A sample collection device
The sample collection device addresses user errors in self-testing by using capillary action and absorbent materials for secure sample storage and controlled release, ensuring accurate and hygienic multiple-test capability.
Patent Information
- Application Number
- GB2024010765
- Authority / Receiving Office
- GB · GB
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-07-23
- Publication Date
- 2026-02-04
AI Technical Summary
Existing self-testing medical diagnostic processes are complex and prone to user error due to the need for precise timing and sufficient sample volume, especially when conducted by untrained users, leading to measurement inaccuracies.
A sample collection device with a liquid collection portion and storage portion that utilizes capillary action and absorbent materials like foam or sponge to securely store and transfer samples, featuring a visible indicator for volume confirmation and an actuator for controlled sample release, allowing for multiple tests from a single sample.
Ensures accurate and hygienic sample handling by minimizing evaporation and overflow, enabling multiple tests from a single sample collection, reducing user complexity and enhancing measurement precision.
Smart Images

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Abstract
Description
Technical Field of the Invention The present invention relates to a sample collection device and a test reader. In particular, the present invention relates to sample collection device for collecting and storing a liquid or liquid-based sample, and a test reader for reading / analysing the sample from the sample collection device. Background to the Invention Sample handling for medical diagnostic testing is usually performed by trained operators using automated laboratory equipment. Samples are delivered to the laboratory in suitable receptacles before being inserted into a measurement device which automatically analyses the samples. However, in some instances at least part of the medical diagnostic testing process may be carried out by an untrained user, for example during self-testing carried out at home. In such instances, a user may collect a sample themselves, which must be safely stored until the sample may be analysed by a measurement device either at home, or in a laboratory. Many existing self-tests are overly complex and require several steps to be carried out by the untrained user. Given that most medical diagnostic tests are highly sensitive, requiring amongst other things, precise timing and a sufficient volume of sample, the complexity of many existing self-tests can result in user error which may subsequently cause measurement errors. Furthermore, users are often required to carry out several different self-tests in order to monitor several different targets. As outlined above, medical diagnostic tests are highly sensitive and as such, they are likely to have different requirements such as timing of the test, which the user must understand to produce an accurate test measurement. Of course, without adequate training, this can be confusing and difficult for the user. It is an object of the present invention to overcome these or other disadvantages and / or to improve an improved sample collection device. Summary of the Invention According to a first aspect of the present invention there is provided a sample collection device comprising: a. a liquid or liquid based sample collection portion to collect a liquid or liquid based sample; and b. a sample storage portion in liquid communication with the liquid or liquid based sample collection portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release at least a portion of the stored liquid or liquid-based sample. The liquid or liquid-based sample collection portion may comprise a wick or material with wicking or characteristics which cause or increase capillary action. The wick may be configured to transfer the liquid or liquid-based sample from the sample collection portion to the sample storage portion. The wick may be configured to transfer the liquid or liquid based sample from the sample collection portion to the sample storage portion via capillary action. The wick may be elongate. The wick may abut an outer housing of the sample storage portion. The sample storage portion may comprise an absorbent material. The absorbent material may be configured to retain the liquid or liquid-based sample at least temporarily. The absorbent material may have any form but may preferably be a foam material. Expandable foam may be used such that as the sample is received by the foam, the foam expands. In one form, the sample storage portion may comprise a sponge. The sponge may be configured to retain the liquid or liquid-based sample at least temporarily. Provision of an absorbent material such as a sponge may assist in the transfer of the liquid or liquid-based sample from the sample collection portion to the sample storage portion via capillary action. Once the liquid or liquid-based sample is in the sample storage portion, it may remain there in a fresh state until the sample is ready to be tested. As such, the sample storage portion may assist in maintaining the freshness and quality of the sample by minimising evaporation of the sample and diffusion out of the sample storage portion. In another form, the sample collection portion may comprise the aforementioned expandable foam provided within a fixed size receptacle, the fixed size receptacle being sized according to a maximum size of expansion of the foam. The fixed size receptacle may be smaller than the maximum size of expansion of the foam. This configuration may allow a fixed volume sample collection. A cellulose foam material may be particularly preferred. The sample storage portion may be configured to absorb a predetermined volume of liquid or liquid-based sample. This may help to ensure that a sufficient volume of liquid or liquid-based sample is available to be delivered to the test portion, thereby helping to allow a more accurate measurement of the sample to be taken. The sample storage portion may comprise a visible indicator. For example, the visible indicator may be a series of markings, a window, or an indicator which changes colour. The visible indicator may signal to the user when the sample storage portion is full. Provision of an indicator may assist the user in knowing when a sufficient volume of the liquid or liquid-based sample has been provided such that accurate measurements of the liquid or liquid-based sample may be made once the sample enters the test portion. The sample storage portion may comprise an overflow channel. The overflow channel may lead to an overflow reservoir. The overflow reservoir may be configured to store excess liquid or liquid-based sample. Alternatively, the overflow channel may discharge excess liquid or liquid-based sample from the sample collection device. Provision of an overflow channel may minimise the chances of the sample collection device overflowing during use, thereby helping to make the sample collection device more user friendly and hygienic. Preferably, the sample storage portion is actuated to release at least a portion of the stored liquid or liquid-based sample. The sample storage portion may be actuated to release a fixed volume of the stored liquid or liquid-based sample. According to a second aspect of the present invention there is provided a sample collection device comprising: a. a liquid or liquid based sample collection portion to collect a liquid or liquid based sample; and b. a sample storage portion in liquid communication with the liquid or liquid based sample collection portion, the sample storage portion at least temporarily storing a fixed volume of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release the fixed volume of the stored liquid or liquid-based sample. The sample collection device of the second aspect may optionally include any optional feature of the sample collection device of the first aspect. According to a third aspect of the present invention there is provided a sample collection device comprising: a. a liquid or liquid based sample collection portion to collect a liquid or liquid based sample; b. a sample storage portion in liquid communication with the liquid or liquid based sample collection portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release