a limited time period until the consumable device can be used, due to gradual deterioration upon exposure to the environmental conditions out of the package. A use of the IVD consumable device outside of this time period can lead to unreliable IVD test results and should therefore be avoided.

[0008] There is therefore a need to automatically determine directly by the IVD analyzer whether at a time of intended use the IVD consumable device is within or outside of an out-of-package usability time period, thereby determining usability or non-usability of the IVD consumable device. The main advantage of an automatic determination is that manual errors or misuses can be prevented. One known way to automatically determine if the IVD consumable device has been out of the package for too long before use is to use pigments arranged on the IVD consumable device adapted to change color after opening of the package as a consequence of exposure to the environmental conditions. The pigment color can be determined before use by an optical detector of the IVD analyzer and can thus be determined at least approximately whether the IVD consumable device is within or outside of the out- of-package usability time period. Upon determining that the IVD consumable device is outside of the out-of-package usability time period, i.e. upon determining that the out-of-package usability time period has expired, the IVD analyzer may be configured to reject the IVD consumable device or otherwise prevent its use. Especially for emergency applications in point of care settings where the life of a patient may depend on a correct diagnosis based on a reliable IVD test result, this may be very important. Also, a patient sample may be spared before it is used with an expired IVD consumable device.

[0009] A problem associated with the use of pigments for this purpose is that they may be difficult to develop in a way that they are applicable to a variety of IVD consumable devices and IVD tests, since the out-of package usability time period may vary for different IVD consumable devices and IVD tests. Thus the change in color may not correlate exactly with the expiration of the out-of-package usability time period for a given IVD consumable device / IVD test.

[0010] One way to partially overcome this problem is to use pigments specifically developed for a particular IVD consumable device / IVD test and that develops a particular color after a predefined time of exposure to the environment that corresponds to the respective out-of-package usability time period for that particular IVD consumable device / IVD test.

[0011] However, being the change in color, per definition, susceptible to the environmental conditions, the kinetics of color change and the color itself, besides being different for different pigments under the same environmental conditions, may be also different for the same pigment under different environmental conditions. Thus it is not easy to reliably determine if the time out of package and of exposure to the environment that has caused a color change actually corresponds to an end of the out- of-package usability time period. Thus, it can happen that an IVD consumable device is rejected while still being within the out-of-package usability time period or worse that an IVD consumable device is used despite being already outside of the out-of-package usability time period. GENERAL DESCRIPTION

[0012] It is against the above background that aspects of the present disclosure provide certain unobvious advantages and advancements over the prior art In particular, a new in-vitro diagnostic (IVD) system comprising an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer in order to carry out an IVD test is herein disclosed that enables to obtain reliable test results by more reliably determining whether the IVD consumable device is within or outside of an out- of-package usability time period. This is achieved by having in the IVD analyzer not only an optical detector for determining an optically detectable property of at least one indicator, but also at least one environmental sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property over time and a controller configured to correlate the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter.

[0013] A respective automated method and presenting the same advantages is herein also disclosed.

[0014] Further advantages will be apparent from the following description and in relation to the appended claims.

[0015] In particular, the IVD system of the present disclosure comprises an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer in order to carry out an IVD test. The IVD consumable device is provided in an environmentally sealed package requiring opening of the package in order to be used together with the IVD analyzer. After opening of the package usability of the IVD consumable device is time-limited within an out-of-package usability time period, due to susceptibility of the IVD consumable device to environmental conditions out of the package. The IVD consumable device comprises an optically detectable area comprising at least one indicator having an optically detectable property adapted to gradually change over time after opening of the package as a consequence of exposure to the environmental conditions. The IVD analyzer comprises an optical detector for detecting the optically detectable property of the at least one indicator and at least one environmental sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property. The IVD analyzer further comprises a controller configured to correlate the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator- specific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use the IVD consumable device is within or outside of the out-of-package usability time period.

[0016] The term “IVD consumable device” as used herein refers to an analytical test element, also referred to as test element, specifically configured for carrying out an IVD test by determining one or more parameters of a biological sample, e.g. for detecting one or more analytes present therein, when used in conjunction with an IVD analyzer. In particular, the IVD consumable device of the present disclosure comprises at least one test chemical and / or sensory element that is susceptible to environmental conditions out of the package. The term “test chemical”, often also referred to as a “test chemistry”, as used herein may refer, without limitation, to an arbitrary material or a composition of materials adapted to change at least one detectable property in the presence of an analyte of interest. Generally, this property may be selected from an electrochemically detectable property and / or an optically detectable property, such as a color change and / or a change in remissive or transmissive properties. Specifically, the test chemical may be a highly selective test chemical, e.g. involving an antibody- antigen binding or enzymatic reaction, which leads to a property change only if the analyte is present in the biological sample applied to the test element. The degree or change of the property may be dependent on the concentration of the analyte in the biological sample, in order to allow for a quantitative detection of the analyte. The change of property of the test chemical in presence of the analyte may also be referred to as “detection reaction”.

