Granted Patent B2

US 12,656,331 · App. 17/352,061 · Granted Jun 16, 2026

Inventors: Clas Sivertsen (Lilburn, GA); Tom Sivertsen (Kristiansund, NO); Roy Larsen (Kristiansund, NO)

Assignee: Assaya LLC

G01N33/48771

Abstract

Claims (55)

1 . A method comprising:

storing in a memory a local testing database having a test configuration profile, with the test configuration profile having an equivalence curve that associates an intensity value with a standardized test result, wherein the equivalence curve associates a plurality of intensity values with a plurality of equivalent cycle time (“eCt”) values;

receiving a lateral flow assay (“LFA”) strip of a user to obtain a result value for the user from the LFA strip;

reading the lateral flow assay (“LFA”) strip using an LFA reader coupled to a processor to obtain an LFA strip image, the reading performed during a testing process to determine the result value for the user from the LFA strip;

transmitting the LFA strip image to the processor;

determining the result value for the LFA strip image by the processor, during the testing process, based on an intensity value of a portion of the LFA strip image using the equivalence curve in the memory, wherein using the equivalence curve comprises matching the intensity value of the portion of the LFA strip image with one of the plurality of intensity values of the equivalence curve to convert the matched intensity value to an eCt result value associated with the matched one of the plurality of intensity values.

2 . The method of claim 1 further comprising:

communicating with a central patient database using a communications interface;

reading a patient identifier using an identity collection accessory;

associating the result value with the patient identifier; and

uploading the result value to the central patient database.

3 . The method of claim 1 , wherein the standardized test result is a value that corresponds to a cycle time of a polymerase chain reaction (PCR) testing.

4 . The method of claim 1 wherein the reading is performed by an LFA strip reader comprises a plurality of LED lights activated based on the test configuration profile and a camera for reading the LFA strip and generating the LFA strip image.

5 . The method of claim 4 , wherein the plurality of LED lights includes visible and ultraviolet light.

6 . The method of claim 1 further comprising: sterilizing at least a portion of an area within a carrier that receives the LFA strip using a light emitting device.

7 . The method of claim 1 , further comprising:

building the equivalence curve for the LFA strip, the building comprising:

receiving, by the processor, test information for the LFA strip, receiving, by the processor, the LFA strip image;

receiving, by the processor, a known concentration of a viral load placed onto the LFA strip;

associating, by the processor, an intensity of a portion of the LFA strip image with the known concentration of the viral load placed onto the LFA strip and a standardized value;

repeating, by the processor, one or more previous steps until the equivalence curve is created.

8 . The method of claim 1 wherein the LFA strip image comprises a plurality of columns, and the intensity value is determined by calculating a maximum median value of an intensity of pixels for each column of the plurality of columns.

9 . A method, comprising:

receiving a lateral flow assay (“LFA”) strip of a user to obtain a result value for the user from the LFA strip;

reading the lateral flow assay (“LFA”) strip, using an imaging device, to generate an LFA strip image including a test line comprising a plurality of columns, the reading performed during a testing process to determine the result value for the user from the LFA strip;

determining, using a processor, during the testing process, a standardized test result based on an intensity value of a portion of the LFA strip image using an equivalence curve stored in a memory, wherein the equivalence curve associates a plurality of intensity values with a plurality of equivalent cycle time (“eCt”) values, wherein using the equivalence curve comprises matching the intensity value of the portion of the LFA strip image with one of the plurality of intensity values of the equivalence curve to convert the matched intensity value to an eCt result value associated with the matched one of the plurality of intensity values; and

providing, using the processor, the standardized test result.

10 . The method of claim 9 , wherein the intensity value is determined, using the processor, by calculating a maximum median value of an intensity of pixels for each column of the plurality of columns.

11 . The method of claim 10 , wherein reading the LFA strip further comprises generating a plurality of LFA strip images.

12 . The method of claim 11 , wherein determining, using the processor, the standardized test result based on the intensity value further comprises determining a median value of the maximum median value of each of the plurality of LFA strip images.

13 . The method of claim 9 , further comprising:

associating the standardized test result with a patient identifier; and

sending to a central patient database the standardized test result associated with the patient identifier.

14 . The method of claim 9 wherein the standardized test result is a value that corresponds to a cycle time of a polymerase chain reaction (PCR) testing.

15 . The method of claim 9 further comprising:

building the equivalence curve for the LFA strip, the building comprising:

receiving, by the processor, test information for the LFA strip,

receiving, by the processor, the LFA strip image;

receiving, by the processor, a known concentration of a viral load placed onto the LFA strip;

associating, by the processor, an intensity of a portion of the LFA strip image with the known concentration of the viral load placed onto the LFA strip and a standardized value;

repeating, by the processor, one or more previous steps until the equivalence curve is created.

16 . The method of claim 9 , wherein the processor is in a testing device and the equivalence curve is used by the processor to convert intensity measurements of the test line to an equivalent, standardized result.

17 . A method comprising:

building an equivalence curve for a lateral flow assay (“LFA”) strip, comprising:

receiving, by a processor, test information for the LFA strip,

receiving, by the processor, an image of the LFA strip;

receiving, by the processor, a known concentration of a viral load placed onto the LFA strip;

associating, by the processor, an intensity of a portion of the image of the LFA strip with the known concentration of the viral load placed onto the LFA strip and a standardized value;

repeating one or more previous steps, by the processor, using varying concentrations of viral load, until the equivalence curve is created; and

storing the equivalence curve in a memory;

receiving a second lateral flow assay (“LFA”) strip of a user to obtain a result value for the user from the LFA strip;

reading the second lateral flow assay (“LFA”) strip, using an imaging device, to generate an LFA strip image including a test line;

determining, using the processor, a result for the LFA strip image based on an intensity value of a portion of the LFA strip image using the equivalence curve that associates an intensity value with a standardized test result to generate the result value for the user, wherein the equivalence curve that associates an intensity value with a standardized test result comprises an equivalence curve that associates a plurality of intensity values with a plurality of equivalent cycle time (“eCt values”), and wherein using the equivalence curve comprises matching the intensity value of the portion of the LFA strip image with one of the plurality of intensity values of the equivalence curve to generate an eCt value associated with the matched one of the plurality of intensity values.

18 . The method of claim 17 , wherein the standardized value corresponds to a cycle time equivalent of a polymerase chain reaction (PCR) testing.

19 . The method of claim 17 , wherein the equivalence curve is created through linear regression.

Assignments (1)

Continuity (1)

References Cited (181)