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CN-121985997-A - Elution kit, analysis kit and method for eluting and analyzing biological sample

CN121985997ACN 121985997 ACN121985997 ACN 121985997ACN-121985997-A

Abstract

An elution kit (1) for eluting a biological sample in a liquid (2) and dispensing the eluted sample liquid (2') onto a test element (102) of an analysis kit (101), the elution kit (1) comprising a sample collection swab (3) for collecting the biological sample, wherein the sample collection swab (3) comprises a rod-shaped part (4) for holding and a deformable head part (5) on the rod-shaped part (4) for collecting the biological sample, wherein the head part (5) is porous for the liquid (2), and an elution liquid tube (6) comprising an inner space (7) for receiving the liquid (2), receiving the sample collection swab (3) and eluting the biological sample in the liquid (2), an insertion opening (10) on a first side of the inner space (7) for inserting the sample collection swab (3) into the inner space (7), a dispensing opening (11) on a second side of the rod-shaped part (4) which is permeable to water, a second, water-impermeable dispensing element (13) on a second side of the inner space (7) adjacent to the liquid (2), which serves to seal the insertion opening (10) in a water-vapor impermeable manner, wherein the first closing element (12) and/or the second closing element (13) comprises a foil, and the liquid (2), wherein the eluting liquid tube (6) accommodates the liquid (2), wherein the inner space (7) is defined by an inner surface (8) comprising an elution zone (16) with at least one elution portion (9) having a minimum side-to-side distance y in the range between about 70% and 140% of the maximum side-to-side distance x of the head portion (5) of the sample collection swab (3), and defining a gap (14) through which the sample collection swab (3) can be pushed and pulled in the closed state of the dispensing opening (11).

Inventors

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

Assignees

  • 豪夫迈·罗氏有限公司

Dates

Publication Date
20260505
Application Date
20241007
Priority Date
20231010

Claims (13)