[0017] The term “sensory element” is herein generically used to indicate an integrated sensitive component of the IVD consumable device that once coupled to a complementary component of the IVD analyzer can detect sample parameters by generating a correlated signal output that can be quantified and digitized. The sensory element can be e.g. a biosensor or chemical sensor, ion selective electrode or the like, potentially also susceptible to environmental conditions, that is selective or specific with respect to one sample parameter of interest or can be configured to detect and quantify a plurality of different sample parameters of interest.

[0018] Examples of analytes of interest include one or more of glucose, triglycerides, lactate, cholesterol, cardiac parameters, e.g. Troponin T, NT-proBNP and / or D-Dimer, sepsis parameters, e.g. Procalcitonin (PCT), and / or traumatic brain injury parameters. Additionally or alternatively, other types of analytes or sample parameters may be determined, e.g. a pH value, gases such as O2 and CO2, electrolytes such as Sodium (Na+), Potassium (K+), Chloride (Cl ), Calcium (Ca++), drugs of abuse, therapeutic drugs, hormones, markers, proteins and the like. Other analytes of interest are Hemoglobin and Hemoglobin derivatives, Bilirubin, Urea, Creatinine. The list is not exhaustive and extends for example also to antigen testing for detecting the presence of viral infection, clinical chemistry analytes, other immunochemistry analytes, coagulation parameters, hematology parameters and the like.

[0019] Thus, the test element may be designed differently according to the particular analytes of interest and respective test chemicals used. However, it typically comprises a flow path that leads an applied biological sample, typically in fluid form, to react with the at least one test chemical followed by detection at the same place of reaction or further downstream along the flow path. Alternatively, sample application, reaction and detection may occur all at the same place of the test element For example the test element can be a strip-shaped test element, comprising one or more test pads with respective test chemical(s) and the sample can be applied directly on a test pad, or else the sample can laterally flow along the strip by capillary force. According to another example, the test element is disc-shaped and comprises one or more fluidic channels, where the applied sample is movable within the fluidic channel(s) by application of a centrifugal force. According to another example, the test element is cartridge or rectangular shaped and comprises one or more fluidic channels, where the applied sample is movable within the fluidic channel(s) by application of a pump force, capillary or centrifugal / centripetal force.

[0020] The IVD consumable device is provided in an environmentally sealed package. The term “environmentally sealed package” refers to any package such as pouch, blister, bag, box or any container that is at least liquid and gas tight and can protect the consumable device enclosed therein from exposure to environmental conditions during its shelflife. The environmental conditions that the IVD consumable device may be susceptible to may include exposure to one or more reactive air components such as water (humidity), oxygen, carbon dioxide or other components, and eventually also light and / or temperature. The package may be configured to protect the IVD consumable device also from light and / or to be thermally insulating. Besides the choice of a suitable material for the package, having the above characteristics, another important factor to protect the IVD consumable device and / or to maintain it in a stable condition during its shelflife may be the inner atmosphere of the package, which may be modified such as to comprise a predefined amount of an inert gas and / or air component, e.g. carbon dioxide, at e.g. a lower or higher and constant level with respect to the environment. For example the package may be filled with CO2whereas the humidity level in the inside of the package may be minimum or near zero, e.g. 0-5% r.h. It may also include desiccants or similar chemical or physical environmental modifiers. In particular, the term “susceptibility to environmental conditions” refers to a change in property or deterioration of the at least one test chemical and / or sensory element of the IVD consumable device that affects its ability or performance at determining one or more parameters of a biological sample, as effect of exposure to a change of conditions outside of the package compared to the conditions inside of the package, over time.

