Abstract
The present invention refers to a Lateral Flow Immunoassay (LFIA) test consumable and a corresponding reader device. The LFIA test consumable (10) comprises a casing (12) and two or more LFIA test strips (14), which are assembled on different side surfaces (A . . . D) of the casing (12) is provided. The corresponding reader device (20) for the LFIA test consumable (10) comprises a casing (22) and a measurement module (30) being assembled within the casing (22) and including (i) a measurement channel (32) adapted for accepting the LFIA test consumable (10); (ii) two or more optical units (34a . . . 34d) assembled on different side surfaces (A . . . B) of the measurement channel (32), each optical unit (34a . . . 34d) comprising at least one light source (36a . . . 36d) and at least one light sensor (38a . . . 38b) adapted for providing an optical signal at a signal output; and (iii) an evaluation module (40) being assembled within the casing (22), connected to the signal output of each optical unit (34a . . . 34d) and adapted for evaluating the test results of an LFIA test consumable (10). Further, a process for LFIA testing is provided.
Claims
1. Lateral flow immunoassay (LFIA) test consumable (10) comprising: a casing (12); and two or more LFIA test strips (14), which are assembled on different side surfaces (A . . . D) of the casing (12).
2. LFIA test consumable (10) according to claim 1, wherein the LFIA test consumable (10) includes a common sample pad (15) for the LFIA test strips (14), or each or some of the LFIA test strips (14) include their own sample pads.
3. LFIA test consumable (10) according to claim 1, wherein the LFIA test consumable (10) includes 2 through 6 LFIA test strips (14).
4. LFIA test consumable (10) according to claim 1, wherein the LFIA test consumable (10) further includes one or more identification units (16) adapted for at least providing an individual reference for the type of LFIA test strips (14) provided on the LFIA test consumable (10).
5. LFIA test consumable (10) according to claim 4, wherein the identification unit (16) is further adapted for providing at least one of producer, supplier, medical instance, date of production, date of storage life, production batch number, information of the orientation of the LFIA test consumable (10), alignment information about the relative position of LFIA tests (14) and interpretation range.
6. LFIA test consumable (10) according to claim 4, wherein each of the LFIA tests (14) is dedicated to a corresponding identification unit (16) being assembled on the same side surface (A . . . D) of the LFIA test consumable (10).
7. LFIA test consumable (10) according to claim 4, wherein the identification unit (16) compromises a barcode.
8. LFIA test consumable (10) according to claim 1, wherein at least one of the side surfaces (A . . . D) and/or at least one of the edges between these side surfaces (A . . . D) comprises a means for alignment (18).
9. Reader device (20) for an LFIA test consumable (10) comprising: a casing (22); a measurement module (30) being assembled within the casing (22) and including (i) a measurement channel (32) adapted for accepting the LFIA test consumable (10); (ii) two one or more optical units (34a . . . 34d) assembled on different side surfaces (A . . . B) of the measurement channel (32), each optical unit (34a . . . 34d) comprising at least one light source (36a . . . 36d) and at least one light sensor (38a . . . 38b) adapted for providing an optical signal at a signal output; and (iii) an evaluation module (40) being assembled within the casing (22), connected to the signal output of each optical unit (34a . . . 34d), and adapted for evaluating the test results of an LFIA test consumable (10).
10. Reader device (20) for an LFIA test consumable (10) according to claim 9, wherein the reader device (20) further comprises an activation button (24) which is designed to be switched when the LFIA test consumable (10) is completely or partly inserted into the measurement channel (32).
11. Reader device (20) for an LFIA test consumable (10) according to claim 9, wherein the evaluation module (40) comprises a data storage unit (42) including at least data sets for identification of LFIA test consumables (10).
12. Reader device (20) for an LFIA test consumable (10) according to claim 11, wherein each data set for a distinct LFIA test consumable (10) includes information on the spatial position of test regions at the LFIA tests being provided on a distinct LFIA test consumable (10).
13. Reader device (20) for an LFIA test consumable (10) according to claim 9, wherein at least one optical unit (34a . . . 34d) comprises N light sources (36a . . . 36d, 36a . . . 36d) and N light sensors (38a . . . 38d, 38a . . . 38d) adapted for providing N optical signals at a signal output, wherein N is greater or equal to 2.
14. Reader device (20) for an LFIA test consumable (10) according to claim 9, wherein the evaluation module (40) comprises: a means for test result and status feedback (42); and/or a means for wireless communication (44).
15. Process of LFIA testing comprising the steps of: a) providing a LFIA test consumable (10) as defined in one of the claims 1 to 8, and providing a reader device (20) for a LFIA test consumable (10) as defined in one of the claims 9 to 14; b) exposing the sample pad (15) of the LFIA test consumable (10) to a sample fluid; c) pulling the LFIA test consumable (10) into and out of the measurement channel (32) of the reader device (20), wherein the measurement module (30) is activated and the LFIA test strips (14) of the LFIA test consumable (10) are measured; d) evaluating at least one test result of the LFIA test consumable (10); and e) presenting a test result and status feedback via the means for test result and status feedback (42) and/or transmitting a test result via the means for wireless communication (44).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] In the following the invention will be described in further detail. The examples given are adapted to describe the invention.
