TEST DEVICE

Abstract

The present invention relates to test devices comprising one or more retaining members for removably retaining a sample applicator, sample applicators for use with such test devices, and kits comprising test devices and sample applicators of the invention.

Claims

1. A test device comprising a housing and a test element, the test element comprising a sample application zone, an analyte detection zone, and a sample flow path, the test device further comprising at least one retaining member for removably retaining a sample applicator in a retained position, wherein at least one retaining member does not extend substantially beyond the housing of the test device, and/or wherein when the sample applicator is in the retained position, the sample applicator does not extend substantially beyond one or more boundaries of the housing of the test device.

2. The test device according to claim 1, comprising retaining members at opposing ends of the housing.

3. The test device according to claim 1, wherein the at least one retaining member comprises; a) a first recess configured to retain an end, such as a tip, of the sample applicator, and/or b) a second recess configured to retain a retaining lug of the sample applicator.

4. The test device according to claim 3, wherein the at least one retaining member comprises the first recess and the second recess.

5. The test device according to claim 1, wherein the housing comprises a base, a top surface and a side wall substantially perpendicular to the base and/or the top surface.

6. The test device according to claim 5, wherein the at least one retaining member is in the side wall and/or top surface.

7. The test device according to claim 6, wherein the at least one retaining member and the sample applicator engage by press fit.

8. The test device according to claim 1, wherein the test device has a horizontal (y) axis, a horizontal (x) axis shorter than the horizontal (y) axis, and a vertical (z) axis and wherein the press fit is operated in the direction of the vertical (z) axis.

9. The test device according to claim 1, wherein in the retained position, the sample applicator does not extend substantially, or at all, beyond one or more of the following: i. a boundary of the device housing defined by a first plane extending in a vertical direction at a proximal end of the device located along the horizontal y axis of the device; ii. a boundary of the device housing defined by a second plane extending in a vertical direction at a distal end of the device located along the horizontal y axis of the device; iii. a boundary of the device housing defined by a third plane extending in the vertical direction at a proximal end of the device located along a horizontal x axis of the device; iv. a boundary of the device housing defined by a fourth plane extending in the vertical direction at a distal end of the device located along a horizontal x axis of the device; v. a boundary of the device housing defined by a fifth plane extending in a horizontal direction from the uppermost point of the housing.

10. The test device according to claim 1, wherein the at least one retaining member comprises a projection and/or a clip.

11. The test device according to claim 1, wherein when the test device is in a horizontal test position, and the sample applicator is in the retained position, the sample applicator is located substantially above at least one of the sample flow path, the analyte detection zone, and the sample application zone.

12. The test device according to claim 1, wherein a) when the sample applicator is in a retained position, less than 50%, less than 25%, less than 10%, less than 5%, or less than 1%, or 0% of the volume of the sample applicator extends beyond one or more boundaries of the housing of the test device, and/or b) less than 50%, less than 25%, less than 10%, less than 5%, or less than 1%, or 0% of the volume of the retaining member extends beyond one or more boundaries of the housing of the test device.

13. The test device according to claim 1, wherein (a) when the sample applicator is in a retained position, the sample applicator at least partially obscures the sample application zone and/or the analyte detection zone, and/or (b) the test device comprises a sample application well in communication with the sample application zone, and an analyte detection zone window, and when the sample applicator is in a retained position the sample applicator at least partially obscures the sample application well and/or the analyte detection zone window.

14. A test device comprising a housing, and a test element, the test element comprising a sample application zone, an analyte detection zone, and a sample flow path, the test device further comprising at least two retaining members for removably retaining a sample applicator in a retained position, wherein the housing comprises a base, a top surface and a side wall substantially perpendicular to the base and/or the top surface, wherein a first retaining member comprises a first recess in the side wall and/or top surface, the recess being configured to retain a first end of the sample applicator, and a second retaining member comprises a second recess in the side wall and/or top surface, the second recess being configured to retain a second end of the sample applicator.

15. The test device according to claim 14, wherein the first retaining member and the second retaining member are at opposing ends of the test device.

16. The test device of claim 14, where the first end of the sample applicator comprises a tip of the sample applicator and the first recess retains the tip and/or wherein the second end of the sample applicator comprises a retaining lug and the second recess retains the retaining lug.

17. A sample applicator comprising a retaining lug configured to engage with a retaining member of a test device to retain the sample applicator.

18. The sample applicator according to claim 17, wherein the applicator is a pipette comprising a tip, a barrel, a bulb, wherein the bulb comprises the retaining lug.

