SYSTEM FOR EVALUATING AT LEAST ONE ANALYTE LIKELY TO BE CONTAINED IN A LIQUID SAMPLE DEPOSITED ON AN IMMUNOCHROMATOGRAPHIC DEVICE
The system addresses the challenge of offline analyte analysis in immunochromatographic devices by enabling autonomous data processing and interpretation, delivering accurate quantitative results without internet connectivity.
Patent Information
- Application Number
- FR2014060852
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2014-11-10
- Publication Date
- 2025-01-03
- Estimated Expiration
- 2034-11-10
AI Technical Summary
Existing immunochromatographic devices lack efficient and autonomous systems for analyzing and interpreting calibration data without internet connectivity, limiting their usability and accuracy in determining analyte concentrations in liquid samples.
A system comprising a reading device paired with an analysis device, capable of processing calibration data from a calibration device, acquiring digital images of immunochromatographic devices, and converting them into quantitative results using a computer program, allowing offline analysis and interpretation of analyte profiles.
Enables autonomous, offline evaluation of analyte concentrations in liquid samples using immunochromatographic devices, providing qualitative and quantitative results without internet connectivity, enhancing usability and accuracy.
Smart Images
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Abstract
Description
This calibration data is presented here in optical form, for example in the form of barcodes or 2D codes (QR codes). Alternatively, the reading device 3 may also comprise reading means (reader) adapted to cooperate with identification means 26 (chip) in a “near field communication” or NFC form. This calibration data is then transmitted, via the communication means 33, 41, to the analysis device 4 for the purpose of interpreting immunochromatographic devices 2 associated with this data. Evaluation process First, the reading device 3 is paired with said analysis device 4, so as to allow an exchange of data through their respective communication means 33, 41. Before reading an immunochromatographic device 2, it is possible to retrieve the calibration data on a calibration device 7 associated with this immunochromatographic device 2. For this, the calibration device 7 is reported at the level of the reading device 3, so as to collect the calibration data that it contains and then transmit them to the analysis device 4. This approach allows the system 1 according to the invention to be used autonomously, without requiring a connection to the Internet network, for example. Then, the liquid sample to be analyzed is deposited in the deposition zone 22 of the immunochromatographic device 2. This immunochromatographic device 2 can then be returned immediately, or after a determined period of time, to the reception means 31 of the reading device 3. Sufficient time is allowed for migration by capillary diffusion of the liquid sample to the revelation zone 24 of the immunochromatographic device 2. This sufficient time can be followed: - manually, in which an individual triggers the acquisition of the digital image of the revelation zone 24, or - automatically (tempering), in which the reading device 3 or the analysis device 4 autonomously triggers the acquisition of the digital image of the revelation zone 24. In this second case, the calibration data advantageously contain an optimal value for this time period. The reading device 3 then acquires a digital image of the revelation zone 24 of the immunochromatographic device 2 present. This digital image is then transmitted from the “transmitter” reading device 3 to the “receiver” analysis device 4, via their communication means 33, 41. The digital image is therefore converted into a digital train between these two means of communication 33, 41. The digital image, received by the analysis device 4, is processed by the computer program of the processing means 42 (algorithm), so as to determine the profile of the revelation zone 24. This profile of the revelation zone 24 can be the result of two phenomena: - the detection reagent, complexed with the analyte, binds to the complementary capture reagent (sandwich format), and / or - the detection reagent binds to the capture reagent (forming competition). The revelation zone 24 thus comprises complexes creating a visible and / or measurable profile (or signal), generally bands parallel to each other and perpendicular to the direction of migration A. This profile is particularly characterized by signal intensity, or even by the number and arrangement of the bands and their respective intensities. This signal intensity is for example expressed in number of pixels, detected on all or part of the revelation zone 24. The profile of the revelation zone 24, in particular its intensity, is then compared with the calibration data, by the implementation of the processing means 42 of the analysis device 4 (in particular the aforementioned program code means for processing said at least one digital image). The processing means 42 thus qualitatively and / or semi-quantitatively and / or quantitatively evaluate the analyte or analytes from the profile obtained. It is then possible to transform this “profile” result into a semi-quantitative value, taking into account the calibration data (in particular a dose-response curve). The visual result obtained can thus be transformed, for example, into a concentration, expressed for example in ng per mL or in mLH per mL of the analyte in the liquid sample to be analyzed. The evaluation result is advantageously recorded on memory means of the analysis device 4. A provision of the result of said qualitative and / or quantitative evaluation can be implemented by the analysis device 4 (in particular by the execution of the computer program of the means of processing), by transmission to different possible destinations, for example: - the screen 43 of this analysis device 4, and / or - the remote server 5, for collecting data in its database, and / or - the remote display device 6, for providing the qualitative and / or quantitative evaluation result to the remote third party. This evaluation result is advantageously associated with contextual data (relating for example to the patient and the test implemented), 10 in particular: - type of immunochromatographic device 2, - patient identification, - timestamp, - location of the patient.
