EP-4741835-A2 - MODULAR ASSAY READER DEVICE

EP4741835A2EP 4741835 A2EP4741835 A2EP 4741835A2EP-4741835-A2

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

XIE, TONG
HENGSTLER, STEPHAN
MOYER, VINCENT C.
LAI, BENNY WING HUNG

Assignees

Becton, Dickinson and Company

Dates

Publication Date: 20260513
Application Date: 20170609

Claims (16)

An interchangeable module for a diagnostic test device, the interchangeable module comprising: one or more mechanical features configured to engage with a bay of a module interface of the diagnostic test device; a barcode scanner configured to image a barcode, to identify a barcode pattern based on the imaged barcode, and to determine content associated with the barcode pattern; and a communication device configured to wirelessly communicate via a network, wherein the interchangeable module is configured to: identify, to the diagnostic test device, barcode scanning and network connectivity capabilities of the interchangeable module, output, to the diagnostic test device, the content associated with the barcode pattern, receive, from the diagnostic test device, a test result determined by the diagnostic test device based on changes in optical characteristics of an assay detected at an optical sensor of the diagnostic test device following application of a biological sample to the assay, receive, from the diagnostic test device, identification information determined by the diagnostic test device based on the content associated with the barcode pattern, and send, using the communication device, the test result in association with the identification information to a remote storage device via the network.
The interchangeable module as claimed in Claim 1, wherein the communication device comprises a cellular modem or a Wi-Fi communication device configured to provide the network connectivity capabilities.
The interchangeable module as claimed in Claim 1, further comprising an information element configured to identify the barcode scanning and network connectivity capabilities.
The interchangeable module as claimed in Claim 1, wherein the interchangeable module is further configured to send, to the remote storage device, instructions to route the test result from the remote storage device to another remote storage device.
The interchangeable module as claimed in Claim 1, wherein the interchangeable module is further configured to send the test result to a personal computing device of a clinician, the clinician identified based on the barcode data.
The interchangeable module as claimed in Claim 1, wherein the one or more mechanical features are configured to lockingly engage corresponding features within the bay of the module interface.
A kit comprising the interchangeable module as claimed in Claim 1 and a second interchangeable module, the second interchangeable module comprising: one or more mechanical features configured to engage with the bay of the module interface of the diagnostic test device; and a second barcode scanner configured to image a barcode, to identify a barcode pattern based on the imaged barcode, and to determine content associated with the barcode pattern, wherein the second interchangeable module is configured to: identify, to the diagnostic test device, the second interchangeable module does not have connectivity capabilities with a remote storage device, and output, to the diagnostic test device, the content associated with the barcode pattern.
The kit as claimed in claim 7, wherein identifying that the second interchangeable module does not have connectivity capabilities with a remote storage device causes the diagnostic test device to automatically store one or more test results in a memory of the diagnostic test device.
A method of operating an interchangeable module for a diagnostic test device, the method comprising: imaging a barcode using a barcode scanner of an interchangeable module engaged with a bay of a module interface of a diagnostic test device; identifying a barcode pattern based on the imaged barcode; determining, by the interchangeable module, content associated with the barcode pattern; identifying, by the interchangeable module to the diagnostic test device, capabilities of the interchangeable module including barcode scanning and network connectivity; outputting, by the interchangeable module to the diagnostic test device, the content associated with the barcode pattern; receiving, from the diagnostic test device, a test result determined by the diagnostic test device based on changes in optical characteristics of an assay detected at an optical sensor of the diagnostic test device following application of a biological sample to the assay; receiving, from the diagnostic test device, identification information determined by the diagnostic test device based on the content associated with the barcode pattern; and sending, using a communication device of the interchangeable module, the test result in association with the identification information to a remote storage device via a network.
The method as claimed in Claim 9, wherein the communication device sends the test result in association with the identification information via a Wi-Fi network or a cellular network.
The method as claimed in Claim 9, wherein identifying the capabilities of the interchangeable module comprises sending at least one signal from an information element of the interchangeable module to the diagnostic test device.
The method as claimed in Claim 9, further comprising sending, to the remote storage device, instructions to route the test result from the remote storage device to another remote storage device.
The method as claimed in Claim 9, further comprising sending the test result to a personal computing device of a clinician, the clinician identified based on the barcode data.
The method as claimed in Claim 9, further comprising lockingly engaging one or more mechanical features of the interchangeable module with corresponding features within the bay of the module interface.
The method as claimed in Claim 9, further comprising: removing the interchangeable module from the bay of the module interface; engaging a second interchangeable module with the bay of the module interface; and identifying, by the second interchangeable module to the diagnostic test device, capabilities of the second interchangeable module including an indication that the second interchangeable module does not have connectivity capabilities with the remote storage device.
The method as claimed in Claim 15, wherein identifying that the second interchangeable module does not have connectivity capabilities with a remote storage device causes the diagnostic test device to automatically store one or more test results in a memory of the diagnostic test device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS 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," the contents of which are hereby incorporated by reference herein. TECHNICAL FIELD The systems and methods disclosed herein are directed to medical testing, and, more particularly, to lateral flow assay techniques and devices. BACKGROUND 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 non-biological fluids. The analytes can include antibodies, antigens, drugs, or hormones. 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 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 ovulation or pregnancy, or has a particular drug or chemical compound in their body, to name a few examples. 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. Accordingly, one aspect relates to 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 th