IP Library Granted Patent US 12,650,439
Granted Patent B2
US 12,650,439 · App. 17/079,513 · Granted Jun 9, 2026

Medical test strip analysis

Inventor: Clas Sivertsen (Lilburn, GA)
Assignee: ASSAYA LLC
G01N35/00029G01N35/00871G01N2035/00108
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,650,439
App. No.
17/079,513
Granted
Jun 9, 2026
Kind
B2
Abstract

A system having a processor and memory coupled to the processor is provided. The memory stores a local testing database having a test configuration profile with the test configuration profile having an intensity threshold value denoting a positive test result. The system includes a carrier for receiving a cassette containing a lateral flow assay (“LFA”) strip and an LFA strip reader coupled to the processor for reading the LFA strip regardless of alignment of the cassette within the carrier and for transmitting an LFA strip image to the processor. The processor determines an LFA test result based on comparing an intensity value of a portion of the LFA strip image to the intensity threshold value and provides the LFA test result on an indication panel.

Claims (47)

1 . A system comprising:

a processor;

memory coupled to the processor having stored therein a local testing database, the local testing database including a plurality of test configuration profiles, wherein each of the plurality of test configuration profiles specifies an intensity threshold value denoting a positive test result for an associated test type;

a carrier for receiving a cassette containing a lateral flow assay (“LFA”) strip;

an LFA strip reader coupled to the processor for obtaining an LFA strip image, the LFA strip reader obtaining the image of the LFA strip and at least a partial image of the cassette, regardless of alignment of the cassette within the carrier, and transmitting the LFA strip image to the processor;

the processor further configured to determine an LFA test result based on comparing an intensity value of a portion of the LFA strip image to the intensity threshold value for an associated test configuration profile for the test type of the LFA strip; and

the processor further configured to provide the LFA test result on an indication panel.

2 . The system of claim 1 wherein the system further comprises:

a communications interface for communicating with a central patient database; and

the processor further configured to associate the LFA test result and the LFA strip image with a patient identifier and upload the LFA test result and LFA strip image to the central patient database.

3 . The system of claim 1 wherein the indication panel comprises a plurality of indicators for indicating respectively a positive, a negative, or an invalid LFA test result.

4 . The system of claim 1 wherein the LFA strip reader comprises a plurality of LED lights activated based on the test configuration profile and a camera for generating the LFA strip image.

5 . The system of claim 4 , wherein the plurality of LED lights includes LED lights outputting one or more of: visible and ultraviolet light.

6 . The system of claim 1 wherein the system further comprises a light emitting device for sterilizing at least a portion of an area within the carrier that receives the LFA strip.

7 . The system of claim 1 , wherein the carrier is replaceable within the system in order to accommodate a variety of LFA strip cartridges.

8 . The system of claim 2 , wherein the communications interface includes at least one of a mobile data interface, an Ethernet interface, and a WiFi interface.

9 . The system of claim 1 , further comprising:

a provider card reader coupled to the processor for reading a provider identification card and sending provider information to the processor.

10 . A system comprising:

a processor;

memory coupled to the processor for storing having stored therein a local testing database having a plurality of test configuration profiles with each test configuration profile including an intensity threshold value denoting a positive test result for an associated test type;

a carrier for receiving a cassette containing a lateral flow assay (“LFA”) strip; and

an LFA strip reader coupled to the processor for reading the LFA strip, to yield an LFA strip image, and a visual feature of the cassette and transmitting the LFA strip image and the visual feature to the processor;

the processor further configured to identify a first test configuration profile based on the visual feature and determine an LFA test result based on comparing an intensity value of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile for the test type of the LFA strip.

11 . The system of claim 10 wherein the system further comprises:

a communications interface for communicating with a central test database; and

the processor is further configured to determine that the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database; and

the processor is further configured to download from the central test database a test configuration profile for storage in the local testing database.

12 . The system of claim 10 wherein the system further comprises:

a communications interface for communicating with a central patient database;

the processor further to associate the LFA test result and the LFA strip image with a patient identifier and upload the LFA test result and LFA strip image to the central patient database.

13 . The system of claim 10 further comprising:

an indicator panel to provide the LFA test result, wherein the indicator panel comprises a plurality of indicators for indicating a positive, a negative, or an invalid LFA test result.

14 . The system of claim 10 wherein the LFA strip reader comprises a plurality of LED lights and a camera for reading the LFA strip and the visual feature.

15 . The system of claim 14 , wherein the plurality of LED lights includes one or more LED lights generating one or more of: visible and ultraviolet light.

