IP Library Granted Patent US 12,405,273
Granted Patent B2
US 12,405,273 · App. 18/496,239 · Granted Sep 2, 2025

Modular assay reader device

Inventors: Tong Xie (San Jose, CA); Stephan Hengstler (Campbell, CA); Vincent C. Moyer (Los Gatos, CA); Benny Wing Hung Lai (Fremont, CA)
Assignee: Becton, Dickinson and Company
G01N33/54388C12M1/34G01N21/01G01N35/00722G01N35/00871G01R1/20G06K7/10G16H10/40B01L2300/021G01N2035/00326G01N2035/00752G01N2035/00841G01N2035/00881
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Quick Facts
Patent No.
US 12,405,273
App. No.
18/496,239
Granted
Sep 2, 2025
Kind
B2
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.

Claims (30)

1. An interchangeable module for a diagnostic test device,

the interchangeable module comprising:

a housing sized and shaped to engage with a bay of a module interface of the diagnostic test device;

a barcode scanner configured to image a barcode and to generate barcode data based on the imaged barcode;

a communication component configured to wirelessly communicate with a remote storage device; and

processing circuitry configured by computer-executable instructions to:

provide, to a first signal path of the module interface of the diagnostic test device, a first signal comprising module information indicating presence of the barcode scanner in the interchangeable module and connectivity capabilities of the interchangeable module;

provide, to a second signal path of the module interface of the diagnostic test device, a second signal comprising the barcode data;

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 barcode data; and

cause the communication component to send the test result in association with the identification information to the remote storage device.

2. The interchangeable module as claimed in claim 1 , wherein the processing circuitry is further configured to receive, from the diagnostic test device, additional information optically detected by the diagnostic test device from the assay or a cartridge holding the assay, wherein the additional information is further sent in association with the test result.

3. The interchangeable module as claimed in claim 1 , wherein the communication component comprises a cellular modem configured to provide the connectivity capabilities.

4. The interchangeable module as claimed in claim 1 , wherein the communication component comprises a Wi-Fi communication device configured to provide the connectivity capabilities.

5. The interchangeable module as claimed in claim 1 , wherein the processing circuitry comprises an information element configured to send the first signal to the first signal path.

6. The interchangeable module as claimed in claim 1 , wherein the diagnostic test device is capable of operation with an alternative module that lacks connectivity capabilities with the remote storage device, and wherein the module information causes one or more processors of the diagnostic test device to distinguish the interchangeable module from the alternative module.

7. The interchangeable module as claimed in claim 1 , wherein the barcode is an instruction barcode, and wherein the barcode data causes the diagnostic test device to retrieve instructions associated with the instruction barcode.

8. The interchangeable module as claimed in claim 7 , wherein the instructions cause the diagnostic test device to determine the test result based at least partly on the instructions.

9. The interchangeable module as claimed in claim 1 , wherein the processing circuitry 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.

10. The interchangeable module as claimed in claim 9 , wherein the another remote storage device is identified at the diagnostic test device based on the barcode data.

11. The interchangeable module as claimed in claim 1 , wherein the processing circuitry is further configured to send the test result to the personal computing device of a clinician, the clinician identified based on the barcode data.

12. The interchangeable module as claimed in claim 1 , wherein the housing further comprises mechanical features configured to lockingly engage corresponding features within the bay of the module interface.

13. The interchangeable module as claimed in claim 12 , wherein the bay of the module interface at least partially encloses the housing of the interchangeable module when the mechanical features engage the corresponding features within the bay.

14. A kit comprising the interchangeable module as claimed in claim 1 and a second interchangeable module, the second interchangeable module comprising:

a housing sized and shaped to engage with the bay of the module interface of the diagnostic test device;

a barcode scanner configured to image a barcode and to generate barcode data based on the imaged barcode; and

processing circuitry configured by computer-executable instructions to:

provide, to a first signal path of the module interface of the diagnostic test device, a first signal comprising module information indicating presence of the barcode scanner in the interchangeable module and indicating that the second interchangeable module does not have connectivity capabilities with a remote storage device; and

provide, to a second signal path of the module interface of the diagnostic test device, a second signal comprising the barcode data;

