SAMPLE TEST CASSETTE AND ANALYTE TEST SYSTEM UTILIZING THE SAME
20230036668 · 2023-02-02
Assignee
Inventors
- Christian BORN (Hilleroed, DK)
- Allan Bjerre ABBONDIO (Hilleroed, DK)
- Steen Hauge MATTHIESEN (Hilleroed, DK)
Cpc classification
B01L2200/16
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/069
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5023
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A sample test cassette includes an inlet configured to introduce a sample liquid into the sample test cassette; an elongate channel configured to receive an elongate lateral flow test strip and configured with a first end that is configured to be in liquid communication with the inlet; and a mechanical transport system that is an integral part of the sample test cassette and is configured to generate a flow of the sample liquid from outside of the inlet and towards the first end of the elongate channel.
Claims
1. A sample test cassette, comprising: an inlet configured to introduce a sample liquid into the sample test cassette; an elongate channel configured to receive an elongate lateral flow test strip and configured with a first end that is configured to be in liquid communication with the inlet; and a mechanical transport system that is an integral part of the sample test cassette and is configured to generate a flow of the sample liquid from outside of the inlet and towards the first end of the elongate channel.
2. The sample test cassette of claim 1, wherein the sample test cassette includes one or more inner surfaces at least partially defining a reservoir that is configured to be in liquid communication with both the first of the elongate channel and with the inlet and is configured to hold the sample liquid for contact with a sample receiving portion of the elongate lateral flow test strip received in the elongate channel.
3. The sample test cassette of claim 1, wherein at least a section of a wall of the sample test cassette that overlies at least a portion of the elongate channel corresponding with an analysis zone of a lateral flow test strip received therein includes an aperture is configured to allow transmission of optical radiation between the portion of the elongate channel and an exterior of the sample test cassette.
4. The sample test cassette of claim 1, wherein the mechanical transport system includes a piston pump assembly having an inner wall at least partially defining a pump chamber and a piston, the piston having a first end configured to slidably engage with the inner wall at least partially defining the pump chamber to delimit, in cooperation therewith, a variable volume fluid receiving space within the pump chamber.
5. The sample test cassette of claim 1, further comprising: the elongate lateral flow test strip in the elongate channel.
6. An analyte test system, comprising: a housing; a reading system; and a holder, wherein the holder is configured to releasably locate the sample test cassette of claim 1 in a reading position at which the reading system is aligned in with the elongate channel of the sample test cassette to permit an interrogation of the elongate lateral flow test strip when the elongate lateral flow test strip is located in the elongate channel to test for a presence of an analyte.
7. The analyte test system of claim 6, wherein the reading system is an optical reading system comprising a complementary arrangement of a light source and an optical detector configured to define therebetween an optical path which, when the sample test cassette is located in the reading position, intersects the elongate channel to permit an optical interrogation of the elongate lateral flow test strip when the elongate lateral flow test strip is located in the elongate channel.
8. The analyte test system of claim 6, wherein the housing comprises a slot configured to receive and releasably retain the holder.
9. The analyte test system of claim 7, wherein one or both of the light source and the optical detector is located internal of the holder.
10. The analyte test system of claim 6, further comprising an actuator mechanism configured to engage with the mechanical transport system of the sample test cassette based on the sample test cassette being located in the holder and to actuate the mechanical transport system to generate the flow of the sample liquid.
11. The analyte test system of claim 10, wherein the holder holds internally the actuator mechanism.
12. The analyte test system of claim 10, wherein the actuator mechanism comprises a drive engagable with the mechanical transport system and rotatable to actuate the mechanical transport system to generate the flow of the sample liquid.
13. The analyte test system of claim 12, wherein the drive comprises a rotatable disc and an arm having a first end fixed to the rotatable disc and a second end configured with a detent configured to releasably mechanically engage with the mechanical transport system.
14. The analyte test system of claim 13, wherein the rotatable disc includes a protrusion that is circumferentially displaced on the rotatable disc from the first end of the arm to contact the arm when the rotatable disc is rotated by a predetermined amount.
15. The analyte test system of claim 13, wherein the mechanical transport system comprises an inner wall at least partially defining a pump chamber configured to be in liquid communication with a first end of a conduit, the conduit having a second end in liquid communication with the inlet, the conduit in liquid communication with the first end of the elongate channel between the first and second ends of the conduit, such that the first end of the elongate channel is in liquid communication between the inlet and the mechanical transport system via the conduit; and a piston having a first end configured to slidably engage with the inner wall at least partially defining the pump chamber to delimit therewith a variable volume fluid receiving space within the pump chamber and having a second end including a surface configured to releasably mechanically engage with the detent.
