Sample test cartridge and analyte testing system using the same

Abstract

The present invention discloses a sample test kit and an analyte testing system using the sample test kit, wherein the sample test kit includes: an inlet (4) for introducing sample liquid into the sample test kit (2); and one or more elongated channels (8), each elongated channel for receiving an elongated transverse flow test strip (10) and each elongated channel being configured with a first end (16) in liquid communication with the inlet (4); wherein the sample test kit (2) further includes an integrated mechanical delivery system (12) operable to generate a liquid flow from outside the inlet (4) toward the first end (16) of each of the one or more elongated channels (8).

Description

Technical Field

[0001] The present invention generally relates to the detection of one or more analytes in a sample liquid using a transverse flow test strip, and includes a sample test kit for said analytes, and an analyte testing system using said sample test kit. Background Technology

[0002] The detection of analytes in sample liquids using immunoassay-based devices employing transverse flow test strips (often also referred to as transverse flow devices or LFDs) is well known. Many of these immunoassay-based devices comprise a rigid housing enclosing an elongated transverse flow test strip of a known type. One such immunoassay-based device is described in US 9,833,783 and includes a housing with at least one elongated channel formed internally for positioning the elongated transverse flow test strip therein, the strip being oriented so that one end is in liquid communication with the liquid flow channel. A liquid receiving cavity is provided as an inlet for receiving the sample liquid and is in liquid communication with the flow channel at a location upstream of at least one elongated channel. The sample liquid is pipetted by a user into the liquid receiving cavity and conveyed by gravity to contact the end of the test strip in liquid communication with the liquid flow channel. Once in contact with the end of the test strip, the liquid flows transversely along the element by capillary flow, and any analyte therein, or a complex thereof, or some other reagent in the test strip, interacts with a suitable trapping agent bound to one or more test zones of the analytical region of the test strip, thereby generating a detectable signal. The presence of analytes in the liquid can be determined visually or using a reader. Control areas, which may also be included within the analytical area, can be similarly inspected to ensure proper operation of the test strips or to aid in the quantification of analytes in the liquid. Summary of the Invention

[0003] According to a first aspect of the invention, a sample test kit is provided, comprising: an inlet for introducing sample liquid into the sample test kit; and one or more elongated channels, each elongated channel for receiving an elongated transverse flow test strip and each elongated channel being configured with a first end in liquid communication with the inlet; wherein the sample test kit further comprises an integrated mechanical delivery system adapted to generate a sample liquid flow from outside the inlet to the first end of each of the one or more elongated channels. The integrated mechanical delivery system allows for the controlled introduction of sample liquid into each transverse flow test strip received in the one or more elongated channels, enabling control and / or automation of one or both of the introduced sample volume and flow rate in a repeatable manner, and allowing simultaneous initiation of multiplexed tests using multiple test strips. Such sample test kits can be used by substantially untrained operators, reducing the likelihood of operator-induced errors.

[0004] In some embodiments, the flow channels include reservoirs, such as those provided by wells and / or absorbent materials, positioned in liquid communication with a first end of each of one or more elongated channels. This has the advantage of retaining a sufficient volume of liquid for absorption by the transverse flow test strips located in the one or more elongated channels without providing a continuous flow within the cartridge.

[0005] In some embodiments, the delivery system includes a piston pump having a variable volume pump chamber in fluid communication with an inlet.

[0006] In some embodiments, at least a section of the wall of the sample test chamber, covering at least a portion of each of one or more elongated channels corresponding to the analysis area received therein by the transverse flow test strip, is adapted to allow light radiation to transmit into and out of the analysis area. This allows for the detection of the analyte of interest by optical interrogation of the transverse flow test strip.

[0007] According to a second aspect of the invention, an analyte testing system is provided, comprising: a housing; a reading system, preferably an optical reading system; and one or more holders; wherein each of the one or more holders is configured to releasably position the aforementioned sample test cartridge in a reading position, wherein the reading system aligns all of the one or more elongated channels to allow interrogation of each test strip located in the one or more elongated channels to test for the presence of an analyte in the sample, for example by detecting light generation at the analytical region of each test strip after transmission, reflection, or passive (e.g., fluorescence) or active (e.g., electrochemiluminescence).