at least a portion of the stored liquid or liquid-based sample; and c. a test portion to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion. The sample collection device of the third aspect may optionally include any optional features of the sample collection and storage device of the first or second aspects. The test portion may comprise any suitable testing mechanism to receive the sample released from the sample storage portion. For example, the test portion may comprise an in situ test which gives an in-device result, such as a lateral flow test. Additionally or alternatively, the test portion may comprise at least one electrode configured to be utilised with a reader to give a result. The test portion may be configured to be read optically and / or electrochemically. Additionally, electrochemical tests offer advantages over optical / colorimetric tests in that they are not affected by factors such as sample opacity or ambient light conditions. According to a fourth aspect of the present invention there is provided a sample collection device comprising: a. a liquid or liquid based sample collection portion to collect a liquid or liquid based sample; b. a sample storage portion in liquid communication with the liquid or liquid based sample collection portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release at least a portion of the stored liquid or liquid-based sample; and c. a test portion to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion, wherein the test portion comprises at least one electrode. According to a fifth aspect of the present invention there is provided a sample collection device comprising: a. a liquid or liquid-based sample collection portion to collect a liquid or liquidbased sample, b. a sample storage portion in liquid communication with the liquid or liquid-based sample collection portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release at least a portion of the stored liquid or liquid-based sample, and c. a test portion comprising at least two separated sample chambers to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion, each sample chamber housing at least one electrode. The sample collection device thus enables the easy collection and safe storage of a sample until the sample is ready to be analysed in the test portion. Furthermore, the provision of at least two sample chambers may allow more than one target to be tested for at the same time. This may mean that from a single liquid sample, several tests which would usually be run separately may be run together. This may assist in providing a greater amount of sample data and therefore a broader overview of the user’s health. Furthermore, by carrying out several tests using a single sample collection device, the number of devices required is minimised, thereby reducing the amount of wasted materials. The liquid or liquid-based sample collection portion may be associated with the sample storage portion in any way. The sample collection portion may be formed integrally with the sample collection portion or may be formed separately and attached or mounted thereto. In one form, the sample collection portion may protrude from the sample storage portion. The liquid or liquid-based sample collection portion may be configured to absorb a liquid or liquid-based sample. The liquid or liquid-based sample collection portion may be configured to absorb a liquid or liquid-based sample until it is saturated. The liquid or liquid-based sample collection portion may comprise an absorbent material. The liquid or liquid-based sample collection portion may comprise a wick or material with wicking or characteristics which cause or increase capillary action. The wick may be configured to transfer the liquid or liquid-based sample from the sample collection portion to the sample storage portion. The wick may be configured to transfer the liquid or liquid based sample from the sample collection portion to the sample storage portion via capillary action. The wick may be elongate. The wick may abut an outer housing of the sample storage portion. The liquid or liquid-based sample may be at least one of urine, saliva, or blood. The liquid or liquid-based sample may comprise at least one target. The or each target may be an indicator of user health. The target may be at least one of a component, compound or molecule. For example, targets may include but are not limited to Glucose, Creatinine, Haemoglobin, Total Protein and Target Protein (for example, Cytokeratin Fragment CYFRA21-1) or similar, Potassium, Sodium and pH. The sample storage portion may comprise an absorbent material. The absorbent material may be configured to retain the liquid or liquid-based sample at least temporarily. The absorbent material may have any form but may preferably be a foam material. Expandable foam may be used such that as the sample is received by the foam, the foam expands. In one form, the sample storage portion may comprise a sponge. The sponge may be configured to retain the liquid or liquid-based sample at least temporarily. Provision of an absorbent material such as a sponge may assist in the transfer of the liquid or liquid-based sample from the sample collection portion to the sample storage portion via capillary action. Once the liquid or liquid-based sample is in the sample storage portion, it may remain there in a fresh state until the sample is ready to be tested. As such, the sample storage portion may assist in maintaining the freshness and quality of the sample by minimising evaporation of the sample and diffusion out of the sample storage portion. In another form, the sample collection portion may comprise the aforementioned expandable foam provided within a fixed size receptacle, the fixed size receptacle being sized according to a maximum size of expansion of the foam. The fixed size receptacle may be smaller than the maximum size of expansion of the foam. This configuration may allow a fixed volume sample collection. A cellulose foam material may be particularly preferred. The sample storage portion may be configured to absorb a predetermined volume of liquid or liquid-based sample. This may help to ensure that a sufficient volume of liquid or liquid-based sample is available to be delivered to the test portion, thereby helping to allow a more accurate measurement of the sample to be taken. The sample storage portion may comprise a visible indicator. For example, the visible indicator may be a series of markings, a window, or an indicator which changes colour. The visible indicator may signal to the user when the sample storage portion is full or that a sufficient sample has been stored in the sample storage portion. Provision of an indicator may assist the user in knowing when a sufficient volume of the liquid or liquid-based sample has been provided such that accurate measurements of the liquid or liquid-based sample may be made once the sample enters the test portion. For example, a hydrochromic material such as a hydrochromic paper may be provided positioned relative to the sample storage portion. In one form, the indicator may be provided in abutment or at least fluid communication with the sample storage portion. The indicator may be visible through a window provided on the device. The sample storage portion may comprise an overflow channel. The overflow channel may lead to an overflow reservoir. The overflow reservoir may be configured to store excess liquid or liquid-based sample. Alternatively, the overflow channel may discharge excess liquid or liquid-based sample from the sample collection device. Provision of an overflow channel may minimise the chances of the sample collection device overflowing during use, thereby helping to make the sample collection device more user friendly and hygienic. The sample storage portion may be provided between the sample collection portion and the test portion. The sample storage portion may be in liquid communication with the test portion. Preferably, the sample storage portion is actuated to release at least a portion of the stored liquid or liquid-based sample. The sample storage portion may be actuated to release a fixed volume of the stored liquid or liquid-based sample. This may enable a fixed volume of liquid or liquid based sample to be released following a non-metered collection i.e., whereby an unknown