16. The analyte test system of claim 12, wherein the drive comprises a sprocket that is engagable with a toothed portion of a piston of the mechanical transport system, and rotatable to impart a linear motion to the piston when engaged with the toothed portion.
17. The analyte test system of claim 10, wherein the sample test cassette holds the actuator mechanism housed in a compartment that is divided internally by a second end of a piston into a spring chamber, housing a spring that is in engagement with the second end of the piston and a damping chamber housing a damping fluid, the second end of the piston being distal to a first end of the piston which is located in slidable engagement with an inner wall at least partially defining a pump chamber.
18. The analyte test system of claim 6, further comprising: an incubation temperature regulator that is housed within the holder, the incubation temperature regulator configured to maintain a temperature of the sample test cassette that is located in the holder at a predetermined temperature, wherein the incubation temperature regulator includes a heating and/or cooling element and a temperature sensor, and wherein the analyte test system is further configured to cause the incubation temperature regulator to maintain the temperature of the sample test cassette at the predetermined temperature based on signals received from the temperature sensor of the incubation temperature regulator.
19. The analyte test system of claim 6, wherein the analyte test system is configured to control the mechanical transport system to control and automate a flow rate of the flow of the sample liquid and a volume of the sample liquid that is introduced to the elongated lateral flow test strip in a repeatable manner.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] These and other features and advantages of the present invention will now be further described with reference to, and will become apparent from, exemplary embodiments which are illustrated in the drawings of the accompanying figures, of which:
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DETAILED DESCRIPTION
[0021] As used within this specification, including in the claims, the singular articles “a”; “an” and “the” include the plural unless the context clearly indicates otherwise. The use of the phrases “one or more”, “at least one” or similar phrases, does not alter the generality of the foregoing.
[0022] An example of a sample test cassette 2 according to the present invention is illustrated in
[0023] An example of an elongate lateral flow test strip 10 which is suitable for use in the sample test cassette 2 of the present invention is illustrated in
[0024] It will be appreciated that other, known, types of lateral flow test strip may be employed without departing from the invention as claimed, for example a lateral flow test strip generally as described above may be employed in which at least one of the sample pad 204, probe pad 206 and the waste pad 205 may be omitted.
[0025] Considering again
[0026] In the present embodiment the mechanical transport system 12 consists of a piston pump assembly which comprises a pump chamber 22 that is arranged in fluid communication with an end of the conduit 14; and a piston 24 having a first end 26 slidably engaged with an inner wall 22a of the pump chamber 22 to delimit therewith a variable volume fluid receiving space 28. A second end 30 of the piston 24 is also provided which is accessible external of the sample test cassette 2.
[0027] In some embodiments the maximum volume of the variable volume fluid receiving space 28 (i.e. when the piston 24 is at maximum extension) is selected to be approximately equal to the volume of liquid necessary to fill the reservoir 18. In this way an amount of sample liquid introduced into the sample test cassette 2 may be limited to that necessary for correct operation of the test strip(s) 10 without liquid being drawn into the variable volume fluid receiving space 28.
[0028] A part of the sample test cassette 2 which overlies at least a portion 8a of each of the one or more elongate channels 8 that corresponds with an analysis zone 208 of a lateral flow test strip 10 when the test strip 10 is received therein is constructed to permit an external optical inspection of the test strip 10, in particular of the analysis zone 208 of the test strip 10. In the present embodiment this part is provided by a transparent wall section 32. By way of example only, the transparent wall section 32 may extend to also cover the conduit 14, the reservoir 18 and the entire length of the elongate channels 8. The transparent wall section 32 may be permanently bonded to the cassette to form a fluid tight cover after insertion of the elongate lateral flow test strip(s) 10 into corresponding channel(s) 8. Thus a disposable, one-time use, sample test cassette 2, may be constructed. This at least simplifies the formation of the conduit 14 which, instead of being constructed as a bore through solid material, may now be more simply and accurately constructed as a channel to be covered by the separate transparent wall section 32.
[0029] In other embodiments, the transparent wall section 32 may be formed as a window covering essentially only the portions 8a of the elongate channel(s) 8 which will overlie the analysis zone(s) 208 of the test strip(s) 10, or may be omitted entirely and a solid wall section 34 provided to cover the conduit 14, the elongate channel(s) 8 and the reservoir 18 once the test strip(s) 10 are loaded into the elongate channel(s) 8. In such embodiments an aperture 36 is formed in the solid wall section 34 to overlie the portions 8a of the elongate channel(s) 8 that corresponds with the analysis zone(s) 208 and provides for external optical inspection of the analysis zone(s) 208. In some embodiments the transparent wall section 32 may be provided as part of a covering bonded to each of the lateral flow test strip(s) 10.