[0008] In some embodiments, the reading system is an optical reading system, which includes its own light source and its own optical detector located inside each retainer. This allows the retainers to move, such as rotating the retainers in and out of the housing, while maintaining the alignment of the optical reading system, enabling interrogation to be performed at different positions of the retainers.

[0009] In some embodiments, the analyte testing system further includes an actuator mechanism adapted to engage with a delivery system of a sample test cartridge located in a holder and to actuate the delivery system to generate a liquid flow.

[0010] In some embodiments, each retainer internally holds its own actuator mechanism.

[0011] In some embodiments, the actuator may include an electric motor, and in other embodiments, the actuator may include a spring-driven motor, wherein, usefully, the spring can be wound by the action of placing the sample test box in the holder or placing the holder in the housing. Attached Figure Description

[0012] These and other features and advantages of the invention will now be further described by way of exemplary embodiments illustrated in the accompanying drawings, and will become apparent from these exemplary embodiments, wherein:

[0013] Figure 1 A first embodiment of the sample test kit is shown;

[0014] Figure 2 It shows what is suitable for use Figure 1 The known types of thin test strips in the sample box;

[0015] Figure 3 It shows having Figure 1 Analytical testing system for sample test kits;

[0016] Figure 4 It shows Figure 3 Holder of the analyte testing system;

[0017] Figure 5 It shows according to Figure 3 The operation of the actuator in the analyte testing system;

[0018] Figure 6 Another embodiment of the actuator is shown; and

[0019] Figure 7 Another embodiment of the conveying system is shown. Detailed Implementation

[0020] As used in this specification (including the claims), unless the context clearly indicates otherwise, the singular article "a" is used; "an" and "the" include the plural. The use of the phrases "a or more," "at least one," or similar phrases does not alter the generality of the foregoing.

[0021] An example of the sample test kit 2 according to the present invention is shown in Figure 1 As shown in the figure. The sample test box 2 includes: an inlet 4 having an opening 6 accessible from the outside through which sample liquid can be transferred into the box 2; one or more (four shown) elongated channels 8 for retaining corresponding elongated transverse flow test strips 10 (one shown here); and a mechanical delivery system 12, which is incorporated into the box (2).

[0022] Examples of elongated transverse flow test strips 10 suitable for use in the sample test kit 2 of the present invention are as follows: Figure 2The diagram illustrates a generally known construction. The elongated transverse flow test strip 10 includes a rigid, elongated support 201 having a downstream end 202 and an upstream end 203. A sample pad 204 for receiving sample liquid is attached to the support 201 proximal to its upstream end 203, while a waste pad 205 is attached to the support 201 near its downstream end 202. A probe pad 206 is attached to the support 201, in physical contact with the sample pad 204, and releasably retains a probe element designed to bind to and flow with a specific analyte in the sample liquid. A porous membrane 207 is attached to the support 201 and extends between and contacts the probe pad 206 and the waste pad 205. The porous membrane 207 has an analytical zone 208 comprising one or more test zones (one shown, 209) and one or more control zones (one shown, 210). Each test zone 209 includes one or more spatially defined test regions (three shown here, 209a, 209b, 209c), which may be strips or dots disposed on the porous membrane 207. Each region permanently holds the same or different specific recognition elements (such as aptamers, receptor protein fragments, or antibodies) that are selectively bound to a specific analyte in the sample liquid. Each control zone 210 includes one or more spatially defined control regions (one shown here, 210a), which may be strips or dots disposed on the porous membrane 207. Each region permanently holds an affinity ligand that typically binds to a probe element initially contained in the probe pad 206. Typically, in use, the sample pad 204 acts as a sponge to hold excess sample liquid. Once the sample pad 204 is soaked, sample fluid flows from the sample pad 204 to the probe pad 206, in which the probe element is releasably stored. The sample fluid, containing the analyte bound to the probe, flows capillarily from the probe pad 206 and along the elongated porous membrane 207 to the test zone 209, where probe elements in specific test areas 209a, 209b, or 209c bind to and capture at least some of the probe-bound analyte. The remaining liquid continues to flow in the elongated porous membrane 207 to the control zone 210 (located downstream of the test zone 209 in the direction of liquid flow along the test strip 10), where the remaining probe elements in the liquid are captured and bound, providing an indication that the test is functioning correctly. The liquid continues to flow in the elongated porous membrane 207 until it reaches the waste pad 205, which acts as a waste reservoir.