volume of sample has been collected, such as during urine collection or saliva collection, thereby enabling a quantitative result, from a test in which a fixed volume of sample is required, such as a lateral flow test. A barrier or valve or similar may be provided between the sample storage portion and the test portion. The barrier or valve or similar may be moveable from a first position to a second position. In the first position, the barrier or valve or similar may block liquid communication between the sample storage portion and the test portion. In the second position, the barrier or valve or similar may allow liquid communication between the sample storage portion and the test portion. The barrier or valve or similar may be at least one of a seal or a pierceable material or film. Provision of such a barrier or valve or similar may assist in retaining the liquid or liquid-based sample within the sample storage portion until a suitable time for the sample to be released into the test portion. The sample collection device may comprise an actuator. The actuator may be configured to actuate the sample storage portion to release at least a portion of the stored liquid or liquid-based sample. The actuator may be configured to move the barrier or valve or similar from the first position to the second position or to otherwise allow and / or force release of the sample from the sample storage portion. The actuator may comprise any suitable actuation mechanism. The actuation mechanism may comprise a wedge. The wedge may be moveable between a disengaged position and an engaged position. The wedge may be moveable over a fixed distance. The wedge may be configured to release a fixed portion of the liquid or liquid-based sample. In the disengaged position, the wedge may not contact the sample storage portion. In the engaged position, the wedge may contact the sample storage portion and move the barrier to the second position. Where the sample storage portion comprises a sponge, when in the engaged position, the wedge may compress the sponge. As such, the liquid sample may flow into the test portion. Alternatively, the actuator may be at least one of a clamping mechanism, a piercing mechanism, or pinching mechanism. Alternatively, the actuator may be provided externally to the sample collection device. For example, a test reader into which the sample collection device may be inserted may comprise the actuator. The actuator may be configured to actuate the sample storage portion to release at least a portion of the stored liquid or liquid-based sample. The actuator may be configured to actuate the sample storage portion when the sample collection device is inserted into the test reader. The actuator may be configured to move the barrier from the first position to the second position. The actuator may comprise any suitable actuation mechanism. For example, the test reader may comprise at least one of a clamping mechanism, piercing mechanism, or pinching mechanism. Alternatively, the test reader may comprise a complementary actuator. The complementary actuator may work in conjunction with the actuator on the sample collection device. In still another form, the actuator may comprise a cover to provide an air vent for example, allowing capillary fill action to take place upon removal of the cover. The test portion may comprise a flow channel. The flow channel may be in liquid communication with the sample storage portion. In the first position, the barrier may prevent the stored liquid or liquid-based sample entering the flow channel. In the second position, the barrier may allow the stored liquid or liquid-based sample to enter the flow channel. The flow channel may extend longitudinally form the sample storage portion. The flow channel may extend toward a distal end of the test portion. The flow channel may have a depth of at least 25 pm, more preferably of at least 50 pm, even more preferably of at least 75 pm, or most preferably of at least 100 pm. The flow channel may have a depth no more than 1000 pm, more preferably no more than 500 pm, even more preferably no more than 250 pm or most preferably a depth no more than 125 pm. The flow channel may have a depth in the range of 25 -1000 pm, more preferably in the range of 50-500 pm, more preferably in the range of 75-250 pm, or most preferably in the range of 100-125 pm. Preferably, the flow channel may have a depth of 100 pm. pm. Provision of a flow channel within the abovementioned values may assist in the efficient transfer of at least a portion of released liquid or liquid-based sample from the sample storage portion into the test portion. The actuator may release at least a portion of the stored liquid or liquid-based sample from the sample storage portion. The flow channel within these small depths may preferably enable capillary action to draw the at least a portion of the stored liquid or liquid-based sample into the flow channel from the storage chamber, to cover the sensors is an important part of the mechanism. Capillary fill into the flow channel may ensure that when the flow channel(s) are full, (and the sample chamber), flow of the stored liquid or liquid-based sample stops. This may result in an additional advantage that the stored liquid or liquid-based sample in the test portion is still to increase the likelihood of a stable measurement. If the stored liquid or liquid-based sample were 'squeezed' into the flow channel(s), then a situation may arise in which the stored liquid or liquid-based sample leaks out of any vent / overflow holes, thereby creating movement and noise in the results signal. The test portion may comprise at least one sample chambers. The number of sample chambers may be selected in accordance with the specific test to which the sample collection device is directed. Each sample chamber may be directed towards a specific target within the liquid or liquid-based sample. Each sample chamber may be configured to produce a response when the liquid or liquid-based sample enters the sample chamber. The response may indicate whether the target is present within the liquid or liquid-based sample. The response may indicate that the target is present within the liquid or liquid-based sample if the quantity of the target present is above a threshold value. The threshold value may be selected in accordance with the specific target to which the test is directed. The response may indicate the quantity of target present within the liquid or liquid-based sample. The test portion may comprise at least two sample chambers, at least three sample chambers, at least four sample chambers, at least five sample chambers, at least six sample chambers, at least seven sample chambers, at least eight sample chambers, at least nine sample chambers, or at least ten sample chambers. The test portion may comprise no more than twenty sample chambers, no more than eighteen sample chambers, no more than sixteen sample chambers, no more than fourteen sample chambers, no more than twelve sample chambers, or no more than ten sample chambers. The test portion may comprise between two and twenty sample chambers, between three and eighteen sample chambers, between four and sixteen sample chambers, between five and fourteen sample chambers, between six and twelve sample chambers, or between seven and ten sample chambers. Each sample chamber may extend from the flow channel. Each sample chamber may extend laterally from the flow channel. Each sample chamber may be arranged in a series. As such, when the sample enters the test portion, the sample may flow into each sample chamber in turn. Each sample chamber may be delimited by at least one wall. The at least one wall may block the flow of liquid or liquid-based sample between each sample chamber. One or each sample chamber may have a “Z” shaped form. Alternatively, one or each sample chamber may have a linear form. A main flow channel may be provided with a number of intermediate flow channels extending therefrom, one intermediate flow channels leading to each sample chamber. Each sample chamber may house at least one electrode. The at least one electrode may be provided at a distal end of the sample chamber i.e., towards the lateral edge of the test portion. Each electrode may be an individual electrode. Alternatively, each electrode may be provided as part of a multi-electrode