[0030] An analyte test system 38 which is suitable for use with a sample test cassette 2 described above is will now be described with reference to the illustrations contained in
[0031] The slots 42 are each adapted to releasably receive and hold a sample test cassette 2 in a reading position at which the optical reading system 48 is aligned in an optical path with the portion(s) 8a of the elongate channel(s) 8 corresponding with the analysis zone(s) 208 of the lateral flow test strip(s) 10 received therein. In the present embodiment each slot 42 is adapted to retain (usefully releasably) a holder 50 which, in turn, is adapted to releasably receive and hold a sample test cassette 2 in a cavity or slot 51 so that the sample test cassette 2 is held in the reading position internal of the holder 50 in the slot 51. In other embodiments each of the one or more slots 42 may be configured to receive and hold the sample test cassette 2 directly.
[0032] In order to provide a better understanding of the analyte test system 38 of the present invention,
[0033] In some embodiments, as illustrated in
[0034] In some embodiments, as illustrated in
[0035] An example of a holder 50 which forms a part of the analyte test system 38 of the present invention is illustrated in section in
[0036] The holder 50 of the present embodiment houses the optical reading system 48 and an actuator mechanism 60. In other embodiments one or both the optical reading system 48 and actuator mechanism 60 may be located external of the holder 50 and housed within the housing 40 of the analyte test system 38.
[0037] In some embodiments at least one electrical connector 59a is provided in the holder 50 to interface with a corresponding connector 59b located in a slot 42 of the housing 40 and thereby establish data, control signal and electrical power connections, as appropriate. A wireless communications unit, such as a known Bluetooth™ or WiFi enabled unit, may be included in the holder 50 for wireless transmission of data (including data from the optical reading system 48 and/or control signals) to and from the holder 50.
[0038] In some embodiments the at least one electrical connector may comprise a cable connector provided with an interface (such as sockets) to mate with a corresponding interface (such as pins) of a cable which terminates within the housing 40.
[0039] In some embodiments a temperature regulator 61 is also housed in the holder 50. The temperature regulator 61 may for example, comprise a Peltier heater/cooler element or a resistive heating element, together with, in some embodiments, a temperature sensor, and may be employed for incubation of the sample liquid prior to testing. The temperature regulator 61 is usefully made responsive to control signals sent via the interface 59a to maintain the sample test cassette 2 (or relevant portions thereof) at a predetermined incubation temperature for a predetermined time. Such control signals may be generated in response to signals received from the temperature sensor, when present.
[0040] The optical reading system 48 is a one known in the art for use in reading elongate lateral flow test strips 10 and in the present embodiment is an optical reading system 48. In other embodiments the reading system may be an electrical capacitance or resistance reader of known type and the test strip(s) will be selected accordingly. The optical reading system 48 comprises a light source 48a and complementary detector 48b located at a position, in this embodiment inside the holder 50, in an optical path to permit optical interrogation of the analysis zone(s) 208 of test strip(s) 10 located in the sample test cassette 2 retained in the holder 50. Typically, and as is known, the optical reading system operates to detect optical changes which occur in the analysis zone(s) 208 of the test strip(s) as a result of interaction between components in the sample liquid flowing in the test strip(s) 10 and recognition elements in the one or more test region(s) 209a,b and/or c and in the one or more control region(s) 210a. It will be appreciated that an advantage of locating both the light source 48a and the detector 48b internal of the housing 40 is that the optical path permitting the optical interrogation remains invariant irrespective of the orientation of the holder 50 so that detection may be performed independently of the orientation of the holder 50 (even when a holder, 50b say, has been rotated, for example to allow removal of the vial 56).
[0041] Data from the detector 48b, representing optical information obtained from the analysis zone(s) 208, may be transmitted to external the holder 50, for example via interfaces (connectors) 59a, 59b or via a wireless communications unit, for receipt by a data processor (not shown) which may be housed in the housing 40; or which may be located external of the housing 40, such as at a remotely located server, in communication with the analyte test system 38 via a wired or wireless communications link; or which may comprise elements located both internal the housing 40 and remote of the housing 40. However configured, the data processor is adapted, through suitable programming, to process the received data to detect changes that may have occurred in the analysis zone(s) 208 and therefrom to determine the presence of one or more analytes of interest in the sample liquid 54. The results of this determination may then be supplied for presentation on the display 44a of the analyte test system 38. The data processor may also be adapted to control the operation of the other elements of the analyte test system 38, such as control of the temperature regulator 61 and of the actuator mechanism 60.