  1. 1. An elution kit (1) for eluting a biological sample in a liquid (2) and dispensing the eluted sample liquid (2') onto a test element (102) of an analysis kit (101), the elution kit (1) comprising: A sample collection swab (3) for collecting the biological sample, wherein the sample collection swab (3) comprises a stick portion (4) for holding in a hand and a deformable head portion (5) on the stick portion (4) for collecting the biological sample, wherein the head portion (5) is porous to the liquid (2), and An elution liquid tube (6) comprising: -an inner space (7) for receiving the liquid (2), receiving the sample collection swab (3), and eluting the biological sample in the liquid (2); an insertion opening (10) on a first side of the interior space (7) for inserting the sample collection swab (3) into the interior space (7); a dispensing opening (11) on a second side of the interior space (7) adjacent to the first side for dispensing the eluted sample liquid; A first closing element (12) to seal the dispensing opening (11) in a water vapor impermeable manner; A second closing element (13) for sealing the insertion opening (10) in a water-vapor-impermeable manner, wherein the first closing element (12) and/or the second closing element (13) comprise a foil, and Said liquid (2), wherein said eluting liquid pipe (6) contains said liquid (2), Wherein the interior space (7) is defined by an interior surface (8) comprising an elution zone (16) having at least one elution portion (9) with a minimum side-to-side distance y in the range between about 70% and 140% of the maximum side-to-side distance x of the head portion (5) of the sample collection swab (3) and defining a gap (14) through which the sample collection swab (3) can be pushed and pulled in a closed state of the dispensing opening (11).
  2. 2. The elution kit (1) according to claim 1, wherein the volume of the interior space (7) of the elution liquid tube (6) is sized to accommodate a liquid volume of less than 1ml, in particular less than 500 μl and more in particular less than 10 μl, and wherein The ratio of the volume of the inner space (7) to the volume of the liquid is less than 10, and/or The ratio of the "liquid volume"/"liquid volume absorbed by the wetted head portion (5)" is between 1 and 10.
  3. 3. The elution kit (1) according to any one of the preceding claims, wherein the elution portion (9) comprises at least one of: at least one elution zone (9 a) having a length in the range between 10% and 98% of the length (l) of the elution liquid tube (6); at least one elution protrusion (9 b) having a length corresponding to less than 10% of the length (l) of the elution liquid tube (6), and/or At least one helical thread-like projection (9 c).
  4. 4. The elution kit (1) according to any one of the preceding claims, wherein the elution liquid tube (6) comprises, on the side on which the dispensing opening (11) is located: a dispensing nozzle (18) defining the dispensing opening (11), and/or A rim configured for positioning the elution liquid tube (6) in an upright orientation, optionally wherein the rim comprises elements of a coupling mechanism (109 a, 109 b) for coupling the elution liquid tube (6) to a test element (102), optionally wherein the coupling mechanism (109 a, 109 b) comprises a screw mechanism (109 b), a bayonet and/or a luer lock mechanism.
  5. 5. The elution kit (1) according to any one of the preceding claims, wherein the interior space (7) comprises: An insertion region (15); The elution zone (16), and -A dispensing zone (17), optionally wherein a maximum diameter (Rb) of the inner space (7) in the insertion zone (15) is greater than a maximum diameter (Rc) of the inner space (7) in the elution zone (16) and/or the maximum diameter (Rc) of the inner space (7) in the elution zone (16) is greater than a maximum diameter (Rd) of the inner space (7) in the dispensing zone (17).
  6. 6. The elution kit (1) according to any one of the preceding claims, wherein the outer diameter of the elution liquid tube (6) is 3 times or more, in particular 8 times or more, and more in particular 20 times or more the side-to-side distance y of the elution portion (9) of the inner space (7).
  7. 7. An assay kit (100) for assaying a biological sample, the assay kit comprising: An elution kit (1) according to any one of the preceding claims, and The test element (102) comprises at least an application function part (104), a test reaction function part (105) and a test detection function part (106).
  8. 8. The assay kit (100) according to claim 7, wherein the test element (102) comprises a test element housing (103) and/or an LFA wick (111).
  9. 9. The assay kit (101) according to claim 7 or 8, Wherein the elution liquid tube (6) and the test element (102) of the elution kit (1) are in a fixed relationship to each other, in particular fixedly attached to each other, and/or supported or housed in a single unit, in particular jointly and at least partially supported by one cardboard, and/or wherein the analysis kit (101) comprises a fluid path (21) permanently arranged between the elution liquid tube (6) and the test element (102) and comprising a fluid path closure element (20) configured to prevent transfer of the liquid from the elution kit (1) to an elution liquid application zone (104) in a closed state of the fluid path (21) and to allow transfer of the liquid from the elution liquid tube to the elution liquid application zone (104) in an open state of the fluid path (21).
  10. 10. The assay kit (101) according to claim 9, wherein the fluid path closure element (20) comprises: A valve element configured to mechanically transition from the open state to the closed state of the fluid path (21), and/or A rupturable barrier capable of having a complete state corresponding to the closed state or a ruptured state corresponding to the open state.
  11. 11. The assay kit (100) according to claim 7 or 8, wherein the eluting liquid tube (6) and the test element (102) are separate elements, optionally wherein the eluting liquid tube (6) and the test element (102) can be brought into fluid connection with each other for transferring the eluted sample liquid onto the test element (102).
  12. 12. The analytical kit (100) according to claim 11, wherein the eluting liquid tube (6) and the test element (102) comprise a coupling mechanism (109 a, 109 b) for coupling the eluting liquid tube (6) to the test element (102) and configured to allow non-overflow transfer of the eluted sample liquid onto the eluent application zone (104) of the test element (102).
  13. 13. A method (200) of eluting and analyzing a biological sample, the method comprising the steps of: Providing (201) an assay kit according to any one of claims 7 to 12, wherein the liquid is provided in the interior space (7) of the elution liquid tube (6); -collecting (203) the biological sample with the head portion (5) of the sample collection swab (3); inserting (204) the sample collection swab (3) into the interior space (7) through the insertion opening (10) with the head portion (5) facing forward; Pushing (205) the head portion (5) into the elution zone (16) at least partially across the at least one elution portion (9) towards the dispensing opening (11) and wetting (206) the head portion (5) of the sample collection swab (3) with the liquid (2); -pulling (207) the sample collection swab (3) inside the elution zone (16) at least partially across the at least one elution portion (9) towards the insertion opening (10); -opening (208) the dispensing opening (11) while the sample collection swab (3) is held in one position; pushing (211) the sample collection swab (3) towards the dispensing opening (11) to dispense the eluted sample liquid onto the test element (102), and The biological sample is analyzed (212) by reading results from a test detection zone (106).

