Recyclable in vitro test system and method for recycling an in vitro test system

Abstract

The present invention relates to a recyclable in vitro test system comprising a diagnostic unit which has a diagnostic reagent that can be converted into a diagnostic product by being brought into contact with a sample taken from an organism, or with sample material that can be obtained from such a sample, the diagnostic product itself being optically perceptible and / or being capable of inducing a reaction, the reaction product of which can be optically perceived, and a housing which surrounds at least part of the diagnostic unit. The housing has, as its main constituent, a polymer originating from a renewable raw-material source. The invention also relates to a method for recycling an in vitro test system, the method comprising the steps of: - providing an in vitro test system which is used to detect a property of an organism and which comprises a housing having, as its main constituent, a polymer originating from a renewable raw-material source; - dividing the housing into at least two housing fragments in order to thereby make a diagnostic unit at least in part accessible; - separating the diagnostic unit from the housing fragments; and - separately disposing of the diagnostic unit and the housing fragments.

Description

[0001] HANNKE BITTNER & PARTNER

[0002] PATENT ATTORNEYS AT LAW

[0003] Prüfeninger Straße 1

[0004] 93049 Regensburg

[0005] LaVita GmbH, December 5, 2025

[0006] Alt Praunheim 46D LAV01-011-WOPT 60488 Frankfurt am Main BI / ME / fa / gu

[0007] Recyclable in vitro test system and method for recycling an in vitro test system

[0008] Description

[0009] The present invention relates to a recyclable in vitro test system and a method for recycling an in vitro test system. In vitro test systems have been known in the art for a long time. They are of particular importance in diagnosing the health status of living organisms, such as humans. Such test systems are used extensively by medical personnel, for example in doctors' offices and hospitals, for diagnosing diseases and analyzing patient samples, but also by medically untrained personnel for self-diagnosis. Particularly during the COVID-19 pandemic, a large number of in vitro test systems for self-testing were launched on the market, providing users with results regarding a possible COVID-19 infection within a short time.

[0010] However, such in vitro test systems are not limited to the diagnosis of diseases, but are frequently used in the analysis of samples taken from an organism. The aim of such tests can be, for example, the detection of deficiencies due to an unbalanced diet. These tests are typically administered by medically untrained personnel and are available over the counter at pharmacies or drugstores. An example of such a test system is blood glucose testing for monitoring blood sugar levels in diabetics. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0011] 2 -

[0012] Furthermore, urine tests are widely used to detect substances such as glucose (sugar), blood, protein, nitrite, or leukocytes (white blood cells) in urine. Pregnancy tests also constitute a large proportion of such self-diagnostic tests. These, too, usually require a urine sample.

[0013] During the COVID-19 pandemic, a particularly large number of in vitro tests were conducted outside of hospitals and doctors' offices. This highlighted the problem of disposing of the test systems used. Since these tests are typically intended for single use and must be disposed of after the test result is read, they generate a large amount of waste. This waste is difficult to dispose of because it comprises a variety of components, some of which, depending on the test and the sample material analyzed, may also be harmful to health.

[0014] Until now, these test systems could not be recycled and had to be disposed of as residual waste or even hazardous waste. With over 10 million in vitro tests conducted annually in Germany alone, this results in at least 1001 units of residual waste, assuming an average test system weighs approximately 10 g. A significant portion of this waste is plastic, which cannot be recycled because it is either inseparable from the other components of the test system or is not separated by the user. Test systems using polylactate as a raw material have already been developed. While this has enabled a degree of biodegradability, it requires specific environmental conditions that are generally only found in industrial composting facilities, and even then, undesirable decomposition products can remain in the resulting compost.

[0015] The present invention therefore aims to provide an in vitro test system which, compared to test systems known from the prior art, has an improved environmental footprint and is preferably easier to recycle. Furthermore, a method is to be presented by which an in vitro test system can be processed after its application in order to enable at least essential parts of such a test system to be recycled.

[0016] This is achieved according to the invention by an in vitro test system and a method for recycling an in vitro test system according to the independent claims. Advantageous embodiments and further developments are the subject of the dependent claims. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0017] - 3 -

[0018] A recyclable in vitro test system according to the invention comprises a diagnostic unit and a housing.

[0019] The diagnostic unit comprises a diagnostic reagent that can be converted into a diagnostic product by contact with a sample taken from an organism or with sample material obtainable from such a sample. The diagnostic product itself is optically perceptible and / or a reaction can be induced by the diagnostic product, the reaction product of which is optically perceptible. Due to the complexity of the diagnostic reagent, the unknown composition of the sample taken from the organism, and the resulting diagnostic product, the diagnostic unit is usually not recyclable and may even have to be disposed of separately due to the chemical substances it contains and / or biohazards.The term “recyclable in vitro test system” should therefore be understood to mean that significant parts of the test system, for example > 70% by weight, > 80% by weight, > 90% by weight or even > 95% by weight, in particular the housing, can be further recycled, whereby thermal recycling should not be understood as recycling.