16 . The system of claim 10 wherein the system further comprises a light emitting device for sterilizing at least a portion of an area within the carrier that receives the LFA strip.

17 . The system of claim 10 , wherein the carrier is replaceable within the system in order to accommodate a wide array of LFA strip cartridges.

18 . The system of claim 11 , wherein the communications interface includes at least one of a mobile data interface, an Ethernet interface, and a WiFi interface.

19 . The system of claim 10 , further comprising a provider card reader coupled to the processor for reading a provider identification card and providing provider information to the processor.

20 . A testing device for testing for disease, the testing device comprising:

a processor;

memory coupled to the processor having stored therein a local testing database, the local testing database including a plurality of test configuration profiles for a plurality of diseases, wherein a each of the test configuration profile specifies an intensity threshold value denoting a positive test result for one of the plurality of diseases;

a carrier for receiving a cassette containing a lateral flow assay (“LFA”) strip for a first disease;

an LFA strip reader coupled to the processor for reading the LFA strip, regardless of alignment of the cassette within the carrier, yielding an LFA strip image, and transmitting the LFA strip image to the processor;

the processor further configured to determine an LFA test result based on comparing an intensity value of a portion of the LFA strip image to the intensity threshold value from the test configuration profile for the first disease; and

the processor further configured to provide the LFA test result on an indication panel on the testing device.