Description

Elution kit, analysis kit and method for eluting and analyzing biological sample Technical Field The present invention relates to an elution kit in the field of In Vitro Diagnostics (IVD), an analysis kit comprising the same and a method for eluting and analyzing a biological sample based on the same. Background During Covid 19 epidemic situations, it has been widely practiced to elute a biological sample in a liquid when a user is self-testing using a lateral flow assay. Test kits used in connection with self-testing typically include a swab for collecting a biological sample, a vial containing a liquid in which the biological sample may be eluted, and a lateral flow assay comprising a test element, such as a test strip, to which the liquid with the eluted sample is applied and from which test results may be obtained. The test results provide information on the presence or absence of an analyte such as Covid viruses in the sample. The sensitivity and reliability of the test results is largely dependent on the canonical handling of the test kit and the correct execution of the sample elution. Typically, the test kit includes a short manual for the user to guide himself to complete the protocol for performing the test. However, in most cases, the test kit leaves a degree of freedom to the user, so that each user may change the performance of the test, which may lead to poor reliability and reproducibility of the test, and may lead to false negative test results. Thus, most test kits requiring elution of biological samples performed by private users cannot guarantee a high degree of reliability and reproducibility, as the users may deviate from the protocols described in the handbook. In more detail, a typical procedure for eluting a sample in a liquid comprises immersing the head of a swab in the liquid provided in a vial so that the collected sample may be eluted therein. Thus, the swab is inserted into the vial and rotated inside the vial, wherein the vial is simultaneously manually squeezed to provide a degree of friction, thereby producing an effect of eluting the collected sample in the liquid. Once the swab is rotated a predetermined number of times while squeezing the vial, the swab is removed and the vial is closed with a cap. Typically, the cap has an application functionality that allows drop-wise application of liquid onto the test element. Thus, the closed vial is turned with its cap down and the vial is squeezed until the droplet is pressed out of the vial through the small opening in the cap of the vial, which may correspond to the application function. The procedure is relatively simple but may be improved in terms of repeatability, reliability and user friendliness. Disclosure of Invention It is therefore desirable to provide a more reliable elution kit, an analysis kit comprising an elution kit and a method of eluting and analyzing a biological sample based on an analysis kit. It is further desirable to provide an elution kit that can be easily, comfortably and/or reliably manipulated by a user. At least one of the problems described is solved by an elution kit, an analysis kit comprising an elution kit and a method of eluting and analyzing a biological sample based on an analysis kit according to the independent claims. Advantageous embodiments are covered by the dependent claims. According to one aspect which may be considered as a first aspect of the present disclosure, an elution kit for eluting a biological sample in a liquid and dispensing the eluted sample liquid onto a test element of an analysis kit, the elution kit comprising a sample collection swab for collecting the biological sample, wherein the sample collection swab comprises a rod-shaped portion for holding and a deformable head portion on the rod-shaped portion for collecting the biological sample, wherein the head portion is porous to the liquid, and an elution liquid tube comprising an interior space for receiving the liquid, receiving the sample collection swab and eluting the biological sample in the liquid, an insertion opening on a first side of the interior space for inserting the sample collection swab into the interior space, a dispensing opening on a second side of the interior space adjacent to the first side for dispensing the eluted sample liquid, a first closure element for sealing the dispensing opening in a water vapor impermeable manner, and a second closure element for sealing the insertion opening in a water vapor impermeable manner, wherein the first closure element and/or the second closure element comprises a foil, wherein the first closure element and/or the second closure element comprises a closure element having a distance of at least one of the top surface of the elution device and the elution device is defined by a maximum distance of at least one of the inner side of the elution device, the elution device having a maximum distance of the elution device being able to pass at least one of a maximu