wherein the first signal causes the diagnostic test device to automatically store one or more test results in a memory of the diagnostic test device.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2025
From: XIE, TONG; HENGSTLER, STEPHAN; MOYER, VINCENT C.; LAI, BENNY WING HUNG
To: BECTON, DICKINSON AND COMPANY
Reel/Frame 071812/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2025
From: XIE, TONG; HENGSTLER, STEPHAN; MOYER, VINCENT C.; LAI, BENNY WING HUNG
To: BECTON, DICKINSON AND COMPANY
Reel/Frame 071812/0037 →
Continuity (6)
Continuation 17814308 · Jul 22, 2022
Continuation 16222348 · Dec 17, 2018
Continuation PCTUS2017036810 · Jun 9, 2017
Provisional Application 62393575 · Sep 12, 2016
Provisional Application 62353505 · Jun 22, 2016
Related Publication 20240319182A1 · Sep 26, 2024
References Cited (108)
US 6136610A · Polito et al. · 2000 [cited by applicant]
US 6440066B1 · Brady · 2002 [cited by applicant]
US 7027931B1 · Jones et al. · 2006 [cited by applicant]
US 7437302B2 · Haskell et al. · 2008 [cited by applicant]
US 7519591B2 · Landi et al. · 2009 [cited by applicant]
US 7575558B2 · Boecker et al. · 2009 [cited by applicant]
US 7651841B2 · Song et al. · 2010 [cited by applicant]
US 7890748B1 · Wyatt · 2011 [cited by applicant]
US 8007999B2 · Holmes et al. · 2011 [cited by applicant]
US 8046175B2 · Kuo et al. · 2011 [cited by applicant]
US 8106780B2 · Goodnow et al. · 2012 [cited by applicant]
US 8115635B2 · Goodnow et al. · 2012 [cited by applicant]
US 8138909B2 · Lewington et al. · 2012 [cited by applicant]
US 8223021B2 · Goodnow et al. · 2012 [cited by applicant]
US 8257654B2 · Maus et al. · 2012 [cited by applicant]
US 8260392B2 · Say et al. · 2012 [cited by applicant]
US 8358210B2 · Goodnow et al. · 2013 [cited by applicant]
US 8428966B2 · Green, III et al. · 2013 [cited by applicant]
US 8606593B1 · Green, III et al. · 2013 [cited by applicant]
US 8669047B2 · Holmes et al. · 2014 [cited by applicant]
US 8737971B2 · Van Rooyen et al. · 2014 [cited by applicant]
US 8773258B2 · Vosch et al. · 2014 [cited by applicant]
US 9310300B2 · Alt et al. · 2016 [cited by applicant]
US 9459200B2 · Dupoteau et al. · 2016 [cited by applicant]
US 9524372B2 · Hengstler et al. · 2016 [cited by applicant]
US 9715579B2 · Hengstler et al. · 2017 [cited by applicant]
US 9792809B2 · Dupoteau · 2017 [cited by applicant]
US 9795331B2 · Stafford · 2017 [cited by applicant]
US 10180417B2 · Hengstler et al. · 2019 [cited by applicant]
US 10309954B2 · Adelman · 2019 [cited by applicant]
US 10458972B2 · Hengstler et al. · 2019 [cited by applicant]
US 10706966B2 · Hengstler et al. · 2020 [cited by applicant]
US 10976298B2 · Hengstler et al. · 2021 [cited by applicant]
US 11152116B2 · Hengstler et al. · 2021 [cited by applicant]
US 11253852B2 · Low et al. · 2022 [cited by applicant]
US 11397181B2 · Xie et al. · 2022 [cited by applicant]
US 11802869B2 · Xie · 2023 [cited by examiner]
US 20020059030A1 · Otworth et al. · 2002 [cited by applicant]
US 20030073931A1 · Boecker et al. · 2003 [cited by applicant]
US 20040167464A1 · Ireland et al. · 2004 [cited by applicant]
US 20040249999A1 · Connolly et al. · 2004 [cited by applicant]
US 20060167381A1 · Azer et al. · 2006 [cited by applicant]
US 20060240568A1 · Petruno et al. · 2006 [cited by applicant]
US 20070016381A1 · Kamath et al. · 2007 [cited by applicant]
US 20070081920A1 · Murphy et al. · 2007 [cited by applicant]
US 20070184847A1 · Hansen et al. · 2007 [cited by applicant]
US 20080024294A1 · Mazar · 2008 [cited by applicant]
US 20080240983A1 · Harris · 2008 [cited by applicant]
US 20090013311A1 · Ooba et al. · 2009 [cited by applicant]
US 20090058635A1 · LaLonde et al. · 2009 [cited by applicant]
US 20090058636A1 · Gaskill et al. · 2009 [cited by applicant]
US 20090132204A1 · Bodlaender et al. · 2009 [cited by applicant]
