GB2530057A - Improvements relating to test sensors and packaging - Google Patents

Improvements relating to test sensors and packaging Download PDF

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Publication number
GB2530057A
GB2530057A GB1416041.0A GB201416041A GB2530057A GB 2530057 A GB2530057 A GB 2530057A GB 201416041 A GB201416041 A GB 201416041A GB 2530057 A GB2530057 A GB 2530057A
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GB
United Kingdom
Prior art keywords
test
portion
cover leaf
test strip
anchor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
GB1416041.0A
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GB201416041D0 (en
Inventor
Tom O'reilly
Nicholas David Long
Robin Brown
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SureSensors Ltd
Original Assignee
SureSensors Ltd
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Filing date
Publication date
Application filed by SureSensors Ltd filed Critical SureSensors Ltd
Priority to GB1416041.0A priority Critical patent/GB2530057A/en
Publication of GB201416041D0 publication Critical patent/GB201416041D0/en
Publication of GB2530057A publication Critical patent/GB2530057A/en
Application status is Withdrawn legal-status Critical

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48778Containers specially adapted therefor, e.g. for dry storage

Abstract

Test sensors and test sensor packaging that restricts ingress of moisture and/or light and apparatus comprising a holder for test sensor packaging, methods of manufacture and use. The test sensor package comprises at least one test sensor having first 28 and second 29 major surfaces comprising: a proximal portion 12; an intermediate portion 14 for receiving a sample; a separable distal portion 16, movable with respect to the proximal and intermediate portions of the test sensor, the separable distal portion comprising a handle portion; at least one force transmitting connection member between the handle portion and at least one of the proximal portion and intermediate portion; and an anchor cover leaf 24 extending over at least part of one of the major surfaces of the test sensor configured to anchor the test sensor, whereby, in use, a user can grip and pull the handle portion, firstly, to move the separable distal portion with respect to the remainder of the test sensor so as to detach it from the anchor cover leaf and, secondly, to exert a force on the remainder of the test sensor via the at least one force transmitting connection member so as to detach the remainder of the test sensor from the anchor cover leaf.

Description

Improvements Relatinu to Test Sensors and PackaginQ

Field

The invention relates to test sensor packages comprising a test sensor, such as diagnostic test sensors, and associated packaging. In particular the invention relates to test sensors and test sensor packaging that restricts ingress of external elements such as moisture andlor light to active regions of the test sensors. The invention also relates to apparatus comprising a holder for test sensor packaging, The invention also relates to methods of manufacturing, and methods of use, of test sensor packaging and of test sensors contained therein.

Background

Test sensors such as diagnostic test sensors for carrying out diagnostic tests on fluids e.g. body fluids are well known. Examples of such test sensors include glucose test sensors for testing glucose concentration in body fluids such as blood, urine or saliva. The present invention is not limited to a particular kind of test sensor or a particular type of test.

Test sensors may have various shapes and arrangements. Test sensors may be provided in the fonn of test sthps, for example substantially planar test strips having two opposing major surfhces. Typically, test strips have test components for conducting a diagnostic test mounted thereon. Thus test strips are typically relatively thin and of generally planar construction having two major surfaces and a side wall fonning the periphery of the test strip lying between the two major surfaces. Test strips may be of rectangular shape having two long edges and two short edges forniing the periphery of the test strip, but other shapes are possible. The present invention finds particular application to test sensors in the forni of test strips but is not limited to particular test sensors, test strips or shape of test sensor or test strip. For convenience, die term test strip' will be used in this application but is not intended to be limiting to a particular test sensor unless the context dictates otherwise, Thus, the present invention is not limited to a specific kind of test sensor or test strip but finds particular application in single use, disposable test strips e.g. blood glucose test strips, that have reactive zone components sensitive to external elements e.g. moisture and/or light.

Blood glucose measurement is used to diagnose and manage diabetes, Electrochemical determination of blood glucose typically involves placing a liquid sample (e.g. blood, urine saliva) onto a reaction zone of a test strip which contains a reagent mixture. The reagent mixture contains au enzyme capable of reacting directly or indirectly with glucose and typically also a redox mediator, The enzymatic chemical reaction is coupled to the mediator redox reaction to enable the electrochemical determination.

The reagent mixture is sensitive to moisture and must be kept dry during storage prior to use. A desiccated plastic vial containing 25 to 50 test strips is a common storage method, Opening a vial to extract a test strip exposes the remaining test strips to deleterious ambient conditions. The desiccant material brings the relative humidity down in the re-closed vial but repeated exposure to ambient conditions when removing test strips becomes a problem as the desiccant becomes additionally loaded with moisture on each occasion and its absorbent properties are consequently reduced. Also, test strips may be removed and carried separately from the vial to avoid carrying the vial around, thus exposing the test strips to ambient conditions for a harmful prolonged period. An old vial (having fiLily moisture loaded desiccant) may be re-used as a llLcky vial by some patients providing minimal moisture absorption and effectively storing the test strips in ambient conditions, Test strips may comprise test components such as measurement electrodes, a sample inlet port, a sample chamber (in which a test reaction can occur) and an air vent, One or more of such test components may be located internally or on (including associated with) one of the major IS surfaces of the test strips. In such test strips, sample fluid typically travels through the sample chamber by capillary action and the sample chamber dimensions (e.g. width and/or height) are selected appropriately to facilitate this.

Openings fonning the sample inlet port and/or air vent may be fornied in one or both of the major surfaces or in the side wall along the short or long edges of the wpically rectangular test strip. WThere a sample inlet port is fornwd in a side wall of a short edge, this is termed an "end fill" test strip. Where a sample inlet port is formed in a side wall of a long edge, this is termed a "side fill" test strip. Where a sample inlet port is formed on an upper major surface of a test strip, this is tcmicd a "top fill" test strip.

One problem with test strips is degradation of reactants provided in test components due to contact with air and/or moisture andlor light. This can provide inaccurate test results, and reduces shelf life and open packaging life of test strips.

Other problems incliLde test strip handling such as packaging, extracting from packaging, picking up and manipulating individual strips, locating the strip (or at least one end of) in a metering device (if required) and disposal of a used strip after the test.

Some of the problems of the vial are overcome by individually wrapping test strips in a sealed moisture proof foil laminate pouch (for example by flow wrapping).

Thus, packaging for test devices such as test strips may comprise flip top vials as described above or cartridges in which multiple test strips (typically from the same batch and having the same calibration code (if required)) arc stored in a single flip top vial or cartridge. Test strips can be packaged in groups of 10, 20, 25, 50 etc. Alternatively, individual packaging for test strips has been provided by some manufacturers in which each test strip is placed between separate top and bottom covers sealed together to surround the periphery of the test strip to provide a moisture S proof foil laminate pouch in a process known as flow wrapping. The top and bottom covers fonn in effect a sealed bag within which the test strip is freely movable.

Both the vial and pouch options present the user with issues relating to usability. Test strips stored in a vial can bc difficult to remove one at a time as they are quite small and tend to come out in multiples. Foil pouches can be difficult to access due to the robust nature of the foil.

Packaging large volumes into vials or pouches requires machines to singulate test strips on a separate line which typically run at slower rates than the othertest strip production processes presenting manufacturing/resource planning difficulties, Where individual packaging about each test strip is provided, the user faces the additional challenges with opening the packaging and extracting the test strip as well as handling and IS locating the test strip in the metering device. It should be remembered that elderly, infirm or diabetic patients may have trouble with fine motor skills and impaired sensitivity of the hands and fingers, Furthemiore, individual packaging can produce unsightly and difficult to handle packaging waste. In some instances used strips may be reinserted into packaging for disposal.

This may be difficult for users to do again requiring fine motor skills and fmger sensitivity, Oftcn used strips and packaging are disposed of separately with patients or carers having to handle contaminated used test strips.

As such there is interest in seeking to address these and other problems by identifying new packaging configurations that aim to: protect each test strip from the effects of moisture and/or improve the ease of use in accessing individual test strips, and/or reduce the cost and complexity of manufacture of such test strips.

GB 1245999 ELFAST describes an integrated testing strip and package for a reagent having a removable covering leaf attached to the strip to protect at least the surfhce of the liquid absorbing material (containing colour change reagent), the covering leaf and the test strip being made of an impervious laminate of aluminium foil and plastic, the liquid absorbing layer being sandwiched between the strip and the covering leaf ELFAST considers strip handling and describes an end ofatest strip remote from the testing end of sufficient length so that it can conveniently be held between the fingers of a user. Such an arrangement may improve utilit of strip handling for users, but also increases cost of manufacture impacting negatively on the amount of materials required per strip, the size of the manufacturing ime (to cope with multiple strips of increased length), the size and cost of secondary packaging such as vials/cartridges.

US6558528 MATZINGER describes electroehemical test strip cards that include integral desiccant, Electrochernical test strip precursors are provided having div reagent in a reaction chamber bounded by opposing (top and bottom) electrodes, the reaction chamber being in gaseous communication with an integrated desiccant. Once singulated, a sample inlet port and air vent are provided in the side walls ofthe test strip along a long edge to form an "edge fill" test scnsor. Top and bottom covers of aluminium foil and acrylic are provided. MATZINGER aims to make less use of packaging materials and provide a strip that, by utilising foil singulated strips containing desiccant, remains diy enough to last at least a month. the desiccant being less than S0% exhausted after 30 days, MATZINGER does not address strip handling.

W02007/057704 LONG describes a disposable device comprising a first portion having a fluid application port, a handle portion hingedly attached to the first portion which normally lies in the plane of the first portion. Grip means arranged to facilitate manual handling by a user defleetably IS coupled to the first portion at a hinge portion are described. Insertion using the liande portion and removal of the test device from a metering device using a second portion defleetably coupled to the first portion at a hingeable portion are described; the sample application zone being located between the first and second portions of the device. LONG appears to address some problems associated with strip manipulation to insert and remove test strips hygienically from a metering device. LONG does not address strip packaging and manipulation challenges associated therewith. Nor does LONG address challenges of reagent degradation.

The Alere DETERMINE MV 1 / 2 Ag/Ab Combo test available from Alere Limited. Stockport.

Cheshire. UK is an example of a packaged test strip.

WO2009/076266 YAO describes a test strip comprising a base, a lid and a spacer, in which the tip portion is moved or removed from the lid and the spacer, but remains attached to the base to expose a channel. YAO describes a test strip, but not a test strip having a cover leaf or indeed a cover leaf comprising a moisture barrier layer.

W02006/065705 FLE1'vIING describes a test strip with a removable tab, which is removable to reveal a capillary chamber. The test strip is described as a se!fcon ta/ned ampoule, optionally with desiccant, indicating that the test strip itself is a small container sealed to external elements.

A cover leaf comprising a moisture barrier ayer is not described, W097/27483 INCORVIA describes a medical test strip having a desiccant applied directly to the test strip and moisture barrier sheets covering the test strip. Alternatively, the moisture barrier sheets have a desiccant deposit attached to them.

US2O 13/0098939 ZELENY describes a cartridge and metering device for fluid testing strips, the cartridge holds the test strips in a sheet-like configuration and a metering device is able to extract test strips from the cartridge in response to an actuation ofa single user interface element.

US6 I 80063B MARKART describes a measuring device for use with a test strip and also describes a test strip package having a plurality of test strips including a container for receiving a card consisting of a pllLrality of test strips which are separable from one another along tear lines.

Co-pending, as yet unpublished, application GB 1304348,4 O'REILLY, filed on 11 March 2013, describes a test device comprising a test strip having first and second major surfhces and comprising a proximal portion for bearing contacts for a metering device, an intermediate portion for receiving a sample comprising a test area on the first major surface, the test area comprising at least one test component. and a separable distal portion, and in which the test device further comprises a cover leaf extending over at least part of the one of the major surfaces of the test strip so as to seal the test area and having a non-moveable portion attached to the separable distal portion of the test strip, The entire contents of GB 1304348,4 O'REILLY are hereby incorporated by reference, O'REILLY alleviates several issues related to moisture ingress and individual test strip packaging, Nevertheless, problems of packaging and handling individual and groups of test strips would benefit from being further addressed.

Indeed, the problems of handling a test strip and any associated packaging before and/or during and/or after a test and the problems of degradation of reagent(s) over time due to moisture and/or light ingress would also benefit from being addressed, The present invention seeks to alleviate one or more of the problems described herein,

Statement of Invention

In a broad sense, the invention relates to a test sensor package comprising at least one test sensor and associated packaging comprising at least one cover leaf The packaging need not encompass the test sensor in its entirety but may simply cover a portion of the test sensor, preferably, so as to restrict (reduce) ingress from external element(s) at least in part in respect of that portion, In a first aspect, the invention provides a test scnsor package comprising: a) at least one test sensor having first and second major surfaces comprising: a proximal portion; an intermediate portion for receiving a sample; a separable distal portion, movable with respect to the proximal and intermediate portions of the test sensor, the separable distal portion comprising a handle portion; b) at least one force transmitting connection member between the handle portion and at least one of the proximal portion and intermediate portion; and c) an anchor cover leaf extending over at least part of one of the major surfaces of the test sensor configured to anchor the test sensor, whereby, in use, a user can grip and pull the handk portion. firsth'. to move the separabk S distal portion with respect to the remainder of the test sensor so as to detach it from the anchor cover leaf and, secondly, to exert a force on the remainder of the test sensor via the at least one force transmitting connection member so a.s to detach the remainder of the test sensor from the anchor cover leaf.