21 . The system of claim 1 , further comprising the processor further adjusting the LFA strip image to adjust for any misalignment of the cassette within the carrier.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: SIVERTSEN, CLAS
To: ASSAYA LLC
Reel/Frame 056840/0562 →
Continuity (1)
Related Publication 20240402198A1 · Dec 5, 2024
References Cited (187)
US 5075078A · Osikowicz et al. · 1991 [cited by applicant]
US 5308775A · Donovan et al. · 1994 [cited by applicant]
US 5717778A · Chu et al. · 1998 [cited by applicant]
US 5875258A · Ortyn et al. · 1999 [cited by applicant]
US 5968839A · Blatt et al. · 1999 [cited by applicant]
US 6061128A · Zweig et al. · 2000 [cited by applicant]
US 6267722B1 · Anderson et al. · 2001 [cited by applicant]
US 6394952B1 · Anderson et al. · 2002 [cited by applicant]
US 6664071B1 · Windhab et al. · 2003 [cited by applicant]
US 7177235B2 · Rund · 2007 [cited by applicant]
US 7236428B1 · Morse · 2007 [cited by applicant]
US 7267799B1 · Borich et al. · 2007 [cited by applicant]
US 9702872B1 · Wang et al. · 2017 [cited by applicant]
US 9857372B1 · Pulitzer et al. · 2018 [cited by applicant]
US 9857373B1 · Pulitzer et al. · 2018 [cited by applicant]
US 10197558B1 · Saaski · 2019 [cited by examiner]
US 10823746B1 · Busa et al. · 2020 [cited by applicant]
US 11740203B2 · Galen et al. · 2023 [cited by applicant]
US 11802868B2 · Pulitzer et al. · 2023 [cited by applicant]
US 12094603B2 · Sivertsen · 2024 [cited by applicant]
US 12311065B1 · Miller · 2025 [cited by applicant]
US 20010053336A1 · Hammer · 2001 [cited by examiner]
US 20030021726A1 · Wu et al. · 2003 [cited by applicant]
US 20030040128A1 · Meador et al. · 2003 [cited by applicant]
US 20030120633A1 · Torre-Bueno · 2003 [cited by applicant]
US 20030139903A1 · Zweig et al. · 2003 [cited by applicant]
US 20030143530A1 · Klepp et al. · 2003 [cited by applicant]
US 20040122790A1 · Walker et al. · 2004 [cited by applicant]
US 20050008538A1 · Anderson et al. · 2005 [cited by applicant]
US 20050203353A1 · Ma et al. · 2005 [cited by applicant]
US 20050255001A1 · Padmanabhan et al. · 2005 [cited by applicant]
US 20050255600A1 · Padmanabhan et al. · 2005 [cited by applicant]
US 20060216832A1 · Nishikawa et al. · 2006 [cited by applicant]
US 20060223192A1 · Smith et al. · 2006 [cited by applicant]
US 20060246599A1 · Rosenstein et al. · 2006 [cited by applicant]
US 20060274145A1 · Reiner · 2006 [cited by applicant]
US 20060292040A1 · Wickstead et al. · 2006 [cited by applicant]
US 20070122914A1 · Curry · 2007 [cited by applicant]
US 20080186499A1 · Krauth · 2008 [cited by applicant]
US 20090061450A1 · Hunter · 2009 [cited by applicant]
US 20090074282A1 · Pinard et al. · 2009 [cited by applicant]
US 20090087926A1 · Hasegawa et al. · 2009 [cited by applicant]
US 20090155811A1 · Natan et al. · 2009 [cited by applicant]
US 20090312663A1 · John et al. · 2009 [cited by applicant]
US 20100045789A1 · Fleming et al. · 2010 [cited by applicant]
US 20100099115A1 · Mach et al. · 2010 [cited by applicant]
US 20100105024A1 · Xu et al. · 2010 [cited by applicant]
US 20100135857A1 · Hunter et al. · 2010 [cited by applicant]
US 20100267049A1 · Rutter · 2010 [cited by examiner]
US 20100331651A1 · Groll · 2010 [cited by applicant]
US 20110213564A1 · Henke · 2011 [cited by applicant]
US 20110213579A1 · Henke · 2011 [cited by applicant]
US 20120071342A1 · Lochhead et al. · 2012 [cited by applicant]
US 20120115214A1 · Battrell et al. · 2012 [cited by applicant]
US 20120122236A1 · Tarpey · 2012 [cited by applicant]
US 20120123686A1 · Xiang et al. · 2012 [cited by applicant]
US 20120281970A1 · Garibaldi et al. · 2012 [cited by applicant]
US 20120282154A1 · Slowey et al. · 2012 [cited by applicant]
US 20130203043A1 · Ozcan et al. · 2013 [cited by applicant]
US 20130273645A1 · Waga · 2013 [cited by applicant]
US 20130288254A1 · Pollack et al. · 2013 [cited by applicant]
US 20130338243A1 · Kentsis et al. · 2013 [cited by applicant]
US 20140014720A1 · Sarkis, Jr. et al. · 2014 [cited by applicant]
US 20140017812A1 · Smith et al. · 2014 [cited by applicant]
US 20140018779A1 · Worrell et al. · 2014 [cited by applicant]
US 20140154792A1 · Moynihan et al. · 2014 [cited by applicant]
US 20140227681A1 · Fleming et al. · 2014 [cited by applicant]
US 20140278832A1 · Glavina et al. · 2014 [cited by applicant]
US 20140324373A1 · Xiang et al. · 2014 [cited by applicant]
US 20140339100A1 · Malecha · 2014 [cited by applicant]
US 20150010992A1 · Fleming et al. · 2015 [cited by applicant]
US 20150099306A1 · Ku · 2015 [cited by applicant]