[0023] It should be understood that other known types of transverse flow test strips may be used without departing from the claimed invention. For example, a transverse flow test strip as generally described above may be used, wherein at least one of the sample pad 204, probe pad 206 and waste pad 205 may be omitted.

[0024] Reconsider Figure 1 The conduit 14 connects the inlet 4 to the first end 16 of each elongated channel 8 and provides a liquid pathway for the sample liquid from the outside of the opening 6 to each end 16. In this embodiment, a reservoir 18 is provided connected to the conduit 14 and the first end 16 of the channel 8. The reservoir 18 provides a common liquid source to each first end 16 for absorption by a transverse flow test strip 10, which is retained in the corresponding elongated channel 8 and oriented such that its sample receiving end (here, the sample pad 204) is positioned toward the first end 16 of the elongated channel 8 in which it is retained. In some embodiments (such as...) Figure 1 As shown, absorbent material 20 may be disposed in or configured within reservoir 18 to maintain contact between sample liquid and sample pad(s) 204. Conduit 14 also connects its first end 16 (shown here via connection to reservoir 18) to mechanical delivery system 12. Mechanical delivery system 12 operates to generate a sample liquid flow from outside opening 6, through sample test cassette 2, and at least into reservoir 18, to provide a source of sample liquid for absorption by one or more elongated transverse flow test strips 10, each located in a respective elongated channel 8. It should be understood that it is not necessary for all elongated channels 8 of sample test cassette 2 to contain test strips 10 for use with sample test cassette 2. Furthermore, it is not necessary for each test strip 10 to have the same number of test areas 209a, 209b, 209c and / or control area 210a, or for each test area 209a, 209b, 209c of different test strips 10 to have the same identification element. In some embodiments, each of the multiple test strips held in the sample kit may include only one test area, but each test area retains a different identification element. Therefore, multiple analytes can be easily and simply tested using the same sample test kit.

[0025] In this embodiment, the mechanical delivery system 12 comprises a piston pump assembly including: a pump chamber 22 arranged in fluid communication with one end of a conduit 14; and a piston 24 having a first end 26 slidably engaging with an inner wall 22a of the pump chamber 22 to define a variable volume fluid receiving space 28. A second end 30 of the piston 24 is also provided, which can be accessed from outside the sample test cartridge 2.

[0026] In some embodiments, the maximum volume of the variable volume fluid receiving space 28 (i.e., when the piston 24 is at its maximum extension) is selected to be approximately equal to the volume of liquid required to fill the reservoir 18. In this way, the amount of sample liquid introduced into the sample test cartridge 2 can be limited to the amount necessary for the proper operation of test strip(s) 10 without drawing liquid into the sample receiving space 28.

[0027] When the test strip 10 is received therein, a portion of the sample test cartridge 2, covering at least a portion 8a corresponding to the analytical area 208 of the transverse flow test strip 10 in each of the one or more elongated channels 8, is configured to allow external optical inspection of the test strip 10, specifically the analytical area 208 of the test strip 10. In this embodiment, this portion is provided by a transparent wall segment 32. By way of example only, the transparent wall segment 32 can extend to also cover the entire length of the conduit 14, the reservoir 18, and the elongated channels 8. After the elongated transverse flow test strip(s) 10(s) is inserted into the corresponding channel(s) 8, the transparent wall segment 32 can be permanently incorporated into the cartridge to form a fluid-impermeable covering. Thus, a disposable, single-use sample test cartridge 2 can be constructed. This at least simplifies the formation of the flow conduit 14, which is no longer constructed as a hole through a solid material, but can now be more simply and accurately constructed as a channel covered by a single wall segment 32.