Thus, the test sensor is anchored in position on a major slLrface of the anchor cover leaf and can be removed by, pulling on the handle typically in a two stage process, to move thc separable dista' portion away from the anchor cover eaf and then to detach the rest of the test sensor from the anchor cover leaf In a second aspect, the invention provides a method of manufacturing a test sensor package comprising forming: a) forming a test sensor having first and second major surfaces and IS comprising: a proximal portion; an intemiediate portion for receiving a sample; a separab'e distal portion movable with respect to the proximal and intermediate portions of the test sensor, the scparablc distal portion comprising a handle portion; at least one force transmitting connection member between the liande portion and at least one of the proximal portion or distal portion; b) applying an anchor cover leaf extending over at least part of one of the maj or surfaces of the test scnsor whereby, in use, a user can grip and pull the handle portion, firstly, to move the separable distal portion with respect to the remainder of the test sensor so as to detach it from the anchor cover leaf and, secondly, to exert a force on the remainder of the test sensor via the at least one force transmitting connection member so as to detach the remainder of the test sensor from the anchor cover leaf.

In a third aspect, the invention provides a method of use of a test sensor package as described herein, or manufactured according to a method as described herein, comprising: a) gripping a handle portion of the separable distal portion; b)pulling on the handle portion to move the separaMe distal portion with respect to the remainder of the test sensor so as to detach it from the anchor cover leaf, and c) pulling on the handie portion to exert a force on the remainder of the test sensor by the force transmitting connection member to detach it from the anchor cover leaf.

In a fourth aspect, the invention provides an apparatus comprising a test sensor package as described herein, or manufactured according to a method as described herein, and a separate holder.

In certain embodiments, the test sensor package may comprise a test sensor releasable attachment member for releasably attaching at least part of a major surface of the test sensor to at least part of a major surface of the anchor cover leaf In certain embodiments, the test sensor releasable attachment member may comprise at least one adhesive layer and/or at least one thennoplastic layer, on, or fonning part of, at least one of the test sensor and/or anchor cover leaf to releasably adhere the test sensor to the anchor cover leaf In certain embodiments. the test sensor releasable attachment member may comprise a selecdvely profiled seal (e.g. a thermoplastic layer preferably forming at least part of the at least one cover leaf) configured to resnict ingress of external element(s) to at least part of the intennediate portion, optionally to, at least a test area comprising at least one test component. In certain embodiments, the test sensor releasable attachment member may releasably attach at least part of the separable distal portion of the test sensor and/or at least part of the proximal portion of thc test sensor to corresponding portion(s) of the anchor cover leaf. The releasable attachment member may comprise a thermoplastic outer layer of the anchor cover leaf.

IS The releasable attachment member allows for anchoring of the test sensor to the anchor cover leaf, or indeed to a remainder of the anchor cover leaf, where the releasable attachment member forms a part of the anchor cover leaf.

In certain embodiments, at least part of the intermediate portion may be attached, optionally weakly, to an opposing portion of the anchor cover leaf whereby the intermediate portion resists being detached from the anchor cover leaf, at least initially. In certain embodiments. an intermediate portion releasable attachment member may be provided releasably attaching at least part of the intermediate portion to a corresponding opposing portion of the anchor cover leaf whereby, the intermediate portion resists being detached from the anchor cover leaf, at least initially. In certain embodiments, the intermediate portion releasable attachment member may be located adjacent but spaced from a proximal end of a test area comprising at least one test component. In certain embodiments, the intermediate portion releasable attachment member may comprise an adhesive layer for adhering the intermediate portion to the anchor cover leaf In certain embodiments, the adhesive layer may comprise one or more nodules (e.g. spots) of adhesive, In certain embodiments, two or more nodules of adhesive may be provided in a row extending from a location adjacent but spaced from a proximal end of a test area toward a proximal portion of the test sensor. In certain embodiments, the intermediate portion adhesive layer may have different, optionally weaker, adhering properties, than a test sensor releasable attachment member for releasably attaching at least part of a major surfhce of the test sensor to at least part of a major surface of the anchor cover leaf a These arrangements variously assist in attaching the intermediate portion to the anchor cover leaf and as the separable distal portion is initially moved, continuing to attach the intermediate portion to the anchor cover leaf at least temporarily, so that it stands proud from the separable distal member.

In certain embodiments, the intermediate portion may be relatively rigid, and/or relatively rigidly connected to the proximal portion, whereby the intermediate portion resists bending forces. In certain embodiments, the intermediate portion and proximal portion may form a single integral member. In certain embodiments, the anchor cover leaf may comprise at least one anchor member configured to resist movement of the anchor cover leaf in the direction of a force exerted by a user when pulling the handle portion of the separable distal portion of the test sensor e.g. orthogonal to a plane of a major surface of a test sensor.

In certain embodiments, the at least one anchor member may be stronger than a releasable attachment member releasably attaching at least part of a major surface of the test sensor to at least part of a major surface of the anchor cover leaf so that, preferentially, the test sensor is IS detached from the anchor cover leaf when a nser pulls on the handle portion. In certain embodiments, the at least one anchor member may comprise an anchor member adhesive layer and the releasable attachment member comprises a test sensor adhesive layer adhering the test sensor to the anchor cover leaf and the anchor member adhesive layer is stronger than the test sensor adhesive layer. In certain embodiments, the anchor member adhesive layer may have a greater area and/or greater adhesive properties than the test sensor adhesive. In certain embodiments, at least one anchor member may comprise at least one lateral portion of the anchor cover leaf extending laterally beyond at least a portion of the perimeter of the test sensor. In certain embodiments, the at least one anchor member may be sized and/or shaped and/or configured so as to be grippable by a user and/or otherwise anchorable to at least one anchor point. In certain embodiments, at least one anchor member may comprise at least one inter-engaging member for inter-engaging with a corresponding inter-engaging member. In certain embodiments, the at least one anchor member may comprise an inter-engaging spigot and/or aperture.

The anchor member, when held in a separate holder (e.g. attached to its corresponding inter-engaging member), allows for easier removal of the test sensor from the anchor cover leaf, as the anchor cover leaf will itself be anchored (held in place within the holder) to resist it moving when the test sensor is pulled upon.

In certain embodiments, the handle portion may comprise an integral handle portion of the separable distal portion. In certain embodiments, the anchor cover leaf and test sensor may be configured so that the handle portion extends beyond a periphery of the anchor cover leaf so that when it is pulled by a user, the user does not pull directly on the anchor cover leaf In certain embodiments, the at least one test sensor may be elongate and the anchor cover leaf extends in a direction orthogonal to a longitudinal axis of the at least one test sensor.

In certain embodiments, the separable distal portion may be rotatably connected to at least one of the proximal portion and the intermediate portion.

In certain embodiments, the separable distal portion may be connected directly to at least one of the proximal portion and the intermediate portion. In certain embodiments, the at least one force transmitting connection member may comprise at least one arm portion of the separable distal portion of the test sensor.

In certain embodiments, the separable distal portion may be completely detachable from the remainder of the test sensor.

In certain embodiments, the separable distal portion may be connected indirectly to at least one of the proximal portion and the intermediate portion. In certain embodiments, the force transmitting connection member may comprise a portion of a further cover leaf on the other major surfhce of the test sensor.

In certain embodiments, the separable distal portion may be frangibly connected to the intermediate portion and/or proximal portion whereby the separable distil portion is detachable from the remainder of the test sensor.

The force transmitting member, whether directly or indirectly connected to the separable distal portion allows for the force exerted on the separable distal portion to be transmitted to the proximal and/or intermediate portions in turn. The separable distal portion can be detached from the anchor cover leaf revealing the intennediate portion, before the remaining test sensor is pulled upon and detached from the anchor cover leaf.

In certain embodiments, the intermediate portion may comprise a test area on the first major surface, the test area comprising at least one test component and the anchor cover leaf extends over at least part of one of the major surfaces of the test sensor so as to seal the test area.

In certain embodiments, a further cover leaf may be provided on the other major surface, In certain embodiments, the further cover leaf may comprise a non-removable portion, non-removably attached to the separable distal portion of the test sensor. In certain embodiments, the further cover leaf may comprise a removable cover leaf having a removable portion extending at least over part of the other major surface of the test sensor so as to seal the test area.

In certain embodiments, the anchor cover leaf may extend over a first major surface of the test sensor having a test area comprising at least one test component so as to seal the test area in respect of the first major surface, and the removable cover leaf extends over the second major surface so as to seal the test area in respect of the second major surface. In other embodiments, the removable cover leaf extends over a first major surface of the test sensor having a test area comprising at least one test component so as to seal the test area in respect of the first major surthee, and the anchor cover leaf extends over the second major surthce so as to seal the test area in respect of the second major surface.

In certain embodiments, the further cover leaf may be completely detachable from a major surface of the test sensor.

The thither cover leaf rtduces access to a major surface of the test sensor by external element(s).

In certain embodiments, the separable distal portion may comprise at least one arm lying alongside the intermediate portion of the test sensor. In certain embodiments, the separnble distal portion may foim a frame about the intermediate distal portion of the test sensor. In certain embodiments, the separable distal portion may be U-shaped having laterally spaced arms lying alongside the intermediate portion and a distal cross staLt there between to form a frame about the intermediate portion. In certain embodiments, a hinge portion may be provided between at least one arm and the proximal portion.

The provision of a separable distal portion forming a frame around an intermediate portion means that as separable distal portion is moved from its position on the anchor cover leaf, the intermediate portion stands out. This facilitates deposition of a fluid sample into the sample chamber.

In certain embodiments, the separable distal portion of the test sensor may lie immediately adjacent the intermediate portion of the test sensor, In certain embodiments, the size and/or shape of the periphery of the separable distal portion opposing the intermediate portion may correspond with the size and/or shape of the opposing periphery of the intermediate portion whereby these lay immediately adjacent one another.

The separable distal portion and the intermediate portion lying immediately adjacent to each other (allowing for manufacturing tolerances), but not directly attached facilitates the displaying of the intermediate portion when the separable distal portion is moved away from the remainder of the test strip, and a lower of volume of air (and moisture) trapped within the test sensor package) and reduced materials required for manufacturing, 1' In certain embodiments, the intermediate portion may be of a narrower width than the proximal portion, and forms an intermediate tip portion for receiving a fluid sample into the test area, In certain embodiments the substrate may be an integral component and comprises one or more lines of weakness andlor cuts delineating between the intermediate portion and the separable distal portion.

In certain embodiments, a removable cover leaf having a removable portion may be provided comprising one or more lines of weakness andlor cuts delineating between a removable portion of the removable cover leaf and a remaining non-removable portion thereof In certain embodiments, at least one cover leaf (e.g. anchor cover leaf, further cover leaf) may comprise a moisture barricr layer, e.g. a metal foil. In certain embodiments, at least one cover leaf may comprise a desiccant loaded plastic layer. In certain embodiments, at least one cover leaf may comprise a thermoplastic layer inwardly facing towards the test sensor aiidlor a desiccant loaded thermoplastic layer inwardly facing towards the test sensor. In certain embodiments, the at least one cover leaf may be a laminate comprising a plastic outer layer, a IS central moisture barrier layer and an inwardly thcing tie-in layer, optionally a thermoplastic, or dessicant loaded thennoplastic. layer. Thus, in certain embodiments, a thennoplastic layer of at least one cover leaf may be heated so as to be sealed to the test sensor to form the test sensor releasable attachment member e.g. the selectively profiled seal configured to restrict ingress of external element(s) to at least part of the intermediate portion, optionally to, at least a test area comprising at least one test component.

At least one cover leaf being a moisture barrier layer reduces the level of moisture entering the test sensor, thus increasing the longevity of the test sensor.

In certain embodiments, the test sensor package may comprise a plurality of test sensors on the anchor cover leaf.

In certain embodiments, the method may comprise: a) providing a test area comprising a test component on the intermediate portion; b) attaching pre-selected regions of the anchor cover leaf to the major surface of the test sensor to form a seal about the test area in respect of one major surface. hi certain embodiments. the method may comprise attaching a further removable cover leaf to the test sensor to the other major surface of the test sensor so as to seal the test area in respect of the other maj or surface. In certain embodiments. the method may comprise attaching pre-selected regions of a further cover leaf to a major surface of the test sensor to form a seal about the test area, In certain embodiments, the method may comprise: a) attaching removably pre-selected regions of a removable portion of a further cover leaf to the other major surface of the test sensor to form a seal about the test area; b) attaching non-removably a non-removable 1' portion of the further cover leaf to the separable distal portion of the test sensor. In certain embodiments, the method may comprise providing cuts and/or lines of weakness in the test sensor andlor in one or each cover leaf before and/or during and/or after assembly of the device.

In certain embodiments, the method may comprise providing any of the features of the test S sensor package as described herein, The method of manufacture allows a large number of test sensor packages to be made quickly, easily and reduced the costs of manufacture, whilst providing the benefits of the test sensor package as described herein.