[0020] The housing surrounds the diagnostic unit at least partially and is characterized in particular by the fact that its main component is a polymer derived from a renewable raw material source.

[0021] Such a design avoids the presence of a large quantity of petroleum-derived plastic in the in vitro test system. This significantly improves the environmental footprint of such an in vitro test system, and in particular its CO2 balance.

[0022] Preferably, the polymer, derived from a renewable raw material source, comprises cellulose, hemicellulose, and / or lignin. These polymers are generated in large quantities as waste products during the processing of renewable raw materials. For many applications, these waste products are unusable because their composition often varies depending on the raw material used and its growth conditions. By using one or more of the raw materials from the group mentioned above, this can be avoided. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0023] 4 - that these must be disposed of in a costly manner, which is usually done through thermal recycling - i.e. CC>2-emitting combustion.

[0024] A particularly preferred embodiment has been found in which the polymer comprises bagasse derived from a renewable raw material source. Bagasse is, for example, a waste product of sugar production and usually refers to the fibrous, ground residue left over after sugar production, such as after pressing sugar cane or extracting syrup from sorghum. Depending on the raw material source and its raw sugar content, approximately 300–400 kg of bagasse are produced during the manufacture of one ton of sugar. To date, this has mostly been used for energy generation as a solid fuel. This often occurs directly at the sugar factory, where the energy from combustion can be used to generate the (electrical) energy and heat required for sugar production. However, a disadvantage of this approach is that CO2 is released directly into the environment without any further use of the bagasse.Furthermore, a complete switch to CO2-free energy sources is not possible with this use of bagasse.

[0025] The polymer derived from a renewable raw material source preferably comprises at least 50% by weight, preferably at least 75% by weight, more preferably at least 90% by weight, and particularly preferably at least 95% by weight of bagasse. It is particularly preferred that the polymer derived from a renewable raw material source is bagasse. A high proportion of bagasse in the polymer has proven advantageous because, on the one hand, bagasse is available in large quantities at a relatively low cost, and on the other hand, recycling is simplified if as few other substances or other polymers (e.g., from fossil raw materials) as possible are added to the bagasse. Pure bagasse, in particular, can be easily reused and is completely compostable.

[0026] Unless otherwise defined in this description of the invention, all percentages shall be understood as weight percentages.

[0027] Preferably, the polymer, derived from a renewable raw material source, is produced using a process that can be described as environmentally friendly and / or without the use of toxic substances. In particular, the use of polymer based on HANNKE BITTNER & PARTNER LAV01-011-WOPT is preferred.

[0028] 5 -

[0029] Bagasse has proven to be particularly advantageous in this respect, as it can be obtained from sugar cane bagasse, for example, in a particularly efficient and clean process that differs significantly from the production of petroleum-based plastics.

[0030] The polymer for manufacturing the housing of the recyclable in vitro test system can be derived from the agricultural residue generated during sugar production. Therefore, no additional land is required for the agricultural production of the raw material. Instead, the sugarcane stalks or stems used for sugar production can be pressed, separating them from the extract and bagasse. The bagasse contains, for example, fibrous plant residues as well as impurities such as sticky sugar residues. These impurities can be largely removed by washing. Drying is then preferably carried out to simplify transport for further processing, if necessary.

[0031] For further processing, bagasse is preferably mixed with water and mechanically processed into a slurry. This results in a moist, soupy, pulp-like slurry (similar to the pulp used in papermaking). This process is preferably carried out without the addition of any further chemicals. For example, the use of bleaching agents or aggressive additives can usually be avoided. The slurry can be converted into a fibrous pulp, which is preferably formable without additional binders (especially without binders derived from petroleum derivatives).

[0032] The shaping is preferably carried out by filling the (bagasse) slurry into specific molds, which are preferably made of metal. The molds are preferably at least two-part, more preferably two-part. The mold halves are placed against each other so that the (bagasse) slurry is enclosed in a cavity between the mold halves. Preferably, different molds are used to form the various parts of the housing of the recyclable in vitro test system.

[0033] Preferably, the solidification of the components into the housing of the recyclable in vitro test system takes place in the molds under temperature and / or pressure. Both temperature and pressure treatment result in water being driven out of the slurry, either as liquid and / or vapor. This process transforms the (bagasse) fibers into HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0034] 6 - a rigid form, namely the parts of the housing of the recyclable in vitro test system. In particular, a combination of temperature and pressure has proven advantageous for solidifying the (bagasse) slurry into the desired (intermediate) products within the cavity of the molded part halves. The temperature application preferably occurs at a temperature of > 60 °C, more preferably > 80 °C, further preferably > 100 °C, particularly preferably > 120 °C, and more preferably < 300 °C, more preferably < 250 °C, more preferably < 200 °C, and particularly preferably < 150 °C. Furthermore, applying both elevated temperature and pressure has also proven advantageous because the solidification process can be particularly rapid.Preferably, the solidification of the slurry is completed within a few minutes, preferably < 20 minutes, more preferably < 15 minutes, more preferably < 10 minutes, and in particular preferably < 5 minutes, at least to the extent that the resulting parts of the housing can be removed from the mold without deforming during subsequent transport or storage.