[0041] FIG. 1 shows a perspective view of a LFIA test consumable partly inserted into a corresponding reader device;
[0042] FIG. 2 shows a schematic view of a first embodiment of a strip-type LFIA test consumable carrying two LFIA test strips with a first type of sample pad;
[0043] FIG. 3 shows a schematic view of a second embodiment of a square shaped LFIA test consumable carrying four LFIA test strips with a first type of sample pad;
[0044] FIG. 4 shows a schematic view of a third embodiment of a rod-type LFIA test consumable carrying two LFIA test strips with a second type of sample pad;
[0045] FIG. 5 shows a perspective view of the inner parts of a reader device for double-sided LFIA test consumables;
[0046] FIG. 6 shows another perspective view of the inner parts of a reader device for double-sided
[0047] LFIA test consumables;
[0048] FIG. 7 shows a bisected perspective view of a LFIA test consumable partly inserted into a corresponding reader device allowing observing the inner parts of the reader device; and
[0049] FIG. 8 shows a process of LFIA testing.
DETAILED DESCRIPTION OF THE INVENTION
[0050] FIG. 1 shows a perspective view of a LFIA test consumable 10 partly inserted into a corresponding reader device 20. The LFIA test consumable 10 comprises a casing 12 for handling. In the given perspective view, the casing 12 shows two openings. These are one opening giving access to a sample pad 15 and one opening to allow an observation of the included LFIA test strip 14. The LFIA test consumable 10 can be fully symmetric in respect to its mid-section or, in case of a single common sample pad 15, the symmetry may be broken by omitting a corresponding opening on the other side of the casing 12. The depicted LFIA test consumable 10 further comprises a means for alignment 18 in the form of a groove here. This alignment groove is supported by a corresponding counterpart, e.g., in the form of a guiding pin, located at the entrance area of the casing 22 of the reader device 20. The casing 22 encloses and protects the inner parts of the reader device 20. It shows no external elements which must be pressed or maintained by a user. There is a line of several LEDs visible on the back section of the reader device 20 which is a form of a direct means for test result and status feedback 44. This means allows giving visually evaluable information in a simple to interpret form to the user. Instead of a LED line, for example, a single low-energy LED or an acoustical feedback could be alternatively applied for user interaction.
[0051] FIG. 2 shows a schematic view of a first embodiment of a strip-type LFIA test consumable 10 carrying two LFIA test strips 14 with a first type of sample pad 15. The sample pad 15 is depicted in the form of a common plunge pad which can be directly inserted with the LFIA test consumable 10 into a test liquid. The plunge pad absorbs the test liquid and moistens the connected LFIA test strips 14 which are located on both side surfaces A, B of the strip-type LFIA test consumable 10. They can be observed by openings in the casing 12 of the LFIA test consumable 10. The depicted LFIA test consumable 10 is fully symmetric to its mid-line. However, there may be differences between the information encoded by the identification units 16 on the two side surfaces A, B. The depicted identification unit 16 on side surface A exemplarily comprises a first section providing reference lines 16a with information about the specific spatial position of the corresponding analyte regions and a barcode 16b which can contain information about LFIA test type, calibration and interpretation ranges, batch number, and so on. The LFIA test consumable 10 further comprises a means for alignment 18 to allow a controlled insertion into a corresponding reader device 20.
[0052] FIG. 3 shows a schematic view of a second embodiment of a square shaped LFIA test consumable 10 carrying four LFIA test strips 14 with a first type of sample pad 15. The square shaped carrier system provides four side surfaces A, B, C, D which can be used for the assembling of four individual LFIA test strips 14. However, as the general structure of the LFIA test consumable 10 is comparable to the strip-type design shown in FIG. 2, the corresponding reference signs are transferable. Thereby, the total number of side surfaces is, in principle, merely limited by the actual size of the comprised LFIA test strips 14 and can be increased to a nearly arbitrary number, e.g. six, eight, nine, or ten side surfaces.
[0053] FIG. 4 shows a schematic view of a third embodiment of a rod-type LFIA test consumable 10 carrying two LFIA test strips 14 with a second type of sample pad 15. The reference signs correspond to the assignment in the previous embodiments. The depicted embodiment corresponds to the LFIA test consumable 10 partly shown in FIG. 1. It mainly differs from the embodiment shown in FIG. 2 in that the design of the casing 12 is more circular than strip-type and that the sample pad 15 is of different type having the form of a wetting pad. A wetting pad can be exposed to a test liquid by simply applying single drops from a pipette to its surface. The sample pad 15 can be common and single-sided or for each individual LFIA test strip 14 an individual sample pad 15 is provided on the LFIA test consumable 10. For a simplified and error-prone insertion of the LFIA test consumable 10 in a corresponding reader device 20, the means for alignment 18 is comprised of different alignment aids here. These are, for example and not limiting, multi-lateral guides for merging the LFIA test consumable 10 to a corresponding reader device 20 and guiding notches along the thin upper and lower side surfaces of the LFIA test consumable 10.
