TEST STRIP ASSEMBLY WITH CONTAINERS

20220347673 ยท 2022-11-03

Assignee

Inventors

Cpc classification

International classification

Abstract

A test strip system having containers and suitable carriers therefor. The test strip assembly is suitable for carrying out different types of chemical, biological or biochemical tests and evaluating them using a suitable analysis device. The test strip assembly has a first region having at least one container and a second region also having at least one container. The container of the first region has a flat transparent bottom, and the container of the second region has a V-shaped or U-shaped bottom.

Claims

1. A test strip assembly comprising containers, wherein the test strip assembly has a first region having at least one container and a second region also having at least one container; wherein the container of the first region has a flat transparent bottom and the container of the second region has a V-shaped or U-shaped bottom.

2. The test strip assembly as claimed in claim 1, wherein the container of the first and the second region has a rim, wherein the rim of the second region is taller than that of the first region and/or wherein the container of the second region is closed using a film.

3. The test strip assembly as claimed in claim 1, wherein the test strip assembly, with the exception of the bottom of the first region, consists of an opaque, light-transmitting, or transparent material.

4. The test strip assembly as claimed in claim 1, wherein the second region consists entirely or partially of an opaque, light-transmitting, or transparent material.

5. The test strip assembly as claimed in claim 1, characterized in that the test strip assembly or the film has a barcode for identifying the test strip assembly.

6. The test strip assembly as claimed in claim 1, wherein it has lateral guide webs.

7. The test strip assembly as claimed in claim 1, wherein the test strip assembly, viewed from above, tapers from the second region towards the first region or the second region has a section in which no guide webs extend.

8. The test strip assembly as claimed in claim 1, wherein the test strip assembly has a clamp having a clamping spring on one side and/or has a lug.

9. The test strip assembly as claimed in claim 1, wherein the test strip assembly has test reagents which are located in the containers of the second region and are sealed by the film.

10. The test strip assembly as claimed in claim 1, wherein the film is manufactured in such a way that it can be pierced using a pipette tip.

11. A carrier for a test strip assembly as claimed in claim 1, wherein the test strip assembly is releasably fixed in the carrier by a clamp or guide webs of the test strip assembly, which are introduced into guide rails or recesses in the carrier matching thereto.

12. The carrier as claimed in claim 11, wherein the carrier additionally has a spring, by which the test strip assembly, which was introduced into the carrier by the guide rails, is additionally releasably fixed.

13. The carrier as claimed in claim 11, wherein the carrier is in the form of a rectangle, a circle, or a segment of a circle.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0028] In the figures:

[0029] FIG. 1 shows a schematic representation of a test strip assembly 10 according to prior art in a perspective view;

[0030] FIG. 2a shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a perspective view;

[0031] FIG. 2b shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a perspective view with film;

[0032] FIG. 3a shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a perspective view;

[0033] FIG. 3b shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a front view;

[0034] FIG. 3c shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a rear view;

[0035] FIG. 3d shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention from below;

[0036] FIG. 4a shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention from FIG. 3 in a side view;

[0037] FIG. 4b shows a schematic representation in a side view of a sectional plane of the embodiment of the test strip assembly 10 according to the invention from FIG. 4a;

[0038] FIG. 5a shows a schematic representation in a top view of an embodiment of the test strip assembly 10 according to the invention within an embodiment of a carrier according to the invention;

[0039] FIG. 5b shows a schematic representation in a top view of an embodiment of the test strip assembly 10 according to the invention within an embodiment of a carrier according to the invention;

[0040] FIG. 6 shows a schematic representation of an embodiment of a carrier according to the invention without test strip assembly 10;

[0041] FIG. 7 shows a schematic representation of an embodiment of a carrier according to the invention having inserted test strip assembly 10 having film 80;

[0042] FIG. 8a shows a schematic representation of the sequence of inserting a test strip assembly 10 according to the invention into an embodiment of a carrier according to the invention;

[0043] FIG. 8b shows a schematic representation of the sequence of inserting a test strip assembly 10 according to the invention into an embodiment of a carrier according to the invention;

[0044] FIG. 8c shows a schematic representation of the sequence of inserting a test strip assembly 10 according to the invention into an embodiment of a carrier according to the invention;

[0045] FIG. 9a shows a further schematic representation of a further possibility of equipping the carrier according to the invention from FIG. 8 with a test strip assembly 10 also from FIG. 8;

[0046] FIG. 9b shows a further schematic representation of a further possibility of equipping the carrier according to the invention from FIG. 8 with a test strip assembly 10 also from FIG. 8;

DETAILED DESCRIPTION

[0047] FIG. 1 shows a test strip assembly 10 according to the prior art. It is clear here that all containers 20 of the test strip assembly 10 have a flat bottom. Furthermore, this test strip can also be used in a holder provided for this purpose, but it then only fits loosely. A further disadvantage of this test strip assembly 10 according to the prior art is that the test strip can be inserted upside down in the carrier and it is thus possible to mix up the sample or the assignment of the sample to a specific patient or reference value can be mixed up. A further disadvantage is that the test strip assembly 10 according to the prior art cannot be releasably fixed in a carrier. For example, air bubbles, which could interfere with the detection reaction, cannot be knocked out manually or automatically.