[0021] Since the IVD consumable device requires opening of the package in order to be used together with the IVD analyzer, its usability after opening of the package is therefore time-limited. The term “out-of- package usability time period” refers to this time limit, beyond which the IVD consumable device should not be used, otherwise the reliability of the IVD test cannot be guaranteed. The out-of-package usability time period can vary for different IVD consumable devices depending on the particular IVD test(s) that they are configured to carry out and therefore on the particular test chemical(s) and / or sensory element(s) used, which may have varying susceptibility to the environmental conditions within the same time period, i.e. different kinetics of property change or deterioration. The out-of-package usability time period is typically fixed for a given IVD consumable device, i.e. it has a fixed duration starting from the time of opening of the packaging or from a measured time as close as possible to the opening of the package. However, according to certain embodiments of the present disclosure, the out- of-package usability time period may be variable since the environmental conditions may be variable.

[0022] The term “indicator” as used herein refers to a material or a composition of materials adapted to gradually change at least one optically detectable property over time in response to exposure to environmental / ambient conditions, allowing the change to be measured / quantified and to be correlated to the time of exposure to environmental / ambient conditions. The indicator can thus be considered as a time indicator. The change in the at least one optically detectable property may include a change in color, a change in light transmissivity, a change in optical density / transparency, polarization changes, contrast changes, reflective changes, structural changes, e.g. expansion or contraction, pattern appearance or disappearance e.g. dots, streaks, bands, lines, character production, barcode, e.g. created by time-dependent and / or temperature-dependent diffusion of a liquid, and the like. The term “optically detectable area” refers to an area on the surface of the IVD consumable device, e.g. a label, tag or printed area comprising at least one indicator at a position which fits in an optical path or field of view of the optical detector of the IVD analyzer when the IVD consumable device is used by the IVD analyzer, for the optical detector to detect the optically detectable property of the at least one indicator. In particular an indicator may occupy a subarea of the optically detectable area and the optically detectable area may comprise a plurality of indicators.

[0023] According to an embodiment, the at least one indicator is a pigment and the optically detectable property is a pigment color. Many pigments have been developed as time indicators, e.g. the color of which is subject to change in response e.g. to temperature differences and / or humidity differences and / or other environmental parameters, as known in the art, and are therefore not further elucidated here, since different pigments may be selected according to the particular IVD consumable device / IVD test and respective out-of-package usability time period. Examples of time indicators, also called “after opening timers”, used e.g. in the food industry, are provided by Insigna Technologies. They provide consumers with a visual indication of how long e.g. a food package has been open, encouraging them to use the product whilst at its optimum freshness and preventing food from being thrown away unnecessarily. Particularly, they are intended for foods packaged within a modified atmosphere. Food packaging manufacturers can print them as ink directly into the lidding film of the package or in a label format and, once opened, the ink changes color over time to indicate how long the package has been opened or if there was a leak. Other examples by the same provider find applications also in the health industry, e.g. visually enhancing decontamination compliance through time-based color changes.

[0024] Another example of time indicator based on an optically detectable property is provided by Varcode that utilizes a sort of barcode that dynamically shifts as a result of ink diffusion in response to temperature changes over time, as e.g. disclosed in W02022 / 244001A2.

[0025] According to an embodiment, the optically detectable area comprises a plurality of pigments adapted to gradually change color differently when compared to each other as a consequence of exposure to the same environmental conditions in order to even more reliably determine whether the IVD consumable device is within or outside of the out-of-package usability time period.

[0026] The term “in-vitro diagnostic analyzer” or “IVD analyzer” as used herein refers to an automated or semi-automated analytical apparatus configured to operate together with the IVD consumable device in order to analyze biological samples in vitro and to provide information for screening, diagnosis or treatment monitoring purposes. For example, in a point-of-care testing environment, IVD analyzers can vary from handheld devices with low throughput, short turn-around time and limited number of measurable parameters to compact benchtop instruments with higher throughput and higher number of measureable parameters. In particular, the IVD analyzer can be configured for temporarily receiving and / or being operatively coupled to and interacting with the IVD consumable device. More in particular, the IVD analyzer can be designed and configured according to the medical area of application and the type of IVD consumable device used, the parameters to be determined and the corresponding detection methods and measuring principles. The IVD analyzer typically comprises a plurality of functional units, each dedicated to a specific task and cooperating with each other in order to enable automated sample processing and analysis in conjunction with the IVD consumable device. Such functional units may include e.g. a sample input interface for introducing a sample, a fluidic system, an analytical measurement unit or detecting unit, a fluid-supply unit, a pipetting unit, a rotor unit for rotating the IVD consumable device in case the IVD consumable device is disc shaped, and the like.