In certain embodiments, a separate holder may comprise at least one clamp for clamping the anchor cover leaf in position in the holder, In certain embodiments, an apparatus may comprise one or more regions of attachment. such as adhesive, to anchorthe cover leaf to the holder, In certain embodiments, the holder may comprise an inter-engaging member for inter-engaging with a corresponding member on the anchor cover leaf to assist with anchoring it within the holder. In certain embodiments. the holder may comprise a window for accessing the handle IS portion of a separable distal portion of a test sensor and for removing the test sensor from the holder by detaching it from the anchor cover leaf The holder provides a stable base from which tile individual test sensors can be removed from the anchor cover leaf, The invention also extends to a test sensor package, an apparatus, a method of manufacture and a method of use substantially as described herein with reference to and/or as illustrated in the accompanying drawings.

Brief Description of the Invention

The following drawings illustrate embodiments of the invention, by way of example only. It will be appreciated by those skilled in the art that the following detailed specific description is intended to illustrate specific example embodiments, and alternative embodiments can be envisaged from the infoimation in the preceding and following description and claims of the present application. In the following figures, like reference numerals refer to like features.

Figure 1 shows schematic, plan views, from above and below, and cross-sectional, elevation views along AA' of a test sensor package, here a test strip package, according to a first example embodiment of the invention.

Figure 2 shows schematic, plan views, from above and below, and cross-sectional, elevation views along AA' of a test sensor package according to a second example embodiment of the inventi on, 1' Figure 3 shows schematic. plan views from above and below, and eross-sectional elevation views along AA' of a test sensor package according to a third example embodiment of the invention.

Figure 4 shows a perspective view from above of an example base substrate with printed layers for fanning an example test strip for use in a test sensor package according to the invention.

Figure 5 shows a perspective, exploded view from above of the base substrate and printed layers of Figure 4.

Figure 6 shows a perspective, exploded view from above of the example base substrate with printed layers of Figure 4. a spacer layer and a hydrophilic layer (also known as a lid or an anti-fog layer) Figure 7 shows a perspective view from above of an example test strip comprising the base substrate with printed layers of Figures 4 and S and the spacer layer and hydrophilic layer of Figure 6.

Figure 8 shows a perspective exploded view from above of an example test sensor package comprising a test strip (such as that of Figure 7) and associated cover leaves specifically first (in this case lLpper) anchor cover leaf and second (in this case lower') removable cover leaf according to an example embodiment of the invention. The test strip has a shaped, seleefively profiled adhesive layer on its upper major surfhee (seen from above) and a shaped, selectively profiled adhesive layer on its lower major surface (seen from below).

Figure 9 shows a perspective view from above of a test sensor package, such as that seen in Figure 8, comprising a test strip and an anchor cover leaf on the first (here upper) major surface of the test strip and a removable cover leaf on the opposing (here lower) maj or surface of the test strip according to an example embodiment of the invention.

Figure I OA shows perspective and plan views of a substrate with, in this example embodiment.

two printed conductive layers.

Figure I OB shows a perspective view from above ofa printed substrate with a conductive layer of Figure bA showing the location ofa dielectric insulation layer.

Figure I OC shows a perspective view from above of the printed substrate of Figure I OB with an adhesive layer to be laid down on it for use in adhering reagent e.g. a separate reagent membrane (such as reagent pad or reagent film). Alternatively reagent may be deposited by wet deposition techniques such as wet film printing as is well known and understood by those skilled in the art, 1' Figure 10D shows perspective and plan views of a substrate with one or more printed layers (such as those seen in Figures 10A to 1OC) and a series of singulation cuts intended to form the basis of the singulation of the substrate into individual strips and cuts for forming intermediate and separable distal portions in the substrate of each test strip.

Figure IOF shows exploded and plan views of a partly formed printed substrate and an associated heat seal, or adhesive layer, profile suitable for adhering a removable cover leaf on a second (here rear) major surface of a test sensor.

Figure 10F shows a perspective, exploded view of a removable cover leaf ready to be laminated into position on a major surface of a printed slLbstrate using, for example, the associated heat seal, or adhesive layer, profile of Figure bE. Thus, Figures 1OE and 10F. show application of one cover leaf, hear a removable cover leaf but optionally an anchor cover leaf, to the rear of a singulated printed substrate, optionally before application of reagent and optionally before lamination to a chamber layer, forming a sample chamber and lid.

Figure 100 shows a perspective exploded view of a printed, cut substrate and a dry reagent pad layer about to be laid down on the substrate.

Figure 1OH shows exploded, perspective and plan views of a laminated chamber layer (e.g. including spacer and lid layers) and cuts to be applied to the laminated chamber layer for singulation into individual strips and for forming intermediate and separable distal portions in the laminated chamber layer. A pre-formed chamber layer having integral spacer and lid portions maybe used.

Figure 101 shows exploded, perspective and plan views of the cut chamber layer of and anchor cover leaf illustrating the selectively profiled (selectively sized, and/or shaped andlor configured) seal (e.g. adhesive) for adhering the anchor cover leaf to the laminated chamber layer and a preferred, but optional, similarly selectively profiled seal (e.g. adhesive) region on the intermediate tip portion, The anchor cover leaf forms a web across a plurality of individualiscd chamber layer portions (each to form part of a singulatcd test strip) once singulation is complete.

Thus. Figures IOH and 101, show applicafion of one cover leaf, here an anchor cover leaf. to the rear of a singulatcd laminated chambcr layer, optionally before lamination to a printed substratc (such as that of Figures IOE and 1OF). Application of cover leaf(s) may take place before or after lamination of a printed substrate to a chamber layer (or to a spacer layer or lid layers). Similarly.

singulation of test strips may take place after the test strips have been fully formed, and before or after application of cover leaf(s) to the card of test strips, 1' Figure 11 shows exploded, perspective and plan views of a sealed chamber layer having a contn1uous web of anchor cover leaf across it ready to be laminated to a base substrate (preferably a sealed base substrate). Here, as in Figures 1OA to 101, multiple test strips are shown in a card substrate fonriat.

Figure 12 shows a series of steps in a method of manufacture according to an example embodiment of the invention somewhat different to the steps illustrated in Figures IDA to Figure Figure 13 shows a plan view from above of a test strip at an optional step 3A in the method of Figure 12.

Figure 14 shows a singulatcd test strip (with cover leaves not shown for clarity).

Figure 15 shows perspective view of the test strip of Figure 14 after a separable distal portion has been rotated slightly about hinge 30 (anchor cover leaf not shown for clarity), Figures 16 and 17 show plan views of a test strip illustrating selectively profiled regions of adhesive on first and second major surfaces respectively for use in steps 4A and 5A of the method of Figure 12 or other methods of the invention.

Figure 18 illustrates plan views of apparatus comprising a holder or ease according to a further aspcct of the invention and an associated test scnsor package comprising a card of test strips for use therein. The test strips are in a card format and are separable (e.g. optionally frangible) from one another but held in fixed relation side by side with one another with opposing edges immediately adjacent to one another, here, along the long edges of rectangular strips on the continuous web of an anchor cover leaf which extends across several test strips (in a direction orthogonal ma longitudinal axis of the, here, elongate test strips).

Figures 19A and 19B show plan views of the apparatus of Figure 18 with the card of strips now located within the holder.

Figures 20A and 20B show perspective front and rear views respectively of apparatus comprising a card holder and test sensor package comprising a card of strips according to a further example embodiment, illustrating inwardly extending stabilising pins 310 which assist in anchoring the card of strips in the card holder by resisting motion of the card of strips from the holder, especially when a user is detaching one test strip from the card of test strips and extracting it from the holder.

Figures 21A and 21B show plan and perspective views of apparatus comprising a holder and a test sensor package comprising a card of strips in the holder (plan view from above) and a 1' removed strip (in perspective view) illustrating methods of use (of the test sensor package and holder) according to further aspects of the invention.

Figures 22A, 22B and 22C show perspective views of test strips according to the invention and a meter for use of same, the test strips having been removed from an anchor cover eaf (not shown) and optionally, also separated from a card of strips associated with a single anchor cover leaf (not shown),

Detailed Description of the Invention

Any feature of any embodiment of any aspect of the invention described herein may be combined with any other feature in any other embodiment of any aspect of the invention described herein. Further embodiments will be envisaged by those skilled in the art from the information disclosed herein and all alternative embodiments are considered to be embodiments of the invention, the invention to be limited by the appended dairns, In the previous and following descriptions and appended claims, the term test sensor package' is used to refer to a combination induding. but not limited to, a test sensor such as a test strip in combination with packaging for the test sensor in the fonn of one or more associated cover leaf or leaves. preferably at least an anchor cover leaf, and the term test strip' is used to refer to a test sensor for conducting a test (e.g. a diagnostic test) of any suitable size or shape, although prefemby of generally or substantially planar construction having npper and lower major surfaces and a side wall (preferably a relativdy thin side wall) between said upper and thwer major surfaces, Thus in this application a test sensor package comprises a test sensor (such as a test strip) and at least one cover leaf The test sensor package may comprise more than one test sensor. A test sensor package (test sensor and cover leaf) with only one test sensor may also be known as a test device and is an example of a test sensor package.

The present invention is not limited to a particular kind of test sensor or test strip or a particular type of test. The present invention finds particular application to test strips of generally or substantially planar construction having upper and lower major surfaces, The invention is not limited to a particular shape of test strip.

In the previous and following descriptions and appended claims, where the terms "first' and "second' are used with respect to the major surfaces of a test sensor, test strip or any portion of a test sensor or test strip, typically the first' major surfhce refers to the major surface on which. in which, or in association with which, at least one test component for conducting a test (such as measurement electrodes, reagent, conductive tracks. sample chamber and hydrophilic layer) is formed and the second' major surface ofa test sensor, test strip or any portion ofa test sensor 1' or test strip refers to the major surface opposing the first' major surface. These terms are not intended to be limiting unless the context dictates otherwise.

Similarly the terms upper and lower' or first' and rear' when used in connection with test sensors, test strips, test sensor packages, test devices, cover leaves and major surfaces is not intended to be limiting unless the context dictates. For example, when a device is turned over, these terms, in so far as they apply, swap round, Nevertheless these terms are used in connection with the Figures illustrating the invention, to referto the orientation of the item shown in the Figures. This is not intended to bc limiting unless context dictates otherwisc, In the previous and following descriptions and appended claims, the terms proximal', intermediate' and distal' may be used with respect to a test sensor or test strip or any component ofa test sensor or test strip e,g, a test strip, a hydrophilic layer, a spacer layer, base substrate, upper cover leaf or lower cover leaf, to indicate corresponding proximal, intermediate and distal portions of each test sensor, test strip or component, Nevertheless, unless indicated otherwise by the context. the terms proximal portion'. intermediate (tip) portion' and IS separable distal portion' are intended to refer to the test sensor component or test strip of the test sensor package.

In the previous and following descriptions and appended claims, the term lateral' may be used with respect to a cover leaf to indicate portions ofthe cover leaf which can extend beyond any edge of the periphery of the test sensor.

Test components. such as measurement electrodes, sample inlet port, sample chamber and air vent, may be provided on a major surface of a base subsuate so as to provide a test area described herein as being on' the corresponding major surfhce of a test strip. It will be understood by those skilled in the art from the disclosure herein that the one or more test components if described as being on' a major surface of the test strip may be located upon or associated with or form part of that major surface of the test strip, for example as described herein, This is somewhat similar to patterns printed on cloth, in that the patterns are printed upon a surthce of cloth but in effect form part of that surfihce of the cloth and are described as being on' the cloth but in effect form part of that surface of the cloth. Nevertheless, the present invention also finds applicability to test sensors in which at least one or all test components are not associated with one or other major surfaces of a test strip (e.g. vents and/or sample inlet may be in a side wall and/or other components may be intemal), In the present invention, test components on a major surface, or those sandwiched within a base substrate and lid of a test sensor, can be further protected and ease of use of the test sensor enhanced by the provision of an anchor cover leaf. 1'

Figure 1 shows a test sensor package, here a test device 10 according to a first embodiment of the invention, Test device 10 comprises a single, generally planar, rectangular, test strip 20, a first (here upper) cover leaf 24 (an anchor cover leaf) and a second (here lower) cover leaf 22 (here a removable cover leaf), overlaying upper and lowermajor surfaces 28 and 29 respectively of test strip 20. Test strip 20 comprises at least one test component for conducting a test which may include one or more of, for example, a sample inlet port, a sample chamber, an air vent, conductive tracks, reagent and measuitment electrodes. These test strip components are omitted to aid clarity. Thus, test strip 20 comprises an upper first major surface 28 bearing at least one and typically mulflple test strip components (not shown) and an opposing lower second major surface 29, Contacts 18, providing external electrical connection to the test strip components, may be provided on a first major surface 28 of test strip 20 if these are required (e.g. optical test strips may omit these). In this example, contacts 18 tenninatc at a proximal portion of test strip 20 but alternative arrangements can be envisaged. Here, test device 10, test strip 20 and second IS removable cover leaf 22 are generally rectangular. but again alternative (including but not limited to square, round. efliptical, oval) shapes can be envisaged. Anchor cover leaf 24 comprises at least one anchor member such as one or more lateral portions 124A, 124B for anchoring the anchor cover leaf as will be described in more detail later. For example. lateral anchor portions 124A, 124B may serve as gripping portions for a user's fingers, or as clampable regions within a holder. Anchor cover leaf lateral portions 124A. 124B extend beyond the periphery of the test strip 20, in this case in a direction orthogonal to a longitudinal axis of the (here elongate, rectangular) test strip. Other types of anchor members and/or methods for anchoring anchor cover leaf 24 can be envisaged from this disclosure such as adhesive and/or bracket portions and/or one or more apertures and/or other components on the anchor cover leaf 24. For example, a releasable attachment member such as adhesive (or other fixing means) on the outermost major surface of anchor cover leaf 24 (see Fignre 9) may be provided for engaging with a surface or corresponding fixing means on a holder, Where adhesive or other releasable attachment members are used to hold the anchor cover in a separate holder, this is preferably configured to be stronger than a first releasable attachment member (e.g. test sensor adhesive layer) anchoring the test sensor to the anchor cover leaf, Test strip 20 has a proximal portion 12, an intennediate portion 14 and a separable distal portion 16. Test strip 20 is preferably formed from a continuous integral substrate, which has been appropriately processed to provide for these three portions. Proximal portion 12 bears contacts 18. Intermediate portion 14 is (in this example) narrower than proximal portion 12 and forms a narrower tongue extending from proximal portion 12 towards the opposing distal end of the test 1' device to form an intermediate tip portion 14. Intermediate tip portion 14 is surrounded on three sides by separable distal portion 16 when viewed from above (or below), Thus, in this example embodiment, intermediate tip portion 14 is narrower than proximal portion 12 and also narrower than separable distal portion 16. Further, in this (arid other) example embodiments, separable distal portion 16 is U-shaped when viewed from above having two spaced apart lateral arms 216, each connected directly to proximal portion 12 and a distal cross-strut connected therebetween.