[0048] FIG. 2a shows a perspective schematic representation of an embodiment of the test strip assembly 10 according to the invention. The test strip assembly 10 shown has a transparent, see-through material. The materials can be selected depending on the application, so that, for example, a black material reduces scattered light or interference, while other materials in turn have other properties.

[0049] Clamping springs 150 for forming a clamp with a suitable carrier according to the invention can also be seen. Furthermore, FIG. 3a also shows the guide webs 100, which are also used to guide and fix the test strip assembly 10 according to the invention in a suitable carrier. Furthermore, a first region 30 having rather cylindrical containers 20 and a second region 40 having rather cuboid containers 20 can be seen in FIG. 2a. It can also be seen that the second region 40 has a taller rim 71 than the first region.

[0050] FIG. 2b shows the test strip assembly 10 according to the invention, already known from FIG. 2a, having a film 80. The cover film 80 is applied to the slightly taller rim 71 of the container 20 of the second region. The film 80, also known as the sealing film, is conceived in such a way that it can be easily pierced using pipette tips. Furthermore, the film 80 has a coating that is designed in such a way that it burns up little and can be structured, inscribed, or printed on. The film 80 also makes it possible to use the test strip assembly 10 as a type of storage container having an integrated test device at the same time. For this purpose, one or more reagents are poured into one or more containers 20 of the second region 40 and sealed using the above-mentioned film 80. This can be done, for example, by welding or adhesive bonding. The protruding rim 71 of the cavities 20 of the second region 40, which preferably has a height of 0.5 mm, achieves a significantly better fastening the cover film 80 to the test strip assembly 10 than is conventionally the case. In this way, a better leak-tightness for longer shelf life and stability of the reagents stored in the test strip assembly 10 can be ensured and achieved. In addition, the test strip and film material has a high vapor barrier, which means that the reagents can be stored with long-term stability. The cavities 20 of the first region 30, also called reaction or dilution cavities 20, can be coated using a product-specific antigen, antibody, or other proteins or chemicals in a further production step. If, for example, such a reaction cavity or a reaction container is coated using a product-specific antigen, a specific antibody present in the patient serum, for example, can be detected. However, not only patient sera but also other analytes such as urine or CSF (cerebrospinal fluid) can be used. In addition, in this example the film 80 has a barcode 90 which ensures a unique and at the same time anonymized assignment of test and sample.

[0051] FIG. 3a shows an embodiment of the invention in which the first region 30 having three containers 20 and the second region 40 having five containers 20 can be clearly seen. The containers 20 of the first region 30 here have a cylindrical configuration, while the containers 20 of the second region 40 show a rather cuboid configuration. The clamping spring 110 having the lug 150 can also be seen, which is used to temporarily fix the test strip assembly 10 in a carrier. The side surfaces in the second region 40 are designed to be flat, which allows easier and more convenient handling for the user, for example when inserting the arrangement into a carrier. FIG. 3b and FIG. 3c show the front and rear view of an embodiment of the test strip assembly 10 according to the invention. The lugs 150, which are used for fixing in the carrier, and the raised rim 71 for the application of a film 80 in the second region 40 can be clearly seen. FIG. 3d shows a bottom view of one embodiment of the test strip assembly 10 of the present invention. The guide webs 100 on the bottom in the first region 30 and in the second region 40 can be seen here above all.

[0052] FIG. 4a shows a schematic representation of an embodiment of the test strip assembly 10 according to the invention in a side view. The clamping with the clamping spring 100 can be clearly seen, which additionally has a small lug 150 formed from the material of the test strip assembly 10. A lug 150 can also be seen on the opposite side of the clamping spring 100. These lugs 150, together with the likewise opposing handles, enable the test strip assembly 10 according to the invention to be securely fixed in a carrier 120 suitable for this purpose. The slightly raised rim 71 of the cavities 20 in the second region 40 in contrast to the cavities 20 of the first region 30 can also be seen.

[0053] FIG. 4b shows an embodiment of the test strip assembly 10 according to the invention from FIG. 4a in an illustration of a longitudinal section which extends centrally through the test strip assembly 10 from the front to the rear, seen from above. It can be seen that the cavities 20 of the first region 30 have a flat bottom 50, while the cavities 20 of the second region 40 have a rather V-shaped or also U-shaped bottom 60. This bottom shape of the cavities 20 of the second region 40 leaves less dead volume when liquids are removed, which means that less test reagents or other liquids have to be used, which in turn reduces the general costs. The clamp having the clamp spring 110 can also be seen having the small lugs 150 formed from the material of the test strip assembly 10.

