Test device

Abstract

Device for the visual detection of analytes, in particular HCG, in a liquid sample originating from the human or animal organism, in particular a urine or saliva sample, comprising a carrier body (1) which receives at least one test strip (3) provided with a sample receiving section (32) and a test section (34), characterized in that a slider (2) is arranged which is mounted so as to be displaceable in the longitudinal direction of the carrier body (1) and which, in at least one sliding position, projects beyond the carrier body (1) in an extended manner, wherein at least the carrier body (1) is made of biodegradable material, in particular of a paper material.

Description

Device for the visual detection of analytes, in particular HCG, in a liquid sample originating from the human or animal organism, in particular urine or saliva sample, according to the preamble of claim 1.Test devices such as pregnancy test devices for detecting HCG in a urine sample are known in various designs. In this case, an immunological rapid pregnancy test regularly checks the presence of the pregnancy-maintaining hormone HCG (human chorionic gonadotropin) in the body. For this purpose, a test strip according to the principle of the lateral flow test is used, which test strip is arranged in a plastic housing. The plastic housing has a loading area with a liquid-permeable grid structure, under which the sample receiving section of the test strip is positioned. Spaced apart from the grid structure is a control window behind which the test section of the test strip is arranged. The control window is positioned in a handle. The plastic housing is of sufficient length to be comfortably held by a user with his area of application into a stream of urine.When urine is applied to the test strip, it flows by capillary forces through a sample receiving pad containing monoclonal antibodies directed against the β chain of the HCG molecule to which colloidal gold particles are coupled. The HCG antigen contained in the urine is loaded with gold particles by the binding of the antibodies. The urine then enters the test portion of the test strip where it binds to immobilized antibodies against the α chain of the HCG molecule occupying the test portion. The coloring of the gold particles produces a reddish line.Downstream of the test line is a control line at which another antigen-antibody reaction indicates adequate wetting of the test strip and the correct progress of the test. This ensures that the test has been carried out correctly and the result appearing through the test line is correct.Pregnancy testing devices of the above-mentioned type have proven themselves in the past and are very popular, but they enable a reliable pregnancy test in a simple, discrete and rapid manner. This, however, causes hundreds of tons of plastic waste.The invention seeks to remedy this. The invention is based on the object of providing a test device which, with appropriate handling and reliability, enables environmentally compatible disposal. According to the invention, this object is achieved by a device having the features of claim 1.The invention provides a test device which, with appropriate handling and reliability, enables environmentally compatible disposal. Due to the fact that a slide is arranged which is mounted displaceably in the longitudinal direction of the carrier body and which, in at least one sliding position, projects beyond the carrier body in an extending manner, wherein at least the carrier body is produced from biodegradable material, in particular from a paper material, an environmentally friendly and at the same time compact design is achieved. By displacing the slide, the length of the carrier body can be changed, whereby compact dimensions for mounting and a comfortable length of device for its use are made possible.The term paper material is understood in the present case to mean in particular the materials cardboard, cardboard and paper, which differ from one another only by their weight per unit area, the so-called grammar. By incorporating fillers and / or by applying biodegradable lacquers, these materials can be designed to be water-impermeable.The term "test strip" is understood in the present case to mean an immunochromatographic test strip (lateral flow test strip).In a further development of the invention, the test strip is accommodated by the carrier body in such a way that its sample-receiving section projects over the carrier body in regions, wherein the slide completely covers the projecting region of the test strip in a slide position. As a result, the sample receiving portion of the test strip is protected from contamination by the slider. By displacing the slide, an unhindered access to the sample receiving section for the purpose of applying a liquid sample can be produced.In one embodiment of the invention, a support tongue is arranged on the carrier body, on which the protruding region of the test strip rests. This provides support for the protruding sample receiving portion of the test strip.In a further embodiment of the invention, a U-shaped web is arranged on the support tongue, between the legs of which web the sample receiving section of the test strip protrudes. This allows effective "collection" of a saliva sample by sweeping over a tongue, thereby achieving the delivery of a maximum amount of saliva sample to the test strip.Preferably, the legs of the web are designed tapering