[0027] In particular, the IVD analyzer of the present disclosure comprises an optical detector for detecting the optically detectable property of the at least one indicator and at least one environmental sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property.

[0028] Specifically, the optical detector may be or may comprise at least one of a one- or two-dimensional optical scanner, an image acquisition device such as a digital camera sensor (e.g. a complementary metal-oxide semiconductor (CMOS), a charge coupled device (CCD), a linear diode, etc.), or any other suitable photodetector, and may include other optical components such as an illumination source, wavelength filters, mirrors and the like. The optical detector may be integrated into the IVD device. Alternatively or additionally, the optical detector may be a separate device, configured to communicate directly or indirectly, e.g. by wired or wireless communication, with the IVD analyzer, such as e.g. a handheld optical device. The optical detector may comprise a processing unit for processing, e.g. decoding, acquired images. Alternatively or in addition, the optical detector may be connected to a processor / controller, e.g. of the IVD analyzer, which processes the acquired images.

[0029] The term “environmental sensor” as used herein refers to a sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property over time. It may thus be configured differently according to the environmental parameter to be determined. Specifically, the at least one environmental sensor may be for example a humidity sensor or hygrometer, an oxygen sensor, e.g. an oxygen optode, a carbon dioxide sensor, e.g. a nondispersive infrared (NDIR) CO2sensor, or any other air component sensor based on known principles, a temperature sensor or thermometer, a photodetector to measure ambient light intensity and / or wavelength, and the like.

[0030] The term “controller” as used herein may include any physical or virtual processing device and in particular a programmable logic controller running a computer-readable program provided with instructions to perform operations in accordance with an operation plan and in particular in accordance with the disclosed process of correlating the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicatorspecific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use the IVD consumable device is within or outside of the out-of-package usability time period. This may include a processor, a controller, a central processing unit (CPU), a microprocessor, a microcontroller, a reduced instruction circuit (RISC), an application-specific integrated circuit (ASIC), a logic circuit, or any other circuit or processor configured to execute one or more of the functions / methods described herein in communication with and cooperation with the at least one optical device and the at least one environmental sensor.

[0031] The term “indicator-specific calibration” in relation to the optically detectable property refers to a stored set of reference values of the optically detectable property, e.g. in a matrix or table format or line or curve format obtained plotting the reference values, obtained by measuring over time, e.g. continuously or at regular intervals, the optically detectable property under varying values of the at least one environmental parameter affecting the change of the optically detectable property, for each indicator. For example, if the indicator is a pigment, the pigment- specific calibration is obtained by measuring the pigment color over time under varying values of the at least one environmental parameter affecting the pigment color change, for example by measuring the pigment color over time under a predefined value of humidity and / or CO2and / or temperature, then repeating the procedure under a different predefined value of humidity and / or CO2and / or temperature and so on.

[0032] The term “obtained by measuring over time” with respect to the indicator-specific calibration refers to a time of process / assay development by the manufacturer and not to a time of use of the IVD analyzer / IVD consumable device. The indicator-specific calibration is thus stored as a reference and made available to the controller / IVD analyzer for later use.

[0033] “Correlating the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration” means correlating the value of the optically detected property to the reference values of the optically detectable property obtained under the same or similar value(s) of the at least one environmental parameter that has been determined by the environmental sensor. “Correlating” may specifically include comparing detected values with the reference values and selecting the reference value(s) corresponding to the optically detected property and / or using the calibration curve or line to determine, e.g. by comparison or extrapolation, the correct value of the optically detected property. For example, if the indicator is a pigment, correlating may specifically include comparing detected pigment colors with the reference pigment colors and selecting the reference pigment color corresponding to the optically detected pigment color and / or using the calibration curve or line to determine, e.g. by comparison or extrapolation, the correct optically detected pigment color, thereby more reliably determining how much time has elapsed from opening of the package and whether at the time of intended use the IVD consumable device is within or outside of the out-of-package usability time period.

[0034] According to an embodiment, upon determining that the IVD consumable device is within the out-of- package usability time period the controller is configured to enable use of the IVD consumable device by the IVD analyzer.

[0035] According to an embodiment, upon determining that the IVD consumable device is within the out-of- package usability time period the controller is configured to provide indication of the duration of the out-of-package usability time period and / or remaining usability time.

[0036] According to an embodiment, upon determining that the IVD consumable device is outside of the out- of-package usability time period the controller is configured to provide a warning and / or to prevent use of the IVD consumable device for carrying out the IVD test or to prevent release of a test result despite use of the IVD consumable device or to flag the test result as unreliable in case of release of test result.