[0035] Preferably, the process for manufacturing the housing components from bagasse can be carried out without additional CO2 emissions. The energy required for temperature control can be obtained, for example, from the waste heat of sugar production. The at least temporary binding of the organic material from the bagasse in the (molded) components of the housing for the recyclable in vitro test system prevents the immediate release of the contained carbon as CO2, such as that which would occur after the currently widespread thermal processing of bagasse. Therefore, by using bagasse as a raw material for the housing components of the recyclable in vitro test system, greenhouse gas emissions can even be reduced compared to other uses of bagasse.

[0036] In a preferred embodiment, the recyclable in vitro test system is characterized by the fact that the diagnostic reagent is applied to a carrier. This makes it particularly easy to position within the housing. Within the scope of this invention, the carrier with one or more diagnostic reagents arranged on it shall be understood collectively as the "diagnostic unit".

[0037] The support is preferably received, at least partially, in a support receptacle formed integrally with the housing. The support receptacle is therefore preferably made of the same material as the housing. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0038] - 7 -

[0039] As detailed below, the housing can be made up of multiple parts. The support receptacle can be integrated into one or more of these housing parts independently. For example, it is conceivable that parts of the support receptacle are arranged in two housing parts. This could include, for instance, a bearing assembly in one housing part and a fastening assembly in another. The fastening assembly could be, for example, a pressurizing and / or clamping device that secures the support in the bearing assembly. This design has the advantage that, on the one hand, inserting the support into the receptacle is very simple, and on the other hand, securing the support in the receptacle can preferably be achieved without an additional step when joining the two housing parts.

[0040] In a preferred embodiment, the carrier receptacle has at least two spaced-apart contact elements for contacting the carrier. Preferably, these contact elements are spaced apart along a longitudinal direction of the test system. It is particularly preferred that at least one opening is located in the housing, providing access to an area situated between the two contact elements. This allows a user to view a section of the carrier located between the contact elements, for example, to read a test result. The opening could, for example, be closed by another element, such as a window.

[0041] Preferably, a first contact element is arranged closer to a housing opening provided for sample reception than a second contact element. In particular, it is preferred that the first contact element is located on a line, especially preferably a straight line, extending from a location where a sample is applied to the carrier to the second contact element.

[0042] Preferably, the housing, i.e., at least one of potentially several existing housing parts, contains a predetermined breaking point. This predetermined breaking point is preferably located in a section of the housing that extends around an area between the first and second contact elements. However, the predetermined breaking point could also run through one of the contact elements. This allows for the following when the housing is broken: HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0043] 8 - along the predetermined breaking point of one of the contact elements is at least partially arranged in a first housing fragment and a second contact element is at least partially arranged in a second housing fragment.

[0044] It is particularly preferred that the two contact elements hold the carrier with different forces. For example, this could be achieved by fixing the carrier with different adhesive and / or clamping forces in the area of ​​the contact elements. The different force used to fix the carrier in the contact elements allows adjustment of which contact element continues to hold the carrier when the housing is split into fragments at the predetermined breaking point. It is also conceivable that the difference in the force holding the carrier, as described above, only occurs when the housing is split along the predetermined breaking point. In this regard, it is conceivable, for example, that one of the contact elements has a reduced contact area with the carrier, thus reducing the force with which the carrier is held.A clamping force could also be reduced, for example by arranging a pressure-applying device on a different housing fragment than a pressure area or support area for the carrier that, before separation at the predetermined breaking point, provided the counter bearing for the pressure-applying device on the carrier.

[0045] Preferably, the carrier is fixed with a stronger force in the area of ​​the first contact element than in the area of ​​the second contact element. If, as described above, the first contact element is located closer to the sample insertion point than the second contact element, this ensures that the carrier, and thus the sample insertion point, remains connected to the housing fragment associated with the first contact element, even if the housing is split into fragments at the predetermined breaking point. In this case, due to the weaker force with which the carrier is fixed in the second contact element, it is detached from the second contact element when the housing is separated into fragments. Preferably, the end of the carrier furthest from the sample insertion point is then free and protrudes from the housing fragment that includes the first contact element.This allows a user to contact the carrier and, for example, pull it out of the housing fragment using the first contact element. This prevents the user from coming into contact with the carrier in the area where the test was performed. This ensures that the user can safely remove the carrier from the HANNKE BITTNER & PARTNER LAV01-011-WOPT.

[0046] 9 -

[0047] The housing fragment comes into contact with the part of the carrier that was in contact with the sample. This, in turn, prevents the user from coming into contact with potentially infectious material from the sample.