like a funnel towards each other in the direction of the test strip. This achieves a supply of the collected saliva to the sample receiving section of the test strip, which projects between the legs of the web.In a further development of the invention, the carrier body has a first stop, by means of which the sliding path of the slide in a first direction is limited, wherein preferably a second stop is present on the carrier body, by means of which the sliding path is limited in the direction opposite to the first direction. As a result, the slide is held on the carrier body in a captive manner. An accidental removal of the slide by excessive sliding from the carrier body is thereby prevented.In one embodiment of the invention, the slide is sleeve-shaped and encloses the carrier body circumferentially at least in regions. As a result, the slide is guided displaceably reliably on the carrier body.In a further embodiment of the invention, the carrier body has a carrier base plate and a carrier cover plate arranged parallel thereto, wherein at least one intermediate plate is present between the carrier base plate and the carrier cover plate, said intermediate plate having a cutout which forms a receptacle for at least one test strip into which said test strip is inserted, and wherein the carrier base plate or the carrier cover plate has a window, as a result of which the test section of at least one test strip is visible. This achieves a simple and cost-effective construction.In a further development of the invention, the carrier body has a sample application pad which projects out of the carrier body in regions and which covers the sample receiving section of the test strip projecting beyond the carrier body. This ensures adequate wetting of the sample receiving section with sample liquid. The sample application pad here functions as a buffer for the sample liquid. For this purpose, the sample application pad is preferably made of an absorbent cellulose.In one embodiment of the invention, at least one tear-off blade is present on the sample application pad, which tear-off blade is connected to the sample application pad via a predetermined breaking line, preferably a perforation line. In parallel with the execution of the rapid test, this allows sample archiving in one or more tear-off blades in the form of a "dried spot" for a subsequent laboratory analysis. The shape of the tear-off blade makes it possible to define the amount of sample absorbed by the latter.In a further embodiment of the invention, the recess of at least one intermediate plate has at least one projection, preferably two oppositely arranged projections, which form a contact for a sample receiving pad to be introduced into the recess. This supports the positionally correct mounting of a sample receiving pad in the carrier body. The sample receiving pad is thus positioned on the end portion of the test strip received by the recess.In a further development of the invention, the carrier body is formed from a first folded blank which has the carrier base plate, the at least one intermediate plate and the carrier top plate, which plates are connected to one another via folding lines. This allows the production of the carrier body from a folded blank solely by means of folding and adhesive bonding processes, as a result of which the production outlay is minimized. To simplify the bonding processes required, adhesive transfer films can also be arranged at the desired positions. Preferably, the folded blank is made of cardboard or cardboard.A connection of two plates via a bending line is present if the two are pivotable relative to one another about at least one bending line. A connection of two plates via a bending line is also present if two (or more) bending lines are present between the two plates, between which (in each case) a connecting web is bounded.In one embodiment of the invention, a first wing is pivotably connected to the carrier base plate, said first wing resting on the carrier top plate on its outer side facing the slide and by means of which the first stop is formed, wherein a first catching portion is preferably connected to the carrier top plate via a bending line, said first catching portion resting on the outer side of the carrier top plate facing the slide and by means of which the second stop is formed. This achieves simple production of the first and second stops.In a further embodiment of the invention, the slide is formed from a second folded blank which has a slide base plate and a slide top plate arranged parallel thereto, between which a connecting plate is arranged, which is connected, preferably bonded, to the slide base plate in regions and on which a second wing is arranged, against which the first stop of the carrier body can be stopped, wherein the folded blank is preferably produced from cardboard. This achieves a cost-minimized production of the slide.In a further development of the invention, a second catch tab is connected to the slide base plate or the slide cover plate via a fold line, which engages the inside of the slide base plate or the slide cover plate facing the carrier body and against which the second stop of the carrier body can be stopped. As a result, a production integrated in the folding process allows a stop for the second stop of the carrier body.In one embodiment of the invention, the slide has a second window which, in a sliding position, is aligned with the first window of the carrier