Claims
- CLAIMS - 1. System for the qualitative and / or quantitative evaluation of at least one analyte likely to be contained in a liquid sample deposited on an immunochromatographic device (2), which immunochromatographic device (2) comprises capillary diffusion means (21) on which said liquid sample is intended to migrate from an upstream deposition zone (22) to a downstream revelation zone (24), characterized in that said evaluation system (1) comprises a reading device (3) and an analysis device (4) which are structurally distinct from each other, in that said reading device (3) comprises: means (31) for receiving said immunochromatographic device (2), - means (32) for acquiring at least one digital image of the revelation zone (24) of said immunochromatographic device (2) attached to said reception means (31), - communication means (33) which are adapted to the exchange of data with at least said analysis device (4), in particular for the transmission of said at least one digital image from said reading device (3) to said analysis device (4), and in that said analysis device (4) comprises: - communication means (41) which are adapted to the exchange of data with at least said reading device (3), in particular for the reception of said at least one digital image from said reading device (3), - means (42) for processing said at least one digital image, adapted to the qualitative and / or quantitative evaluation of said at least one analyte likely to be contained in said liquid sample, and - means for providing the result of said qualitative and / or quantitative evaluation, and in that said analysis device (4) is located remotely, so that said digital image acquired by said reading device (3) is intended to be transmitted, via a telecommunications network (R), 35 up to said analysis device (4).
2. System for the qualitative and / or quantitative evaluation of at least one analyte, according to claim 1, characterized in that the reading device (3) is devoid of: - means for processing said at least one digital image, suitable for the qualitative and / or quantitative evaluation of said at least one analyte likely to be contained in said liquid sample, and - possibly means for providing the qualitative and / or quantitative evaluation result.
3. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 or 2, characterized in that the analysis device (4) comprises a screen (43), and in that the supply means comprise means for displaying the result of said qualitative and / or quantitative evaluation on said screen (43).
4. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 3, characterized in that the analysis device (4) comprises a computer program comprising: - program code means for receiving said at least one digital image from said reading device (3), - program code means for processing said at least one digital image, taking into account calibration data, - program code means for providing the result of said qualitative and / or quantitative evaluation, when said computer program is executed by said analysis device (4).
5. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 4, characterized in that the receiving means (31) of the reading device (3) are removable and interchangeable, so as to adapt said receiving means (31) according to the immunochromatographic device (2) to be analyzed.
6. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 5, characterized in that the reading device (3) comprises means (32) for reading of identification means (26) carried by the immunochromatographic device (2), 7. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 6, characterized in that the analysis device (4) consists of a dedicated computer server.
8. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 7, characterized in that it further comprises a remote display device (6), for providing the qualitative and / or quantitative evaluation result to a remote third party, which remote display device (6) is connected to the analysis device (4) via a telecommunications network (R), advantageously the Internet, and in that the means for providing the analysis device (4) comprise means for transmitting the evaluation result to said remote display device (6) via said telecommunications network (R).
9. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 8, characterized in that it comprises an immunochromatographic device (2) comprising: ~ an upstream release zone (22) which comprises at least one detection reagent conjugated with a visible and / or measurable marker, said detection reagent being capable of moving as a result of the migration of the liquid sample in said capillary diffusion means (21), and - said downstream revelation zone (24) which comprises at least one capture reagent, immobilized on said capillary diffusion means (21).
10. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 9, characterized in that it further comprises a calibration device (7), intended to be attached to the level of the reception means (31) of the reading device (8) and comprising calibration data intended to be collected prior to the reading of the immunochromatographic device (2) to be analyzed, and in that the reading device (3) comprises means for the acquisition of the calibration data carried by said calibration device (7).
11. System for the qualitative and / or quantitative evaluation of at least one analyte, according to any one of claims 1 to 10, characterized in that the reading device (3) also comprises at least one of the means chosen from the following means: - means (35) for connecting wired communication means, ~ means (36) for illuminating the revelation zone (24) of the immunochromatographic device (2).
12. Method for the qualitative and / or quantitative evaluation of at least one analyte likely to be contained in a liquid sample deposited on an immunochromatographic device (2), by means of an evaluation system (1) according to any one of claims 1 to 11, which method comprises the following successive steps: - a pairing of said reading device (3) with said analysis device (4), - an installation of said immunochromatographic device (2) at the level of the reception means (31) of the reading device (3), - an acquisition of said at least one digital image of the revelation zone (24) of said immunochromatographic device (2) attached to said reception means (31), and a transmission of said at least one digital image from said reading device (3) to said analysis device (4) located remotely, via the telecommunications network (R) - processing of said at least one digital image by said analysis device (4), for the qualitative and / or quantitative evaluation of said at least one analyte likely to be contained in said liquid sample, and - provision of the result of said qualitative and / or quantitative evaluation.