[0037] According to an embodiment, the controller is configured to prevent use of the IVD consumable device upon failure to detect the optically detectable property and / or upon failure to determine the value of the at least one environmental parameter. According to an embodiment, the out-of-package usability time period is variable and is dynamically determined by the controller depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects change of the optically detectable property also affects usability of the IVD consumable device. Thus it is possible to determine if the time out of package and of exposure to the environment that has caused a color change actually corresponds to an end of the out-of-package usability time period. If that is not the case the out-of-package usability time period may be either shortened or extended, depending on the circumstances, thereby preventing that an IVD consumable device is rejected while still being within the out-of-package usability time period or worse that an IVD consumable device is used despite being already outside of the out-of- package usability time period.

[0038] A method of using an IVD consumable device together with an IVD analyzer in order to carry out an IVD test, is herein also disclosed, where the IVD consumable device is provided in an environmentally sealed package requiring opening of the package in order to be used together with the IVD analyzer and where after opening of the package usability of the IVD consumable device is time-limited within an out-of-package usability time period, due to susceptibility of the IVD consumable device to environmental conditions out of the package. In particular, the method comprises detecting by an optical detector of the IVD analyzer an optically detectable property of at least one indicator on an optically detectable area of the IVD consumable device adapted to gradually change over time after opening of the package as a consequence of exposure to the environmental conditions, determining by at least one environmental sensor of the IVD analyzer a value of at least one environmental parameter affecting the change of the optically detectable property, and correlating by a controller of the IVD analyzer the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator- specific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use the IVD consumable device is within or outside of the out-of-package usability time period.

[0039] According to an embodiment, the method comprises using a pigment as indicator, where the optically detectable property is a pigment color.

[0040] According to an embodiment, the method comprises using a plurality of pigments on the optically detectable area adapted to gradually change color differently when compared to each other as a consequence of exposure to the same environmental conditions thereby even more reliably determining whether the IVD consumable device is within or outside of the out-of-package usability time period.

[0041] According to an embodiment, the at least one environmental parameter is air humidity and / or temperature and / or O2and / or CO2levels.

[0042] According to an embodiment, the method comprises enabling by the controller use of the IVD consumable device by the IVD analyzer, upon determining that the IVD consumable device is within the out-of-package usability time period.

[0043] According to an embodiment, the method comprises providing by the controller a warning and / or preventing by the controller use of the IVD consumable device for carrying out the IVD test or preventing by the controller release of a test result despite use of the IVD consumable device or flagging by the controller the test result as unreliable in case of release of test result, upon determining that the IVD consumable device is outside of the out-of-package usability time period.

[0044] According to an embodiment, the method comprises preventing by the controller use of the IVD consumable device upon failure to detect the optically detectable property of the at least one indicator and / or upon failure to determine the value of the at least one environmental parameter.

[0045] According to an embodiment, the out-of-package usability time period is variable and the method comprises dynamically determining by the controller the out-of-package usability time period depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects the change of the optically detectable property also affects usability of the IVD consumable device.

[0046] Other and further objects, features and advantages will appear from the following description of exemplary aspects and accompanying drawings, which serve to explain the principles more in detail.

[0047] BRIEF DESCRIPTION OF THE DRAWINGS

[0048] FIG. 1 shows schematically an exemplary in-vitro diagnostic (IVD) system comprising an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer as well as a method of using the IVD consumable device by the IVD analyzer. FIG. 2 shows in more detail and magnification an example of indicator-specific calibration as used in connection with FIG. 1.

[0049] FIG. 3 shows another example of indicator-specific calibration.

[0050] FIG. 4 is a flowchart illustrating additional aspects and possible configurations of the controller of the IVD analyzer as well as of the method of using the IVD consumable device by the IVD analyzer, in addition to FIG. 1.

[0051] Skilled artisans appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements whereas other elements may have been left out or represented in a reduced number in order to enhance clarity and improve understanding of the aspects of the present disclosure.