A distal portion 116 of the cross-strut extends beyond the periphery of anchor cover leaf 24 (here orthogonal to the periphery) and forms a handle portion for gripping by a user, Thus, in this example and preferred embodiment, separable distal portion 16 forms a U-shaped bendable frame about intermediate tip portion 14, the U-shaped bendable frame being hingedlv connected directly to proximal portion 12, Intermediate (tip) portion 14 is not connected directly to separable distal portion 16. This means that separable distal portion can be moved with respect to the remainder of the test strip (proximal portion 16 and intenuediate tip portion 14 without, at least initially, moving intenuediate tip portion 14. Separable distal portion 16 may be L-shaped IS having one lateral arm connected to the proximal portion 12. The lateral ann(s) 216 of separable distal portion 16 each form a force transmitting connection member between the distal end handle portion 116 of separable distal portion and the remainder of the test strip 20 (proximal portion 12 and intermediate portion 14).

The inner facing periphery of separable distal portion 16 matches the outer periphery of intermediate tip portion 14, preferably being of substantially the same size andlor shape. Thus, the separable distal portion surrounds and protects the side walls forming the periphery of the intennediate tip portion 14. A number of cuts 36 through test strip 20 (and optionally kiss cuts through cover leaf 22) may be used to create and define the periphery of intenuediate tip portion 14. It is preferred that the inner facing periphery of separable distal portion 16 lies immediately adjacent the periphery of the intermediate tip portion 14 about its three protruding sides. In a strip of the order of few cm long and around 0,5 cm side, a small gap of the order of a few hundred microns to a few millimetres (up to 5 mm) may be used. The gap may be 5mm or less, although a gap of I or 2 mm or less is preferred. Preferably, the gap between intermediate tip portion 14 and separable distal portion 16 is the same, within manufacturing tolerances, around substantially all the periphery of the intermediate tip portion 14. Thus, the separation of these peripheries may be small e.g. around 1-2mm or less. Thus, the volume of air (and therefore moisture) trapped within the test device is kept relatively low, Here, intermediate tip portion 14 is generally rectangular. Other shapes of intermediate tip portion may be envisaged. It is noted that at the distal end of intermediate tip portion 14, the corners may be bevelled to create a slightly narrower distal end tip on intermediate tip portion 1' 14. This may serve to guide a user as to where to place a sample, especially in an end fill' test strip.

In the example embodiment shown in Figure 1, upper first major surfhee 28 of test strip 20 is provided with an upper anchor cover leaf 24, Lower second major surface 29 of test strip 20 is provided with a (here lower) removable cover leaf 22 which forms a removable cover leaf being removable (from its initial position) along with separable distal portion 16 of test strip 20, In more detail, lower removable cover leaf 22 comprises a central removable portion 32 overlaying intcrmcdiatc tip portion 14 and a non-removable portion 34A fixedly attached to separable distal portion 16 of test strip 20. Removable portion 32 is movable (from its initial position) along with removable distal portion 16. Further. a further non-removable portion 34B is attached to proximal portion 12 of test strip 20. These are described in more detail in co-pending application GB 1304348,4 O'REILLY the content of which in respect of these features is incorporated into this application and may be claimed as forming one or more embodiments of the present invention.

IS As described in detail in GB 1304348.4 and as will be seen hereinafter in various embodiments of the invention, or envisaged from the disclosure herein, the removable portion of a removable cover leaf may be removable by moving away from an initial position overlaying a major surface of a test strip without being completely detached from the remainder of the test device, In Figure 1 the removable portion 32 separates from intermediate portion 14 of the test strip and travels with associated non-removable portion 34A and separable distal portion 16 as these move for example, as these rotate out of position (out of the plane of the remainder of the test sensor) e.g. under the action of a user gripping handle portion 116 and optionally. lateral portions 124A.

124B of the anchor cover leaf, and rotating handle portion 116 and separable distal portion 16 away from anchor cover leaf 124, In this and other embodiments, the terms removable portion' and non-removable portion' when used in connection with a removable cover leaf indicate the following: the portion may be moved away from its initial position (for example, overlaying a major surface of a test strip 20 and/or in line with a plane through a major surface of the test strip) -a removable portion'; altematively, the portion may not be moved from its initial position (for example, overlaying a major surface of a test strip 20 and/or in line with a plane through a major surface of the test strip) -a non-removable portion'.

Providing a cover leaf over a maj or surface of a test strip restricts ingress of external elements to the major surface. This can be enhanced by providing a cover leaf of suitable material. Thus, one or more preferably both cover leaves (a first anchor cover leaf and a second cover leaf where 1' " provided) comprise a moisture barrier layer eg. a moisture barrier layer comprising optionally metal foil, optionally a desiccant loaded plastic layer, optionally a thermo-plastic layer facing the test sensor, optionally a desiccant loaded thermoplastic layer, optionally, a triple layer comprising an outer layer e.g. of plastic, a central moisture barrier layer (e.g. metal foil) and an inwardly facing tie-inlayer which may be thermo-plastic or desiccant loaded thermoplastic. Thus, in certain embodiments in which a thermoplastic layer is provided (either as part of the cover leaf or as a separate layer), the themioplastic layer may be heated (e.g. the cover leaf may be heated) so as to seal the thermoplastic layer to the test sensor. Thus, the thermoplastic layer (e.g. of the cover leaf) is selectively sealed in a profiled configuration to the test sensor to restrict ingress of external element(s) to at least part of the intemiediate portion, optionally to, at least a test area of the test sensor. Thus, the selectively profiled seal portion of the thermoplastic layer forms (in this embodiment) a test sensor releasable attachment member for releasable attaching the test sensor to the at least one cover leaf (in the example, in which the thermo plastic layer is part of the cover leaf, to the remainder of the cover leaf comprising a moisture barrier layer such IS as metal foil).

In this and other embodiments typically the removable cover leaf will be fonned of a single piece (e.g. a single piece of optionally laminated material) with, preferably, predefined removable and non-removable portions. Alternatively, the removable cover leaf may be formed from two or more separate pieces (e.g. separate pieces of (optionally laminated) material) fonning removable and non-removable portions which pieces may be joined together to fonn a complete removable cover leaf Similarly, the anchor cover leaf may be formed from a single (integral) piece e.g. a single piece of, optionally laminated, material or from two or more pieces connected together, In certain embodiments, no second cover leaf, or a completely detachable second cover leaf, or an entirely non-removable second cover leaf (see Figures 2 and 3) preferably with frangible portions (e.g. profiled to correspond to intermediate tip portion 14), may be provided on a major surface opposite a surface bearing anchor cover leaf 24.

In Figure I. it will be noted that removable portion 32 of lower removable cover leaf 22 is removable from its initial position overlaying lower major surface of intemediate portion 14, but non-removable portion 34A remains attached to separable distal portion 16 during movement of separable distal portion 16 from its initial position in line with the plane of the remainder of the test strip. It will be noted that in this embodiment, a further optional non-removable portion 34B overlays a major surthee of proximal portion 12 and is also not removed from its initial position with respect to that surface. 1'

The removable portion' e.g. removable portion 32, of a removable cover leaf may be peelably adhernd or sealed to a major surface of a test strip but preferably is not attached to a major surfhce of the test strip. One or both of the non-removable portions' e.g. non removable portion 34A and fUrther non-removable portion 34B may be non-peelably (e.g. pemianently) attached by adhering or welding to the test strip. Alternatively the non-removable portions (34A, 34B) may be provided with peelable or non-pernmnent adhesive to provide adhesion to the major surface of the test strip, but is arranged so as not to he removable (for example by not providing a fite tab for gripping. Examples of adhesives, welds, seals or joints include hot welding (e.g. thermoplastic welding using polyethylene), pressure sensitive adhesives (e.g. ethylene vinyl acetate, ethyl acrylic acid), and themiosetting adhesives (e.g. acrylic, polyurethane. natural rubber).

In Figure I. an upper anchor cover leaf 24 is provided with lateral portions I 24A, I 24B extending beyond the periphery of the test strip 20, beyond the long edges of a rectangular test strip. Typically, a releasable attachment member in the form of a peelable adhesive is used IS between anchor cover leaf 24 and test strip 20 to anchor the test sensor 20 in position on anchor cover leaf and to seal selectively (in selected regions) so as to surround the periphery of intermediate tip portion 14 (preferably at least in respect of a test area) sealing it from above.

The seal may be provided by the peelable adhesive and may extend inwardly a little over the gap formed by the cuts 36 to surround and cover the periphery of intermediate tip portion 14, This may provide addifional sealing about the side walls of intermediate portion 14 (as the adhesive or thermal weld or seal may creep into the gap). The portion of anchor cover leaf overlaying the intennediate tip portion 14 may be provided with a releasable attachment means such adhesive to hold intermediate tip pordon 14 adjacent to anchor cover leaf 24 at least inirially, Examples of adhesives, welds, seals orjoints, that may provide releasable attachment and/or sealing between cover leaf and test sensor, include hot welding (e.g. theimovelding. thermoplastic welding e.g. using polyethylene), pressure sensitive adhesives (e.g. ethylene vinyl acetate, ethyl acn'lic acid), and thermosetting adhesives (e.g. acrylic, polyurethane, natural rubber), Other means of releasably attaching the test sensor to the anchor cover leaf can be envisaged e.g. VeleroR7ç suction, but these are less preferred. Where a releasable attachment member other than adhesive or thcrmo welding is used, it may be necessary to provide an additional profiled seal as described herein. An adhesive layer forming the profiled seal may be provided on one or both of the test sensor and anchor cover leaf or as a distinct layer.

Thus. upper anchor cover leaf 24 overlays most of upper major surfhce 28 of test strip 20, but preferably stops short over proximal portion 12 so as to expose contacts 18, Indeed, in this example, the anchor cover leaf 24 is shorter than the test strip 20 is long, so that at least one end 1' of the test strip (e.g. handle portion 116 and/or at least part of proximal portion 12) extends laterally beyond a long edge of the periphciy of a (here rectangular) anchor cover leaf 24 to enable a user to grip handle portion 116 without gripping anchor cover leaf 24. This aids removal of test strip 20 from anchor cover leaf 24. The test strip 20, or at least that portion of test strip 20 for conducting a test, is completely detachable from anchor cover leaf 24. Test strip 20 can be detached from the anchor cover leaf 24 by pulling on the separable distal portion e.g. via its handle portion 116 whilst the anchor cover leafis anehotud e.g. in a user's hands or a special holder, Test strip 20 comprises a substrate with printed layers as will be described later. The substrate is typically formed as an integral component of a suitable material such as plastic. Examples of plastics used include polyethylene terephthalate, polypropylene. Test strip 20 is here provided with at least one and preferably two laterally spaced hinge portions 30. optionally formed from a line of weakness or other hinge mechanism, joining proximal portion 12 and separable distal portion 16, and enabling separable distal portion 16 to form a bendable U-shaped frame IS (bendable about hinge portions 30) surrounding intermediate tip portion 14 having two arms 216 lying alongside intermediate tip portion 14. In this example embodiment both the intermediate tip portion 14 and the separable distal portion 16 arc directly connected to the proximal portion 12. Preferably, there is no hinge portion between proximal portion 12 and intermediate tip portion 14 so that these form a relatively rigid single integral component.

The test device of the invention may be provided with one or two cover leaves at least one being an anchor cover leaf It will be appreciated by those skilled in the art that whilst an anchor cover leaf on a first major surface of a test strip (comprising at least one test strip component) is described, these may be reversed and an anchor cover leaf 24 may be provided on a second major surface of a test strip opposite the first maj or surface and a removable cover leaf 22, or other cover leaf, or no cover leaf may be provided on the first maj or surfhce of the test strip 20 (here an upper surfhce).

