Lateral flow assay machine testing quality verification

A method comprising:

• maintaining a local testing database in a memory having stored thereon a test configuration profile for a cassette having a lateral flow assay (“LFA”) strip having a test line, the test configuration profile including an intensity threshold value for the test line that represents an intensity value which indicates a positive test result;
• reading the test line of the LFA strip using an LFA strip reader;
• determining an LFA test result based on comparing a measured intensity value of a portion of the test line from the LFA strip reader to the intensity threshold value of the test line from the memory, subsequent to a sample being added to the LFA test strip;
• receiving an operator-provided result at an operator interface on a display, the operator-provided result indicating whether the sample on the LFA strip results in one of a positive test result or a negative test result, wherein receiving the operator-provided result from the operator interface occurs without first displaying the LFA test result on the operator interface;
• analyzing the LFA test result and the operator-provided result to yield a comparison between the LFA test result and the operator-provided result;
• and
• storing a result of the comparison in the memory.

A system comprising:

• a local testing database having stored thereon a test configuration profile for a cassette having a lateral flow assay (“LFA”) strip having a test line, the test configuration profile including an intensity threshold value for the test line that represents an intensity value which indicates a positive test result;
• an LFA strip reader for reading the test line of the LFA strip;
• a programmable data processing apparatus, in communication with the LFA strip reader and the local testing database, configured to determine an LFA test result based on comparing a measured intensity value of a portion of the test line from the LFA strip reader to the intensity threshold value from the test configuration profile;
• the programmable data processing apparatus further configured to display an operator interface on a display connected to the programmable data processing apparatus for receiving an operator-provided result, the operator-provided result indicating whether the LFA strip has one of a positive test result or a negative test result, wherein receiving the operator-provided result from the operator interface occurs without first displaying the LFA test result on the operator interface;
• and
• the programmable data processing apparatus further configured to store the LFA test result and the operator-provided result in a result database connected to the programmable data processing apparatus.

A system comprising:

• a memory having stored therein a local testing database having a test configuration profile for a cassette having a lateral flow assay (LFA) strip with a test line, the test configuration profile including an intensity threshold value for the test line representing an intensity value which indicates a positive test result;
• an LFA strip reader configured to read the test line of the LFA strip;
• a programmable data processing apparatus configured by executable instructions stored in the memory to:
• receive image data from the LFA strip reader,
• compare a measured intensity value of the test line to the intensity threshold value,
• determine an LFA test result based on the comparison of the measured intensity value of the test line to the intensity threshold value,
• receive, from an operator interface on a display connected to the programmable data processing apparatus, an operator-provided result indicating a positive or negative test result, the operator-provided result being received without first displaying the LFA test result to an operator on the operator interface, and
• compare the LFA test result and the operator-provided result to generate a comparison outcome;
• a result database in the memory connected to the programmable data processing apparatus;
• and
• the programmable data processing apparatus further configured to store the comparison outcome in a the result database.