US 20150244852A1 · Erickson et al. · 2015 [cited by applicant]
US 20150310182A1 · Henze et al. · 2015 [cited by applicant]
US 20150338387A1 · Ehrenkranz · 2015 [cited by applicant]
US 20150350605A1 · Price et al. · 2015 [cited by applicant]
US 20160030613A1 · Paul et al. · 2016 [cited by applicant]
US 20160085913A1 · Evans et al. · 2016 [cited by applicant]
US 20160131645A1 · Wang · 2016 [cited by applicant]
US 20160157598A1 · Anelevitz · 2016 [cited by applicant]
US 20160178607A1 · Husheer et al. · 2016 [cited by applicant]
US 20160188937A1 · Tyrrell et al. · 2016 [cited by applicant]
US 20160265032A1 · Sethi et al. · 2016 [cited by applicant]
US 20160356800A1 · Glavina et al. · 2016 [cited by applicant]
US 20160356801A1 · Glavina et al. · 2016 [cited by applicant]
US 20160370366A1 · Fleming et al. · 2016 [cited by applicant]
US 20170049915A1 · Brais et al. · 2017 [cited by applicant]
US 20170160258A1 · Hengstler et al. · 2017 [cited by applicant]
US 20170184586A1 · Hopper · 2017 [cited by applicant]
US 20180031551A1 · Karlovac et al. · 2018 [cited by applicant]
US 20180052916A1 · Abebe et al. · 2018 [cited by applicant]
US 20180071741A1 · Kelly et al. · 2018 [cited by applicant]
US 20180106789A1 · Pulitzer et al. · 2018 [cited by applicant]
US 20180107790A1 · Pulitzer et al. · 2018 [cited by applicant]
US 20180149600A1 · Farrell · 2018 [cited by applicant]
US 20180164222A1 · Pulitzer et al. · 2018 [cited by applicant]
US 20180246038A1 · Hunter · 2018 [cited by applicant]
US 20180259449A1 · Poulsen et al. · 2018 [cited by applicant]
US 20180293350A1 · Dimov et al. · 2018 [cited by applicant]
US 20180348198A1 · Broadwell · 2018 [cited by applicant]
US 20180372734A1 · Pfenninger et al. · 2018 [cited by applicant]
US 20190070324A1 · Hardin et al. · 2019 [cited by applicant]
US 20190096516A1 · Pulitzer et al. · 2019 [cited by applicant]
US 20190122768A1 · Pulitzer et al. · 2019 [cited by applicant]
US 20190224685A1 · Benenati · 2019 [cited by applicant]
US 20190229907A1 · Nicolson et al. · 2019 [cited by applicant]
US 20190267822A1 · Voit et al. · 2019 [cited by applicant]
US 20190317115A1 · Maclean et al. · 2019 [cited by applicant]
US 20190339264A1 · Gary et al. · 2019 [cited by applicant]
US 20190369094A1 · Ishikawa et al. · 2019 [cited by applicant]
US 20200217835A1 · Darmstadt et al. · 2020 [cited by applicant]
US 20200330979A1 · Cyr et al. · 2020 [cited by applicant]
US 20200386753A1 · Somes et al. · 2020 [cited by applicant]
US 20200408715A1 · Galen et al. · 2020 [cited by applicant]
US 20210086177A1 · Lin · 2021 [cited by applicant]
US 20210132035A1 · Adelman · 2021 [cited by applicant]
US 20210172945A1 · Armbruster et al. · 2021 [cited by applicant]
US 20210263018A1 · Taran · 2021 [cited by applicant]
US 20210293688A1 · Chang et al. · 2021 [cited by applicant]
US 20210319911A1 · Hall et al. · 2021 [cited by applicant]
US 20210327056A1 · Needham et al. · 2021 [cited by applicant]
US 20210389233A1 · Hatamian · 2021 [cited by applicant]
US 20220091114A1 · Levin et al. · 2022 [cited by applicant]
US 20220178920A1 · Howard · 2022 [cited by applicant]
US 20220254027A1 · Lin et al. · 2022 [cited by applicant]
US 20220254133A1 · Adsul et al. · 2022 [cited by applicant]
US 20220258155A1 · Ren et al. · 2022 [cited by applicant]
US 20220296755A1 · Wurmfeld et al. · 2022 [cited by applicant]
US 20220304560A1 · Jackson et al. · 2022 [cited by applicant]
US 20220399109A1 · Sivertsen · 2022 [cited by applicant]
US 20220404354A1 · Robinson et al. · 2022 [cited by applicant]
US 20220405551A1 · Jain et al. · 2022 [cited by applicant]
US 20220412961A1 · Jolly et al. · 2022 [cited by applicant]
US 20230213452A1 · Minobe et al. · 2023 [cited by applicant]
US 20230274538A1 · Sia et al. · 2023 [cited by applicant]
US 20230351754A1 · Satish et al. · 2023 [cited by applicant]
US 20240363206A1 · Mayer · 2024 [cited by applicant]
US 20240387010A1 · Sivertsen et al. · 2024 [cited by applicant]
US 20240402198A1 · Sivertsen · 2024 [cited by applicant]
US 20240404658A1 · Sivertsen et al. · 2024 [cited by applicant]
US 20240412829A1 · Sivertsen · 2024 [cited by examiner]
US 20240424160A1 · Sivertsen et al. · 2024 [cited by applicant]
US 20240428905A1 · Sivertsen · 2024 [cited by applicant]
CN 102482702A · 2012 [cited by applicant]
CN 102539735A · 2012 [cited by applicant]
CN 104838383A · 2015 [cited by applicant]
CN 105022911A · 2015 [cited by applicant]
CN 106680496A · 2017 [cited by applicant]
CN 110312935A · 2019 [cited by applicant]
CN 211086092U · 2020 [cited by applicant]
EP 2839264A1 · 2015 [cited by applicant]