[0054] FIGS. 5a and 5b show a schematic representation of a carrier 120 according to the invention, which is equipped with embodiments of a test strip assembly 10 according to the invention, once with films 80 (FIG. 5b) and without films (FIG. 5a). The advantage of such a combination of carrier and test strip assembly is that the individual test strip assemblies 10 can be easily detached from the carrier 120, but the other test strip assemblies 10 can remain stationary in the carrier 120.

[0055] As can also be seen in FIG. 3, for example, the test strip assembly 10 tapers somewhat in the first region 30 compared to the second region 40. This tapering enables the test strip assembly 10 to be inserted correctly in the carrier 120 provided for it later and thus offers a high degree of usability. Because of this shape, the test strip assembly 10 can only be inserted in one direction into the carriers 120 provided for this purpose according to the invention, also referred to as frames. Incorrect handling is thus avoided from the outset. The end user removes a test strip assembly 10, for example having prefilled reagents and/or coated reaction or dilution containers 20, from a packaging material provided for this purpose and inserts this test strip assembly 10, for example from the front or from above, into a carrier 120 provided for this purpose. Such a carrier 120 according to the invention having the test strip assembly 10 according to the invention is then positioned in an analysis device and the test is processed automatically or semi-automatically.

[0056] FIG. 6, for example, shows a schematic representation of an embodiment of a carrier 120 of the present invention in the shape of a segment of a circle without test strip assemblies 10 of the present invention. The additional spring 130 of the carrier, which can detachably fix the test strip assembly 10 by means of a counterforce, can be seen clearly here. The guide rails 140 or recesses are also visible, into which the guide webs 100 of the test strip assemblies 10 are introduced and thus additionally prevent the test strip assemblies 10 from slipping out of the carrier 120 in an upward direction. It can also be seen that the carrier 120 has recesses in the form of through holes 160 in the region in which the first region 30 of the test strip assembly 10 will later be located. These through holes 160 are provided to ensure the analysis of the tests or test reactions.

[0057] FIG. 7 shows a schematic representation of an embodiment of a carrier 120 according to the invention having inserted test strip assemblies 10. Each individual test strip assembly 10 can also be detached separately from the carrier 120 in this embodiment, without the other test strip assemblies 10 being adversely affected as a result.

[0058] In the schematic sequence representations in FIGS. 8a-c, the insertion of a test strip assembly 10 according to the invention into an embodiment of a carrier 120 according to the invention is shown. Here, the test strip assembly 10 is pushed laterally into the carrier 120 (FIG. 8a). The test strip assembly 10 is securely fixed in the carrier by means of the guide webs 100 and the guide rails 140 or recesses provided for this purpose. Due to the tapering of the test strip assembly 10 in the first region 30 and a tapering of the carrier 120 complementary thereto, the test strip assembly 10 can also only be fully pushed into the carrier 120 in one direction. The additional spring 130, which is installed in the carrier 120, protects the test strip assembly 10 from slipping out. However, this clamping connection can be released again by the end user with little force, so that the test strip assembly 10 can be removed from the carrier 120 again.

[0059] FIGS. 9a and 9b each show a further schematic representation of a possibility of equipping the carrier 120 according to the invention from FIG. 8 with a test strip assembly 10. For this purpose, the test strip assembly 10 is introduced into the carrier 120 from above. Due to the mentioned tapering in the second region 40 of the test strip assembly 10 and the complementary shape of the carrier 120, the test strip assembly 10 can only be inserted into the carrier in one direction from above. In the last step of this procedure, the test strip assembly 10 is again pushed forward with little force in order to be protected from slipping out by the additional spring 130 installed on the carrier 120. The guide elements close to the bottom such as the guide rail 140 or recess of the carrier 120 and the webs 100 of the test strip assembly 10 enable precise guiding and positioning of the test strip assembly 10 during pipetting, washing, evaluating, and ejecting of the test strip assembly 10 or the tests located therein. The additional springs or spring clamping elements 110 enable simple installation, removal, and supply of the entire test strip assembly 10. Likewise, by means of the spring 130 provided on the carrier 120, the test strip assembly 10 can snap into place in the carrier 120 in an audible and perceptible manner for the user, in order to ensure that the test strip assembly 10 has been correctly inserted into the carrier 120.

LIST OF REFERENCE NUMERALS

[0060] 10 test strip assembly [0061] 20 containers [0062] 30 first region [0063] 40 second region [0064] 50 transparent bottom [0065] 60 V-shaped or U-shaped bottom [0066] 70 rim [0067] 71 rim of the second region [0068] 80 film [0069] 90 bar code [0070] 100 guide webs [0071] 110 clamp having clamping spring [0072] 120 carrier [0073] 130 spring [0074] 140 guide rail [0075] 150 lug [0076] 160 through hole