Lower removable cover leaf 22 overlies at least part of lower major surfhce 29 of test strip 20 in the embodiment in Figure I. The lower removable cover leaf 22 is sealed in selected regions to lower major surface 29, In particular, preferably, the lower removable cover leaf is sealed so as to surround the periphery of the intermediate tip portion 14 (e.g. so as to seal the test area) as will be described in more detail later, but the seal does not extend over the intermediate tip portion 14 to any appreciable extent so this is not sealed to the removable portion 32 of the removable cover leaf 22 or is not sealed to any appreciable extent. The seal may be permanent or temporary (e.g. a thermo plastic weld or peelable adhesive). As described above, the seal may extend inwardly a little over tile gap formed by cuts 36 to surround and cover the periphery of the intermediate tip portion 14. This may provide additional sealing of the side walls of inteimediate tip portion 14 as the seal (e.g. adhesive or thermoplastic) may creep into the gap. Examples of seal layouts (e.g. thermo weld or adhesive layouts) for use with cover leaves will be described in more detail below. Thus, typicallv the lower removable cover leaf 22 is not sealed to the intermediate tip portion 14, so that, the removable portion 32 of the lower removable cover leaf 22 can be removed without pulling on or bending the intermediate tip portion 14 at least initially when separable distal portion 16 and associated non-removable portion 34A of removable cover leaf 22 are rotated about hinge portions 30. As described above, non-removable portion 34A of removable cover leaf 22 may be sealed, e.g. pernianently welded, permanently adhered, or peelably adhered to separable distal portion 16 and moves with it, A further non-removable portion 34B may be similarly sealed to the proximal portion 12 of the test strip.

The separable distal portion of the test strip may be directly connected to the remainder of die test strip but separable by moving the separable distal portion away from its initial position with IS respect to part or all of the remainder of the test strip 20 (Figure I). Alternatively, the separable distal portion 16 of the test strip may be detached or detachable from the remainder of the test strip and indirnctly connected to the remainder of the test strip, and also separable by moving the separable distal portion away from its initial position (Figures 2 and 3).

In use. where a completely detachable second (here lower) cover leaf is provided (not shown), this may first be detached from the lower major surface of test strip 20 (e.g. by gripping a tite tab in the detachable cover leaf).

In use. in the example embodiment shown in Figure 1 (and indeed Figures 2 and 3), movement of the separable distal portion 16 (and associated removable portion 32 mid non-removable portion 34A of lower removable cover leaf 22 where provided) first exposes the intermediate tip portion 14 ready for use (ready to receive a sample). Continued movement of the separable distal portion 16 causes detachment of test strip 20 (and any associated lower cover leaf 22) from upper anchor cover leaf 24.

Referring to Figure I, in use in step I. a test sensor package lOis provided comprising a test strip having an anchor cover leaf 24 (here an upper cover leaf) preferably selectively adhered to the first major surface of test strip 20 so as to anchor it to the anchor cover leaf and provide a seal about intermediate tip portion 14. The test strip 20 has a proximal portion 12. an intermediate tip portion 14 and a separable distal portion 16 optionally in the form of a U-shaped bendable frame surrounding the intermediate tip portion 14 on three sides. Optionally, a lower removable cover leaf 22 is provided, having a removable portion 32 not adhered to but extending 1' -.

over intermediate tip poiflon and a non-removable portion 34A adhered to the separable distal portion 16, In step 2, separable distal portion 16 is gripped (typically by an enlarged, grippable portion exposed beyond anchor cover leaf 24, acting as a dedicated handle portion 1 16) rotated about hinge portion 30 relative to proximal portion 12 and relative to intermediate tip portion 14 in the direction of arrow A, The removable portion 32 of the removable cover leaf 22 initially overlying intermediate tip portion 14 simply rotates with the separable distal portion 16 (and with non-removable portion 34A) out of thc plane of the remainder of the test devicc (proximal portion 12 and intermediate tip portion 14) thereby exposing the lower major surfhce of intermediate tip portion 14.

In step 3, the handle portion 116 (and possibly also the now exposed separable distal portion 16) is gripped and pulled farther by a user in the direction of arrow A to detach test strip 20, typically in a peelable manner, from anchor cover leaf 24 in the direction of arrow B. (forming a gap a'). The pulling force is transmitted to the remainder of the test strip by the arms 216 of the IS separable distal portion. Detachment from the anchor cover leaf 24 exposes, in this example embodiment, a test area of test strip 20 comprising at least one test component located on intermediate tip portion 14 on a first major surface 28, Intermediate tip portion 14 now stands proud of the separable distal portion 16 and removable portion 32 of removable cover leaf 22 and provides easy access for a user to a sample inlet port e.g. at an end (for end fill") or at a side (for "side fillS') of intennediate tip portion 14.

Intermediate tip portion 14 is preferably mounted relatively stiffly or rigidly on proximal portion 12 so that these do not (easily) move relative to one another. The intermediate tip portion 14 and proximal portion 12 remain (at least initially) located adjacent, optionally releasably attached to, anchor cover leaf 24 as will be described later, Separable distal portion 16 may be bendable backwards through almost 180° about hinge portion to lie alongside the proximal portion 12 of the test device to provide additional length (in effect an extended handle') to the test device 10 to facilitate device handling. Thus separable distal portion 16 may be used as a haiidle before, and/or during, and/or after sample application and sample measurement, Furthemiore. as separable distal portion 16, in this example embodiment, carries removable portion 32 of removable of removable cover leaf 22, replacement of separable distal portion 16 to its initial position, in the plane containing the remainder of test strip 20, re-covers the exposed intermediate tip portion 14 about its lower major surface and about its periphery. 1'

Proximal portion 12 is optionally not completely covered by a cover leaf or is covered but not scaled to a cover leaf so electrical contacts 18 are exposed when these arc provided, Thus, in this and other embodiments an ILnused strip can be inserted (typically electrical contacts first) into a metering device before exposing test components to atmosphere. The metering device may then be usable as a handle to hold the test device 100. Furthermore in this and other embodiments this arrangement enables the metering device to be used to conduct measurement before the removable cover leaf/leaves are removed. This pit-test measurement may be used to assess the viability of the test strip 20 and/or the degradation of the reagent and/or assess the test strip for manufacturing flaws before the test strip is used. If an error or out of scope reading is taken in a pre-test measurement, an error message can be delivered to a user before a test is conducted, reducing the possibility of an incorrect test measurement being delivered to a user and the risk of inappropriate treatment and avoiding the inconvenience of multiple wasted strips, or multiple finger sticks to obtain a sample as well as time taken conducting a wasted test, In Figure 2, an example test sensor package 100 (here a test device comprising a single test strip IS 20) is shown. Here test strip 20 has a proximal portion 12, an intermediate tip portion 14 within which is located a test area 27 and a separable distal portion 16', which is completely detachable from the remainder of the test strip. The intermediate portion and separable distal portion may be frangibly held together along cuts or lines of weakness 36 or may be completely separate and held together by anchor cover leaf 24 and/or removable cover leaf 22, Upper anchor cover leaf 24 overlays a first major surface 28 and in this embodiment extends beyond the periphery of test strip 20 (from the long edges) to form lateral portions I 24A, I 24B that may be gripped by a user or othenvise held by an anchor mechanism during use. Lower removable cover leaf 22 comprises a non-removable distal portion 34A overlying major surface 29 of separable distal portion 16', removable portion 32 overlying test strip area 27 and a non-removable portion 34B overlying the remainder of intermediate test portion 14 and optionally also overlaying proximal portion 12. A force transmitting connection member between separable distal portion 16' and the interniediate portion 14 is provided by part of removable cover leaf 22, Upper anchor cover leaf 24 extends over at least the intermediate portion 14 and at least part of the (here rectangular) separable distal portion 16' so as to provide a seal about a test area 27 comprising test component (seal and test component not shown) and may extend over proximal portion 12. The intermediate portion 14 is the same width as proximal portion 12 to which it is attached and as separable distal portion 16' to which it is not attached directly or only frangibly attached. This enables separable distal portion 16' to be moved without moving (at least initially) intermediate portion 14, F -.

The lower major surface 29 of the test strip 20 is overlaid by a second removable cover leaf 22 having a centrally located removable portion 32 overlaying test area 27, a non-removable portion 34A overlaying the separable distal portion 16' of the test strip and a further non-removable portion 34B overlaying the proximal portion of the test strip and overlaying the intermediate tip portion 14 either side of test area 27. The removable portion 32 is connected to the non-removable portion 34B which is fixedly attachcd to the proximal portion 12 by a hinge portion 30. I Sower removable portion 32. non-removable portion 34A and separable distal portion 16 are rotatable, in usc, about a hinge portion 30' in second cover leaf 22. Typically hinge portion 30' is formed by a line of weakness (such a score or partial cut or other hinge mechanism) in the second cover leaf 22. The removable portion 32 of the second cover leaf is configured to act as a force transmitting member between the separable distal portion 16 and the remainder of the test strip 20, so hinge 30' should be configured to be sufficiently robust to do so.

Figure 3 shows a similar embodiment to that seen in Figure 2 save that in this case lower removable cover leaf 22 comprises a removable portion 32 which extends to the periphery of the IS test strip from one edge (here a long edge) to another, and also extends between a hinge portion 30'' and a cut or line of weakness 36 between intermediate portion 14 and separable distal portion 16', Thus, separable distal portion 16 is completely detachable from direct connection to the remainder of test strip 20 but remains attached to it indirectly via removable cover portion 32. Removable cover portion 32 acts as a force transmitting connection member between the separable distal portion 16' and the proximal portion 12 and intermediate portion 14 so that upon continued rotation in the direction of arrow E, and/or applying a force in the direction F. a user can detach the remainder of test strip 20 comprising proximal portion 12 and intermediate portion 14 from a major surface of anchor cover leaf 24.

In respect of Figures 1, 2 and 3. anchor cover leaf 24 may overlay at least around % of the upper major surface 28 of test strip 20. In these and other embodiments, hinge portions 30, 30', 30" may simply be bendable portions of a lower removable cover leaf 22 and/or test strip 20 (between and/or part of proximal portion 12 and/or separable distal portion 16) ora hinge mechanism may be provided in one or more ofthese layers. Lower portions e.g. 32, 34A, 34B of second cover leaf may be frangibly connected te one another at lines of weakness (e.g. by kiss cutting). Thus lower cover leaf 22 may be initially intact providing a seal over at least part or substantially all of the lower major surfaces 29 of test strip 20 and at least over the test area 27.

The anchor cover leaf 24 is selectively sealed in regions on upper surface 28 in a numner so that at least an inwardly located test area 27 on intermediate portion 14 is surrounded by a seal between the anchor cover leaf 24 and the test strip 20. Optionally, the region of the anchor cover 1' leaf 24 directly opposite test area 27 is completely or substantially free of the adhesive forming the seal for the test area 27 so that when the separable distal portion is removed from anchor cover leaf, the test area 27 is not pertlLrbed. Thus, the test area 27 is at less risk from blockages (e.g. of air vents) by such adhesive forming the seal, However, as will be described later, optionally, the test area 27 or adjacent portions of the intermediate portion may be provided with a selectively profiled temporary heat seal or adhesive region (preferably avoiding any air vents or sample inlets on the surface) to secure the intermediate portion to the anchor cover leaf until sufficient force is exerted via force transmitting connection member, to lift it from the anchor cover leaf. This is particularly useful when intermediate portion 14 is narrower than the separable distal portion arid the separable distal portion forms around one or both sides of the intermediate portion 14 as shown in Figure 1, In the embodiment in Figures 2 and 3. intermediate portion 14 is generally rectangular and test area 27 is generally rectangular and located inside intermediate portion 14 (although sharing a common edge at cuts or lines of weakness 36 with separable distal portion 16). A generally IS rectangular seal slightly bigger than the test area 27 is provided forming a continuous seal about the test area 27 overlaying intermediate portion 14 (in part) and separable distal portion 16 (in part). In this example the continuous seal is made up of preferably a temporary (e.g. peelable) seal extending along the side portions of (here rnctangular) intermediate portion 14 and across the separable distal portion 16 therebetween (from long edge to long edge) so that at least the test area 27 on the intermediate tip portion is sealed from above by the anchor cover leaf 24. It may be that the seal extends over (and slightly into) the narrow gap 36 between intermediate tip portion 14 and separable distal portion 16'.

Similarly, in Figures ito 3, a selectively profiled adhesive layer or seal may be provided for lower removable cover leaf 22 having regions that are selectively adhered to lower major surface 29 (for example to separable distal portion 16', and the proximal portion 12) and about test area 27 on intermediate portion 14 but not adhered to any appreciable extent (physically or chemically) to test area 27, The lower profiled adhesive layer may extend over the gap in the region of cut 36 (as described above) between intermediate portion 14 and separable distal portion 1 6, 1 6'.

