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CN-122029429-A - IVA test unit, test kit comprising an IVA test unit and method for producing the same

CN122029429ACN 122029429 ACN122029429 ACN 122029429ACN-122029429-A

Abstract

An IVA test unit (1) comprising a test strip (2) for detecting an analyte, wherein the test strip comprises at least an application function, a test reaction function and a test detection function, and a housing (3) for storing the test strip (2), wherein the housing (3) comprises an insertion tray (4) and an insertion hole (5) for inserting the test strip (2) into the insertion tray (4), characterized in that the housing (3) is formed in one piece.

Inventors

  • M. BLOOM
  • Y. Igoran
  • S. Maiev dos Santos

Assignees

  • 豪夫迈·罗氏有限公司

Dates

Publication Date
20260512
Application Date
20241007
Priority Date
20231010

Claims (16)

  1. 1. An IVA test unit (1), comprising: A test strip (2) for detecting an analyte, wherein the test strip comprises at least an application function, a test reaction function and a test detection function, and A housing (3) for storing the test strip (2), wherein the housing (3) comprises an insertion tray (4) and an insertion hole (5) for inserting the test strip (2) into the insertion tray (4), characterized in that the housing (3) is formed as one piece.
  2. 2. The IVA test unit (1) of claim 1, wherein the housing (3) comprises a first wall (6) and a second wall (7) adjacent to the first wall (6), and wherein the first wall (6) and the second wall (7) define the insertion tray (4) between the first wall (6) and the second wall (7).
  3. 3. The IVA test unit (1) according to claim 1 or 2, wherein the housing (3) comprises: an application recess (8) for allowing application of a sample liquid (23) to the test strip (2), and/or A control zone (9) for reading test results from the test strip (2).
  4. 4. The IVA test unit (1) of any one of the preceding claims, further comprising one of the following closure elements: an insertion plug (10) configured to plug into the insertion hole (5) to close the insertion hole (5) and/or to stabilize the test strip (2) from falling out of the insertion tray (4); A cap (30) configured to be clamped to the housing (3) over the insertion hole (5).
  5. 5. The IVA test unit (1) of claim 3 or 4, further comprising at least one transparent cover plate (24) configured to cover (140) and/or enclose the control area (9) and/or the application recess (8).
  6. 6. The IVA test unit (1) of claim 5, further comprising at least one of: A desiccant as a compound of the housing (3), the closing element and/or the cover plate; desiccant as an element placed in at least one chamber and/or recess of the housing (3), the plug-in plug (10) and/or the cover plate (24) for storing the desiccant.
  7. 7. The IVA test unit (1) of claim 5 or 6, wherein the IVA test unit (1) comprises at least one of: A water vapor impermeable material comprised as a unitary material of the housing (3), the closure element and/or the cover plate (24); A water vapor impermeable upper layer sprayed and/or coated onto the housing (3), the closing element and/or the cover plate (24); a water vapor impermeable film, preferably wherein the water vapor impermeable film encapsulates the entire IVA test unit (1).
  8. 8. The IVA test unit (1) of any one of the preceding claims, wherein the housing (3) comprises a securing mechanism configured to secure a position of the test strip (2) in the insertion tray (4), optionally wherein the securing mechanism comprises at least one of: A hook as an element of the housing (3) and a recess as an element of the test strip (2), the recess being configured to snap into the hook; A spring element configured to secure the test strip (2) by a spring force; The housing (3) is configured to hold the elements of the test strip (2) by friction.
  9. 9. A method (100) of producing an IVA test unit (1), the method comprising the steps of: Providing (110) a one-piece housing (3) for storing a test strip (2), wherein the housing (3) comprises an insertion tray (4) and an insertion hole (5) for inserting the test strip (2) into the insertion tray (4); -placing (120) the test strip (2) in the housing (3).
  10. 10. The method (100) according to claim 9, wherein providing the housing (3) comprises producing the housing (3) as one piece by injection molding (110 a) and/or by additive manufacturing (110 b), in particular by 3D printing.
  11. 11. The method (100) according to claim 9 or 10, wherein placing the test strip (2) into the housing (3) comprises: Providing (121) a strip (18), preferably from a roll, having a longitudinal strip axis (B), wherein the strip (18) comprises the test strip (2) among a plurality of test strips (20) along the longitudinal strip axis (B); -conveying (122) the belt (18) along the longitudinal belt axis (B); -cutting (123) the strip (18) perpendicular to the longitudinal strip axis (B) to separate the test strips (2) from the plurality of test strips (20); aligning (124) the housing (3) with a longitudinal housing axis (A) parallel or perpendicular to the longitudinal strip axis (B) and the insertion hole (5) facing the test strip (2), and -Inserting (125) the test strip (2) through the insertion hole (5) into the insertion tray (4).
  12. 12. The method (100) according to any one of claims 9 to 11, further comprising closing the insertion hole (5) by at least one of: Inserting a plug (10) into the insertion hole (5) a plug (130); a cap (30) is clamped to the housing (3) over the insertion hole (5).
  13. 13. The method (100) of any one of claims 12, further comprising providing a desiccant as at least one of: -a compound of the housing (3), the insertion plug (10) and/or the cap (30); -an element placed in at least one chamber and/or recess of the housing (3), the insertion plug (10) and/or the cap (30).
  14. 14. The method (100) according to any one of claims 9 to 13, further comprising at least one of: Spraying and/or coating a water vapor impermeable upper layer onto the housing (3); the entire IVA test unit (1) is enclosed by a water-vapor impermeable film.
  15. 15. The method (100) according to any one of claims 9 to 14, further comprising fixing the position of the test strip (2) in the insertion tray (4) using a fastening mechanism based on a snap-in mechanism, a spring force and/or a friction force.
  16. 16. A test kit (17), comprising: the IVA test unit (1) according to any one of claims 1 to 8; A swab (29) for collecting a biological sample, and A vial (19) comprising a liquid for eluting the sample.