19. The sample applicator of claim 18 wherein the test device comprises a housing, and a test element, the test element comprising a sample application zone, an analyte detection zone, and a sample flow path, the test device further comprising at least two retaining members for removably retaining a sample applicator in a retained position, wherein the housing comprises a base, a top surface and a side wall substantially perpendicular to the base and/or the top surface, wherein a first retaining member comprises a first recess in the side wall and/or top surface, the recess being configured to retain a first end of the sample applicator, and a second retaining member comprises a second recess in the side wall and/or top surface, the second recess being configured to retain a second end of the sample applicator.

20. A kit comprising a test device according to claim 16, wherein the sample applicator is a pipette, the pipette comprising a tip, a barrel, a bulb, and wherein the bulb comprises the retaining lug.

21. The sample applicator of claim 18, wherein the test device comprises: a housing and a test element, the test element comprising a sample application zone, an analyte detection zone, and a sample flow path, the test device further comprising at least one retaining member for removably retaining a sample applicator in a retained position, wherein at least one retaining member does not extend substantially beyond the housing of the test device, and/or wherein when the sample applicator is in the retained position, the sample applicator does not extend substantially beyond one or more boundaries of the housing of the test device.

22. A kit comprising a test device according to claim 3, wherein the sample applicator is a pipette, the pipette comprising a tip, a barrel, a bulb, and wherein the bulb comprises the retaining lug.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Embodiments of the invention will now be described, by way of example, with reference to the drawings, in which:

[0043] FIG. 1 shows a line drawing of an assay device and sample applicator in the retained position according to one embodiment of the invention.

[0044] FIG. 2 shows a line drawing of an assay device and sample applicator of FIG. 1 in the unretained position.

DETAILED DESCRIPTION

[0045] The test device of the invention can be further understood with reference to FIG. 1, which shows a test device (100) comprising a test element located within a housing (112). The housing extends along two horizontal axes, labelled x and y, and a vertical axis, labelled z. The housing extends further along the y axis than the x axis. A removable sample applicator (101) is releasably retained on the test device. The housing (112) comprises a top surface (113), a bottom surface (not visible in the figure) substantially parallel to the top surface and a side wall (114) joining the top and bottom surfaces. The side wall extends generally in the direction of the vertical z axis of the device. The test device has a distal end situated along the y axis comprising a first recess (102), and a proximal end situated along the y axis comprising a second recess (103). The first recess (102) is in a portion of the side wall (114) which extends above the top surface (113) of the housing. The second recess (103) is also in a portion of the side wall which extends above the top surface (113) of the housing (112). The test element (not visible in the figure) contained within the housing (112) comprises an analyte detection zone (115). The analyte detection zone (115) comprises a test zone and a control zone (identified as lines T and C respectively in the figure). The top surface (113) comprises an analyte detection zone window (105) for viewing the analyte detection zone (115). A sample application well (104) is provided in the top surface (113) for applying sample to the sample application zone of the test element using the sample applicator. The removable sample applicator (101) comprises a tip (108), a bulb (110) and a barrel (109) connecting the tip (108) to the bulb (110). A retaining lug (111) is provided at the end of the bulb (110) that does not connect to the barrel (109).

[0046] The test device is configured such that the tip (108) of the sample applicator (101) is received by the first recess (102), and the retaining lug (111) of the sample applicator (101) is received by the second recess (103). The first recess (102) is configured such that a tip (108) of the sample applicator (101) can be inserted into the first recess (102).

[0047] The second recess (103) is “U” shaped, so that the retaining lug (111) of the sample applicator (101) can be pushed into the recess (103) from above. The retaining lug (111) is held in the second recess (103) by friction after the parts are pushed together i.e. by a press fit. Advantageously, when the sample applicator is in the retained position, neither the retaining members nor the sample applicator extend substantially beyond the housing of the test device. Furthermore, in this embodiment, the tip is tucked inside the side wall of the housing. This minimises the likelihood that the sample applicator will be caught on packaging or otherwise interfere with the packaging process. It also minimises the amount of packaging required.

[0048] In the retained position shown in FIG. 1, the sample applicator at least partially obscures the sample application well (104), sample application zone, and the analyte detection zone window (105). This is advantageous in that it indicates to the user that, in order to commence an assay, the sample applicator must first be removed from the test device.

[0049] In order to use the sample applicator to apply liquid to the test device, the sample applicator is removed from the test device by lifting it upwards so that the retaining lug (111) disengages the second recess (103) and the tip (108) is withdrawn from the first recess (102).

[0050] FIG. 2 shows the test device and sample applicator of FIG. 1 separately i.e. in the unretained state. The sample well (104) is no longer obscured by the sample applicator (101) and is accessible allowing a user to apply sample to the test device (100) using the sample applicator (101). Similarly, the analyte detection zone window (105) is no longer obscured by the sample applicator (101) and can be readily observed by a user.