[0048] In a preferred embodiment, the carrier is strip-shaped. This design has proven particularly suitable for many test systems, as many tests are already available as test strips, which can thus be easily adapted for such a test system. Furthermore, the strip-shaped design has the advantage that the sample introduction point on such a strip-shaped carrier can be located far from the point where the test result is read. Even when the housing is separated at a predetermined breaking point as described above and the carrier is removed from a housing fragment, it is particularly easy with a strip-shaped carrier to grasp the carrier at the point of maximum distance from the sample introduction point. With the same surface area, a strip-shaped system, or...A strip-shaped beam has a significantly larger maximum extent in one direction than other geometries such as circles, rings, or squares.

[0049] Such a strip-shaped carrier preferably has at least a first area in which contact between the carrier and the sample or sample material is provided, and extends at least to a second area in which optical detection of the diagnostic product is possible. Since separation of impurities typically occurs during the movement of components of the sample material along the carrier—as the latter move at different speeds and / or would have to pass through zones on the carrier that act as a barrier to these impurities—this ensures particularly thorough purification. Furthermore, it makes it possible to allow any necessary chemical reactions to take place between reagents provided on the carrier and individual components of the sample, ultimately enabling the detection of the diagnostic product.

[0050] Preferably, the housing has at least one opening, more preferably at least two openings, more preferably at least three openings, and particularly preferably exactly three openings. It is especially provided that at least one opening is a sample inlet. This opening makes it particularly easy for a HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0051] 10

[0052] Sample material can be applied to the carrier. This eliminates the need to separately open the housing and / or introduce the sample.

[0053] Additionally or alternatively, it is preferred that an opening be a detection opening. Preferably, this opening allows visual perception of the carrier and thus also of the diagnostic product, which is preferably located on the carrier after undergoing a test. Such a detection opening is significantly easier to implement than a closed detection window or an electronic result display. Since different components made of different housing materials would be necessary for the aforementioned elements, designing a detection window as a detection opening allows for considerably simpler disposal or recycling.

[0054] In addition to or as an alternative to the openings already described above, it is preferred that one opening be a sample outlet. Excess sample material can exit the housing directly through such a sample outlet. This prevents excess sample material from potentially falsifying the detection result. Furthermore, excess organic sample material, such as urine and / or other potentially infectious samples, can be drained directly from the housing, thus enabling comparatively safe and hygienic handling of the test system.

[0055] Preferably, a sample inlet and a sample outlet are positioned opposite each other along a longitudinal axis of the housing. This allows a sample to be introduced into the housing interior through the sample inlet, while excess sample material can exit the housing interior directly through the sample outlet. Preferably, a section of the carrier, in particular the section where the sample is applied, lies on a direct line between the sample inlet and the sample outlet. The section of the carrier where the detection or optical perception of the diagnostic product is possible is preferably not located on a direct line between the sample inlet and the sample outlet.

[0056] In a preferred embodiment of the recyclable in vitro test system, the housing comprises at least two, preferably exactly two, housing parts. This allows for a particularly simple housing design and, in particular, simplifies production. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0057] 11

[0058] In particular, it is therefore preferred that the housing comprises at most five, preferably at most four, housing parts.

[0059] At least two, preferably exactly two, housing parts are preferably joined to each other by positive locking and / or material bonding to form the housing. These connections have proven to be particularly easy to implement. Furthermore, no additional components are required for positive locking, thus simplifying the recycling of the housing parts. Material bonding can also be advantageous, as established processes are available for this, and, for example, adhesives are available that do not significantly impede recycling, can be separated, or incinerate (at least almost) without residue during thermal recycling.

[0060] In a preferred embodiment, at least one housing part has a planar shape. The geometry of this housing part is thus essentially defined by its dimensions along its longitudinal and lateral directions, as well as its material thickness in the vertical and vertical directions. Preferably, these directional characteristics coincide with the directional characteristics of the housing as a whole, as described below. As also described in more detail below in connection with the figures, such housing parts are particularly easy to handle. Furthermore, this design provides a particularly large surface area available for a material-bonded connection with another housing part.

[0061] To ensure sufficient stability of the housing and / or individual housing components, it has proven particularly preferred that the material thickness of the housing and / or a housing component be in the range of 0.5–3 mm, preferably 0.7–2.5 mm, more preferably 0.8–2 mm, more preferably 0.9–1.5 mm, and most preferably approximately 1 mm (±0.1 mm). These material thicknesses have proven advantageous because, on the one hand, they allow the test system to be kept particularly lightweight, which has a positive effect on transport costs. On the other hand, such a material thickness also provides sufficient protection and stability to allow the test system to be handled, transported, and stored safely. This material thickness has proven particularly advantageous for housing components containing bagasse, with regard to low weight, good handling, and sufficient stability. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0062] 12

[0063] Material thickness, as defined above, is to be understood in particular as the minimum extent through a wall of a housing and / or individual housing part (perpendicular to the surface of this housing and / or individual housing part). Preferably, the material thickness is that extent through a wall of a housing and / or individual housing part (perpendicular to the surface of this housing and / or individual housing part) which is present in the region of the largest (sum) wall surface area.Naturally, it is therefore possible that different material thicknesses exist in other areas of the housing and / or individual housing parts, for example in the area of ​​the support mounting and / or connecting elements between different housing parts (for example to form a positive connection between housing parts) and / or stiffening elements, which could be intended for shaping the housing.