array. One or more electrode may be configured to take amperometric measurements. Additionally or alternatively, one or more electrode may be configured to take potentiometric measurements. The or each sample chamber comprising one or more electrodes configured to take amperometric measurements may be grouped together in the series. The or each sample chamber comprising one or more electrodes configured to take potentiometric measurements may be grouped together in the series. This may help the electrodes to be easily read as when the test portion is read, for example by a test reader, the amperometric electrodes may form part of a separate circuit to the potentiometric electrodes. In a configuration in which one or more electrodes for potentiometric measurements are provided on a test portion with and one or more electrodes for amperometric measurements, the one or more electrodes for potentiometric measurements and one or more electrodes for amperometric measurements are preferably provided on separate portions of the test portion. This separation may minimise noise (e.g. from leakage currents) between the one or more electrodes for potentiometric measurements and one or more electrodes for amperometric measurements. Each sample chamber may comprise one or more reagent. Each sample chamber may comprise a different one or more reagent. Each one or more reagent may be selected in accordance with the specific test to which the sample collection device is directed. Each one or more reagent may be a material configured to produce a specific indicator. Each material may be configured to produce a specific indicator based on the specific target present within the liquid or liquid-based sample. Provision of such one or more reagents which are configured to produce a specific indicator may be easier to detect and / or measure than the targets themselves. This may help to improve the ease and accuracy of both detecting and quantifiably measuring the presence of specific targets within the liquid or liquid-based sample. Each reagent may be a solid or particulate. Each reagent may be configured to produce a specific indicator when wetted by at least a portion of released liquid sample. Provision of solid reagents may help retain each reagent within each sample chamber prior to use, thereby minimising mixing of different reagents. Provision of reagents in a dry solid state also acts to enhance the stability and shelf life of the product which can be further enhanced by storing the device in a protective moisture resistant packaging. Each reagent may comprise at least one enzyme. Suitable enzymes include but are not limited to glucose oxidase, creatinase, creatininase, sarcosine oxidase, and horseradish peroxidase. Each reagent may comprise at least one ionophore. Suitable ionophores include but are not limited to valinomycin, II, Bis[(12-crown-4)methyl] dodecylmethylmalonate. Tridodecylamine, and other additives. Each reagent may comprise a buffer. Suitable buffers may include but are not limited to pH buffers and ionic buffers. Suitable pH buffers may include but are not limited to phosphate buffer, Tris, or citric acid. Suitable ionic buffers may include but are not limited to lithium chloride. Provision of a buffer may be particularly advantageous for enzyme based biosensors such as glucose and creatine as each enzyme has an optimal pH. Furthermore, when used to test urine whose pH may range from pH 4-8, provision of a buffer is particularly advantageous as low buffering may result in inaccurate measurements. In addition, provision of a buffer may also be particularly advantageous for electrodes configured to take potentiometric measurements as ionic strength may affect the measurement and as such, if there was low buffering, this may result in inaccurate measurements. Each reagent may comprise at least one additive. Suitable additives may include but are not limited to Pullulan and Dioctyl Sebacate. Each reagent may comprise at least one stabiliser. Suitable stabilisers may include but are not limited to trehalose. Each reagent may comprise at least one oxidant. Suitable oxidants may include but are not limited to lithium perchlorate. Each reagent may comprise at least one mediator. Suitable mediators include but are not limited to Ruthenium compounds, Osmium compounds, Ferrocene compounds, Tetramethylbenzidine, Carbon Black and Prussian Blue. Each reagent may comprise at least one surfactant. Suitable surfactants may include but are not limited to Tween. Each sample chamber may have a depth of at least 25 pm, more preferably of at least 50 pm, even more preferably of at least 75 pm, or most preferably of at least 100 pm. Each sample chamber may have a depth no more than 1000 pm, more preferably no more than 500 pm, even more preferably no more than 250 pm or most preferably a depth no more than 125 pm. Each sample chamber may have a depth in the range of 25 -1000 pm, more preferably in the range of 50-500 pm, more preferably in the range of 75-250 pm, or most preferably in the range of 100-125 pm. Preferably, each sample chamber may have a depth of 100 pm. Pio vision of a sample chamber within the abovementioned values may assist in the efficient transfer via capillary action of at least a portion of released liquid or liquid-based sample from the flow channel into each separated sample chamber such that each electrode is covered by the liquid or liquid based sample. As such, when each sample chamber is full, no more liquid or liquid based sample is drawn in. This may help provide a still fluid within each sample chamber which may assist in providing a stable measurement. In contrast, if the liquid or liquid-based sample was forced into each sample chamber, the liquid or liquid based sample may leak out of the vent holes (where present) creating movement and therefore noise within the signal. Furthermore, such sample chambers of a defined, minimal volume may help limit diffusion of each reagent as the capillary volume is limited. As such, the likelihood of each reagent diffusing out into the sample in the flow channel may be minimised, helping to prevent mixing between each sample chamber. Furthermore, the buffer concentration may be less diluted, so the buffering capacity remains high. Buffering in a restricted volume capillary preferably minimises reagent diffusion which in turn ensures that a high concentration of the buffer is maintained in the immediate vicinity of the measurement electrode capillary hence increasing its buffering capacity. Urine has a wide pH range for example and a pH change if there was low buffering may lead to inaccurate measurements. Effective buffering may result in a more accurate result, whereas buffering is less important in analysis of a blood sample for example, as blood has a relatively stable pH. Without a restrictive capillary, the buffering capacity of any buffer in the formulation may be weakened by allowing it to dissolve and diffuse out into a much larger volume of sample (particularly in an embodiment in which one or more reagents are dried down on the working electrode during manufacture and dissolve up again when the sample is added to the sensor to ‘wet’ the one or more reagents). This solution is preferred over adding an oversupply of buffering reagents, which may be likely to have other knock on effects on the product performance such as a slower dissolution of reagents. Controlling the volume of the sample chambers with a restrictive size of the capillary may effectively minimise the amount of buffering reagent needed. This may also be important for ion selective electrodes as ionic strength can influence the measurement, so an ionic strength adjustment buffer is needed. An ionic strength change, if there was low buffering, would likely lead to inaccurate measurements The sample collection device may have a length of at least 8 cm, more preferably of at least 10 cm, even more preferably of at least 12 cm, or most preferably of at least 14 cm. The sample collection device may have a length no greater than 22 cm, more preferably no greater than 20 cm, even more preferably no greater than 18 cm, or most preferably, no greater' than 16 cm. The sample collection device may have a length in the range of 8-22 cm, more preferably in the range of 10-20 cm, even more preferably 12-18 cm, or most preferably 14-16 cm. Provision