Description

IVA test unit, test kit comprising an IVA test unit and method for producing the same Technical Field The present invention relates to an In Vitro Assay (IVA) test unit, in particular a Lateral Flow Assay (LFA) test unit, in the field of In Vitro Diagnostics (IVD), a method for the production thereof, and a test kit comprising the IVA test unit. Background Conventional LFAs, such as LFA strip or dipstick tests, are often used in diagnostic applications. Test films that may be used in such tests may specifically include, but are not limited to, nitrocellulose films. A specific wire is typically applied to a membrane containing a specific chemical capture reagent or compound designed to react with and bind to a predetermined analyte, specifically a biological marker that may be present in a test sample liquid such as, but not limited to, sputum, urine, blood, water, a liquefied food sample, and a surface swabbing sample. A specific example of an LFA is a rapid antigen test piece for detecting the presence of an analyte (such as a viral fragment of an infectious disease) in a biological sample. Generally, LFA test units are often used in the form of test strips (such as, for example, pregnancy test strips, pharmaceutical test strips, influenza and/or Covid test, and/or allergen rapid test). When a sample liquid is applied to the application area of the LFA test strip, the sample liquid is drawn by capillary forces along the longitudinal axis of the membrane (also referred to as a membrane analyte measurement strip). The presence of a predetermined analyte is typically indicated when enzymes, target proteins and/or biomarkers corresponding to these analytes migrate along the membrane and interact with chemical capture reagents in the strip of the membrane, thereby producing a measurable and detectable signal/change in the analyte measurement test zone(s). The resulting detectable and measurable signal at the striped region may be caused by, but is not limited to, binding to, colloidal gold, charcoal beads, latex-dyed beads, magnetic or paramagnetic beads, and/or agents or particles capable of emitting fluorescence, autofluorescence, luminescence, phosphorescence or chemoluminescence. Test kits/test kits based on such test units, in particular LFA test units, comprise several individual elements, which each have different functions and which are complicated, difficult and/or time-consuming to produce and assemble. Thus, increasing the production yield requires a great effort in terms of machine performance. Furthermore, this requires multiple assembly steps to provide an assembled test kit that is packaged and ready to be shipped. In general, the volume and shape of the packages do not allow for easy stacking of multiple packages and require a lot of space. In fig. 1, the elements of a typical LFA kit 200 (i.e., LFA rapid antigen test kit for detecting the presence of Covid in a biological sample) are shown. The included LFA rapid antigen test piece typically corresponds to a single use test, meaning that it is disposed of after the test is performed, and thus the test kit is considered disposable. The LFA rapid antigen test element comprises a test strip, in particular an LFA core strip 202, and a plastic housing 201 consisting of at least two elements, an upper element (cover element) and a lower element (support element). Further, LFA kit 200 includes a swab (not shown) for collecting a biological sample, a desiccant/desiccant 204, and a water vapor impermeable aluminum pouch 203 into which LFA rapid antigen test piece, swab and desiccant 204 are inserted, packaged and sealed. LFA rapid antigen test pieces are typically assembled by a pick-and-place procedure, wherein LFA core strip 202 is positioned on a lower piece of plastic housing 201, followed by the step of assembling and clamping an upper piece of plastic housing 201 onto the lower piece to form an LFA unit (LFA rapid antigen test piece in this case). Production can be time-intensive and, in some cases, inefficient. In addition, the transport of such LFA rapid antigen test kits can often be inefficient. Furthermore, the cost of production and/or shipping of such LFA rapid antigen test kits can be high. Disclosure of Invention It is therefore desirable to provide a simplified, quick and/or efficient method of producing an IVA test unit. In epidemic situations, there is a particular need for a method of producing large numbers of IVA test units in a short period of time. Such dynamic situations often require a simple and/or rapid scaling up and/or down of the production rate to cope with the possibility of increased and/or decreased infection. Thus, the provider can increase agility and quickly respond to changing epidemic situations. Epidemic situations often also require a large number of test kits/kits to be transported efficiently and/or quickly to the point of care and/or the site of an epidemic outbreak. It is therefore also desirable to provide a