[0064] As mentioned above, in a preferred embodiment the housing has at least one predetermined breaking point. At this predetermined breaking point, the housing can be divided into at least two housing fragments. Preferably, the predetermined breaking point is different from the joining point of the housing parts. Accordingly, the shape of the housing fragments (obtained after dividing the housing at the predetermined breaking point) preferably differs from the shape of the housing parts (which are assembled to form the housing).

[0065] Preferably, the predetermined breaking point extends along a width direction of the housing. A contact surface between the two housing parts, on the other hand, preferably extends along a length direction of the housing. Within the scope of this invention, the length direction of the housing, or housing longitudinal direction, is understood to be the direction along which the test system has its greatest extent. Accordingly, the width direction of the housing, or housing width direction, is preferably a direction perpendicular to this. A height direction of the housing is preferably perpendicular to the plane defined by the housing's length direction and width direction.

[0066] Preferably, the detection opening and / or the sample inlet and / or the sample outlet is an opening in a housing part that extends substantially along the longitudinal and wide directions of the housing. This means that the extent of the detection opening and / or the sample inlet and / or the sample outlet along HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0067] 13 in the longitudinal direction of the housing and in the width direction is larger, preferably significantly larger (i.e. at least a factor of 5) than in the vertical direction of the housing.

[0068] A variant of the recyclable in vitro test system has proven particularly advantageous, in which the test system is designed and set up to detect pregnancy.

[0069] Pregnancy detection tests are widely used and sold over the counter, for example in drugstores, to people without medical training. Used pregnancy tests are usually disposed of with household waste. Until now, these tests had to be disposed of with residual waste. However, a test system like the one described above allows it to be recycled (at least largely) via the almost universally available recycling system (possibly after separating individual components). It is conceivable that a test system like the one described above could be easily opened so that the diagnostic unit could be disposed of separately from the housing. A recyclable plastic housing could then be recycled according to the standard plastic recycling process.

[0070] Particularly in the embodiment described above, which includes a housing containing bagasse, even (preferably complete) composting (preferably with (at least almost) no harmful residues) is possible. This allows a raw material, in this case even a waste product from sugar production, to be used instead of being destroyed, in a test system as described above. After using such a test system, the housing and / or the bagasse can be reused and / or composted. Using bagasse in a test system housing in this way avoids both the immediate (thermal) disposal of the bagasse and the use of other synthetic raw materials. As a result, such test systems have a particularly good environmental footprint and, in particular, a favorable carbon footprint.

[0071] The present invention further relates to a method for recycling an in vitro test system, in particular a recyclable in vitro test system as described above. The method comprises the steps: HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0072] 14

[0073] Provision of an in vitro test system used to detect a property of an organism, comprising a housing with a polymer derived from a renewable raw material source as its main component;

[0074] Dividing the housing into at least two housing fragments in order to make a diagnostic unit accessible at least partially, separating the diagnostic unit from the housing fragments, and disposing of the diagnostic unit and the housing fragments separately.

[0075] It is particularly preferred that the casing fragments be composted.

[0076] Preferably, the polymer derived from a renewable raw material source is selected as the main component for the casing from a raw material comprising cellulose, hemicellulose and / or lignin, preferably comprising bagasse, further preferably comprising at least 50% by weight, more preferably at least 75% by weight, more preferably at least 90% by weight, and in particular preferably comprising at least 95% by weight, and in particular preferably being bagasse itself.

[0077] Further advantages and embodiments can be seen from the attached drawings.

[0078] It shows:

[0079] Fig. 1 A schematic oblique view of a test system according to the invention;

[0080] Fig. 2 A sectional view along the longitudinal and vertical directions of a test system according to the invention;

[0081] Fig. 3 A top view of a test system according to the invention along the vertical direction from above;

[0082] Fig. 4 A top view of a test system according to the invention along the vertical direction from below; and

[0083] Fig. 5 A top view of a test system according to the invention along its

[0084] Longitudinal direction. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0085] - 15 -

[0086] Figure 1 shows a schematic oblique view of a test system 1 according to the invention, in this case a pregnancy test 1. The test system as a whole is characterized by reference numerals 1. It comprises a housing 2, which in the example shown is composed of two housing parts, namely an upper housing part 2a and a lower housing part 2b. In the present example, both housing parts are bagasse-based and their dimensions are selected accordingly to ensure sufficient stability of the test system. The two housing parts are in contact along the contact surface designated by reference numerals 20 in Figure 1. At this contact surface 20, the two housing parts 2a and 2b are bonded together in the example shown. Thus, in the example shown, there is a material-bonded connection between the two housing parts 2a and 2b.This is particularly preferred for housing parts containing bagasse, since adhesives and glues exist that securely and permanently bond bagasse together, and which, on the other hand, can also be recycled together with bagasse without negatively affecting it or forming harmful residues.