of a sample collection device having a length within the abovementioned ranges may help provide the user with a portion of the sample collection device to grip which is sufficiently distanced from the sample collection portion such that in use, the risk of a portion of the liquid or liquid-based sample contacting the user may be minimised. The sample collection device may comprise an outer housing. The outer housing may surround at least a portion of the sample collection device. The outer housing may comprise a main body and a lid. The lid may be removable. The lid may be removed to reveal the sample collection portion. The outer housing may be formed from a hard plastic. The outer housing may comprise a gripping portion. The gripping portion may be provided toward the sample storage portion of the test portion. The gripping portion may comprise a plurality of surface features such as ribs, or projections. As such, the user may be encouraged to grip the sample collection device away from the sample collection portion, thereby minimising the risk of the user coming into contact with the liquid or liquid-based sample. The outer housing may be transparent. This may allow the user to see whether the required amount of liquid sample has been collected. Alternatively, the outer housing may be opaque. The outer housing may comprise at least one transparent window. Additionally or alternatively, the outer housing may comprise the visual indicator. The outer housing may comprise at least one opening. The at least one opening may be provided over each electrode. As such, this may allow the sample collection device to be read by another device such as a test reader. According to a sixth aspect of the present invention there is provided a test reader configured to read a test portion of a sample collection device, the test reader comprising a sensing portion having at least one sensor configured to read an electrode housed in at least two separated sample chambers of a test portion of a sample collection device. In a more particular form, the test reader may be configured to complement a sample collection device comprising: a. a liquid or liquid-based sample collection portion to collect a liquid or liquid-based sample, b. a sample storage portion in liquid communication with the liquid or liquid-based sample portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuable to release at least a portion of the stored liquid or liquid-based sample, and c. a test portion comprising at least two separated sample chambers to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion, each sample chamber housing at least one electrode. The test reader may comprise at least a portion of an actuator to actuate the release at least a portion of the stored liquid or liquid-based sample from the sample storage portion upon engagement of the sample collection device with the test reader. The actuation may only occur when the sample collection device is fully engaged with the test reader. This may prevent accidental or premature release of the stored liquid or liquid-based sample. Optionally, the test reader may be configured to read a test portion of the sample collection device of the fifth aspect. The number of complementary sensors may be selected in accordance with the specific test to which the sample collection device is directed. Alternatively, the number of complementary sensors may be chosen in accordance with the maximum number of electrodes the sample collection device may comprise. The test reader may be configured to read the at least one electrode and indicate whether a target is present within a sample in the sample collection device. The test reader may indicate whether the target is present within the sample if the quantity of the target present is above a threshold value. Alternatively, the test reader may indicate whether the target is present within the sample if the quantity of indicator detected is above a threshold value. The test reader may indicate the quantity of target present within the sample. The test reader may be configured to output a reading. The test reader may comprise a user interface. The user interface may comprise a touchscreen. The reading may be output via the touchscreen. Alternatively, the test reader may comprise a first data link. The first data link may be provided between the test reader and a cloud service platform. The reading may be output to the cloud service platform. As such, the results may be received by an external user such as a doctor, medical worker, or data analyst. Additionally or alternatively, the test reader may comprise a second data link. The second data link may be provided between the test reader and an electronic device. The second data link may comprise the first data link, i.e., the second data link may be provided via the cloud service platform. The electronic device may be a mobile phone, tablet, or computer for example. As such, the test reader may enable the user to receive the readings via their personal electronic device, for example in an app which may be used to track a user’s health metrics. The test reader may be configured to receive the sample collection device. The test reader may comprise an opening. The opening may correspond in size and / or shape to the test portion of the sample collection device. The test reader may be configured to actuate a sample storage portion of the sample collection device upon insertion of the sample collection device to release at least a portion of a stored liquid sample into the test portion. The test reader may preferably comprise a reader portion corresponding in configuration to the test portion of the sample collection device. The test reader may be configured to read the at least one electrode after a predetermined period of time. The test reader may be configured to read each electrode after a different predetermined period of time. As such, the reader may automatically read each electrode after the correct period of time, helping to minimise errors in measurement. According to a seventh aspect of the present invention there is provided a system for collecting and testing a liquid or liquid-based sample, the system comprising: a. the sample collection device of the first aspect; and b. the test reader of the second aspect. The sample collection device may optionally comprise any optional features of the fifth aspect of the present invention. The test reader may optionally comprise any optional features of the sixth aspect of the present invention. According to an eighth aspect of the present invention there is provided a method of testing a sample using a sample collection device comprising the steps of: a. providing a sample collection device according to the fifth aspect; b. providing the liquid sample collection portion with a liquid sample; c. storing at least a portion of the liquid sample at least temporarily within the sample storage portion; d. actuating the sample storage portion to release at least a portion of the stored liquid sample; and e. testing the sample using the test portion to detect specific targets within the sample. Detailed Description of the Invention In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which: Figure 1 shows a schematic view of a system for collecting, storing and analysing a liquid or liquid-based sample according to the present invention; Figure 2 shows a front view of a cross-section of the sample collection device of Figure 1; Figure 3 shows a side view of the sample collection device of Figure 2; Figure 4 shows a front view of a cross-section of the sample collection device of Figures 1-3; Figure 5 shows a front view of the test portion of the sample collection device of Figures 1-4; Figure 6 shows a side view of the test portion shown in Figure 5; Figure 7 shows a side view of the sample collection device of Figures 1 -6 inserted into the test reader of figure 1; and Figure 8 shows an isometric view of the sample collection device of Figures 1-6 inserted into the test reader of Figure 1. With reference initially to Figure 1, a system 1 for collecting, storing and analysing a liquid or liquid-based sample is shown. The system 1 comprises a sample collection device 2 and a test reader 3. In use, the sample collection device 2 is be used to collect a liquid or liquid-based sample, store at least a portion of the liquid