body. In this sliding position, a free view of the test section of at least one of the at least one test strip is thereby ensured. Advantageously, in this slide position of the slide, the protruding region of the test strip is completely covered.Other developments and embodiments of the invention are specified in the remaining dependent claims. An exemplary embodiment of the invention is illustrated in the drawings and is described in detail below. The following are shown: FIG. 1 is a schematic illustration of a test device; FIG. 2 shows the schematic illustration of the carrier body of the test apparatus from FIG. 1 ; FIG. 3 shows the schematic illustration of the slide of the test device from FIG. 1 ; FIG. 4 shows the schematic illustration of the test strip of the test device from FIG. 1 ; FIG. 5 shows the representation of the folding steps of a first cardboard packaging blank with arranged test strip for producing a carrier body according to FIG. 2 a) cardboard packaging blank (unfolded); b) first intermediate plate folded onto carrier base plate; c) test strip inserted into the recess of the first intermediate plate folded onto carrier base plate; d) second intermediate plate folded onto carrier top plate and sample receiving pad inserted into the recess of the second intermediate plate; e) fully folded carrier body in view from the front; f) fully folded carrier body in view from the rear; FIG. 6 shows the representation of the folding steps of a second cardboard sheet blank for producing a slide according to FIG. 3 a) cardboard sheet blank (unfolded); b) slide base plate provided with transfer adhesive film; c) connecting plate folded onto slide top plate; d) slide base plate folded onto connecting plate and bonded. FIG. 7 shows the illustration of the test device from FIG. 1 a) in the view from the front with the first stop drawn in; b) in the view from the rear with the second stop drawn in; FIG. 8 shows the illustration of a test device in a second embodiment a) in plan view; b) in plan view-without slide; c) in plan view-without carrier body; FIG. 9 shows the test device from FIG. 7 a) in a partially unfolded representation; b) in a view from the front with the first stop drawn in; FIG. 10 shows the illustration of a test device in a third embodiment a) in plan view; b) in plan view-without slide; c) in plan view-without carrier body; FIG. 11 shows the representation of the folding steps of a first cardboard packaging blank with arranged test strip for producing a carrier body according to FIG. 9 b) a) cardboard packaging blank (unfolded); b) first intermediate plate on carrier base plate folded with inserted test strip; c) In the completely folded state, in the view from the front with the first stop drawn in.The test device as an exemplary embodiment according to FIG. 1 consists of a carrier body 1 which accommodates a test strip 3 and on which a slide 2 is arranged so as to be longitudinally displaceable.The carrier body 1 is produced from a first cardboard packaging blank 11. The carton blank 11 comprises a first intermediate plate 12, a carrier base plate 13 connected thereto via a folding line 16, as well as a carrier top plate 14 and a second intermediate plate 15 connected thereto via a folding line 16.The first intermediate plate 12 and the second intermediate plate 15 are largely identical. They have a substantially rectangular basic shape and are each provided with a substantially rectangular recess 18 which extends as far as the upper end of the intermediate plate 12, 15 facing the supporting web of the carrier base plate 13. On its side facing the supporting web, the recess 18 merges into a narrower end section 181. Spaced apart from the end section 181, two support knobs 182 are arranged in the recess opposite one another, the spacing between them corresponding approximately to the width of the end section 181. Furthermore, the recess 18 of the first intermediate plate 12 has two first rectangular webs 183 at a distance from its upper, open side and the recess 18 of the second intermediate plate 15 has two second rectangular webs 184 at a distance from its upper, open side. The two first webs 183 of the first intermediate plate 12 are positioned above the two second webs 184 of the second intermediate plate 15.The carrier base plate 13 likewise has a substantially rectangular basic shape. On its side facing the open end of the recesses 18, a rectangular support tongue is arranged on the carrier base plate 13. Above the support knobs 182 of the recesses 18, a rectangular wing 132 is arranged laterally in the base plate 13, which wing is pivoted out of the base plate via a bending line 16.The carrier top plate 14 likewise has a substantially rectangular basic shape. On its side facing the support tongue 131, a catch tab 141 is arranged on the carrier top plate 14, which is connected to the carrier top plate 14 via a bending line 16. Above the support knobs 182 of the recesses 18, a window 142 is introduced into the carrier cover plate 14.To produce the carrier body 1, the first intermediate plate 12 is first folded over the bending line 16 onto the carrier base plate 13 (FIG. 5 b) ), after which a test strip 3 is placed in the recess 18 of the first intermediate plate 12, which lies against the end section 181 and extends beyond the recess 18 as far as the support tongue 131. In this case, the test strip 3 is held laterally in position between the supporting knobs 182 and the