[0028] In other embodiments, the transparent wall section 32 may be formed as a window that substantially only covers the portion 8a of the elongated channel(s) 8 that will cover the analytical area(s) 208(s) of the test strip(s) 10, or may be omitted entirely after the test strip(s) 10 are loaded into the elongated channel(s) 8, and a solid wall section 34 is provided to cover the flow conduit 14, the elongated channel(s) 8, and the reservoir 18. In such embodiments, an orifice 36 is formed in the solid wall section 34 covering the portion 8a of the elongated channel(s) 8 corresponding to the analytical area(s) 208 and providing external optical inspection of the analytical area(s) 208. In some embodiments, the transparent wall section 32 may be provided as part of a cover incorporated into each of the transverse flow test strip(s) 10.

[0029] Now refer to Figure 3 and Figure 4The illustrations contained herein depict an analyte testing system 38 suitable for use with the sample test kit 2 described above. The analyte testing system 38 includes: a housing 40 having a plurality of slots 42 (three in this case) formed therein; a reading system 48; and a user interface 44 for inputting data into and / or receiving data from the system 38. The user interface 44 is shown herein as including a display, usefully with a touch display area 44a, and a keypad area 44b through which the user can interact with the system 38. In some embodiments, the user interface 44 may be fully or partially incorporated into a smart device such as a smartphone or tablet computer. The analyte testing system 38 may be powered by an external power source (e.g., AC power); an internal power source (e.g., a battery); or both selectively. An optical reader (not shown) may be usefully incorporated into the housing 40 and may be configured to read barcodes or QR codes associated with the kit 2 and may hold or point to information related to one or more tests to be performed by one or more test strips 10 housed in the kit 2. This type of information can be used in the analyte testing system 38 to control the operation of certain components of the system 38 in order to provide a test plan specific to the sample test kit 2.

[0030] Each slot 42 is adapted to releasably receive and hold the sample test cartridge 2 in a read position, where the optical read position is aligned in the optical path with one or more portions 8a of the elongated channel(s) 8 corresponding to the analysis areas 208 of the transverse flow test strip(s) 10(s) received therein. In this embodiment, each slot 42 is adapted to retain (usefully releasably) a retainer 50, which in turn is adapted to releasably receive and hold the sample test cartridge 2 in a cavity or slot 51, such that the sample test cartridge 2 is held in the read position within the slot 51 inside the retainer 50. In other embodiments, each of the one or more slots 42 may be configured to directly receive and hold the sample test cartridge 2.

[0031] To provide a better understanding of the analyte testing system 38 of the present invention, Figure 3 A first retainer 50a is shown that is fully inserted into and retained in its corresponding slot 42; a second retainer 50b is shown that is partially inserted into its corresponding slot 42 and an empty slot 42, wherein one of a pair of guide slots 52 can be seen in this embodiment. All slots 42 are filled with retainers 50 so that it is not necessary to use the analyte testing system 38.

[0032] In some embodiments, such as Figure 3As shown, when the retainer (e.g., 50a) is fully inserted into the corresponding slot 42, the open end (e.g., 6a) of the inlet (e.g., 4a) of the sample test cartridge (e.g., 2a) can be immersed in the sample liquid 54 in the sample vial 56. When the retainer (e.g., 50b) rotates in the corresponding slot 42, the corresponding open end (e.g., 6b) of the inlet (e.g., 4b) can be moved to allow removal of the vial 56 (and any sample liquid 54 it contains), for example, for use in other analyzers that may employ different analytical methods, while lateral flow analysis is still in progress.

