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US 2025/0052747 A1Published application
Biofluid-based diagnostic screening system and methods of use
AssigneeCellectGen, Inc.
InventorsRobert Gellibolian, Adam Markaryan
Life of this patent
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Abstract
A biofluid-based diagnostic screening system and associated methods are disclosed for screening a volume of biofluid of a patient for an at least one medical condition. In at least one embodiment, the system provides a lateral flow test strip, a test housing sized and configured for removably receiving the test strip therewithin, and a user application residing locally in memory on an imaging device and configured for screening a volume of biofluid of a patient, as deposited on the test strip, for an at least one medical condition.
Claims20
A biofluid-based diagnostic screening system configured for screening a volume of biofluid of a patient for an at least one medical condition, the system comprising:
- a lateral flow test strip providing a rigid backing on which is positioned:
- an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid;
- a corresponding at least one detection zone containing an at least one biological component for detecting a presence or absence of an at least one target analyte in the volume of the patient's biofluid, the at least one biological component immobilized and arrayed into each of a test line and a control line within said detection zone;
- and
- an identification code that identifies a test type to be performed on the volume of the patient's biofluid by the system using the test strip;
- a test housing sized and configured for removably receiving the test strip therewithin, the test housing comprising:
- a substantially planar top panel configured for temporarily supporting an imaging device thereon;
- an opposing, substantially planar bottom panel;
- a sidewall extending vertically between the top and bottom panels, along a perimeter edge of the top and bottom panels, the top panel, bottom panel and sidewall cooperating to form an enclosed space within the test housing;
- a strip placeholder positioned on an upper surface of the bottom panel and configured for assisting in the proper positioning of the test strip within the test housing;
- an upper surface of the top panel providing an imaging aperture positioned so as to be substantially vertically aligned with the at least one detection zone of the test strip when the test strip is positioned on the strip placeholder within the test housing, the imaging aperture sized for providing an image capture device of the imaging device visual access into the enclosed space within the test housing;
- and
- an at least one image calibration indicia positioned on the upper surface of the bottom panel or the backing of the test strip, the image calibration indicia configured for assisting with a calibration of the image capture device of the imaging device;
- and
- a user application residing locally in memory on the imaging device, the user application configured for, upon an appropriate volume of the patient's biofluid being deposited onto the at least one sample pad of the test strip, the test strip subsequently being positioned on the strip placeholder within the test housing, and the imaging device being positioned on the upper surface of the top panel of the test housing so that the image capture device is positioned over the imaging aperture of the top panel:
- capturing an image of the identification code of the test strip using the image capture device of the imaging device;
- determining the at least one test type to be performed on the volume of the patient's biofluid based on the captured image of the identification code;
- obtaining a local temperature relative to the imaging device;
- setting an appropriate calibration curve metric and a timer duration for each of the at least one test type, based on the at least one target analyte of the at least one test type as a function of the local temperature;
- and
- for each of the at least one test type to be performed on the volume of the patient's biofluid, upon the associated timer duration being reached for said test type:
- capturing, via the image capture device of the imaging device, at least one image of the corresponding at least one detection zone of the test strip and the image calibration indicia;
- adjusting a white balance of the captured at least one image of said detection zone based on the image calibration indicia;
- calculating a pixel density value of the test line of said detection zone, based on an intensity of said test line depicted in the at least one image;
- obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone;
- and
- communicating the obtained analyte concentration value to at least one of the patient or a medical service provider of the patient.
24 more elements
A biofluid-based diagnostic screening system configured for screening a volume of biofluid of a patient for an at least one medical condition, the system comprising:
- a lateral flow test strip providing a rigid backing on which is positioned:
- an at least one sample pad configured for receiving and absorbing a volume of the patient's biofluid;
- a corresponding at least one detection zone containing an at least one biological component for detecting a presence or absence of an at least one target analyte in the volume of the patient's biofluid, the at least one biological component immobilized and arrayed into each of a test line and a control line within said detection zone;
- and
- an identification code that identifies a test type to be performed on the volume of the patient's biofluid by the system using the test strip;
- a biofluid collection device configured for collecting a volume of the patient's biofluid and subsequently depositing an appropriate volume of the biofluid onto the at least one sample pad of the test strip;
- a test housing sized and configured for removably receiving the test strip therewithin, the test housing comprising:
- a substantially planar top panel configured for temporarily supporting an imaging device thereon;
- an opposing, substantially planar bottom panel;
- a sidewall extending vertically between the top and bottom panels, along a perimeter edge of the top and bottom panels, the top panel, bottom panel and sidewall cooperating to form an enclosed space within the test housing;
- a strip placeholder positioned on an upper surface of the bottom panel and configured for assisting in the proper positioning of the test strip within the test housing;
- an upper surface of the top panel providing an imaging aperture positioned so as to be substantially vertically aligned with the at least one detection zone of the test strip when the test strip is positioned on the strip placeholder within the test housing, the imaging aperture sized for providing an image capture device of the imaging device visual access into the enclosed space within the test housing;
- and
- an at least one image calibration indicia positioned on the upper surface of the bottom panel or the backing of the test strip, the image calibration indicia configured for assisting with a calibration of the image capture device of the imaging device;
- and
- a user application residing locally in memory on the imaging device, the user application configured for, upon an appropriate volume of the patient's biofluid being deposited onto the at least one sample pad of the test strip, the test strip subsequently being positioned on the strip placeholder within the test housing, and the imaging device being positioned on the upper surface of the top panel of the test housing so that the image capture device is positioned over the imaging aperture of the top panel:
- capturing an image of the identification code of the test strip using the image capture device of the imaging device;
- determining the at least one test type to be performed on the volume of the patient's biofluid based on the captured image of the identification code;
- obtaining a local temperature relative to the imaging device;
- setting an appropriate calibration curve metric and a timer duration for each of the at least one test type, based on the at least one target analyte of the at least one test type as a function of the local temperature;
- and
- for each of the at least one test type to be performed on the volume of the patient's biofluid, upon the associated timer duration being reached for said test type:
- capturing, via the image capture device of the imaging device, at least one image of the corresponding at least one detection zone of the test strip and the image calibration indicia;
- adjusting a white balance of the captured at least one image of said detection zone based on the image calibration indicia;
- calculating a pixel density value of the test line of said detection zone, based on an intensity of said test line depicted in the at least one image;
- obtaining an analyte concentration value corresponding to the pixel density value of the test line of said detection zone;
- and
- communicating the obtained analyte concentration value to at least one of the patient or a medical service provider of the patient.
25 more elements
Dependencies are inferred from the claim text.