In use. in this and other embodiments anchor cover leaf 24 may be fixedly held by some mechanism e.g. an anchor mechanism (for use with a clamp and/or screw and/or nail) and/or adhesive holding anchor cover leaf 24 in position. Indeed, it will be understood by those skilled in the art that anchor cover leaf 24 may also be gripped fixedly (altholLgh temporarily) by a user in one hand. I, "

In Figures 2 and 3. in use, the user grips a separable distal portion 16' and rotates this about hinge 30' in a direction generally away from anchor cover leaf 24. In step 2, continued rotation by applying a force e.g. in direction arrow F separates separable distal portion 16' completely from the remainder of the test strip (comprising proximal portion 12 and intermediate portion 14). Continued rotation about hinge 30' in the direction of arrow F will result in some component of force being applied in the direction F, as shown in step 3, along force transmitting connection member (here provided by lower cover leaf removable portion 32). Itwill be understood by those skilled in the art that as it is intended that force is transmitted via removable portion 32 of lower cover leaf 22, that the lower cover leaf is sufficiently süong to transmit the force to the remainder of test strip 20 to remove it from anchor cover leaf 24 in the direction of arrow F. As can be seen in step 3. once separable distal portion 16' is moved with respect to the remainder of the test strip and the remainder of the test strip is detached from upper anchor cover leaf 24, sample inlet 42 (and any associated test strip components such as air vents located on the upper major surfhce in this Figure) are now available for use. The separable distal portion 16' IS can be used as a handle to facilitate conducting a test.

Thus, embodiments of the invention can be envisaged in which separable distal portion 16 may be joined to intermediate portion 14 and/or proximal portion 12 of tcst strip 20 indirectly via a removable portion of a cover leaf; rather than being directly connected via portions of the test strip (e.g. via the side arm(s) 216 acting as force transmitting connection member(s) between the handle portion 116 and the proximal and intermediate portions 12, 14, seen in Figure 1). In both configurations. separable distal portion 16 remains connected to the rest of the test strip and facilitates removal of the test strip from the anchor cover leaf.

Figures 4 to 9 show example embodiments to illustrate the invention and describe, by way of example only, a single use blood glucose test strip that eleetroehemically determines analyte presence or concentration in blood. The invention is however applicable to other types of test sensors, test strips and tests as would be well understood by those skilled in the art.

Referring to Figures 4 and 5, each test strip 20 comprises a base substrate with printed layers 60 comprising a base substrate 50 on an upper major surface of which is disposed a conductive layer 52 comprising carbon tracks 54 forming carbon pads 56 and electrical contacts 18. Tn certain embodiments, a second conductive layer 52' is provided comprising silver tracks 58 overlying part of carbon tracks 54, Next, an insulating layer 62is overlaid the conductive layer(s) 52, 52', leaving an insulation window 64 to define the width of the carbon pads 56 within the test area. Next a shaped adhesive layer 66; and an appropriately shaped reagent pad 68 carn'ing reagent mixture are located over insulation layer 62 and insulation window 64, Thus 1' --measurement electrodes (not shown) are formed by carbon pads 56 overlaid with reagent pad 68 via insulation window 64, Thus a base substrate with printed layers 60 is formed (see Figure 6).

A furthest most end of substrate 50 may form a handle portion 11 6A. 116 and may be extended in one or more directions and/or othenvise adapted (e.g. with a gripping portion and/or surface formations) to facilitate gripping by a user, Referring now to Figures 6 and 7. the now formed base substrate with printed layers 60 and a spacer layer 70 and a hydrophilic layer 80 are laminated together to provide test strip 20, Hydrophilic layer 80 may also be known as an anti-fog layer or lid forming a roof of a sample chamber 44 in spacer layer 70. These may be formed as a single layer. Each of the layers comprise corresponding features e.g. intermediate portion 14 (14A. 14B. 14C). separable distal portion 16 (16A. l6B, 16C), hinge portions 30 (30A, 30B, 30C), handle portions 116 (316A, 31 6B. 316C). periphery 74 (74A, 74B, 74C) so that these layers can be laminated together.

Alternatively, lamination occurs first then these features are delineated by cutting or kiss cutting and other methods known to those skilled in the art. Exposed contacts 18 are located on a IS proximal portion 12 of test strip 20. An interniediate portion 14 comprising test strip components (for example measurement electrodes, sample inlet port 42, sample chamber 44 and air vent 46) in a test area is provided. Typically, the test area comprises the measurement electrodes (here carbon pads 56 overlaid with reagent (such as a printed reagent layer or reagent pad 68)) located on a lower floor of the sample chamber 44, a sample inlet port 42 at a distal end of the sample chamber and an air vent 46 being at a proximal end of the sample chamber.

In an example embodiment, test strip 20 may have connecting junctions (not shown) (e.g. frangible portions of substrate 50 and/or cover leaves 22 and 24 in Figure 1) on its perimeter 74 connecting test strip 20 to its neighbours. Alternatively, or in addition, as shown later anchor cover leaf extends laterally e.g. from the start of long edges of test strip 20 and one or more further test strips 20 are provided on the same anchor cover leaf as will be described later.

The size and/or shape of the outer periphery of the intermediate tip portion 14 corresponds to the size and/or shape of the inner periphery of the separable distal portion 16 (here U-shaped bendable frame 16) preferably so that these almost abut one another. Indeed, preferably the intermediate tip portion 14 and separable distal portion 16 (and also preferably the proximal portion 12) of the test strip 20 are formed from the same integral substrate 50 with, for example having cuts 36 andlor hinge portions 30 formed in the substrate 50 as appropriate, to define the different portions.

Referring now to Figures 8 and 9 a test sensor package 100 is shown having a releasable attachment member for releasably attaching at least part of a major surface ofthe test strip to at 1' least part of a major surface of an anchor cover leaf in this example in the form of a profiled upper seal layer 48, Profiled upper seal layer 48is shown bonding anchor cover leaf 24 (here an upper cover leaf) to a first major surfhce 28 of test strip 20. (In fact in use it would be more usual for the anchor cover leaf 24 to be located lowerniost and a user to pull a test strip upwardly to detach it from the anchor cover leaf as will be described later). The upper profiled seal layer 48 is shaped preferably to completely surround the intermediate tip portion 14 optionally without scaling to inteniiediate tip portion 14 to any appreciable extent, although as will he seen later an inner seal to intermediate tip portion 14 may bc preferred in certain embodiments. Nevertheless, the upper profiled seal may seal upper anchor cover leaf 24 partially within the perimeter of the intermediate tip portion 14 (e.g. across cuts 36) as described elsewhere herein. A generally, rectangular shaped portion of the profiled seal (here a distal seam 38 of an adhesive layer) joins the anchor cover leaf 24 to a corresponding portion of the upper major surface 28 of separable distal portion 16 of test strip 20. The anchor cover leaf 24 is sealed at least in part to at least part of the remainder of the bendable frame (removal distal portion 16), and indeed in this example IS embodiment to at least part of the proximal portion 12, in such a way that the test area 27 is surrounded and the test strip can be removed from the anchor cover leaf 24 by a user e.g.by peeling off. Upper anchor cover leaf 24 may for example be removably sealed to upper surface 28 by provision of upper seal 48 as a peelable seal and/or peelable adhesive and/or peelable weld (e.g. a thenual weld). The seal may be an adhesive seal (formed from an adhesive layer) or a weld (e.g. thermoplastic weld) or other join as known to those to skilled in the art. Distal portion 38 of the upper profiled seal 48 may have a bevelled or pointed periphery to facilitate the start of a peeling action.

A lower profiled seal 49 bonds a lower (for example a second) removable cover leaf 22 to the test strip 20 in manner so that the seal 49 does not seal the removable cover leaf 22 to test strip 20 in the region of test area 27 or not to any appreciable extent. The lower profiled seal 49 may be shaped to avoid test area 27 to achieve this andlor may have lower quality sealing properties in the region of test area 27 (typically within intermediate tip portion 14). The seal 49 preferably seals the lower removable cover leaf 22 to the rest of the lower surface of the test strip 20 and in particular to the separable distal portion 16 and preferably the proximal portion 12) so as to surround at least the test area 27 of the intermediate tip portion 14. This may be a permanent seal for example a permanent weld or other pernunent joint.

Having had upper and lower cover leaves 24 and 22 mounted thereon via respective seals 48 and 49 (which may be provided by separate adhesive layers and/or regions of thermal or chemical sealing), a test sensor package (here a test device 100), comprising a now sealed test strip 20 is provided as shown in Figure 9. The upper anchor cover leaf 24 and/or the lower removable cover leaf 22 are moisture barriers and/or moisturn adsorbing laminate andlor opaque. One, or preferably both, removable cover leaves comprise a desiccant e.g. in a layer of desiccant loaded plastic.

Whilst the upper and lower cover leaves 24 and 22 cover, surround and improves protection of the intermediate tip portion 14 from exposure to moisture in the atmosphere via major surfaces 28 and 29 of test strip 20, the edges ofthe test strip 20 about its perimeter 74 are not covered.

Thus, moisture may be absorbed into the test strip viathis exposed perimeter. The inventors have appreciated that this is a limited route for introduction of moisture into the strip and such moisture introduction may be offset by use of one or more cover leaves having moisture adsorbing properties and/or a supplementary carrying pouch which may have moisture adsorbing properties and/or other measures, Indeed, sealing across and partially within cuts 36 via one or both major surfaces may further impede moisture ingress by providing partially sealing ofthe side wall forming the periphew of intermediate tip portion 14 (having the test components).

Anchor cover leaf 24 typically comprises one or more lateral extending regions 24A, 24B IS extending beyond the periphery of the test strip to enable these to be anchored e.g. by a user grasping hold of one or more of these lateral portions with one hand and with the other hand the test strip e.g. in the region of handle portion 116, to separate these, Altcmatively, lateral portions 24A, 24B i'nay be fixedly attached to a holder or case as will be described later. Thus, lateral portions 24A, 24B form an anchor member for anchoring the anchor cover leaf in position, Alternatively, or in addition, a further anchor member may be provided in the fonn of attachment member 24C on an exposed (here uppermost) major surfhce of anchor cover leaf 24. Anchor member 24C may comprise strong Velcro or an adhesive layer or similar attachment means to hold anchor cover leaf in position in a holder or case over a reasonably large portion of the area of the exposed (here uppermost) major surface of cover leaf 24 in the region of test strip 20, Whern anchor member 24C is adhesive typically, the adhesive is relatively strong eompaitd to the selectively profiled seal 48 (or adhesive fonning it) connecting test strip 20 to an opposing (here lowermost) major surface of anchor cover leaf 24, The following describes how to manufacture a test sensor, and how to manufacture a test sensor package. It will be understood that the steps may be adapted or left out or different steps added for different kinds of test sensors, It will further be understood that the steps may be performed in a different order from that described for diffemnt kinds of sensors, Referring to Figures 5. 6, 7 and iDA to 101, various steps in a method of manufacturing are shown. In Figure bA. a printed substrate with layers 60 is fomwd from a first sheet-like insulating substrate material in aweb of suitable width and length (forniing base substrate 50). A 1' first series of carbon tracks 54 forming a first conductive layer 52 is disposed 011 a first major surface of base substratc 50 (Figure iDA). At one end conductive tracks 54 form carbon pads 56 which form part of the measlLrement electrodes. Optionally, a second series of conductive tracks (silver tracks 58) fonri a second conductive layer 52' disposed on and substantially covering part S of carbon tracks 54 (Figure iDA) A first portion of carbon tracks 54 not covered by silver tracks 58 form the carbon pads 56 in a working area of the test strip 60. A second portion of the carbon tracks 54 not covered by the silver tracks 58 form the electrical contacts 18 that communicate with an extcrnal metering device.

In Figure lOB, an electrically insulating layer 62, formed of e.g. dielectric material, is disposed on first (here upper) major surface of the base substrate 50 and substantially covers the carbon/silver tracks 54, 58, A first portion of the carbon tracks 54 defined by insulation window 64 is not covered with insulating layer 62 completing the definition of the test strip working area.

The contacts 18 are not covered with insulating layer 62. In Figure lOc, an optional adhesive layer 66 is disposed on and partially covers the insulating layer 62 and substantially surrounds IS the working area of the test strip 60 (Figure 1 OC). Adhesive layer 66 is U-shaped or otherwise shaped to avoid blocking access to the working area within insulation window 64. A reagent layer 68 disposed on the adhesive layer 66 and substantially covers the working area within insulation window 64 (see Figure lOG). This may be deposited before or after singulation into individual test strip portions in Figure 1OD and after scaling with a removable cover leaf 122 (sec Figure lOB). The completed siLbstratc with printed layers 60 is seen in Figures 5 and 6.

In Figure 1OD, a first series of cuts 136 are made through the thickness of the printed base substrate 60 defining the perimeter of the test strip 20. A series ofju.nctions (not shown) of base substrate 50 may not be cut so that each printed base substrate 60 remains connected to its neighbour. A second series of cuts 36A (optionally formed at the same time as cuts 136) through the thickness of the base siLbstratc, bitt within the substrate perimeter 74 partially siLrrounds the carbon pads 56 in the working area to define the base substrate portion I I 4A of a sample application tip (intermediate tip portion 14) and the base substrate portion II 6A of a bendable frame (separable distal portion 16) substantially surrounding the intermediate tip portion 14, First and second series of cuts 136. 36A may be formed simultaneously or one preceding another (Figure 1OD). Lines of weakness 30A (not shown) may be provided before, at the same time or later in base substrate 50 to provide hinge portions between the laterally spaced side arms of the bendable frame (separable distal portion 16A) and the proximal portion 12A bearing contacts 18.