[0033] In some embodiments, such as Figure 3 and Figure 4 As shown, the retainer 50 may be provided with an outwardly projecting pin 58 that engages with a guide slot 52 of the empty slot 42 and is rotatable therein to allow the retainer (e.g., 50b) to be inserted into and removed from the housing 40. In some embodiments, rotation of the retainer (e.g., 50b) in the slot allows the open end 6b of the sample cassette 2b held in the retainer 50b to move to contact with and not contact with the sample liquid, and thereby facilitates the introduction of the sample vial for sample testing.

[0034] An example of a holder 50 forming part of the analyte testing system 38 of the present invention is shown in Figure 4 The cross-section shown and equivalent to Figure 3 Holders 50a and 50b are shown. Sample test box 2 is also indicated by the dashed line structure. Figure 4 The position of the component relative to the retainer 50 is shown in the diagram so that it is fully located within the retainer 50.

[0035] In this embodiment, the holder 50 houses the optical readout system 48 and the actuator mechanism 60. In other embodiments, one or both of the optical readout system 48 and the actuator mechanism 60 may be located outside the holder 50 and housed within the housing 40 of the analyte testing system 38.

[0036] In some embodiments, at least one electrical connector 59a is provided in the retainer 50 to interface with a corresponding connector 59b located in the slot 42 of the housing 40, thereby establishing data, control signal, and power connections as needed. A wireless communication unit, such as a known Bluetooth™ or WiFi-enabled unit, may be included in the retainer 50 for wirelessly transmitting data (including data and / or control signals from the optical reading system 48) to and from the retainer 50.

[0037] In some embodiments, at least one electrical connector may include a cable connector having an interface (such as a receptacle) for mating with a corresponding interface (such as a pin) of a cable terminating within the housing 40.

[0038] In some embodiments, a temperature regulator 61 is also housed in the holder 50. For example, the temperature regulator 61 may include a Peltier heater / cooler element or a resistance heating element, in some embodiments, along with a temperature sensor, and may be used to incubate the sample liquid prior to testing. The temperature regulator 61 usefully responds to control signals transmitted via interface 59a to maintain the sample cartridge 2 (or a related portion thereof) at a predetermined incubation temperature for a predetermined time. Such control signals may be generated in response to a signal received from the temperature sensor (if present).

[0039] The reading system 48 is a reading system known in the art for reading elongated transverse flow test strips 10, and in this embodiment, it is an optical reading system 48. In other embodiments, the reading system may be a known type of capacitive or resistive reader, and the test strip(s) will be selected accordingly. The optical reading system 48 includes a light source 48a and a complementary detector 48b located in the optical path (in this embodiment, inside the holder 50) to allow optical interrogation of the analytical regions(s) 208 of the test strip(s) 10(s) located in the sample test cassette(s) 2 held in the holder 50. Typically, and as is known, the optical reading system operates to detect optical changes that occur in the analytical regions(s) 208 of the test strip(s) 10 due to the interaction between components in the sample liquid flowing in the test strip(s) 10 and identification elements in one or more test areas 209a, b and / or c and in one or more control areas 210a. It should be understood that the advantage of positioning both the light source 48a and the detector 48b inside the housing 50 is that it allows the optical path of the optical interrogation to remain unchanged, regardless of the orientation of the holder 50, so that detection can be performed independently of the orientation of the holder 50 (even when the holder, for example 50b, has been rotated, for example, to allow the removal of the vial 56).

[0040] Data from detector 48b representing optical information obtained from one or more analysis zones 208 can be transmitted, for example, via interfaces 59a, 59b or via a wireless communication unit to the outside of holder 50 for reception by a data processor (not shown), which may be housed within housing 40; or may be located outside housing 40, such as at a remote server, communicating with system 38 via a wired or wireless communication link; or may include elements located both inside and far from housing 40. Regardless of the configuration, the data processor, when properly programmed, is adapted to process the received data to detect possible changes in one or more analysis zones 208 and thereby determine the presence 54 of one or more analytes of interest in the sample liquid. The results of this determination can then be provided for presentation on display 44a of analyte testing system 38. The data processor may also be adapted to control the operation of other components of analyte testing system 38, such as the temperature regulator 61 and the actuator mechanism 60.