US 20090132287A1 · Spivey et al. · 2009 [cited by applicant]
US 20090155921A1 · Lu et al. · 2009 [cited by applicant]
US 20090163832A1 · Sunderani · 2009 [cited by applicant]
US 20090192410A1 · Freeman et al. · 2009 [cited by applicant]
US 20090271066A1 · Underdal et al. · 2009 [cited by applicant]
US 20090292340A1 · Mass et al. · 2009 [cited by applicant]
US 20100045789A1 · Fleming et al. · 2010 [cited by applicant]
US 20100159599A1 · Song et al. · 2010 [cited by applicant]
US 20100185711A1 · Subramaniam · 2010 [cited by applicant]
US 20100257027A1 · Greenberg et al. · 2010 [cited by applicant]
US 20100267049A1 · Rutter et al. · 2010 [cited by applicant]
US 20110015504A1 · Yoo · 2011 [cited by applicant]
US 20110053121A1 · Heaton · 2011 [cited by applicant]
US 20110134203A1 · Smelyansky et al. · 2011 [cited by applicant]
US 20110165688A1 · Dupoteau et al. · 2011 [cited by applicant]
US 20110230743A1 · Inciardi et al. · 2011 [cited by applicant]
US 20110291643A1 · Ravindran et al. · 2011 [cited by applicant]
US 20110293153A1 · Plickert et al. · 2011 [cited by applicant]
US 20110295078A1 · Reid et al. · 2011 [cited by applicant]
US 20110295091A1 · Azer et al. · 2011 [cited by applicant]
US 20110311988A1 · Crawford et al. · 2011 [cited by applicant]
US 20110312011A1 · Valla · 2011 [cited by applicant]
US 20120100557A1 · Fox et al. · 2012 [cited by applicant]
US 20120112908A1 · Prykari et al. · 2012 [cited by applicant]
US 20120232367A1 · Allegri et al. · 2012 [cited by applicant]
US 20130018668A1 · Goldberg et al. · 2013 [cited by applicant]
US 20130066562A1 · Hengstler et al. · 2013 [cited by applicant]
US 20130066563A1 · Hengstler et al. · 2013 [cited by applicant]
US 20130184188A1 · Ewart et al. · 2013 [cited by applicant]
US 20130200140A1 · Kawabata et al. · 2013 [cited by applicant]
US 20130203620A1 · Glezer et al. · 2013 [cited by applicant]
US 20130210163A1 · Hopwood et al. · 2013 [cited by applicant]
US 20130281310A1 · Weidemaier et al. · 2013 [cited by applicant]
US 20140228225A1 · Triener et al. · 2014 [cited by applicant]
US 20140260568A1 · Modzelewski et al. · 2014 [cited by applicant]
US 20140316732A1 · Dupoteau · 2014 [cited by applicant]
US 20150173669A1 · Simon · 2015 [cited by applicant]
US 20150323461A1 · Chan et al. · 2015 [cited by applicant]
US 20170175169A1 · Lee · 2017 [cited by applicant]
US 20180137940A1 · Hengstler et al. · 2018 [cited by applicant]
US 20190229907A1 · Nicolson et al. · 2019 [cited by applicant]
US 20210372985A1 · Hengstler et al. · 2021 [cited by applicant]
US 20220165409A1 · Hengstler et al. · 2022 [cited by applicant]
CN 1329471A · 2002 [cited by applicant]
EP 2787352A · 2014 [cited by applicant]
JP 2016507727A · 2016 [cited by applicant]
WO WO2013052318A1 · 2013 [cited by applicant]
WO WO2011115028A1 · 2013 [cited by applicant]
WO WO2014159672A1 · 2014 [cited by applicant]
WO WO2015008094A1 · 2015 [cited by applicant]
IP Location Finder, “How to find Geolocation of an IP Address?” Nov. 1, 2010; downloaded from http://www.iplocation.net, 3 pages. [cited by applicant]
IP Location, How Do I find a geographical location from an IP Address?, http://www.iplocation.net, Nov. 15, 2010; 2 pages. [cited by applicant]
Martinelli, Nicole, “How Hospitals are Using the iPad”, downloaded from http://www.cultofmac/com/64565/how-hospitals-are-using-the-ipad; Oct. 19, 2010, 4 pages. [cited by applicant]
The Free Dictionary, “Definition of Protocol”, downloaded from http://www.thefreedictionary.com/p/protocol; Jul. 2014, 3 pages. [cited by applicant]
TÜV (Technischer Überwachungs Verein—Süd), “In vitro diagnostic devices directive—Understanding”, (98/79/EC) 2008, in 9 pages. [cited by applicant]
International Search Report and Written Opinion dated Aug. 25, 2017 in International Application No. PCT/US2017/036810. [cited by applicant]