first webs 183 (FIG. 5 c )). The second intermediate plate 15 is folded over the folding line 16 onto the carrier top plate 14 and a sample receiving pad 4 is placed on the catch tab 141 of the carrier top plate 14 and pushed into the recess 18 until it abuts against the second webs 184. In this position, the sample receiving pad 4 is bonded to the carrier cover plate 14 (FIG. 5 d)). In the exemplary embodiment, the sample receiving pad 4 is of cuboidal design and is produced from absorbent material. Subsequently, the two intermediate plates 12, 15 with the carrier base plate 13 and the carrier top plate 14 are folded onto one another and glued to one another (FIG. 5 e )). The connecting web 17 now forms a side wall of the test device. The test strip 3 is held protected in the receiving space formed by the two recesses 18 of the two intermediate plates 12, 15. The window 142 of the carrier cover plate 14 is located above the test section of the test strip.The slider 2 is made from a second carton blank 21. The carton blank 21 comprises a substantially rectangular slide base plate 22 and a likewise substantially rectangular slide top plate 23, which are connected to one another via two folding lines 26, between which a connecting web 25 is formed. At one end of the slider cover plate 23, a second catch tab 231 is arranged, which is connected to the slider cover plate 23 via a bending line 26. The second catch tab 231 is trapezoidal and substantially corresponds to the first catch tab 141 of the carrier top plate 14. In the transition region of the slider top plate 23 with the second catch tab 231, a rectangular window 232 is introduced, which extends halfway over the slider top plate 23 and the second catch tab 231, so that the bending line 26 forms an axis of mirror symmetry of the window 232.Furthermore, a connecting plate 24 is arranged, which is connected to the slide base plate 22 via two folding lines 26, between which a connecting web 25 is formed. The connecting plate is L-shaped and has an outwardly extending, substantially rectangular second wing 241.To produce the slide 2, the slide base plate 22 is provided on its side facing away from the slide top plate 23 with an adhesive transfer film 221 and the second catch flap 231 is folded over about the fold line 26 so that it rests on the slide top plate 23. An open, rectangular cutout is formed by the window 232 (FIG. 6 b )). Subsequently, the connecting plate 24 is folded over about the two folding lines 26, whereby the connecting web 25 bounded between the folding lines 26 forms a side wall. Then, the slider base plate 22 is folded onto the connecting plate 24 and bonded thereto via the adhesive transfer film 221 (FIG. 6 d)).The slide 2 thus formed is pushed onto the carrier body 1 from the support tongue 131, wherein the second catch tab 231 of the slide 2 slides over the first catch tab 141 of the carrier body 1 facing the latter. The slide 2 can now be pushed until the second wing 241 of the slide abuts the first wing 132. The slide 2 can now be displaced in the opposite direction until the second catch tab 231 of the slide 2 abuts the first catch tab 141 of the carrier body 1. The slide 2 is thus held such that it cannot be displaced on the carrier body 1, its sliding path being limited by the two stops of the first wing 132 / second wing 241 and the first catch tab 141 / second catch tab 231.The test strip 3 is shown in step section in FIG. 4. The test strip 3 has a carrier film 31, on which a sample receiving section 32 is arranged at one end. Immediately adjacent and partially below the sample receiving section 32 there is an antibody coating 33 on the carrier film 31 which contains antibodies which are conjugated with gold particles and which match an analyte to be determined or an antigen of this analyte and can enter into an immunological reaction. The antibody coating section 33 is followed by a test section 34 which is in the form of a membrane on which are situated at a distance from one another a test line 341 and a control line 342 which are formed by antigen contained in a reagent for the detection of a particular analyte and are invisible before application of a sample.In the embodiment according to FIG. 8, the sample receiving pad 4 is made of absorbent filter paper. On its longitudinal side, an arrangement of tear-off blades 41 positioned at a distance is present on the sample receiving pad 4, which are connected to the sample receiving pad 4 via predetermined breaking lines. In the exemplary embodiment, the predetermined breaking lines are formed as perforation lines ( 42). The tear-off blades 41 are dimensioned identically to one another and have a defined liquid-receiving volume.In the exemplary embodiment according to FIG. 10, the support tongue is arranged in the form of a collecting spatula 5, which has, on its upper side facing the test strip 3, a U-shaped web 51, the legs 52 of which are designed to taper towards one another like a funnel in the direction of the test strip 3. The test strip 3 protrudes with its sample receiving section between these legs. A sample receiving pad is not arranged in this exemplary embodiment.The test device of the invention is made from cardboard and recycled to 100 percent. It is distinguished by very compact dimensions, as a result of which it also finds sufficient space in smaller pockets. The production on the basis of two carton blank blanks also enables very cost-effective production.