[0041] The actuator mechanism 60 is operable to actuate the delivery system 12 of the sample test cartridge 2 held in the holder 50 to induce sample liquid (e.g., held in the holder) from the outside of the opening end 6 of the inlet 4. Figure 3 The sample liquid 54 in the vial 56 shown flows to be absorbed by the sample pads 204 of the elongated transverse flow test strips 10 held in the box 2.

[0042] In some embodiments, the actuator mechanism 60 may include an arm 62 having a first end 64 pivotally mounted on a rotatable disk 66, and a pawl 68 forming at least a portion of a second end 70 for releasably mechanically engaging the delivery system 12 at a surface 72 of the second end 30 of the piston 24. The arm 62 is biased toward the piston 24 by a spring bias 74 such that the pawl 68 engages the surface 72 face-to-face when the sample cartridge 2 enters the holder 50. In some embodiments, a motor (not shown) is also disposed within the holder 50 to impart rotational movement to a shaft 76 on which the rotatable disk 66 is mounted. In other embodiments, the motor, or both the motor and the shaft 76, may be located outside the holder 50 and inside the housing 40 of the analyte testing system 38 to engage the rotatable disk 66 when the holder 50 is fully positioned within a corresponding slot 42 of the housing 40. In some embodiments, a protrusion 78, such as a pin, is provided on the rotatable disk 66 at a location circumferentially displaced from the first end 64 of the arm 62.

[0043] Now refer to Figure 5 The diagram further explains the operation of actuator mechanism 60. The sample test box 2 is inserted into holder 50. Figure 5(i)), until the opening 6 of inlet 4 is submerged in the sample liquid 54 in vial 56 and the pawl 68 engages with the surface 72 of piston 24. Figure 5 (ii) to lock the box 2 in the retainer 50 in its read position. The arm 62 of the actuator mechanism 60 is now in or near its highest position and the spring bias 74 maintains frontal contact between the pawl 68 and the surface 72. The disc 66 rotates ( Figure 5 (iii) The curved arrow causes arm 62 to move in a generally downward direction. This causes piston 24 to move downward accordingly, resulting in an increase in the volume of the variable volume fluid receiving space 28 and the sample liquid 54 being drawn into the sample test chamber 2. Rotation of disk 66 continues and protrusion 78 on disk 66 engages arm 62 ( Figure 5 (iv) At this point, the variable volume fluid receiving space 28 is at its maximum volume and the transfer of sample liquid 54 into the cartridge 2 is complete. Rotation is now typically stopped and the optical reading system 48 (or other known reading system) is operated to optically query (one or more) the test strips 10 to determine the presence of analytes in the sample liquid 54 that has been transferred into the sample test cartridge 2. Rotation of the disk 66 can then continue. The protrusion 78 pushes against the arm 62, causing the pawl 68 to disengage from the surface 72. The sample test cartridge 2 is now no longer locked in the retainer 50 by the pawl 68 and can be removed.

[0044] In some embodiments, the rotational speed of disk 66 can be variable in order to maintain a constant linear movement of piston 24. This is useful for avoiding cavitation in sample liquid 54, which can generate unwanted bubbles in the sample liquid within cartridge 2. In fact, any desired linear movement profile of piston 24 can be achieved by appropriately adjusting the rotation of disk 66.