or liquid based sample, at least temporarily, and test the portion of liquid or liquid-based sample. The sample collection device 2 may be inserted into the test reader 3, which may be configured to read the sample collection device and output a reading. The test reader 3 is connected to the internet 4, and the system 1 comprises a first data link 5 between the test reader 3 and a cloud service platform 6 such that the test results may be output to the cloud service platform 6. The system 1 also comprises a second data link 7 between the test reader 3 and an electronic device which may be a tablet, mobile phone or computer. The second data link 7 in this particular instance also comprises the first data link 5 such that the test reader 3 outputs the reading to the electronic device 8 via the cloud service platform 6. Once the reading has been output, the sample collection device 2 may be discarded, for example into waste 9. With reference now to Figures 2 and 3, the sample collection device 2 of the system 1 is shown. The sample collection device 2 has a liquid or liquid-based sample collection portion 10 to collect a liquid or liquid-based sample, a sample storage portion 11, and a test portion 12. The sample storage portion 11 is provided between the sample collection portion 10 and the test portion 12. The sample collection portion 10 is in liquid communication with the sample storage portion 11, and the sample storage portion 11 is in liquid communication with the test portion such that the sample collection device 2 comprises a continuous liquid connection from the sample collection portion 10 to the test portion 12. The liquid or liquid-based sample collection portion 10 has an elongate rectangular wick 13, which protrudes from the sample storage portion 11. The wick 13 is configured to absorb a liquid or liquid-based sample until it is saturated and to transfer liquid or liquid-based sample from the sample collection portion 10 to the sample storage portion 11 via capillary action. The sample storage portion 11 comprises an absorbent sponge 14 which assists in the transfer of the liquid or liquid-based sample from the sample collection portion 10 to the sample storage portion 11 via capillary action. The sponge 14 is configured to retain the liquid or liquid-based sample at least temporarily in a fresh state until it is ready to be tested. The sponge 14 helps to maintain the sample or liquid-based sample in a fresh state by minimising evaporation and diffusion out of the storage portion 11. Although in this particular embodiment the sample storage portion comprises an absorbent sponge, the skilled person will appreciate that in alternative embodiments, either an alternative absorbent material may be provided, or no absorbent material may be provided. For example, the sample storage portion 11 may comprise an enclosed container which may also minimise evaporation out of the sample storage portion, 11 thereby helping to retain the quality of the liquid or liquid based sample. In this particular embodiment, the sponge 14 is configured to absorb a predetermined volume of liquid or liquid based sample. As many medical diagnostic tests are sensitive to the volume of liquid or liquid-based sample, this helps to provide the test portion 12 with a sufficient volume of liquid or liquid-based sample, thereby helping a more accurate measurement of the sample to be taken. Although not shown, the sample storage portion 11 comprises a visible indicator which indicates to the user that the sample storage portion 11 is full. In addition, the sample storage portion 11 comprises an overflow channel (not shown) such that any excess liquid or liquid-based sample i.e., liquid or liquid-based sample provided in addition to the volume absorbed by the sponge 14, may be either stored in an overflow reservoir, or discharged from the sample collection device 2. The overflow channel minimises the risk of the sample collection device 2 overflowing during use, thereby helping make the sample collection device 2 more user friendly and hygienic. A barrier 15 is provided between the sample storage portion 11 and the test portion 12. The barrier 15 is movable from a first position whereby liquid communication between the sample storage portion 11 and the test portion 12 is blocked, to a second position whereby the barrier 15 allows fluid communication between the sample storage portion 11 and the test portion 12. In this particular embodiment, the barrier 15 is a seal which assists in in retaining the liquid or liquidbased sample within the sample storage portion 11 until a suitable time for the sample to be released into the test portion 12. However, the skilled person will appreciate that in alternative embodiments, the barrier 15 may be a pierceable material or film for example. With additional reference to Figure 4, the barrier 15 is moveable from the first position to the second position to release at least a portion of the stored liquid or liquid based sample into the test portion 12 by an actuator. In this particular embodiment, the actuator is a mechanism comprising a wedge 16 which is moveable between a disengaged position and an engaged position. The wedge 16 may be moved between said positions by virtue of a corresponding component of the actuation mechanism. In this particular embodiment, the wedge 16 is slidingly mounted such that an angled portion 17 of the wedge may be moved from the disengaged position to the engaged position by external actuation i.e., the application of force by a human to slide the wedge and / or the application of force exerted by a corresponding component, for example, a corresponding component provided on the test reader 3 which causes the wedge 16 to move to the engaged position when the sample collection device 2 is inserted. When the wedge 16 is actuated, the barrier 15 is moved from the first position to the second position, and simultaneously, the sponge 14 is compressed by the wedge 16, thereby releasing the portion of liquid or liquid based sample into the test portion 12. The skilled person will appreciate that alternative actuation mechanisms including clamping mechanisms, piercing mechanisms and pinching mechanisms may also be used. With additional reference now to Figures 5 and 6, the test portion 12 comprises a flow channel 18 in liquid communication with the sample storage portion 11. In the first position, the barrier 15 prevents a portion of the stored liquid or liquid-based sample entering the flow channel, but in the second position, the barrier 15 allows the stored liquid sample to enter the flow channel 18. The flow channel 18 has a substantially elongate rectangular form which extends longitudinally from the sample storage portion 11 towards a distal end of the test portion 12. In this particular embodiment, the flow channel has a depth of 100 pm. As such, the flow channel 18 assists in the efficient transfer of at least a portion of released liquid sample from the sample storage portion 1 1 into the test portion 12. The test portion 12 also comprises eight sample chambers 19 arranged in series and which extend laterally from the flow channel 18. Each sample chamber 19 is delimited by at least one wall 20 which separates each sample chamber. The or each wall 20 also defines the shape of each sample chamber 19. In this particular embodiment, the five sample chambers proximal to the sample storage portion 11 have a “Z” shaped form, whereas the three sample chambers 19 distal to the sample storage portion 11 have a substantially linear form. Although in this particular embodiment the test portion 12 comprises eight sample chambers 19, the skilled person will appreciate that the number of sample chambers may be selected in accordance with the specific test to which the sample collection device 2 is directed. In this particular embodiment, the sample collection device 2 is directed towards testing a urine sample comprising a plurality of targets. Each target present in the sample provides an indication of the users’ health. Although this particular embodiment is directed towards testing a urine sample, the skilled person will appreciate that alternative embodiments may be directed towards testing other liquid or liquid-based samples such as blood or saliva which may each comprise different targets. Each sample chamber 19 is directed