TW 201833554A · 2018 [cited by applicant]
TW M588797U · 2020 [cited by applicant]
WO 2013119266A1 · 2013 [cited by applicant]
WO 2013158504A1 · 2013 [cited by applicant]
WO 2020174895A1 · 2020 [cited by applicant]
WO 2020251460A1 · 2020 [cited by applicant]
Anfossi et al., Multiplex Lateral Flow Immunoassay: An Overview of Strategies towards High-throughput Point-of-Need Testing, Biosensors (Basel). Mar. 2019; 9(1): 2. (Year: 2018). [cited by applicant]
AssayGenie, Rapid covid19 antibody detection test principles and methods, published: 2020, https://www.assaygenie.com/rapid-covid 19-antibody-detection-tests-principles-and-methods (Year: 2020). [cited by applicant]
Azzi et al, Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study, Journal of Infection, vol. 81, Issue 3, Sep. 2020, pp. e75-e78 (Year: 2020). [cited by applicant]
Badi et al., The Effect of Gold Salt Concentration in the Production of Gold Nanospheres, Jan. 2020, Journal of Applied Mathematics and Physics (Year: 2020). [cited by applicant]
Baker et al., The SARS-COV-2 Spike Protein Binds Sialic Acids and Enables Rapid Detection in a Lateral Flow Point of Care Diagnostic Device, 2020, vol. 6, 2046-2052 (Year: 2020). [cited by applicant]
Contreras-Aguilar, Changes in Saliva Analytes in Dairy Cows during Peripartum: A Pilot Study, Mar. 9, 2021, Animals, vol. 11, issues 3 (Year: 2021). [cited by applicant]
Independent Forensics, Developmental Validation of RSID-Urine, Mar. 2021, Independent Forensics, https://www.ifi-test.com/rsid-urine/ (Year: 2021). [cited by applicant]
Larsen et al., Fluorometric determination of uric acid in bovine milk, 2010, Journal of Dairy Research, vol. 77, 438-444 (Year: 2010). [cited by applicant]
Old et al., Developmental Validation of RSIDTM-Saliva: A Lateral Flow Immunochromatographic Strip Test for the Forensic Detection of Saliva, J Forensic Sci, Jul. 2009, vol. 54, No. 4 (Year: 2009). [cited by applicant]
Richardson et al., Amylase in Cow's Milk, 1936, Journal of Dairy Science, vol. 19, Issue 12, 761-772 (Year: 1936). [cited by applicant]
Stattechnologies, Adulteration Test Strips, 2017, StatTechnologies, https://stat-technologies.com/product/adulteration-test-strips/ (Year: 2017). [cited by applicant]
Stuart Patton, Some Practical Implications of the Milk Mucins, 1999, Journal of Dairy Science, vol. 82, Issue 6, 1115-1117 (Year:1999). [cited by applicant]
Thao et al. (American Clinical Society, 2017, p. 6781-6786). [cited by applicant]
Zhou et al. Paper electrode integrated lateral flow immunosensor for quantitative analysis of oxidative stress induced DNA damage, 2014, Analyst, 139(11), 2850-2857 (Year: 2014). [cited by applicant]
Correa, M. E. et al, Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health 2017, 750-53. (Year: 2017). [cited by applicant]
De Silva, D. A. et al, Journal of Obstetrics and Gynaecology Canada 2014, 36, 605-612. (Year: 2014). [cited by applicant]
Filippini, D. et al, Analyst 2006, 131, 111-117. (Year: 2006). [cited by applicant]
Hou, Y. et al, Nanoscale Research Letters 2017, 12, paper 291, 13 pages. (Year: 2017). [cited by applicant]
Lin, C.-S. et al, Optik 2004, 115, 363-369. (Year: 2004). [cited by applicant]
Magiati, M. et al, Microchimica Acta 2018, 185, paper 314, 9 pages. (Year: 2018). [cited by applicant]
O'Farrell, B., in Lateral Flow Immunoassay 2009, Wong, R. C. et al. (eds.), Humana Press, New York, 1-33. (Year: 2009). [cited by applicant]
Panic, G. et al, Parasites & Vectors 2019, 12, paper 298, 7 pages. (Year: 2019). [cited by applicant]
Tucker, K. et al, Pregnancy Hypertension 2018, 12, 161-168. (Year: 2018). [cited by applicant]
Urusov AE et al. (2019) Towards Lateral Flow Quantitative Assays: Detection Approaches. Biosensors, 9(3), 16 pgs; https://doi.org/10.3390/bios9030089 (Year: 2019). [cited by applicant]
Waters, L. C. et al, Journal of Hazardous Materials 1995, 43, 1-12. (Year: 1995). [cited by applicant]
Waugh, J. J. S. et al, BJOG: an International Journal of Obstetrics and Gynaecology 2005, 112, 412-417. (Year: 2005). [cited by applicant]
Xu, Y. et al, Analytical Chemistry 2018, 90, 708-715 with 13 pages of supporting information. (Year: 2018). [cited by applicant]
Grant et al. (May 7, 2020, Intellectual Ventures Lab, p. 1-11). [cited by applicant]
Office Action, TW App. No. 113101211, Jul. 29, 2024, 18 pages (09 pages of English Translation and 09 pages of Original Document). [cited by applicant]
First Office Action, CN App. No. 202110214133.9, Jan. 8, 2026, 22 pages (12 pages of English Translation and 10 pages of Original Document). [cited by applicant]