[0045] In another embodiment, the actuator mechanism 80 is in Figure 6 As shown in the image, together with Figure 1 The relevant parts of the equivalent transport system of the sample test box 2 transport system 12 shown are illustrated together. The toothed portion 84 of the piston 86 of the piston pump assembly is shown, similar to... Figure 1 The piston pump assembly of the delivery system 12 in the illustrated embodiment. The actuator mechanism 80 includes a sprocket 88 mounted on a rotatable shaft 82 of a motor (not shown). When the sample test cartridge is inserted into the holder 50, the sprocket 88 engages the toothed portion 84. Rotation of the sprocket 88 in one direction R causes a linear movement M of the piston 86 to increase the volume of the variable-volume fluid receiving space of the piston pump assembly and the absorption of sample liquid from the outside of the sample test cartridge.

[0046] Another embodiment of the conveying system 92 is in Figure 7 As shown, it can replace Figure 1The conveyor system 12 shown. (And...) Figure 1 Unlike the delivery system 12, and as will be described below, this delivery system 92 does not require an external drive motor to maintain the sample liquid flow within the sample test box of the present invention.

[0047] The delivery system 92 includes: a pump chamber 94 arranged in fluid communication with one end of a conduit 14; and a piston 96 having a first end 98 slidably engaged with an inner wall 94a of the pump chamber 94 to define a variable-volume fluid receiving space 100. The piston 96 exits the pump chamber 94 through a fluid-impermeable seal 102 into a compartment 104, in which it terminates at a second end 106. The second end 106 provides a fluid-impermeable seal and divides the compartment 104 into a spring chamber 108 and a damping chamber 110, the damping chamber 110 being sealed at an end 112 opposite to the second end 106. The second end 106 is provided with a plurality of through-holes (one shown, 106a) providing a fluid passage between the damping chamber 110 and the spring chamber 108, and in this embodiment, each through-hole is sealed by a pressure-sensitive, burstable seal 107. Spring chamber 108 houses a tensioned spring 114 and provides a biasing force acting on the second end 106 of piston 96 to tend to move piston 96 to increase the variable volume fluid receiving space 100. Damping fluid 116 fills damping chamber 110 and provides hydraulic pressure that generates a force opposite to but less than the biasing force of the tensioned spring 114. Spring 114 and damping fluid 116 cooperate to form an actuator mechanism. Latch 118 is provided to releasably engage piston 96 and hold it in a stationary position against the biasing force. In this embodiment, latch 118 is positioned against the lower surface 120 of the second end 106 of piston 96 to prevent piston 96 from moving until sample fluid needs to be delivered into the cartridge, and is movable to disengage from piston 96 in this embodiment by rotation about pivot 122.

[0048] When latch 118 disengages, piston 96 moves under the influence of the biasing force applied by spring 114 to compress damping fluid 116 and increase hydraulic pressure. The increase in hydraulic pressure eventually causes seal 107 to rupture, which in turn allows damping fluid to flow into spring chamber 108, and results in continuous controlled movement of piston 96 to increase the volume of variable volume fluid receiving space 100.

[0049] In other embodiments, the through-hole 106a and latch 118 are removed, and a breakable seal 124 can be provided. Figure 7The dashed line in the diagram represents the portion that at least partially replaces the sealing end 112 of the damping chamber 110. In the event of a rupture of the seal 124, which in some embodiments can be done manually, the damping fluid 116 can exit the damping chamber 110. This results in a reduction in the reaction force exerted by the damping fluid 116 and allows the piston 96 to move under the influence of the force exerted by the spring 114.

[0050] Other embodiments may include a delivery system other than a piston pump system, such as a peristaltic pump system fluidly connected to the inlet of an integrated sample test cartridge, and operable to deliver liquid from the outside of the cartridge to an elongated transverse flow test strip located therein.

Claims

1. A sample testing kit, comprising: An inlet, the inlet being used to introduce sample liquid into the sample test box; The sample test chamber further includes an elongated channel for receiving elongated transverse flow test strips and having a first end in liquid communication with the inlet; wherein the sample test chamber further includes an integrated mechanical delivery system adapted to generate a sample liquid flow from outside the inlet to the first end of the elongated channel for absorption by one or more elongated transverse flow test strips located in the respective elongated channels. as well as The conduit has a first conduit end connected to the inlet and a second conduit end connected to the integrated mechanical conveying system, the conduit extending from the first conduit end to the second conduit end to realize the connection between the inlet and the integrated mechanical conveying system; The first end of the elongated channel is connected between the inlet and the integrated mechanical conveying system via a branch connection structure. The branch connection structure is formed at the first end of the elongated channel and at the conduit segment between the first conduit end and the second conduit end.

