US-20260123863-A1 - A Housing for Sample Collection

US20260123863A1US 20260123863 A1US20260123863 A1US 20260123863A1US-20260123863-A1

Abstract

A housing for sample collection is disclosed. The housing comprises an actuating member configured to move between a first position and a second position, a sample collector and an assay component. In the first position the sample collector is in contact with the assay component and in the second position the sample collector is separated from the assay component and configured to collect a sample.

Inventors

Alexander Patto

Assignees

CAMBRIDGE ENTERPRISE LIMITED

Dates

Publication Date: 20260507
Application Date: 20230929
Priority Date: 20220930

Claims (20)

1 . A housing for sample collection, the housing comprising: an actuating member configured to move between a first position and a second position; a sample collector; and an assay component; wherein in the first position the sample collector is in contact with the assay component and in the second position the sample collector is separated from the assay component and configured to collect a sample.
2 . The housing of claim 1 , further comprising a needle, wherein in the first position the needle is disposed within the housing and in the second position the needle protrudes from an aperture in the housing.
3 . The housing of claim 1 wherein the sample collector is a pad.
4 . The housing of claim 1 further comprising: an excess sample collector, wherein the sample collector is configured to hold a predetermined volume of liquid and when the actuator is in the second position, the excess sample collector is configured to collect or absorb excess liquid from the sample collector once the sample collector holds its predetermined volume, and wherein the sample collector and the excess sample collector are separated from the assay component, and in the first position, the sample collector is separated from the excess sample collector.
5 . A housing for sample collection, the housing comprising: an actuating member configured to move between a first position and a second position; a piercing member; and a needle; wherein in the first position the needle is disposed within the housing and in the second position the needle protrudes from an aperture in the housing, and wherein the piercing member is configured to pierce a seal of a fluid reservoir upon movement from the first position to the second position.
6 . The housing of claim 2 wherein the needle is disposed on a surface of the actuating member.
7 . The housing of claim 5 further comprising a sample collector configured to receive bodily fluid.
8 . The housing of claim 7 wherein moving the actuating member from the first position to the second position causes the needle to pierce the sample collector, or causes the needle to move past the sample collector.
9 . The housing of claim 1 wherein the housing comprises a base and a cover, and wherein the actuating member is attached to, and moveable relative to, the base.
10 . The housing of claim 1 when dependent on claim 5 further comprising an adhesive arranged on a surface of the housing.
11 . The housing of claim 9 further comprising an excess sample collector configured to receive bodily fluid from the sample collector or from a body.
12 . The housing of claim 1 further comprising a sample collector aperture or a sample collector window in a surface of the housing configured to allow visual inspection of the sample collector.
13 . The housing of claim 1 further comprising a buffer fluid reservoir comprising a seal.
14 . The housing of claim 1 further comprising a buffer component configured to receive fluid from a, or the, buffer fluid reservoir.
15 . The housing of claim 2 when dependent on any of claim 5 wherein once the actuating member has reached the second position, an end-stop or a spring causes the needle to move to a needle position between the needle position in the first position and the needle position in the second position.
16 . The housing of claim 13 , wherein when the housing comprises a sample collector configured to receive a bodily fluid and at least one of an assay component or a buffer component configured to receive fluid from the buffer fluid reservoir, in the first position, the reservoir is in contact with the assay component or the pad and in the second position, there is a space between the reservoir and the assay component or the buffer component.
17 . The housing of claim 1 further comprising a lateral flow test strip viewing aperture or window configured to allow the viewing of a lateral flow test strip.
18 . A test device comprising an assay component disposed in a housing according to claim 5 .
19 . The test device of claim 18 wherein the assay component is configured to detect the presence or absence of a vitamin.
20 . (canceled)

Description

FIELD OF THE INVENTION The present invention relates to a housing for sample collection and to a method of determining a concentration range of vitamin K. Specifically, the present invention relates to a housing for the collection of a bodily fluid for analysis using an assay. BACKGROUND When performing an assay or test on a sample (for example, bodily fluid), it can be crucial that the assay steps are performed in the correct order, for example, if a buffer is required, the sample must be deposited before the buffer runs on the assay component, such as a lateral flow test strip. If the sample is added to the assay component without the buffer, or the buffer floods the assay component before the sample is added, the results of the assay or test may not be reliable. Unreliable results may influence diagnosis or treatment recommendations, and may require the test to be carried out again which can be distressing to a subject having the test, and also waste valuable resources. Further, the volume of sample for performing an assay or test can greatly influence the results. Therefore, there is a need to ensure a relatively consistent sample volume to improve results from semi-quantitative, or qualitative tests. Typically, to ensure consistent volumes of samples are collected, additional sterile apparatus are required. Ensuring that a test is performed correctly can involve performing multiple complex steps manually, and a mistake or error in any one of these steps can result in unreliable test results. Currently, running an immunoassay, or lab based method as a point-of-care is highly complex and can involve multiple steps for sample collection, sample measurement, and buffer administration, before the sample and buffer mixture can be tested using an assay. This can introduce high costs, additional equipment and also errors. For a test to be most useful, it needs to be simple, quick, and accurate to reduce errors and lower operational costs. Thus, there is a need for a test that is highly automated in terms of sample collection and volume measurement, and buffer administration. SUMMARY According to a first aspect of the invention, there is provided a housing for sample collection. The housing comprises an actuating member configured to move between a first position and a second position, a sample collector, and an assay component. In the first position the sample collector is in contact with the assay component and in the second position the sample collector is separated from the assay component and configured to collect a sample. When the sample collector is in contact with the assay component, the contact allows for liquid communication between the sample collector and the assay component. For example, when the sample collector is in contact with the assay component, a sample (e.g. a bodily fluid, a bodily-derived fluid, or excretion from a human or other animal) may be passed from the sample collector to the assay component, for example, by capillary action. When the sample collector is separated from the assay component, liquid communication between the sample collector and the assay component is not possible. The sample collector may be a pad, an ampule, a cup or a tube suitable for collecting the sample to be analysed. The assay component may be, for example, a pad, an ampule, a cup or a tube suitable for holding reagents and/or analytes to perform an assay or test. The assay component may comprise or be adjacent to an assay test component. The assay may be, for example, a lateral flow assay or an enzyme linked immunosorbent assay (ELISA). The sample collector may be separated from the assay component by a space or a barrier that prevents liquid communication between the sample collector and the assay component. The housing may further comprise a needle. In the first position the needle may be disposed within the housing and in the second position the needle may protrude from an aperture in the housing. In the first and/or second positions, the needle may or may not protrude through the sample collector. In the first position, the needle may be separated from the sample collector. The sample collector may be a pad. The sample collector may be a fibre pad, for example, a wicking pad. The sample collector may be configured to hold a predetermined volume of liquid. The sample collector may collect the sample via capillary action. The housing may further comprise an excess sample collector. The sample collector may be configured to hold a predetermined volume of liquid. When the actuator is in the second position, the excess sample collector may be configured to collect or absorb excess liquid from the sample collector once the sample collector holds its predetermined volume. The sample collector and the excess sample collector may be separated from the assay component when the actuator is in the second position. When the actuator is in the first position, the sample collector is separated from the excess sampl