CA-3024569-C - MODULAR ASSAY READER DEVICE

CA3024569CCA 3024569 CCA3024569 CCA 3024569CCA-3024569-C

Abstract

Certain aspects relate to systems and usage techniques for modular lateral flow assay reader devices that can receive a number of different modules having a barcode scanning input device and optional network connectivity capabilities. A barcode scanning module can provide a simple input method that reduces errors compared to manual data entry. A network connectivity module can enable transmission of test results over a public network for standardizing, tracking and electronically connecting test results from assay reader devices located throughout a network. Such devices can programmatically implement a simplified workflow whereby pressing a single button readies the device for imaging, analyzing, and data storage/transmission and, in some implementations, configures the device to operate in one of a plurality of device operation modes.

Inventors

Tong Xie
Stephan Hengstler
Vincent C. Moyer
Benny Wing Hung Lai

Assignees

BECTON, DICKINSON AND COMPANY

Dates

Publication Date: 20260505
Application Date: 20170609
Priority Date: 20160622

Claims (20)

WHAT IS CLAIMED IS: 1. A diagnostic test device comprising: an optical sensor positioned to detect changes in optical characteristics of an assay following application of a biological sample to the assay, the optical sensor configured to generate a signal indicating the detected changes in optical characteristics of the assay; a module interface comprising a bay configured to receive and lockingly engage a connected module of a plurality of interchangeable modules, a first signal path configured to identify characteristics of the connected module, the characteristics indicative of presence of a barcode scanner in the connected module and connectivity capabilities of the connected module, and a second signal path configured to receive barcode data from the connected module, the barcode data representing a barcode imaged by the connected module; at least one processor; and a memory having instructions stored thereon that configure the at least one processor to determine a test result based at least partly on the signal generated by the optical sensor, identify the barcode as an identification information barcode, determine identification information based on the barcode data, determine the connectivity capabilities of the connected module, in response to determining that the connected module has connectivity capabilities with a remote storage device, automatically send the test result in association with the identification information to the remote storage device, and in response to determining that the connected module does not have connectivity capabilities with a remote storage device, automatically store the test result in association with the identification information in the memory.
2. The diagnostic test device of Claim 1, further comprising an additional optical sensor positioned to detect additional information on the assay or a cartridge Date Rer;ue/Date Received 2023-08-07 holding the assay, wherein the at least one processor is configured to use the additional information to establish operating parameters of the diagnostic test device.
3. The diagnostic test device of Claim 1, further comprising an additional optical sensor positioned to detect additional information on the assay or a cartridge holding the assay, wherein the at least one processor is configured to store the additional information in association with the test result.
4. The diagnostic test device of Claim 1, further comprising the connected module.
5. The diagnostic test device of Claim 4, wherein the connected module comprises the barcode scanner.
6. The diagnostic test device of Claim 4, wherein the connected module comprises a cellular modem configured to provide the connectivity capabilities.
7. The diagnostic test device of Claim 4, wherein the connected module comprises an information element, wherein the at least one processor is configured to retrieve, via the first signal path, module information from the information element and determine the connectivity capabilities of the connected module based on the module information.
8. Non-transitory computer-readable media configured with computerexecutable instructions that, when executed, cause a hardware processor to: identify characteristics of a connected module inserted into a bay of an assay reader device, the characteristics indicative of presence of a barcode scanner in the connected module and connectivity capabilities of the connected module; receive assay image data from an assay reading image sensor of the assay reader device, the assay image data representing detected changes in optical characteristics of an assay inserted into or positioned adjacent to the assay reader device; determine a test result based at least partly on analyzing the assay image data; determine, based on the identified characteristics, the connectivity capabilities of the connected module; in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay Date Rer;ue/Date Received 2023-08-07 reader device, automatically send the test result to the remote storage device; and in response to determining that the connected module does not have connectivity capabilities with a remote storage device, automatically store the test result in a memory of the assay reader device.
9. The non-transitory computer-readable media of Claim 8, further having stored thereon instructions that, when executed, cause the hardware processor to: receive barcode image data from the connected module representing at least one barcode; identify, based on analysis of the barcode image data, the at least one barcode as an instruction barcode; and retrieve instructions associated with the instruction barcode.
10. The non-transitory computer-readable media of Claim 9, further having stored thereon instructions that, when executed, cause the hardware processor to determine the test result based at least partly on the instructions associated with the instruction barcode.
11. The non-transitory computer-readable media of Claim 9, further having stored thereon instructions that, when executed, cause the hardware processor to instruct the assay reading image sensor to obtain the assay image data at a predetermined timing after insertion of the assay into the assay reader device based at least partly on the instructions associated with the instruction barcode.
12. The non-transitory computer-readable media of Claim 8, further having stored thereon instructions that, when executed, cause the hardware processor to: receive barcode image data from the connected module representing at least one barcode; identify, based on analysis of the barcode image data, the at least one barcode as an identification barcode; determine information represented by the identification barcode; in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay reader device, automatically send the information represented by the identification barcode with the test result to the remote storage device; and in response to determining that the connected module does not have connectivity capabilities with a remote storage device, automatically store the Date Rer;ue/Date Received 2023-08-07 information represented by the identification barcode with the test result in a memory of the assay reader device.
13. A diagnostic testing process compnsmg, by one or more hardware processors: identifying characteristics of a connected module inserted into a bay of an assay reader device, the characteristics indicative of presence of a barcode scanner in the connected module and connectivity capabilities of the connected module; receiving assay image data from an assay reading image sensor of the assay reader device, the assay image data representing detected changes in optical characteristics of an assay inserted into or positioned adjacent to the assay reader device; determining a test result based at least partly on analyzing the assay image data; determining, based on the identified characteristics, the connectivity capabilities of the connected module; in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay reader device, automatically sending the test result to the remote storage device; and in response to determining that the connected module does not have connectivity capabilities with a remote storage device, automatically storing the test result in a memory of the assay reader device.
14. The process of Claim 13, further comprising: receiving barcode image data from the connected module representing at least one barcode; identifying, based on analysis of the barcode image data, the at least one barcode as an instruction barcode; and retrieving instructions associated with the instruction barcode.
15. The process of Claim 14, further comprising determining the test result based at least partly on the instructions.
16. The process of Claim 14, further compnsmg instructing the assay reading image sensor to obtain the assay image data at a predetermined timing after Date Rer;ue/Date Received 2023-08-07 insertion of the assay into the assay reader device based at least partly on the instructions.
17. The process of Claim 13, further comprising: receiving barcode image data from the connected module representing at least one barcode; identifying, based on analysis of the barcode image data, the at least one barcode as an identification barcode; and determining information represented by the identification barcode.
18. The process of Claim 17, further comprising: in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay reader device, automatically sending the information represented by the identification barcode with the test result to the remote storage device; and in response to determining that the connected module does not have connectivity capabilities with a remote storage device, automatically storing the information represented by the identification barcode with the test result in a memory of the assay reader device.
19. The process of Claim 17, further comprising in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay reader device, automatically sending instructions to route the test result from the remote storage device to another remote storage device, the another remote storage device identified based on the information represented by the identification barcode.
20. The process of Claim 17, further comprising in response to determining that the connected module has connectivity capabilities with a remote storage device physically separated from the assay reader device, automatically sending the test result to the personal computing device of a clinician, the clinician identified based on the information represented by the identification barcode.