towards a different target in the sample and is configured to produce a response when the sample enters the sample chamber 19. The response indicates whether the target is present within the sample if the quantity of target present within the sample exceeds a threshold value, selected in accordance with the specific target to which the test is directed. Each sample chamber 19 houses an electrode 21. In this particular embodiment, each electrode 21 forms part of a single multi-electrode array 21. The electrodes 21 provided in the five sample chambers 19 proximal to the sample storage portion 11 are configured to take amperometric measurements. The electrodes 21 provided in the three sample chambers 19 distal to the sample storage potion 11 are configured to take potentiometric measurements. Additionally, each sample chamber 19 comprises a different solid reagent selected in accordance with the specific test to which the sample collection device 2 is directed i.e., a urine test. Each reagent is a material configured to produce a specific indicator when wetted by the sample. The specific indicator is based on the specific target present within the sample that the sample chamber 19 is directed towards. Said indicators may be easier to detect and / or measure than the targets themselves so this may help to improve the ease and accuracy of both detecting and quantifiably measuring the presence of specific targets within the sample. Each reagent may comprise at least one of the following: enzyme, ionophore, buffer, additive, stabiliser, oxidant, mediator, or surfactant. In this particular embodiment, the first sample chamber 19a, is directed towards detecting the target glucose within the urine sample. The first sample chamber comprises the enzyme glucose oxidase, the stabiliser trehalose, the surfactant Tween, and a mediator Ruthenium compound (or similar). The second sample chamber 19b is directed towards detecting the target creatinine within the urine. The second sample chamber 19b comprises the enzymes creatininase, creatinase, sarcosine oxidase, horseradish peroxidase, the stabiliser trehalose, the surfactant Tween, a mediator such as carbon black, prussian blue or TMB (or similar). The third sample chamber 19c is directed towards detecting haemoglobin within the urine. The third sample chamber 19c comprises the oxidant lithium perchlorate, a mediator such as carbon black or osmium compounds. The fourth sample chamber 19d is directed towards to detecting total protein within the urine sample. The fourth sample chamber 19d comprises a metal salt and a mediator such as carbon black (or similar). The fifth sample chamber 19e is directed towards detecting a protein such as CYFRA-21-1 within the urine sample. The fifth sample chamber 19c comprises antibodies and a mediator such as carbon black (or similar). Each of the first to the fifth sample chambers 19a, 19b, 19c, 19d, 19e further comprise a pH buffering additive such as a phosphate buffer. The sixth sample chamber 19f is directed towards detecting potassium within the urine sample. The sixth sample chamber 19f comprises a potassium ionophore valinomycin (or similar). The seventh sample chamber 19g is directed towards detecting sodium within the urine sample. The seventh sample chamber 19g comprises a sodium ionophore Bis[(12-crown-4)methyl] dodecylmethylmalonate (or similar). The eighth sample chamber 19h is directed towards detecting pH of the urine sample. The eighth sample chamber 19h comprises a hydrogen ionophore Tridodecylamine (or similar). Each of the sixth to the eighth sample chambers 19f, 19g, 19h further comprise a plastic membrane such as PVC, a plasticiser such as Dioctyl sebacate, ionic additives such as tetrakis (4-chlorophenyl) borate ions, and a buffer such as lithium chloride. Of course, the skilled person will appreciate that the number and configuration of sample channels 19 provided may be selected in accordance with the test towards which the sample collection device 2 is directed. For example, a different sample may be tested such as blood or saliva, containing different targets. As such, the skilled person will appreciate that each sample chamber will comprise a different reagent directed towards the specific targets. Each sample chamber 19 has a depth of 100 pm such that when the urine sample enters the flow channel 18, a portion of the urine sample is drawn into each sample chamber 19 by capillary action. Given the shallow depth of each sample chamber 19, the volume of the sample chamber 19 is limited. Therefore, the buffering capacity of the reagent remains high as the buffer is less diluted. As such, the reaction within each sample chamber 19 may be more efficient. Furthermore, the likelihood of either the urine sample or the reagents diffusing out of their individual sample chambers 19 and mixing is minimised. The sample collection device 2 comprises an outer housing 22 having a main body 22a surrounding the sample collection portion and the test portion, and a removable lid 22b (not shown) which surrounds the sample collection portion and may be removed when the user would like to provide a sample. The outer housing 22 is formed from a hard plastic which protects the sample collection device 2 within. In this embodiment, the outer housing 22 is transparent such that the user can tell when the sample collection portion 11 is full. The housing also comprises at least one opening provided over each electrode 21 such that the sample collection device 2 may be read by the test reader 3. With reference now to Figures 7 and 8, the test reader 3 of the system 1 is shown. The test reader 3 is configured to receive a sample collection device 2 through an opening 23 which corresponds in size and shape to the test portion of the sample collection device 2. The test reader is configured to read the test portion 12 of the sample collection device 2 and indicate whether the target is present within the sample if the quantity of the target present (or the quantity of indicator produced which is proportional to the quantity of target present) is above a threshold value. The test reader 3 also indicates the quantity of the target present within the sample and outputs a reading on this basis. In this embodiment, the test reader 3 comprises eight complementary sensors (not shown). Each complementary sensor is configured to read an electrode 21 of the sample collection device 2. The skilled person will appreciate that the test reader may comprise a user interface such as a touchscreen such that results may be output via the user interface. With reference to Figures 2 to 8, in use, a user removes the lid 22b of the outer housing 22 and provides a mine sample directly onto the wick 13 of the sample collection portion 10. The urine sample is absorbed by the wick 13 and transported into the sample storage portion 11 by capillary action where it is retained within the sponge 14 until an appropriate time for the sample to be tested. When the user would like to test the urine sample, the test portion 12 of the sample collection device 2 is inserted into the test reader 3. The insertion of the sample collection device 2 into the test reader 3 actuates the storage portion 11, causing the barrier to move from the first position to the second position, thereby allowing liquid communication between the sample storage portion 11 and the test portion 12. Simultaneously, the wedge 16 is forced to move from the disengaged position into an engaged position whereby the sponge 14 is compressed by the wedge 16. This causes the urine sample to flow into the flow channel 18. As the urine sample flows through the flow channel, each sample chamber 19 draws a portion of the urine sample. Once the urine sample enters each sample chamber 19, it reacts with the reagents therein. After a predetermined period of time, the test reader is configured to read each electrode 19 and output a reading. The reading may be output via the first data link 5 to the cloud service platform 6. Alternatively, the reading may be output via the second data link 7 to an app on the electronic device. The readings may be analysed by the relevant machine and / or operator. The one or more embodiments are described above by way of example only. 5 Many variations are possible without departing from the scope of protection afforded by the appended claims.