[0052] DETAILED DESCRIPTION

[0053] FIG. 1 shows schematically an exemplary in-vitro diagnostic (IVD) system 400 comprising an IVD analyzer 300 and an IVD consumable device 100 configured to be used together with the IVD analyzer 300 in order to carry out an IVD test, where the IVD consumable device 100 is provided in an environmentally sealed package 200 requiring opening of the package 200 in order for the IVD consumable device 100 to be used together with the IVD analyzer 300, and where after opening of the package 200 usability of the IVD consumable device 100 is time-limited within an out-of-package usability time period 111, due to susceptibility of the IVD consumable device 100 to environmental conditions out of the package 200. The IVD consumable device 100 is schematically shown in dashed lines and light shades when still in the environmentally sealed package 200 and in solid lines outside of the package 200. The IVD consumable device 100 comprises an optically detectable area 110 comprising at least one indicator 101, 102, 103 having an optically detectable property adapted to gradually change over time after opening of the package 200 as a consequence of exposure to the environmental conditions. The IVD analyzer 300 comprises an optical detector 301 for detecting the optically detectable property of the at least one indicator 101, 102, 103 and at least one environmental sensor 302, 303 configured to determine a value of at least one environmental parameter affecting the change of the optically detectable property of the at least one indicator 101, 102, 103 and a controller 350 configured to correlate the optically detected property of the at least one indicator 101, 102, 103 to the determined value of the at least one environmental parameter by reference to a stored indicator- specific calibration 120 of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use 112 the IVD consumable device 100 is within or outside of the out-of-package usability time period 111.

[0054] The IVD analyzer 300 may comprise an internal optical detector (not shown) for detecting the optically detectable property of the at least one indicator 101, 102, 103 when the IVD consumable device 100 is inside the IVD analyzer 300 and not necessarily visible from the outside. Also the IVD analyzer 300 may comprise a mark reader (not shown) for reading an identification mark 104, e.g. an optical identifier, such as a QR code of the IVD consumable device 100.

[0055] In the example shown, the at least one indicator 101, 102, 103 is a pigment and the optically detectable property is a pigment color. In particular, the optically detectable area 110 comprises a plurality of pigments 101, 102, 103 adapted to gradually change color differently when compared to each other as a consequence of exposure to the same environmental conditions in order to even more reliably determine whether the IVD consumable device 100 is within or outside of the out-of-package usability time period 111.

[0056] Only as arbitrary example, the environmental parameters affecting color change of the pigments 101, 102, 103 are in this case air humidity, temperature and CO2levels, while it may be sufficient to determine only air humidity and temperature by a humidity sensor 302 and a temperature sensor 303 respectively.

[0057] According to an embodiment, the out-of-package usability time period 111 is variable and is dynamically determined by the controller 350 depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects change of the optically detectable property also affects usability of the IVD consumable device 100. This means that the out-of- package usability time period 111 maybe either shortened or extended, depending on the circumstances, thereby preventing that an IVD consumable device 100 is rejected while still being within the out-of- package usability time period 111 or worse that an IVD consumable device 100 is used despite being already outside of the out-of-package usability time period 111. In the example shown, the end of the out-of-package usability time period 111 is postponed (End’). FIG. 2 shows in more detail and magnification the example of indicator-specific calibration 120 of the optically detectable property shown in FIG. 1, that is a pigment-specific calibration of a pigment color. In particular, the optically detectable property is a pigment color (converted to gray scale in FIG. 2), detected under varying values of relative humidity (r. h.) over time, e.g. every 10 minutes over a period of 60 minutes, at 25 °C, which is the same room temperature determined by the temperature sensor 303 of FIG. 1. It can be observed how the pigment color (for an arbitrary pigment) may differently vary over time at different values of relative humidity. For example, if the pigment color is detected under a relative humidity value of 11% (first row), the pigment color appears to remain nearly unchanged even after 60 minutes, and is for example the same color that can be detected after only 10 minutes under a relative humidity value of 40%. Without determining the actual value of relative humidity and temperature by the humidity sensor 302 and temperature sensor 303 of FIG. 1, and without reference to the indicator-specific calibration 120, simply determining the pigment color would therefore lead to an unreliable determination of how much time the IVD consumable device 100 has been out of the package and whether at a time of intended use the IVD consumable device 100 is within or outside of the out-of-package usability time period 111.

[0058] FIG. 3 shows another example of indicator-specific calibration 120’ of the optically detectable property, that is also a pigment-specific calibration of a pigment color for an arbitrary pigment. In particular the graph shows three time series of how the color of the same pigment changes (represented as % of color change from an initial color to a final color on the ordinate) over time (in minutes on the abscissa) under the same value of CO2 and relative humidity but varying values of temperature, 12 °C, 22 °C and 32 °C respectively. For example it can be seen that a ca 50% color change for the same pigment is obtained after about 10 min at 12 °C, after about 20 min at 22 °C and after about 50 min at 32 °C. Thus, also in this case, without determining the actual value of environmental parameters such as temperature, and without reference to the indicator- specific calibration 120’, simply determining the pigment color would therefore lead to an unreliable determination of how much time the IVD consumable device 100 has been out of the package and whether at a time of intended use the IVD consumable device 100 is within or outside of the out-of-package usability time period 111.