Claims

Device for the visual detection of analytes, in particular HCG, in a liquid sample originating from the human or animal organism, in particular a urine or saliva sample, comprising a carrier body (1) which accommodates at least one test strip (3) provided with a sample receiving section (32) and a test section (34), characterised in that a slide (2) is arranged which is mounted displaceably in the longitudinal direction of the carrier body (1) and which, in at least one slide position, projects beyond the carrier body (1) extending the latter, wherein at least the carrier body (1) is produced from biodegradable material, in particular from a paper material.Device according to claim 1, characterised in that the test strip (3) is accommodated by the carrier body (1) in such a way that its sample-accommodating section (32) projects beyond the latter in regions, wherein the slide (2) completely covers the projecting region of the test strip (3) in a slide position.Device according to claim 2, characterised in that a support tongue (131) is arranged on the carrier body (1), on which the protruding region of the test strip (3) rests.Device according to claim 3, characterised in that a U-shaped web (51) is arranged on the support tongue (131), between the legs (52) of which the sample receiving section (32) of the test strip (3) projects, wherein the legs (52) are preferably designed so as to taper towards one another like a funnel in the direction of the test strip (3).Device according to one of the preceding claims, characterized in that the carrier body (1) has a first stop, by means of which the sliding path of the slide (2) in a first direction is limited, wherein preferably a second stop is present on the carrier body (1), by means of which the sliding path is limited in the direction opposite to the first direction.Device according to one of the preceding claims, characterized in that the slide (2) is of sleeve-shaped design and surrounds the carrier body (1) at least in regions.Device according to one of the preceding claims, characterized in that the carrier body (1) has a carrier base plate (13) and a carrier cover plate (14) arranged parallel thereto, wherein at least one intermediate plate (12, 15) is present between the carrier base plate (13) and the carrier cover plate (14), said intermediate plate having a recess (18) which forms a receptacle for at least one test strip (3) which is inserted therein, and wherein the carrier base plate (13) or the carrier cover plate (14) has a first window (142), as a result of which the test section (34) of at least one test strip (3) is visible.Device according to one of Claims 2 to 7, characterized in that the carrier body (1) has a sample application pad (4) which projects regionally from the carrier body (1) and which covers the sample receiving section (32) of the test strip (3) projecting beyond the carrier body (1).Device according to claim 8, characterised in that at least one tear-off blade (41) is present on the sample application pad (4), which is connected to the sample application pad (4) via a predetermined breaking line, preferably a perforation line (42).Device according to Claims 7 to 9, characterized in that the recess (18) of at least one intermediate plate (12, 15) has at least one projection, preferably two oppositely arranged projections, which form a contact for a sample receiving pad (4) to be introduced into the recess.Device according to one of Claims 7 to 10, characterized in that the carrier body (1) is formed from a first folded blank (11) which has the carrier base plate (13), the at least one intermediate plate (12, 15) and the carrier top plate (14), which plates are connected to one another via fold lines (16), the folded blank (11) preferably being produced from cardboard or cardboard.Device according to claim 11, characterised in that on the carrier base plate (13) a first wing (132) is pivotably connected thereto, which rests on the carrier cover plate (14) on its outer side facing the slide (2) and by which the first stop is formed, wherein preferably on the carrier cover plate (14) a first catch tab (141) is connected thereto via a bending line (16), which rests on the outer side of the carrier cover plate (14) facing the slide (2) and by which the second stop is formed.Device according to one of the preceding claims, characterized in that the slide (2) is formed from a second folded blank (21) and has a slide base plate (22) and a slide cover plate (23) arranged parallel thereto, between which a connecting plate (24) is arranged, which is connected, preferably bonded, in regions to the slide base plate (22) and on which a second wing (241) is arranged, against which the first stop of the carrier body (1) can be stopped, wherein the second folded blank (21) is preferably produced from cardboard.Device according to claim 12, characterised in that on the slide base plate (22) or the slide cover plate (23) a second catch tab (231) is connected to the latter via a bending line (26), which engages on the inside of the slide base plate (22) or the slide cover plate (23) facing the carrier body (1) and against which the second stop of the carrier body (1) can be stopped.Device according to one of Claims 6 to 13, characterized in that the slide (2) has a second window (232), which, in a sliding position, is aligned with the first window (142) of the carrier body (1).

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