Claims
1. A sample collection and storage device comprising:a. a liquid or liquid based sample collection portion to collect a liquid or liquid based sample; andb. a sample storage portion in liquid communication with the liquid or liquid based sample collection portion, the sample storage portion at least temporarily storing at least a portion of the liquid or liquid-based sample as a stored liquid or liquid-based sample and actuablc to release at least a portion of the stored liquid or liquid-based sample.
2. A sample collection and storage device as claimed in claim 1 wherein the sample storage portion is sized to at least temporarily store a fixed volume of the liquid or liquid-based sample as a stored liquid or liquid-based sample and release the fixed volume of the stored liquid or liquid-based sample.
3. A sample collection device as claimed in claim 1 or claim 2 further comprising a test portion to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion.
4. A sample collection device as claimed in claim 3 wherein the test portion comprises at least one electrode.
5. A sample collection device as claimed in either claim 3 or claim 4 wherein the test portion comprises at least two separated sample chambers to receive at least a portion of a released liquid or liquid-based sample upon actuation of the sample storage portion, each sample chamber housing at least one electrode.
6. The sample collection device of any one of the preceding claims wherein the liquid or liquid-based sample collection portion comprises a wick configured to transfer the liquid or liquid-based sample from the sample collection portion to the sample storage portion.
7. The sample collection device of any preceding claim wherein the liquid or liquidbased sample is at least one of urine, saliva, or blood.
8. The sample collection device of claim 7 wherein the liquid or liquid-based sample comprises at least one target (from the list of: Glucose, Creatinine,Haemoglobin, Total Protein and Target Protein (for example, Cytokeratin Fragment CYFRA21 -1) or similar, Potassium, Sodium and pH).
9. The sample collection device of any preceding claim wherein the sample storageportion comprises an absorbent material configured to retain the liquid or liquidbased sample at least temporarily.
10. The sample collection device of claim 9 wherein the sample storage portion comprises an expandable foam provided within a fixed size receptacle, the fixed size receptacle being sized according to a maximum size of expansion of the foam and to allow a fixed volume of sample to be collected.
11. The sample collection device of any preceding claim wherein the sample storageportion is provided between the sample collection portion and the test portion and the sample storage portion is in liquid communication with the test portion.
12. The sample collection device of claim 11 further comprising a barrier provided between the sample storage portion and the test portion wherein the barrier is moveable from a first position to a second position wherein in the first position, the barrier blocks liquid communication between the sample storage portion and the test portion and in the second position, the barrier allows liquid communication between the sample storage portion and the test portion.
13. The sample collection device of any preceding claim further comprising an actuator configured to actuate the sample storage portion to release at least a portion of the stored liquid or liquid-based sample and to move the barrier from the first position to the second position.
14. The sample collection device of claim 13 wherein the actuator comprises a wedge which is moveable between a disengaged position and an engaged position, wherein the wedge is configured to release a fixed portion of the liquid or liquid-based sample.
15. The sample collection device of any preceding claim wherein the test portion comprises a flow channel in liquid communication with the sample storage portion.
16. The sample collection device of any preceding claim wherein the test portion comprises a plurality of sample chambers wherein the number of sample chambers is selected in accordance with the specific test to which the sample collection device is directed.
17. The sample collection device of claim 16 wherein each sample chamber is directed towards a specific target within the sample and each sample chamber is configured to produce a response indicating whether the target is present within the sample when the sample enters the sample chamber.
18. The sample collection device of claim 16 or 17 wherein the test portion comprises between two and twenty sample chambers.
19. The sample collection device of claim 18 wherein the test portion comprises between five and fourteen sample chambers.
20. The sample collection device of any one of claims 16-19 wherein each sample chamber extends from the flow channel.
21. The sample collection device of any one of claims 16-20 wherein each sample chamber houses at least one electrode.
22. The sample collection device of any one of claims 16-21 wherein each sample chamber comprises a reagent selected in accordance with the specific test to which the sample collection device is directed.
23. The sample collection device of claim 22 wherein each reagent is a material configured to produce a specific indicator based on the specific target present within the sample.
24. The sample collection device of claim 22 or claim 23 wherein each reagent comprises at least one of the following: at least one enzyme, at least one ionophore, at least one buffer, at least one additive, at least one stabiliser, at least one oxidant, at least one mediator, and at least one surfactant.
25. The sample collection device of any one of claims 16-22 wherein each sample chamber has a depth in the range of 50-500 pm.
26. The sample collection device of claim 25 wherein each sample chamber has a depth in the range of 100-125 pm.
27. A test reader configured to read a test portion of a sample collection device, the test reader comprising a sensing portion having at least one complementary 5 sensor configured to read at least one electrode of a test portion of a samplecollection device.
28. The test reader of claim 27 wherein the number of complementary sensors is selected in accordance with the specific test to which the sample collection device is directed.10 29. The test reader of claim 27 or claim 28 wherein the test reader is configured toread the at least one electrode and indicate whether a target is present within a sample in the sample collection device.
30. A system for collecting and testing a liquid or liquid based sample, the system comprising:15 a. the sample collection device of any one of claims 5-26; andb. the test reader of any one of claims 27-29.
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