2. The sample test kit of claim 1, wherein the reservoir is configured to be in liquid communication with the first end of the elongated channel and the inlet, and is adapted to maintain sample liquid in contact with the sample receiving portion of the elongated transverse flow test strip received in the elongated channel.

3. The sample test box according to claim 1, wherein at least a section of the wall of the sample test box, covering at least a portion of the analysis area corresponding to the transverse flow test strip received therein in the elongated channel, is adapted to allow light radiation to be transmitted into and out of said portion of the elongated channel.

4. The sample test kit of claim 1, wherein the integrated mechanical delivery system comprises a piston pump assembly having a pump chamber and a piston; a first end of the piston is slidably engaged with the inner wall of the pump chamber to cooperate in defining a variable volume fluid receiving space.

5. The sample test kit according to claim 1, further comprising an elongated transverse flow test strip received in the elongated channel.

6. An analyte testing system, comprising: shell; Read the system; and retainer; The retainer is configured to releasably position the sample test cartridge according to any one of the preceding claims in a reading position, wherein the reading system is aligned with the elongated channel to allow interrogation of the test strip located in the elongated channel to test for the presence of the analyte.

7. The analyte testing system of claim 6, wherein the readout system is an optical readout system comprising a complementary light source and an optical detector arrangement configured to define an optical path therebetween, the optical path intersecting the elongated channel to allow optical interrogation of a test strip located in the elongated channel when the sample test cartridge is in the readout position.

8. The analyte testing system of claim 6, wherein the housing includes a slot for receiving and releasably retaining a retainer.

9. The analyte testing system of claim 7, wherein one or both of the complementary light source and the optical detector are located inside the holder.

10. The analyte testing system of claim 6, further comprising an actuator mechanism adapted to engage with and actuate the integrated mechanical delivery system of the sample test cartridge located in the holder to generate the sample liquid flow.

11. The analyte testing system of claim 10, wherein the retainer internally holds its own actuator mechanism.

12. The analyte testing system of claim 10 or claim 11, wherein the actuator mechanism includes a driver that is engageable with and rotatable to actuate the integrated mechanical delivery system to generate the sample liquid flow.

13. The analyte testing system of claim 12, wherein the actuator comprises a rotatable disk and an arm having a first end fixed to the rotatable disk and a second end configured with a pawl adapted to releasably engage mechanically with the integrated mechanical conveying system.

14. The analyte testing system of claim 13, wherein the protrusion is formed on the rotatable disk, and when the rotatable disk rotates a predetermined amount, the protrusion is circumferentially displaced on the rotatable disk from the first end of the arm to contact the arm.

15. The analyte testing system according to any one of claims 13 or 14, wherein the integrated mechanical conveying system comprises: A pump chamber arranged to communicate with the second conduit end of the conduit via liquid; The piston has a first end and a second end, the first end being slidably engaged with the inner wall of the pump chamber to define a variable volume fluid receiving space therewith, and the second end being provided with a surface for releasably engaging mechanically with the pawl.

16. The analyte testing system of claim 12, wherein the drive includes a sprocket that engages with a toothed portion of the piston of the integrated mechanical delivery system and, when engaged with the toothed portion, is rotatable to impart linear motion to the piston.

17. The analyte testing system of claim 10, wherein the sample test chamber holds the actuator mechanism housed in a compartment internally divided by a second end of a piston into a spring chamber housing a spring configured to engage with the second end and a damping chamber housing damping fluid, the second end being distal to a first end of the piston, the first end being positioned to slidably engage with the inner wall of the pump chamber.

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