Cuts 136, 36A may be made before or after printing on base substrate 50 to form printed base substrate 60 with printed layers, or part way through printing all layers or after a completed test 1' sensor has been formed from printed substrate 60, and chamber layers 70. 80 or after a cover leaf is provided on one major surface.

At the same time or separately, a second sheet-like insulating material e.g. of about 50mm wide by e.g. several cm or metres even up to about 1 kilometre in length by e.g. 0.100mm thick, is S provided to form a spacer layer 70, 170 (see Figures 6 and lOB) and/or a hydrophilic layer 80, 180, Optionally, a hydrophilic layer/lid layer 80, 180 is laminatedto spacer layer 70, 170 or integrally formed to provide a laminated chamber layer 200 before the following series of cuts are made, Thus, as shown in Figure 1OH, a laminated chamber layer 200 may be provided having cuts defining the sample chamber pre-formed in spacer layer 170, before cuts 336 delineating between test strips, or cuts 36B defining intermediate, distal and proximal portion, are made.

Alternatively, the two orthree or more, or all layers (printed substrate 60, 160, spacer layer 70, 170, hydrophilic layer orlid 80. 180) maybe laminated before strip singulation cuts 336, or intermediate portion cuts 36 are made, Thus the following steps may apply to hydrophilic layer/lid layer 80, 180, a laminated chamber IS layer 200 or to a completed test sensor 20 or card of test sensors 120, but will be described in reference to a spacer layer. Spacer layer 70,170 may be cut (or pre-cut) to have a first series of cuts 336 through the thickness of the spacer layer 70, 170 separating the outline of the spacer layer precursor for one test strip from its neighbour (and forming perimeter 74B) mid defining a series of inter-connecting junctions 72B so that each spacer layer precursor remains connected to its neighbour. Hem spacer layer 70, 170 is cut to provide a spacer layer handle portion 1 16B. for overlaying handle portion 1 16A of substrate 50.

A second series of cuts 36B through the spacer layer within perimeter 74B defines the spacer portion of a sample application tip (intermediate portion I 4B) and the spacer portion of a bendable frame (removal distal portion 16B) substantially surrounding the intermediate tip portion 14B.

A third series of cuts through the spacer layer within the perimeter 74B of the intenuediate tip portion 14B creates a hole or void defining the spacer portion of a sample chamber 44. Sample chamber 44 may be pre-fonned in the spacer layer rather thaii being cut on the fly. The three series of cuts may be formed simultaneously, or one after the other, A hydrophilic layer 80, 180 is also known as an anti-fog layer. The hydrophilic layer 80, 180 comprises a hydrophilic coating (not shown) disposed on a major surface of hydrophilic layer 80, facing the test area 27 defined by sample chamber 44 and insulation window 64, The hydrophilic layer 80, 180 may also comprise an adhesive or heat activated binding polymer coating disposed on a second major surfhce (facing outwards). This may form a selectively -. ,. --profiled seal which functions as a releasable attachment member to an anchor cover leaf 24. A third sheet forming hydrophilie layer 80, 180 is preferably cut at the same time as spacer layer 170, but may be pre-cut and then laminated. A third series of cuts may be made through the antifog layer to create a hole or void within the perimeter of the tip defining the sample chamber air vent 46, Air vent 46 may be pre-formed in hydrophilic layer 80. Indeed, first, second and third series of cuts may be pre-formed in base substrate 50, spacer layer 70, 170 and/or liydrophilic layer 80, 180 rather than being cut on the fly.

The outer facing major surface of the spacer layer 70 is formed or bonded (for example with the adhesive) to the inner facing major surface of the hydrophilic layer 80 in register such that: the rectangular cut-out or void of the spacer layer defines the width of the sample chamber 44; the air vent 46 on the hydrophilic layer 80 lies at one end ofthe sample chamber 44 (typically the proximal end); the outer perimeters 74B. 74C of the spacer layer 70 and hydrophilic layer 80 are in register when these are formed or laminated. Any junctions on the spacer layer 70 and hydrophilie layer 80 are of the sante geometry so that these are also in register, and the spacer IS layer and hydrophilic layertip portions 14B and l4C are similarly sized and shaped so that these also match and are in register.

At some point, the upper major surface 28 of the printed base substrate 60 is bonded to and is substantially covered by the spacer layer/hydrophilic layer laminate to fonn a test strip 20, These are of substantially the same size and are in register so that: the contacts 18 are not covered; the sample chamber 44 is fully defined; the perimeter 74A on the base substrate with printed layers 60, that defines the test strip width, matches the perimeter 74B. 74C of the spacer/hydrophilie laminate; the geometry of the intermediate tip portion 14A on the printed base substrate 60 matches the geometry of the intermediate tip portion 14B. 14C on the laminate and the bendable frame 16 that surrounds the intermediate tip portion 14 is filly defined from portions 16A, 16B and 16C.

Referring now to Figttres 8. 9 and 101, a fourth sheet-like moisture barrier material of e.g. about 50mm wide by e.g. several cm or metres even up to 1 kilometre in length by e.g. 0.150mm thick, is provided to fom anchor cover leaf 24, 124 covering one or preferably several test strips 20, Typically. this is a multi-laminate material with moisture barrier properties and/or moisture adsorption properties. Optionally, anchor cover leaf 24. 124 is a laminate such as a triple layered laminate and may comprise a durable plastic as an outside facing layer, a thermo-fomiable material that may have a desiccant material as part of its structure as an inside facing layer (facing inward towards test strip 20) and a high moisture barrier film between the outside and the inside facing layers. Preferably, the inside facing surface of the anchor cover leaf 24, 124 is 1' laminated to a first major surface 28 of the test strip 20 (here a first major surface of a laminated chamber layer 200) so that the inside facing layer of the anchor cover leaf 24. 124 comes into contact with major surface 28 of the test strip bearing a test strip component. Here, this forms a sealed laminated chamber layer 202, Alternatively, anchor cover leaf 24, 124 may be used on a S second major surface of a test strip 20 (or a test strip with no test strip components on the surface). Furthermore. preferably the anchor cover leaf 24, 124 opfionally completely covers at least thc test area and preferably also extends over part or all of the intermediate portion 14 and the separable distal portion 16 of the first major surface 28 of the test strip.

One or more separate adhesive layer and/or a profiled heat seal may hold test strips 20 in place on anchor cover leaf 24, 124. Thus, a next step may include applying an adhesive and/or a profiled heat seal so that: an area of the anchorcover leaf 24, 124 is selectively sealed to an area of the test strip 20 by profiled seal member 48 (a releasable attachment member) such that the bendable frame (separable distal portion 16) is substantially scaled to the anchor cover leaf 24, 124 at seal 148A; the intermediate tip portion 14 is partially scaled to the top cover at inner IS seal/adhesive region l48B and is completely surrounded by seal 148A; and the properties of the seal region 48 (1 48A, I 48B) is designed to facilitate peeling of the anchor cover leaf 24, 124 away from the test strip 20, In Figure IOF, a fifth sheet-like moisture barrier material of about 50mm wide by e.g. several cm or metres even up to 1 kilometre in length by e.g 0.150mm thick is provided to form bottom cover with singulation cuts 222 (lower removable cover leaf 22). Typically, this is a multi-laminate material with moisture barrier properties and/or moisture adsorption properties and structure as described above in connection with the anchor cover leaf 24. Thus, an inside facing surface of the lower removable cover leaf 222 is laminated to a second major surface 29 of test strips 20 so that the inside facing layer comes into contact with lower major surface 29 of the test strip 20, preferably completely covering it.

In the same way as seal region 48, a next step may be applying a heat seal and/or adhesive so that a profiled seal member 49 (a releasable attachment member) selectively seals lower cover leaf 122 to an area of the test strip 20 on its rear major surface so that: the bendable frame (separable distal portion 16) is substantially sealed to the lower removable cover leaf 22; the intermediate tip portion 14 is not sealed (or not sealed to any appreciable extent) to the removable cover leaf 22 (in the region of removable portion 32), and the intermediate tip portion is completely surrounded by a seal. Thus, a sealed printed substrate 204 is fonued.

Figure 11 shows exploded, perspcctive and plan views of test sensor package 110. The figure shows a sealed chamber layer 202 comprising chamber layer 200 and an upper continuous 1' anchor cover leaf 124 ready to be laminated to a sealed base substrate 204 comprising printed base substrate 160 and lower removable cover leaf 122 to from test sensor package 110, It will be appreciated by those skilled in the art that the steps described in relation to Figures IOA to ID! and II may take p'ace iii various different orders, to create bespoke manufacturing S processes that suit available equipment.

Figure 12 shows a series of steps in a method of manufacture according or a thither example embodiment of the invention. Here in step I. a substrate with printed ayers 160 in card fomiat (having a plurality of printed layers) for forming a plurality of test strips 120 in a card format, is provided as known to those skilled in the art andlor described elsewhere herein. An insulation layer 62 covers a carbon layer leaving conductive tracks 18 and conductive pads 56 exposed. A reagent ayer (here a screen printed reagent layer 68 but optionally a reagent impregnated membrane or fdm or the like) is applied to fonri test components. In step 2, a chamber layer 200, which is wpically provided by a laminate of a spacer layer and a hydrophilic layer as is known to those skilled in the art bitt may be foimed as an integral component, is overlaid on base siLbstrate IS card 160 so that for each individual test strip a sample chamber 44 is in register with and overlays test components formed by conductive pads overlaid by reagent 68 to fonu a card of test strips 120.

In step 3, cuts 436 through the combined chamber ayer 200 and through the base substrate card are made to delineate between test strips 120, As can be seen in Figure 13, in step 3A, frangible connection 105 between the singulatcd strips and the surrounding substrate may be left upon fonning cuts 436 so that the card containing test strips 120 remains an integral component and can be handled more easily. Also, as can be seen in Figure 13, the cuts 436 can be divided into an outer perimeter cut 636 delineating between test strips and an inner perimeter U-shaped cut 536 defining the intermediate tip portion 14 and separating this from separable distal portion 16. Following inner cut 536, the newly formed intermediate tip portion 14 remains attached to proximal portion 12, and in this embodiment the newly formed distal portion 16 also remains attached to proximal portion 12. It will be understood by those skilled in the art that inner perimeter cut 536 may be made at the same time or separately from outer perimeter cut 636 (before or after), In certain embodiments, it is important that inner perimeter cut 536 intersects with sample chamber 44 to provide a sample inlet and one way to achieve this is for sample chamber 44 to extend slightly into the separabk distal portion 16 to facilitate easier registration during manufacture. This is to ensure that when intermediate tip portion 14 is exposed by bending separable distal portion 16 out of the plane and with respect to the remainder of the test strip, a sample chamber opening 42 is provided and formed correcfly. 1'

Turning back to Figure 12, in step 4, a selectively profiled adhesive layer which funchons to releasably attach test strips 120 to anchor cover leaf 124 is provided on one or both of test strips and anchor cover leaf 124. An adhesive profile 148 which may be used in such a layer is shown in Figure lOT, This adhesive layer profile 148 finds particular utility when the anchor cover leaf is overlaid on a first major surface or a test strip and a U-shaped separable distal portion lôis provided. This is because, as shown in Figure 101, adhesive profile 148 has an inner tip adhesive region 148B (hem a single round nodule) which helps interniediate tip portion 14 resist bending away from anchor cover leaf 24, 124 at least initially, If the anchor cover leaf overlays a second major surface having no test component, the adhesive profile 149 in Figure I OF may be used. In either case the interniediate tip portion 14 may be relatively rigid and/or rigidly mounted on orto or integrally formed with a proximal portion 12 to resist bending. Next, the anchor cover leaf 124 is attached to test strips 120 so that handle portions 116 of test strips (and contacts 18 where required) remain exposed beyond an edge of anchor cover leaf 124, Anchor cover leaf 124 is provided with one or more (here two) anchor members in the form of IS bracket regions 192 with apertures 193 for engaging with one or more upstanding spigots in a holder or case for a test sensor package. It will be appreciated that preferably multiple test strips are provided on a single anchor cover leaf 124. Cover leaf 124 acts as a web to hold these together in fixed relation, preferably, side by side with one another.

In step 5, a second cover leaf 122 is provided on the opposing major surface 29 of the card of test strips 120. As has been described elsewhere, the back cover may be adhered to the test strips using a selectively profiled sealing adhesive layer (not shown) as described elsewhere (e.g. 149 in Figure bE). Step 4 may occur before Step S or vice versa. Heat seal and/or adhesive profiles (148, 149) in steps 4A and 5A (see Figure 5, 16 and 17) may be applied to the card of test strips and/or to the cover leaves (124, 122) e.g. as speared layers and/or as heat sealing treatment before these are laminated together.

