Electronic analyte assaying device
First Claim
1. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:
- a casing having a display;
a lateral flow diagnostic strip having a first end and an opposite second end, wherein at least a portion of said lateral flow diagnostic strip is received in said casing and said lateral flow diagnostic strip first end is configured to receive a fluid sample, said lateral flow diagnostic strip having;
a capture region intermediate said lateral flow diagnostic strip first and second ends,a labeled conjugate comprising a first binding member, configured to be reactive with a first epitope of the analyte in the fluid sample and a detectable label, located proximate said lateral flow diagnostic strip first end,a capturable component comprising of a second binding member configured to be reactive with a second epitope of the analyte located intermediate said labeled conjugate and said capture region, anda capture component located at said lateral flow diagnostic strip capture region,a processor received in said casing;
at least one light source received in said casing and operatively coupled to said processor; and
at least one sensor received in said casing and operatively coupled to said processor, said at least one sensor positioned proximate said lateral flow diagnostic strip so as to sense said capture region;
whereinwhen the fluid sample is received at said lateral flow diagnostic strip first end said labeled conjugate is reconstituted in the sample fluid;
the fluid sample and said reconstituted labeled conjugate move toward said capture region;
said at least one light source, said at least one sensor and said processor are configured to detect a valid fluid front by detecting a persistent presence of said labeled conjugate in the fluid sample as it passes said capture region prior to detecting the presence of the analyte.
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Accused Products
Abstract
The invention is an electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a LCD display. The LCD display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The electronic processing system includes red and green LEDs which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the LCD. If not, No− is displayed on the LCD.
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Citations
23 Claims
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1. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:
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a casing having a display; a lateral flow diagnostic strip having a first end and an opposite second end, wherein at least a portion of said lateral flow diagnostic strip is received in said casing and said lateral flow diagnostic strip first end is configured to receive a fluid sample, said lateral flow diagnostic strip having; a capture region intermediate said lateral flow diagnostic strip first and second ends, a labeled conjugate comprising a first binding member, configured to be reactive with a first epitope of the analyte in the fluid sample and a detectable label, located proximate said lateral flow diagnostic strip first end, a capturable component comprising of a second binding member configured to be reactive with a second epitope of the analyte located intermediate said labeled conjugate and said capture region, and a capture component located at said lateral flow diagnostic strip capture region, a processor received in said casing; at least one light source received in said casing and operatively coupled to said processor; and at least one sensor received in said casing and operatively coupled to said processor, said at least one sensor positioned proximate said lateral flow diagnostic strip so as to sense said capture region; wherein when the fluid sample is received at said lateral flow diagnostic strip first end said labeled conjugate is reconstituted in the sample fluid; the fluid sample and said reconstituted labeled conjugate move toward said capture region; said at least one light source, said at least one sensor and said processor are configured to detect a valid fluid front by detecting a persistent presence of said labeled conjugate in the fluid sample as it passes said capture region prior to detecting the presence of the analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:
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a casing having a display; a lateral flow diagnostic strip having a detectable labeled conjugate and a first end and an opposite second end, wherein said lateral flow diagnostic strip is received in said casing and said lateral flow diagnostic strip first end is configured to receive a fluid sample, said lateral flow diagnostic strip having a capture region intermediate said lateral flow diagnostic strip first and second ends; a processor received in said casing; at least one light source mounted in said casing and operatively coupled to said processor; and at least one sensor mounted in said casing and operatively coupled to said processor, said at least one sensor positioned proximate said lateral flow diagnostic strip so as to sense said capture region; wherein when the fluid sample is received at said lateral flow diagnostic strip first end said detectable labeled conjugate is reconstituted in the sample fluid and moves laterally along said lateral flow diagnostic strip toward said capture region, and said at least one light source, said at least one sensor and said processor are configured to detect a valid fluid front by detecting a presence of said detectable labeled conjugate in the fluid sample as it passes said capture region, said detecting based on a plurality of time spaced measurements of the capture region. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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20. A method of detecting a valid fluid front in a diagnostic device for detecting the presence of an analyte in a fluid sample, said method comprising:
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providing a lateral flow diagnostic strip having a first end configured to receive a fluid sample, said lateral flow diagnostic strip having a capture region and a detectable labeled conjugate proximate said first end, a processor, at least one light source operatively coupled to said processor and positioned proximate said lateral flow diagnostic strip capture region, and at least one sensor operatively coupled to said processor and positioned proximate said lateral flow diagnostic strip capture region; illuminating said lateral flow diagnostic strip capture region with said at least one light source; electronically sensing said lateral flow diagnostic strip capture region with said at least one sensor at at least a first and a second predetermined time; electronically detecting the presence of a valid fluid front by detecting the persistent presence of said detectable labeled conjugate using the capture region sensing at said at least first and second predetermined times prior to detecting the presence of the analyte to determine whether the lateral flow diagnostic strip is operating correctly. - View Dependent Claims (21, 22, 23)
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Specification