[0059] With continued reference to FIG. 1-3 and in conjunction to FIG. 4 additional aspects and possible configurations of the controller 350 of the IVD analyzer 300 as well as a method of using the IVD consumable device 100 by the IVD analyzer 300, in order to carry out an IVD test, as being performed by the controller 350, are also shown. In particular, the method comprises detecting by an optical detector 301 of the IVD analyzer 300 an optically detectable property of at least one indicator 101, 102, 103 on an optically detectable area 110 of the IVD consumable device 100 adapted to gradually change over time after opening of the package 200 as a consequence of exposure to the environmental conditions, determining by at least one environmental sensor 302, 303 of the IVD analyzer 300 a value of at least one environmental parameter affecting the change of the optically detectable property, and correlating by the controller 350 of the IVD analyzer 300 the optically detected property of the at least one indicator 101, 102, 103 to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration 120, 120’ of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use 112 the IVD consumable device 100 is within or outside of the out- of-package usability time period 111.

[0060] Upon determining that the IVD consumable device 100 is outside of the out-of-package usability time period 111 or upon failure to detect the optically detectable property of the at least one indicator 101, 102, 103 or upon failure to determine the value of the at least one environmental parameter, the controller 350 may be configured to provide a warning and / or to prevent use of the IVD consumable device 100 for carrying out the IVD test or to prevent release of a test result despite use of the IVD consumable device 100 or to flag the test result as unreliable in case of release of test result.

[0061] On the other end, upon determining that the IVD consumable device 100 is within the out-of-package usability time period 111 the controller 350 may be configured to enable use of the IVD consumable device by the IVD analyzer 300.

[0062] The out-of-package usability time period 111 may be variable and the method may comprise dynamically determining by the controller 350 the out-of-package usability time period depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects the change of the optically detectable property also affects usability of the IVD consumable device 100.

[0063] Modifications and variations of the disclosed aspects are also certainly possible in light of the above description. It is therefore to be understood, that within the scope of the appended claims, the invention may be practiced otherwise than as specifically devised in the above examples. Particularly, it is to be understood that at least some of the drawings or parts are only schematic and provided as way of example only. Also the relationship between elements may be other than the one shown, whereas parts not relevant for the purpose of this disclosure have been omitted.

[0064] Also, reference throughout the preceding specification to "one aspect ", 'an aspect ", "one example" or "an example", “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the aspect or example or embodiment is included in at least one aspect, example or embodiment. Thus, appearances of the phrases "in one aspect ", "in one aspect ", "one example" or "an example ", “one embodiment” or “an embodiment”, in various places throughout this specification are not necessarily all referring to the same aspect or example or embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable combinations and / or sub-combinations in one or more aspects or examples or embodiments.

Claims

CLAIMS1. An in-vitro diagnostic (IVD) system (400) comprising an IVD analyzer (300) and an IVD consumable device (100) configured to be used together with the IVD analyzer (300) in order to carry out an IVD test, wherein the IVD consumable device (100) is provided in an environmentally sealed package (200) requiring opening of the package (200) in order to be used together with the IVD analyzer (300), wherein after opening of the package (200) usability of the IVD consumable device (100) is time -limited within an out-of-package usability time period (111), due to susceptibility of the IVD consumable device (100) to environmental conditions out of the package (200), and wherein the IVD consumable device (100) comprises an optically detectable area (110) comprising at least one indicator (101, 102, 103) having an optically detectable property adapted to gradually change over time after opening of the package (200) as a consequence of exposure to the environmental conditions, wherein the IVD analyzer (300) comprises an optical detector (301) for detecting the optically detectable property of the at least one indicator (101, 102, 103) and at least one environmental sensor (302, 303) configured to determine a value of at least one environmental parameter affecting the change of the optically detectable property of the at least one indicator (101, 102, 103) and a controller (350) configured to correlate the optically detected property of the at least one indicator (101, 102, 103) to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration (120, 120’) of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use (112) the IVD consumable device (100) is within or outside of the out- of-package usability time period (111).