[0087] Figure 1 shows two openings 6 and 10 in the housing part 2a, which is also referred to below as the upper housing part 2a. A diagnostic unit 12 is at least partially visible through these openings. The opening 10 forms a sample inlet 10 through which a sample can be applied to the diagnostic unit 12. The test result can be read through the detection opening 6. For this purpose, a designated area of ​​the diagnostic unit 12 is visible in this region. To simplify reading the test result, this opening 6 is not partially covered by a grid, as is the case with the sample inlet opening 10, in order to protect the diagnostic unit 12 from mechanical stress during sample application.

[0088] Furthermore, a predetermined breaking point 8 is indicated in Figure 1. The test system 1 can be divided at this predetermined breaking point. The housing is thereby divided into a first housing fragment 24 and a second housing fragment 26.

[0089] Figure 2 shows a sectional view along the longitudinal and vertical directions of a test system 1 according to the invention. The openings 6 and 10 formed in the upper housing part 2a are visible. Furthermore, the diagnostic unit designated by reference numeral 12 is visible in this sectional view, which is located in the lower HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0090] 16

[0091] Housing part 2b is formed into a carrier receptacle 4. This diagnostic unit 12 extends in the carrier receptacle along the longitudinal direction of the test system 1 and at least from the sample inlet 10 to the detection opening 6. In the present case, the detection unit extends significantly beyond the detection opening.

[0092] Figure 2 also shows a sample outlet 18 with its longitudinal ends 18a and 18b. The sample outlet 18 is located opposite the sample inlet 10 with respect to the diagnostic unit 12. This allows excess sample material, which is applied to a corresponding area of ​​the diagnostic unit or the carrier 12 through the sample inlet 10, to flow directly back out of the housing 2 through the sample outlet 18. As indicated in Figure 2 by the boundaries 18a and 18b of the sample outlet 18, its longitudinal extent is slightly less than that of the sample inlet 10.

[0093] Figure 2 further illustrates that the carrier receptacle 4 has a first contact surface 14 and a second contact surface 16, which are in contact with the diagnostic unit 12 on their underside. The diagnostic unit 12 is fixed in the area of ​​the first and second contact surfaces 14 and 16, respectively. This can be achieved, for example, by adhesive forces. Because the detection window 6, or rather the area within the housing that can be viewed by a user through the detection window 6, is located between the first contact surface 14 and the second contact surface 16, it can be ensured that the diagnostic unit 12 remains in the intended position in the area of ​​the detection opening 6.

[0094] When a sample is introduced onto the detection unit 12 through the sample inlet opening 10, the substances to be labeled move along the diagnostic unit 12 towards the detection opening 6. During this process, cleaning processes can take place within the diagnostic unit 12, ensuring that the substances to be detected are detectable in the area of ​​the detection opening 6 without interfering interactions with other substances in the sample in this area. Preferably, the diagnostic unit 12 has at least one labeling reagent (not shown) in the area of ​​the detection opening 6, which reacts with the substance to be labeled to form an optically perceptible reaction product. This product can then be visually perceived by a user through the detection opening 6. HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0095] - 17 -

[0096] Figure 3 shows a top view of a test system 1 according to the invention, viewed along the vertical direction from above. The openings 6 and 10 arranged in the upper housing shell 2a are visible. Since the housing is shown empty, i.e., without an inserted diagnostic unit 12, the inside of the lower housing part 2b is visible through the detection opening 6. The slightly smaller sample outlet opening 18 is visible through the sample inlet opening 10. The predetermined breaking point 8, at which the test system can be divided into a first housing fragment 24 and a second housing fragment 26, is also indicated.

[0097] Figure 4 shows a top view of a test system 1 according to the invention, viewed from below along the vertical direction. Accordingly, the lower housing half 2b with the carrier receptacle 4 formed therein is essentially visible. Only the sample outlet 18 reveals webs that partially cover the sample inlet 10 to protect an inserted diagnostic unit from mechanical stress.

[0098] Of particular importance in the view shown in Figure 4 are the contact surfaces 14 and 16, which are also visible in this top view. These surfaces hold an inserted diagnostic unit (not shown in Figure 4) in the carrier holder 4. The carrier holder 4 is narrower in the areas of the first contact surface 14 and the second contact surface 16 than in (all) other areas, so that preferably the side surfaces of the carrier holder 4 contact an inserted diagnostic unit and, if necessary, clamp it between them. This prevents the diagnostic unit from shifting along its width (i.e., on the plane of the paper perpendicular to the longitudinal direction of the test system 1 in Figure 4).