[0054] FIG. 5 shows a perspective view of the inner parts of a reader device 20 for double-sided LFIA test consumables 10. This embodiment illustrates a reader device 20 which corresponds to a strip- or rod-type LFIA test consumable 10 carrying two LFIA test strips 14 at maximum. It mainly consists of two different functional sections. These are first a measurement module 30 comprising a measurement channel 32 with two side-surfaces A, B for inserting the LFIA test consumable 10 into it, and second an evaluation module 40 comprising a data storage unit 42 for data storage, a means for test result and status feedback 44 in the form of a LED line, and a lithium battery 48 for energy supply. The measurement module further comprises an activation button 24 at the end of the measurement channel 32, and two optical units 34a, 34b located on each of the side-surfaces A, B of the measurement channel 32 including light sources 36, light sensors 38a, 38b and on-chip amplifiers and data buffer systems 39 for increasing the signal-to-noise ratio of the detection. The depicted measurement channel 32 is provided in total with four light sources 36 and four light sensors 38a, 38b. By that, it is possible to optically readout all provided LFIA test strips 14 of a corresponding LFIA test consumable 10 at once in direct conjunction with optical information which can be provided by two individual identification units 16 located on the two side surfaces of the LFIA test consumable 10. The measured data is then directly processed by the on-chip amplifiers and data buffer systems 39 before being transferred to the evaluation module 40.
[0055] FIG. 6 shows another perspective view of the inner parts of a reader device 20 for double-sided LFIA test consumables 10. The reference signs directly correspond to the reference sign assignment given in FIG. 5. In this view, the identical layout of the two optical units 34a, 34b can be seen. Next to the battery 48 is a means for wireless communication 46 which allows the reader device 20 to interact with an external electronic data reader or device. For example, this reader can be in the form of a mobile device application or an external software program on a notebook or other portable computer.
[0056] FIG. 7 shows a bisected perspective view of a LFIA test consumable 10 partly inserted into a corresponding reader device 20 allowing observing the inner parts of the reader device. The depicted view corresponds to FIG. 1 and shows elements introduced in FIGS. 4 and 6. The used references sign are identical with the previous assignment made. By pulling the LFIA test consumable 10 into the measurement channel 32 of the reader device 20, the measurement module 30 can be activated by striking the activation button 24 at the end of the measurement channel 32 such that by pulling the LFIA test consumable 10 out of the measurement channel 32 of the reader device 20 the LFIA test strips 14 and the identification units 16 of the LFIA test consumable 10 are optically measured simultaneously. Afterwards, the measurement results are further processed by the on-chip amplifiers and data buffer systems 39 of the optical units 34a, 34b to be further analyzed and evaluated by the evaluation module 40.
[0057] In the following, a process of LFIA testing will be depicted in more detail and with respect to FIG. 8. In S1, a LFIA test consumable 10 and a corresponding reader device 20 are provided. In S2, a sample pad 15 of the LFIA test consumable 10 is exposed to a sample fluid. The form of exposure depends on the specific type of sample pad 15. If it is a common sample pad 15, single sample fluid exposure is sufficient for wetting all LFIA test strips 14 comprised by the LFIA test consumable 10. In S3, the LFIA test consumable 10 is pulled into and out of a measurement channel 32 of the reader device 20. Thereby, an activation button 24 preferably located at the end of the measurement channel 32 may be contacted at the inner pulling turning point such that the reader device 20 is activated and ready for measurement when the pulling out procedure begins. The measurement results are then processed by the on-chip amplifiers and data buffer systems 39 of the optical units 34a, 34b and transferred to the evaluation module 40. In S4, at least one test result of the LFIA test consumable 10 is evaluated by the evaluation module 40. If the LFIA test consumable 10 comprises multiple LFIA test strips 14 for different LFIA tests, other independent test results may be also evaluated. Furthermore, at least semi-quantitative results can be evaluated by providing LFIA test consumables 10 with different sensitivities for a single LFIA test. In S5, a test result and status feedback is presented to a user via a means for test result and status feedback 42 and/or transmitted via a means for wireless communication 44.
REFERENCE LIST
[0058] 10 LFIA test consumable [0059] 12 casing [0060] 14 LFIA test strip [0061] 15 sample pad [0062] 16 identification unit [0063] 16a reference lines [0064] 16b barcode [0065] 18 means for alignment [0066] 20 reader device [0067] 22 casing [0068] 24 activation button [0069] 30 measurement module [0070] 32 measurement channel [0071] 34a . . . 34b optical units [0072] 36a . . . 36d light sources [0073] 38a . . . 38b light sensors [0074] 39 on-chip amplifiers and data buffer systems [0075] 40 evaluation module [0076] 42 data storage unit [0077] 44 means for test result and status feedback [0078] 46 means for wireless communication [0079] 48 battery [0080] A . . . D side surfaces (of a LFIA test consumable (10)) [0081] A . . . B side surfaces (of a measurement channel (32))