2. The IVD system (400) according to claiml wherein the at least one indicator (101, 102, 103) is a pigment and the optically detectable property is a pigment color.

3. The IVD system (400) according to claim 2 wherein the optically detectable area (110) comprises a plurality of pigments (101, 102, 103) adapted to gradually change color differently when compared to each other as a consequence of exposure to the sameenvironmental conditions in order to even more reliably determine whether the IVD consumable device (100) is within or outside of the out-of-package usability time period (Hl).

4. The IVD system (400) according to any of the preceding claims wherein the at least one environmental parameter is air humidity and / or temperature and / or O2and / or CO2levels.

5. The IVD system (400) according to any of the preceding claims wherein upon determining that the IVD consumable device (100) is within the out-of-package usability time period (111) the controller (350) is configured to enable use of the IVD consumable device (100) by the IVD analyzer (300).

6. The IVD system (400) according to any of the preceding claims wherein, upon determining that the IVD consumable device (100) is outside of the out-of-package usability time period (111) or upon failure to detect the optically detectable property of the at least one indicator (101, 102, 103) or upon failure to determine the value of the at least one environmental parameter, the controller (350) is configured to provide a warning and / or to prevent use of the IVD consumable device (100) for carrying out the IVD test or to prevent release of a test result despite use of the IVD consumable device (100) or to flag the test result as unreliable in case of release of the test result.

7. The IVD system (400) according to any of the preceding claims wherein the out-of-package usability time period ( 111 ) is variable and is dynamically determined by the controller (350) depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects change of the optically detectable property also affects usability of the IVD consumable device (100).

8. A method of using an IVD consumable device (100) together with an IVD analyzer (300) in order to carry out an IVD test, wherein the IVD consumable device (100) is provided in an environmentally sealed package (200) requiring opening of the package (200) in order to be used together with the IVD analyzer (300), wherein after opening of the package (200)usability of the IVD consumable device (100) is time -limited within an out-of-package usability time period (111), due to susceptibility of the IVD consumable device (100) to environmental conditions out of the package (200), the method comprising- detecting by an optical detector (301) of the IVD analyzer (300) an optically detectable property of at least one indicator (101, 102, 103) on an optically detectable area (110) of the IVD consumable device (100) adapted to gradually change over time after opening of the package (200) as a consequence of exposure to the environmental conditions,- determining by at least one environmental sensor (302, 303) of the IVD analyzer (300) a value of at least one environmental parameter affecting the change of the optically detectable property,- correlating by a controller (350) of the IVD analyzer (300) the optically detected property of the at least one indicator (101, 102, 103) to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration (120, 120’) of the optically detectable property obtained under varying values of the at least one environmental parameter, thereby more reliably determining whether at a time of intended use (112) the IVD consumable device (100) is within or outside of the out-of-package usability time period (111).

9. The method according to claim 8 wherein the at least one indicator (101, 102, 103) is a pigment and the optically detectable property is a pigment color.

10. The method according to claim 9 wherein the optically detectable area (110) comprises a plurality of pigments (101, 102, 103) adapted to gradually change color differently when compared to each other as a consequence of exposure to the same environmental conditions thereby even more reliably determining whether the IVD consumable device (100) is within or outside of the out-of-package usability time period (111).

11. The method according to any of the claims 8 to 10 wherein the at least one environmental parameter is air humidity and / or temperature and / or O2and / or CO2levels.

12. The method according to any of the claims 8 to 11 comprising enabling by the controller (350) use of the IVD consumable device (300) by the IVD analyzer (300), upon determining that the IVD consumable device (300) is within the out-of-package usability time period(Hl).

13. The method according to any of the claims 8 to 12 comprising providing by the controller (350) a warning and / or preventing by the controller (350) use of the IVD consumable device (100) for carrying out the IVD test or preventing by the controller release of a test result despite use of the IVD consumable device (100) or flagging by the controller (350) the test result as unreliable in case of release of test result, upon determining that the IVD consumable device (100) is outside of the out-of-package usability time period (111) or upon failure to detect the optically detectable property of the at least one indicator (101, 102, 103) or upon failure to determine the value of the at least one environmental parameter.

14. The method according to any of the claims 8 to 13 wherein the out-of-package usability time period (111) is variable and the method comprises dynamically determining by the controller (350) the out-of-package usability time period (111) depending on the value of the at least one determined environmental parameter if the at least one environmental parameter that affects the change of the optically detectable property also affects usability of the IVD consumable device (100).

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