[0099] The carrier receptacle 4 has a contour that is wider than in the areas of the contact surfaces 14 and 16. Accordingly, the diagnostic unit is free in these other areas. As can be seen particularly in conjunction with Figure 3, the diagnostic unit is also not held in place on the top and bottom sides in the other areas of the carrier receptacle 4.

[0100] The contour of the support receptacle 4 features widenings and constrictions. These improve the stability of the test system 1, particularly with regard to its bending and torsional stiffness. Figure 4 shows an exemplary contour along the HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0101] 18

[0102] The longitudinal direction of the carrier receptacle 4 and the altered width of the carrier receptacle 4 have proven particularly advantageous when using a bagasse-containing material for the housing and / or a housing part, as this ensures the necessary stability of the test system 1 for safe transport and safe handling, even with a raw material such as bagasse with a variable composition.

[0103] A diagnostic unit 12 preferably has a length selected such that, when inserted into the carrier receptacle 4, it extends from the sample inlet opening 10 or the sample outlet opening 18 beyond the first and second contact surfaces to, or at least nearly to, the end of the carrier receptacle 4 furthest from the sample inlet 10. The diagnostic unit thus preferably projects at least slightly beyond the second contact surface 16 in the direction of the end of the carrier receptacle 4 furthest from the sample inlet opening 10.

[0104] If the housing 2 is now divided in the area of ​​the predetermined breaking point 8, it is preferred that the diagnostic unit 12 remains fixed by the first contact surface 14. It is also preferred that the diagnostic unit is not also divided. As shown in Figure 4, the predetermined breaking point is preferably located in the area of ​​the second contact surface 16. This reduces the force with which a diagnostic unit 12, fixed by the second contact surface, is held in place. For example, it is conceivable that a pressure-applying element, which presses the diagnostic unit 12 against the second contact surface 16, remains in a first housing fragment, while the second contact surface 16 is assigned to the second housing fragment 26. This would spatially separate these elements upon separation, so that no pressure can be applied between them.This results in the diagnostic unit 12 being held in the first housing fragment 24 exclusively by the forces acting in the area of ​​the first contact surface 14.

[0105] Since the diagnostic unit 12 is preferably not divided when the housing is split into the first housing fragment 24 and the second housing fragment 26, the diagnostic unit 12 protrudes from the first housing fragment 24 at the end furthest from the sample inlet opening 10. A user can grasp it there and pull it out of the first housing fragment. This allows for easy separation of the housing fragments 24 and 26 from the diagnostic unit 12. This enables the diagnostic unit 12, HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0106] 19 which, due to its heterogeneous composition and the possibly contained multitude of chemical (diagnostic) substances, is not or only poorly recyclable, is disposed of with residual waste, whereas the housing fragments 24 and 26 can be recycled.

[0107] Figure 5 shows a top view of a test system 1 according to the invention along its longitudinal direction. In Figure 5, the upper housing part 2a is shown on the left and the lower housing part 2b with the carrier receptacle 4 formed on or from it is shown on the right. In contrast to the lower housing part 2b with the carrier receptacle 4, the upper housing part 2a is completely flat. This simplifies the production and handling, especially of the upper housing part. For example, this upper housing part could simply be stamped out of a flat sheet of material. Handling of the individual upper housing parts 2a obtained in this way is also simplified, as they can be easily stacked and slid relative to one another.Furthermore, this ensures that there is a comparatively large contact area 20 between the upper housing part 2a and the lower housing part 2b, on which the bonding 20 for closing the housing is possible and provides the necessary adhesive force for securely closing the housing.

[0108] In contrast to the embodiment shown in Figure 5, it would also be conceivable to provide complementary features in the housing parts 2a and 2b, enabling these two housing parts 2a and 2b to interlock, thus creating a positive-locking closure of the housing 2. An advantage of such a design would be that bonding could be avoided, thereby reducing the number of materials to be handled.

[0109] Figure 5 shows the carrier receptacle 4, as mentioned above. Only a schematic representation of a possible position within this carrier receptacle 4 is shown. It is evident that the diagnostic unit 12 neither contacts the upper housing half 2a nor rests on the base 4a of the carrier receptacle 4, which faces away from the upper housing half 2a. Instead, it is held in such a way that it is essentially freely positioned between the two aforementioned upper and lower boundaries (2a and 4a) of the interior volume of the housing 2. Preferably, the diagnostic unit 12 is only located in the area not shown in Figure 5.

[0110] 20

[0111] Contact surfaces 14 and 16 are held within the carrier receptacle 4. This first contact surface 14 and second contact surface 16 are preferably spaced apart from the base 4a of the carrier receptacle 4 and thus hold the diagnostic unit 12 in the position shown in Figure 5.