Description

MODULAR ASSAY READER DEVICE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/393,575, filed on September 12, 2016, entitled "MODULAR ASSAY READER DEVICE," and U.S. Provisional Patent Application No. 62/353,505, filed on June 22, 2016, entitled "MODULAR ASSAY READER DEVICE". TECHNICAL FIELD [0002] The systems and methods disclosed herein are directed to medical testing, and, more particularly, to lateral flow assay techniques and devices. BACKGROUND [0003] In patient care, immunoassay technology provides simple and relatively quick means for determining the presence of analytes in a subject sample. Analytes are substances of interest or clinical significance that may be present in biological or nonbiological fluids. The analytes can include antibodies, antigens, drugs, or hormones. [0004] The analyte of interest is generally detected by reaction with a capture agent, which yields a device more easily detected and measured than the original analyte. Detection methods can include a change in absorbance, a change in color, change in :fluorescence, change in luminescence, change in electrical potential at a surface, change in other optical properties, or any other easily measured physical property indicating the presence or absence of an analyte in a sample. SUMMARY [0005] Immunoassay devices play an important role in areas such as clinical chemistry and have been made portable for use in the field. Assays are routinely performed to detect the presence of particular analytes that are present when a human or non -human subject has a particular disease or condition. For example, an assay as described herein can be used to detect whether a patient has flu A, flu B, RSV, group A strep, or another illness, is experiencing Date Rer;ue/Date Received 2022-09-29 WO 2017/222833 PCT/0S2017/036810 ovulation or pregnancy, or has a particular drug or chemical compound in their body, to name a few examples. [0006] Such assays and assay reader devices are used by skilled clinicians and laypersons alike. Accordingly, an assay reader device according to the present disclosure is designed to be simple and reliable, for example by including a module for simple barcode scan input of any needed additional information and by minimizing a number of steps required for the user to perform between sample application and result notification. The barcode scan input can provide for a high level of traceability and compliance by allowing clinics, laboratories, and the like to implement custom test result documentation standards. Some examples can enforce compliance with such standards at the reader level, for example by pre-configuring the readers to require input of designated types of information before transmitting results. As another example, communications between the reader and a centralized database can be used to ascertain whether transmitted test data complies with such standards and, if not, to send instructions back to the reader device to prompt a user for any missing information. Further, such assays and assay reader devices can be used in a variety of contexts, both inside and outside of the clinical setting. Accordingly, an assay reader device according to the present disclosure can include a module providing network connectivity capabilities for providing test results to one or more centralized databases. [0007] Accordingly, one aspect relates to a diagnostic test device compnsmg an optical sensor positioned to detect changes in optical characteristics of an assay following application of a biological sample to the assay, the optical sensor configured to generate a signal indicating the detected changes in optical characteristics of the assay; a module interface comprising a bay configured to receive and lockingly engage a connected module of a plurality of interchangeable modules, a first signal path configured to identify characteristics of the connected module, the characteristics indicative of presence of a barcode scanner in the connected module and connectivity capabilities of the connected module, and a second signal path configured to receive barcode data from the connected module, the barcode data representing a barcode imaged by the connected module; at least one processor; and a memory having instructions stored thereon that configure the at least one processor to determine a test result based at least partly on the signal generated by the optical sensor, identify the barcode as an identification information barcode, determine identification information based on the barcode WO 2017/222833 PCT/0S2017/036810 data, determine the connectivity capabilities of the connected module, in response to determining that the connected module has connectivity capabilities with a remote storage device, automatically send the test result in association with the identification information to the remote storage device, and in response to determining that t