Method of processing assay test results

• US 7,214,542 B2
• Filed: 01/30/2003
• Issued: 05/08/2007
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Michael Hutchinson
• Original Assignee: Michael Hutchinson
• Inventors: Hutchinson, Michael
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Cheu; Jacob
• Application Number:
  US10/356,452
• Publication Number:
  US 20040152208A1
• Time in Patent Office: 1,559 Days
• Field of Search: 436/164, 436/514, 436/50, 436/55, 435/7.1, 435/7.92, 435/288.7, 422/58, 422/67
• US Class Current: 436/164
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/12 Condition responsive control

Abstract

In accordance with certain disclosed embodiments of the present invention, there is provided a method of analyzing assay test results for determining whether a fluid under test contains a certain substance. The disclosed method includes detecting the certain substance in the fluid under test received on a test strip, and generating an electrical signal indicative of the amount of the substance detected. The disclosed method further includes responding to the signal, and determining whether or not the fluid under test contains a predetermined quantity of the certain substance to generate an electric output signal. The method disclosed also includes responding to the output signal to indicate the presence or absence of a predetermined quantity of the certain substance contained within the fluid under test. The disclosed method includes delaying in the detecting until after a predetermined time delay interval, and storing the detected information at the completion of the time delay interval. The stored information is compared with stored threshold electric signals to determine whether or not the fluid under test contains a predetermined quantity of the certain substance.

Claims

1. A method of testing a fluid sample to determine whether or not it contains a certain substance, comprising:

using an assay test device having sample and reaction sensors mounted within a housing;

storing a predetermined threshold range for readings of the sample and reaction sensors indicative of a desired amount of light within the housing prior to introduction of the fluid sample;

using the sample sensor to determine an initial sample sensor reading;

using the reaction sensor to determine an initial reaction sensor reading;

storing the initial readings of the sample and reaction sensors;

comparing the initial sample sensor reading to the predetermined threshold range;

determining in response to the comparing the initial sample sensor reading to the predetermined threshold range whether or not the initial sample sensor reading is acceptable;

comparing the initial reaction sensor reading to the predetermined threshold range;

determining in response to the comparing the initial reaction sensor reading to the predetermined threshold range whether or not the initial reaction sensor reading is acceptable;

generating a signal in response to either determining step finding an unacceptable initial reading to alert the user that the test device is faulty;

flowing the fluid sample along an elongated test strip;

using the sample sensor spaced from the test strip to detect the presence of the fluid sample using the light reflecting from a first location on the test strip;

starting a timer for a predetermined time delay interval in response to the sample sensor detecting the fluid sample under test being received at the first location on the test strip;

generating an electric time-out signal at the end of the predetermined time delay interval started by the sample sensor;

using the reaction sensor remote from the sample sensor starting the time delay interval for detecting the fluid sample under test at a second location on the test strip in response to the time-out signal at the end of the time delay interval started by the sample sensor;

determining whether or not the fluid sample under test at the second location on the test strip contains a predetermined quantity of the certain substance in response to the reaction sensor detecting the fluid sample under test;

generating an electric output signal in response to the determination in the reaction sensor; and

indicating the presence or absence of a predetermined quantity of the certain substance contained within the fluid sample under test,

wherein the sample sensor and the reaction sensor are photo-optic sensors.

2. The method according to claim 1, wherein said timer is a software timer.

3. The method according to claim 1, wherein said time delay interval is about three minutes.

4. The method according to claim 1, wherein said determining step in response to reaction sensor for a predetermined quantity of the certain substance includes initiating a photo optic sensing of the results of a reaction on the test strip.

5. The method according to claim 1, wherein said indicating step includes initiating the illumination of a light source.

6. The method according to claim 5, wherein said light source is at least one light emitting diode.

7. The method according to claim 1, further including monitoring to determine if a power up signal is received to start a test operation.

8. The method according to claim 7, further including illuminating a light source indicating that the test is ready to commence.

9. The method according to claim 8, wherein said illumination changes to a blinking mode after a predetermined time delay interval indicating that the test sample should be introduced to the test strip prior to exhaustion of a battery.

10. The method according to claim 7, further including initially reading the sample sensor and the reaction sensor after a light adaptation time interval for threshold determination purposes.

11. The method according to claim 1, further including determining whether the sample sensor readings exceeds a predetermined threshold.

12. The method according to claim 1, further including determining whether the reaction sensor readings exceed a predetermined reaction sensor threshold.

13. The method according to claim 11, further including starting the timer when it is determined that the sample sensor readings exceed the predetermined sample sensor threshold.

14. The method according to claim 12, further including determining whether or not the fluid under test contains a predetermined quantity of the certain substance after the determination is made of the reaction sensor readings exceed the reaction sensor threshold.

15. The method according to claim 14, further including illuminating at least one light source indicating a positive test result in response to the reaction sensor determination.

16. The method according to claim 14, further including illuminating at least one light source indicating a negative test result in response to the reaction sensor determination.