[0112] The applicant reserves the right to claim all features disclosed in the application documents as essential to the invention, provided they are novel, individually or in combination, compared to the prior art. It is further noted that the individual figures also describe features which may be advantageous on their own. A person skilled in the art will immediately recognize that a particular feature described in a figure may be advantageous even without incorporating other features from that figure. Furthermore, a person skilled in the art will recognize that advantages may also arise from a combination of several features shown in individual or different figures.

[0113] The applicant points out that all features disclosed relating to the in vitro test system also represent preferred embodiments of the method described above. Likewise, all features disclosed in connection with the method are intended to specify the in vitro test system.

[0114] HANNKE BITTNER & PARTNER LAV01-011-WOPT

[0115] 21

[0116] Reference symbol list

[0117] 1 in vitro test system,

[0118] 2 cases,

[0119] 2a (upper) housing part, upper housing half,

[0120] 2b (lower) housing part, lower housing half,

[0121] 4 Carrier attachment

[0122] 4a Bottom of the support bracket,

[0123] 6 Detection aperture

[0124] 8 Breakaway point

[0125] 10. Trial entry, opening

[0126] 12 diagnostic units,

[0127] 14 first contact surface,

[0128] 16 second contact surface,

[0129] 18 Test outlet, opening

[0130] 18a, b Limitations of the sample outlet

[0131] 20 Contact surface, bonding,

[0132] 24 first case fragment,

[0133] 26 second case fragment,

Claims

HANNKE BITTNER & PARTNER LAV01-011-WOPT Recyclable in vitro test system and method for recycling an in vitro test system Patent claims 1. Recyclable in vitro test system (1) comprising a diagnostic unit (12) which includes a diagnostic reagent which can be converted into a diagnostic product by contact with a sample taken from an organism or a sample material obtainable from such a sample, which is itself optically perceptible and / or by which a reaction can be induced, the reaction product of which is optically perceptible, and a housing (2) which surrounds the diagnostic unit (12) at least partially, characterized in that the housing (2) comprises as its main component a polymer derived from a renewable raw material source.

2. Recyclable in vitro test system (1) according to claim 1, characterized in that the polymer derived from a renewable raw material source comprises cellulose, hemicellulose and / or lignin, preferably comprises bagasse, more preferably comprises at least 50% by weight, more preferably at least 75% by weight, more preferably at least 90% by weight, and in particular preferably is bagasse.

3. Recyclable in vitro test system (1) according to at least one of the preceding claims, characterized in that the diagnostic reagent is applied to a carrier (12), wherein this carrier (12) is preferably received at least partially in a support receptacle (4) formed in one part with the housing (2). HANNKE BITTNER & PARTNER LAV01-011-WOPT 23 4. Recyclable in vitro test system (1) according to claim 3, characterized in that the carrier (12) is strip-shaped and preferably extends at least from a first area in which contact of the carrier with the sample or sample material is provided to a second area in which optical perception of the diagnostic product is possible.

5. Recyclable in vitro test system (1) according to at least one of the preceding claims, characterized in that the housing (2) has at least one opening (6, 10, 18), preferably at least two openings (6, 10, 18), more preferably at least three openings (6, 10, 18) and particularly preferably exactly three openings (6, 10, 18), wherein preferably one opening (10) is a sample inlet, one opening is a sample outlet (18) and / or one opening is a detection opening (6).

6. Recyclable in vitro test system (1) according to at least one of the preceding claims, characterized in that the housing (2) comprises at least two, preferably exactly two housing parts (2a, 2b) which are preferably connected to each other by positive locking and / or material locking to form the housing (2).

7. Recyclable in vitro test system (1) according to at least one of the preceding claims, characterized in that the housing (2) has at least one predetermined breaking point (8) at which the housing (2) can be divided into at least two housing fragments (24, 26), wherein the shape of the housing fragments (24, 26) preferably differs from the shape of the housing parts (2a, 2b).

8. Recyclable in vitro test system (1) according to at least one of the preceding claims, characterized in that HANNKE BITTNER & PARTNER LAV01-011-WOPT 24 the test system (1) is designed and set up for the detection of pregnancy.

9. Method for recycling an in vitro test system (1), in particular a recyclable in vitro test system (1) according to at least one of the preceding claims, comprising the steps: Provision of an in vitro test system (1) used for the detection of a property of an organism, comprising a housing (2) with a polymer derived from a renewable raw material source as its main component; parts of the housing into at least two housing fragments (24, 26) in order to make a diagnostic unit (12) accessible at least in sections, Separating the diagnostic unit (12) from the housing fragments (24, 26), and disposing of the diagnostic unit (12) and the housing fragments (24, 26) separately.

10. Method according to claim 9, characterized in that at least one of the housing fragments (24, 26), preferably two housing fragments (24, 26), more preferably all housing fragments (24, 26) are composted.

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