In step 6 (not shown), a kiss cut i'nay be perfonned to cut through the rear cover leaf 122 and the laminated test strips 120 singulating these but not the anchor cover leaf 124, The outer perimeter cut 636 (see in Figure 13) if present can be completed to break junctions lOS at the same time or before or after such a kiss cut, Thus, the anchor cover leaf 124 ftmctions as a ribbon holding the now singulated test strips in place. In a preferred embodiment, the removable cover leaf 22, 122 can be constructed or processed slLch that the robust outer material of the multi-laminate thin film forming the cover leaf is cut but not the middle moisture barrier (e.g. aluminium layer) and/or not the inner facing tie-in layer (e.g. thennoplastic layer) although the inner facing thermoplastic layer may also be cut, Thus the cover leaf 22, 122 is provided with lines of weakness to facilitate singulation of test strips and/or it breaking into two sections (a first section 1' " --comprising a removable portion 32 and non-removable portion 34A and a second section comprising non-removable portion 34B). The moisture barrier properties of the cover leaf 22.

122 are not affected because die moisture bather layer of, for example, metal foil such as aluminium is not cut. This method of cutting material is known as kiss cutting.

The anchor cover leaf 24, 124 can be, for example, a multi-laminate thin film material whereby a moisture barrier layer such as aluminium is sandwiched between a robust outer layer of plastic exposed to the outside environment and an internal tie layer such as adhesive or thermoplastic that binds to the lid or base major surfaces of the test strip.

Figure 14 shows a completed singulated test strip without cover leaves for clarity. Figure 15 shows a partially open completed test strip having been removed from the anchor cover leaf. A removable portion 32 of a lower removable cover leaf can be seen to the rear of intermediate tip portion 14, Figure 16 and Figure 17 show the detail of selectively profiled regions of adhesive on the first major surface 28 and second major surface 29 respectively of an individual test strip 20.

Profiled seal 48 on the first major surfhcc comprises an outer seal zone 148C arranged to IS surround test area 27 at least and, in this particular example also surrounds intermediate tip portion 14. An inner seal zone (e.g. an inner adhesive region) 148B is provided. optionally provided as part of profiled seal 48 and laid down at the same time, spaced apart from test aita 27 and in this example located on the proximal side of test area 27, Inner seal zone 148B may comprise one or more nodules (e.g. 2 or 3 nodules) of adhesive preferably clear of any components e.g. inlets/vent on the surfhcc. Inner seal zone 148B releasably attaches die intennediate (tip) portion 14 to the anchor cover leaf It may be any suitable shape and is preferably located to one side e.g. a proximal side of a test area 27. Other shapes of inner seal zone 148B may be used, e.g. square, rectangular several nodules of adhesive, e.g. in a row from the test area towards the proximal portion. The purpose of inner seal zone 148B is to assist in retaining intermediate tip portion 14 attached to anchor cover leaf 24 124 during the initial stages of rotation of separable distal portion 16 away from anchor cover leaf 24, 124. On the second major surface 29, a seal zone 149 is arranged to seal at least test area 27 and, in this particular embodiment also intermediate tip portion 14, by surrounding these with adhesive which ftmnctions as a seal, Thus, at least test area 27, and preferably also intermediate tip portion 14, are sealed between moisture barrier cover leaves 24, 124 and 22, 122 on respective first and second major surfaces.

Figures 18. 19A and 19B show a test sensor package 110 comprising a pack of (e.g. ten) test strips 120 from the rear, with singulated test strips 20 in card format bearing singLLlated front cover leaves 122 mounted on an anchor cover leaf 124 in web forniat (which is to the rear in the 1' --Figure). A holder 300 comprises a holder base 302, a holder door 304 and a hinge there between.

It will be appreciated by those skilled in the art that holder base 302 and holder door 304 may be provided as sepante components without a hinge bitt may be clamped or otherwise attached together in a removable manner to allow insertion of a test sensor package 120, 220, An elongate anchor cover leaf 124 is provided with bracket regions 192 at either end with four apertures 193 for locating on raised pins 195 of a holder base 302. it will be appreciated that the raised pins and apertures 194 are handed so that the pack often strips 220 can only he inserted in a particular way, in this casc with anchor cover leaf 124 located immediately adjacent the inwardly facing surfhce of the holder base 302. The brackets 192, apertures 193 and raised pins 194 cooperate with the holder base 302 and holder door 304 to anchor cover leaf 124 (and so anchor test sensor package 110) in position in holder 300. Holder door 304 comprises a window 306 sized and shapcd to correspond to the outer periphery of the test sensor package 110 such that at least handlc portions 116 and, preferably also intermediate portions 14, arc exposed. Typically, as can be seen in Figures 19A and 19B, the entire outline of the singulated test strips is visible I 5 through window 306, Referring now to Figures 20A and 20B. a further example holder 300 is shown having opening and closing handles 3 12A and 31 2B for facilitating opening of holder 300 and insertion and replacement of test sensor packages 110. Holder 300 here comprises one or more pins 310 extending across the front of the test strips for further anchoring the test sensor package 110 in position. In particular, pins 310 extend in the plane of window 306 and in line with singulauon lines between test strips 20 to assist in resisting movement of a neighbouring test strip 20 from the test holder when a first test strip is being removed. Figure 20B shows a holder 300 with a rear window 308 in which contacts 18 may oprionally be viewed or contacted (e.g. for manufacturing or pre use tests).

Figures 2 1A and 2 lB show a test strip 20 after having been removcd from a test sensor packagc ID, 100, 110 mounted in a holder 300. Regions of selectively profiled adhesive I 48A and I 48B can be seen on anchor cover leaf 124 (here to the rear of test sensor package 10, 100, 110). Tn use, a user grasps holder 300 (or test sensor package 10, 100, I 10) in one hand and a hasidIc portion 116 of a test sensor 20 in the other and pulls the separable distal portion 16 by the handle portion 116 away from, the now anchored, anchor cover leaf 24, 124, Where provided additional pins, optionally extending along (here alternate) singulation cuts between test snips 20, also assist in anchoring the remaining test sensor package 10, 100,110 in position, as a user removes a single test sensor 20 from it. The handle portion 116 may be sized and/or shaped so as to aid distinction between test strips to a user, Here handle portions are rounded (see Figure 21A) or I. * --square but narrower than individual strips (see Figure 2 1B). Other shapes and or sizes can be used.

In Figures 21A and 21W the test sensor 20 is shown having been removed from an anchor cover leaf and opened' so that holding now bent back bendable frame (separable distal portion 16), the proximal portion 12 of test strip 20 can be inserted into an external metering device 400, In use, a user pufls the handle portion 116 and, initially at least, the separable distal portion rotates out of the plane of the remainder of the test strip whilst grasping the holder with the other hand, As the intermediate tip portion 14 is not connected to separable distal portion 16, it does not move as separable distal portion 16 is initially rotated. Indeed, the intermediate (tip) portion 14 is stiffly mounted to proximal portion 12 and/or is adhered to the anchor cover leaf by its own separate s&ectively profiled adhesive 148B, so it remains in position adjacent anchor cover eaf 24 (at least initially), Jfthe user does not have a secure grasp they can adjust their grip and hold the now larger handle formed by the entire separable distal portion 16. As the user continues pulling on the handle portion 116 or now separated separable distal portion 16, the remainder of IS the test strip (including the intermediate (tip) portion 14) separates (preferably peels away) from the anchor cover leaf 124.

Thus, this two stage process is assisted by: firstly, preferably intennediate (tip) portion 14 being detached, or easily detachaMe, from separable distal portion 16; secondly, preferably intermediate (tip) portion 14 being rigidly and/or relatively stiffly connected to the proximal portion 12. and/or relatively rigid and/or stiff; thirdly, preferably, intermediate tip portion 14 being independently releasably attached to anchor cover leaf 124 (independent from separable distal portion 16). Thus, the intermediate (tip) portion 14 and proximal portion 12 may be formed using reativey rigid and/or stiff substrate 50 so that intermediate (tip) portion 14 resists bending from any torque transmitted to it as separable distal portion 16 is first rotated away from the remainder of the test strip.

As separable distal portion 16 is pulled further away from the anchor cover leaf a force is exerted on the remaining regions of the test strip by the side arms of the separable distal portion 16 in Figure I (or by the removable cover leaf portion 32 attaching the separable distal portion to the remainder of the test strip 20 in Figures 2 and 3). Thus, the (one ormore) side arms of separab'e distal portion 16 (or removable cover leaf portion 32 where provided) act as force transmitting connection member(s), pulling the remainder of the test strip so as to cause it to delaminate (come away) from the anchor cover leaf 124. The intermediate tip portion is now exposed in respect of both major surfaces (in this embodiment). 1'

Further, in embodiments in which an L-shaped or U-shaped frame is provided as a separable distal portion, the narrower intermediate tip portion 14 stands proud from the now rotated separable distal portion exposing the test area and, in this embodiment, an end fill sample inlet 42. Referring back to Figures 21 A and 21 B, still grasping the handle portion 116, a now singulated test strip can be presented (contacts 18 end first) to a strip port connector 406 of a meter 400. A test can then be conducted (e.g. automatically or using conuol button 404) and result displayed on display 402. lndecd by providing test strips 20, 120 face down (first major surface) on anchor cover leaf 24, 124, then once a user has pulled and rotatcd a test strip, in this manner, the first major slLrface of any associated test components am visible and face up to a user, available for use.

In certain embodiments the present invention advantageously enables the sample inlet port 42 to be made accessible by the bending ofthe bendable frame 16 away from the tip and readily presented to a user. Thus, a fluid sample can now be easily presented to the sample inlet port 42 in the end wall of the intermediate tip portion 14. The fluid sample is drawn into the sample IS chamber 44 by capillaiy action with chamber gases being vented through the air vent 46, An assay is conducted on the fluid sample. V/hen the assay is complete, the test sensor 20 can be removed from the external metering dcvice by gripping the handle portion 116, and/or bendable frame (separable distal portion 16) and pulling the test sensor 20 out of the metering device 300, There is an option to bend the bendable frame (separable distal portion 16) back into its initial position in which it surrounds the intermediate tip portion 14 so that removable cover leaf 22 can be laid across a major surface of the device so as to some provide protection against touching any residual fluid sample adhered to exposed surfaces or the edges of the intermediate tip portion 14. The test sensor 20 is rcady for safe disposal.

Finally, atest sensorpackage 10, 100, 110 may comprise a row oftestdevices (e.g. 2, 3, 4, 5. 6 or 7 or here 10 or more) and optionally be packaged in a secondary packaging such as flow wrapped high moisture bather laminated material, such as a desiccant loaded pouch (preferably re-sealable). The pouch may provide an additional moisture bather to keep such rows of test devices 10. 100, 110 stable while these are in the pouch. The upper and lower cover leaves 24, 124 and 22, 122 provide environmental protection for each individual test sensor 20, or card of test sensors 120. after removal from the pouch for a prolonged period of time so that the test sensor packages according to the invention can be taken and stored in a non-protective container e.g. a pocket or a wallet for journeys or extended periods away from home. The anchor cover leaf 24 between test sensors in test sensor packaging 110 provides a means to keep materials and

F

test devices in web format. This provides for a packaging method that packages individual test sensors 20 in web format or as an array, This reduces the cost of manufacture.

It is preferred that the front face of a test sensor (die first major surface bearing at least one test component) is placed adjacent (e.g. face down onto) an anchor cover leaf, and a further cover leaf is provided on the rear face (second major surface) as being a particularly useful embodiment so that upon removal by a user, a test sensor is rotated so its front face is uppermost and thereby visible to a user, However, it will be apparent to those skilled in the art that either major surface of a test sensor may be placed adjacent (e.g. face down) on the anchor cover leaf, In various aspects, die invention provides packaging configurations that improve protection of each strip individually from the effects of external element(s) such as moisture and/or light and/or reduces the cost of manufacture and/or improves the ease of use of accessing individual test strips, whilst enhancing handling by providing an anchor cover leaf, In various embodiments, the invention provides a means to detach the test strip from a cover leaf e.g. from a supportive, protecrive web (anchor cover leaf in a web fonnat) and to open die test strip to IS provide access to a sample chamber, a means to visually expose the sample chamber and to physically expose an air vent in a two-step process. The invention provides individually packaged test strips held in a web format that are easy to open while providing an efficient and cost effective method of mass production.

F

GB1416041.0A 2014-09-10 2014-09-10 Improvements relating to test sensors and packaging Withdrawn GB2530057A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1416041.0A GB2530057A (en) 2014-09-10 2014-09-10 Improvements relating to test sensors and packaging
PCT/GB2015/052516 WO2016038334A1 (en) 2014-09-10 2015-09-01 Improvements relating to test sensors and packaging

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GB2530057A true GB2530057A (en) 2016-03-16

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050196318A1 (en) * 2004-03-04 2005-09-08 Matusewicz Richard S. Analyte collection and detection devices
WO2006065705A2 (en) * 2004-12-13 2006-06-22 Bayer Healthcare Llc Self-contained test sensor
WO2009076266A1 (en) * 2007-12-10 2009-06-18 Bayer Healthcare Llc Reagent strip with removable tip

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2968083B1 (en) * 2010-11-25 2015-03-06 Biomerieux Sa Article for biological analysis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050196318A1 (en) * 2004-03-04 2005-09-08 Matusewicz Richard S. Analyte collection and detection devices
WO2006065705A2 (en) * 2004-12-13 2006-06-22 Bayer Healthcare Llc Self-contained test sensor
WO2009076266A1 (en) * 2007-12-10 2009-06-18 Bayer Healthcare Llc Reagent strip with removable tip

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GB201416041D0 (en) 2014-10-22

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