[0042] The actuator mechanism 60 is operable to actuate the transport system 12 of a sample test cassette 2 held in the holder 50 to cause a flow of sample liquid (say sample liquid 54 held in vial 56 illustrated in
[0043] In some embodiments, the actuator mechanism 60 may comprise an arm 62 having a first end 64 pivotably mounted on a rotatable disc 66 and a detent 68 forming at least a part of a second end 70 for releasably mechanically engaging the transport system 12 at a surface 72 of the second end 30 of piston 24. The arm 62 is biased towards the piston 24, here by a spring bias 74, so that as the sample test cassette 2 is entered into the holder 50 the detent 68 positively engages the surface 72. In some embodiments a motor (not shown) is also provided internal the holder 50 to impart rotary movement to a shaft 76 on which the rotatable disc 66 is mounted. In other embodiments the motor or both the motor and the shaft 76 may be located external of the holder 50, internal of the housing 40 of the analyte test system 38 to engage the rotatable disc 66 when the holder 50 is fully located in a corresponding slot 42 of the housing 40. In some embodiments a protrusion 78, such as a pin, is provided on the rotatable disc 66 at a location circumferentially displaced from the first end 64 of the arm 62.
[0044] The operation of the actuator mechanism 60 will now be further explained with reference to the drawings of
[0045] In some embodiments, the speed of rotation of the disc 66 may be variable in order to maintain a constant linear movement of the piston 24. This is useful in order to avoid cavitation in the sample liquid 54 which may produce undesirable bubbles in the sample liquid within the sample test cassette 2. Indeed, any desired linear movement profile for the piston 24 may be achieved through suitable regulation of the rotation of the disc 66.
[0046] A further embodiment an actuator mechanism 80 is illustrated in
[0047] A further embodiment of transport system 92 is illustrated in
[0048] The transport system 92 comprises a pump chamber 94 that is arranged in fluid communication with an end of the conduit 14; and a piston 96 having a first end 98 slidably engaged with an inner wall 94a of the pump chamber 94 to delimit therewith a variable volume fluid receiving space 100. The piston 96 passes out of the pump chamber 94 through a fluid tight seal 102 into a compartment 104 where it terminates at a second end 106. The second end 106 provides a fluid tight seal and divides the compartment 104 into a spring chamber 108 and a damping chamber 110 which is sealed at an end 112 opposite the second end 106. The second end 106 is provided with a number of through holes (one illustrated 106a) which provide a liquid passageway between the damping chamber 110 and the spring chamber 108 and each of which, in the present embodiment, are sealed by a pressure sensitive, rupturable seal 107. The spring chamber 108 houses a spring 114 under tension and provides a biasing force which acts on the second end 106 of piston 96 to tend to move the piston 96 to cause the variable volume fluid receiving space 100 to increase. A damping liquid 116 fills the damping chamber 110 and provides a hydraulic pressure which produces a force opposing but less than the biasing force of the tensioned spring 114. The spring 114 and damping liquid 116 co-operate to form an actuator mechanism. A latch 118 is provided to releasably engage the piston 96 and hold it against the bias force in a rest position. In the present embodiment the latch 118 locates against a lower surface 120 of the second end 106 of the piston 96 to prevent movement of the piston 96 until transportation of sample liquid into the cassette is required and is moveable to disengage from the piston 96, in the present embodiment by rotation about a pivot 122.
[0049] When the latch 118 is disengaged the piston 96 moves under influence of the bias force exerted by the spring 114 to compress the damping liquid 116 and the hydraulic pressure increases. The increase in hydraulic pressure eventually causes the seal 107 to rupture which, in turn, allows damping liquid to flow into the spring chamber 108 and a continued, controlled, movement of the piston 96 to increase the volume of the variable volume fluid receiving space 100 occurs.
[0050] In other embodiments the through holes 106a and latch 118 are removed and a rupturable seal 124 (broken line construction in
[0051] Other embodiments may include a transport system other than a piston pump system, for example may include a peristaltic pump system, which is fluidly connected to the inlet of a sample test cassette with which it is integrated and which is operable to transport liquid from external of the cassette to elongate lateral flow test strips located in therein.