Point of care diagnostic systems
First Claim
1. A method for determining a risk or identifying a condition associated with the presence of fetal fibronectin (fFN) in a cervicovaginal sample, comprising:
- obtaining a cervicovaginal sample and reacting it with an antibody on a lateral flow test device to produce an image on the test device indicative of the presence of fFN in the sample;
moving a reader head in a reflectance reader to a position over the test device;
measuring a first amount of light reflected from a surface that comprises the image;
uniformly illuminating the surface with light of a first wavelength, and measuring a second amount of light reflected from the surface;
uniformly illuminating the surface with light of a second wavelength, and measuring a third amount of light reflected from the surface; and
repeating each of the measuring and illuminating steps at additional positions on the surface until the surface of the test device that comprises the image is scanned, thereby providing data to determine the intensity and shape of the image to indicate the presence or amount of fFN in the sample.
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Accused Products
Abstract
Systems and methods for medical diagnosis or risk assessment for a patient are provided. These systems and methods are designed to be employed at the point of care, such as in emergency rooms and operating rooms, or in any situation in which a rapid and accurate result is desired. The systems and methods process patient data, particularly data from point of care diagnostic tests or assays, including immunoassays, electrocardiograms, X-rays and other such tests, and provide an indication of a medical condition or risk or absence thereof. The systems include an instrument for reading or evaluating the test data and software for converting the data into diagnostic or risk assessment information.
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Citations
19 Claims
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1. A method for determining a risk or identifying a condition associated with the presence of fetal fibronectin (fFN) in a cervicovaginal sample, comprising:
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obtaining a cervicovaginal sample and reacting it with an antibody on a lateral flow test device to produce an image on the test device indicative of the presence of fFN in the sample;
moving a reader head in a reflectance reader to a position over the test device;
measuring a first amount of light reflected from a surface that comprises the image;
uniformly illuminating the surface with light of a first wavelength, and measuring a second amount of light reflected from the surface;
uniformly illuminating the surface with light of a second wavelength, and measuring a third amount of light reflected from the surface; and
repeating each of the measuring and illuminating steps at additional positions on the surface until the surface of the test device that comprises the image is scanned, thereby providing data to determine the intensity and shape of the image to indicate the presence or amount of fFN in the sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 17, 18, 19)
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10. A method for determining a risk or identifying a condition associated with the presence of fetal fibronectin (fFN) in a cervicovaginal sample, comprising:
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obtaining a cervicovaginal sample and reacting it with an antibody on a lateral flow test device to produce an image comprising a stripe on the test device indicative of the presence of fFN in the sample;
moving a reader head in a reflectance reader to a position over the test device;
measuring a first amount of light reflected from the surface that comprises the image;
transmitting light of a first wavelength onto the surface at an angle normal to the surface, and measuring a second amount of light reflected normally from the surface;
transmitting light of a second wavelength onto the surface at an angle normal to the surface, and measuring a third amount of light reflected normally from the surface;
repeating each of the moving, transmitting and measuring steps at additional positions on the surface until the surface of the test device that comprises the image is scanned to obtain measurement data indicative of the presence or amount of fFN in the sample.
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11. A method for determining a risk or identifying a condition associated with the presence of fetal fibronectin (fFN) in a cervicovaginal sample, comprising:
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obtaining a cervicovaginal sample and reacting it with an antibody on a lateral flow test device to produce an image on the test device indicative of the presence of fFN in the sample;
with a reader head in a reflectance reader at a position over the test device, measuring a first amount of light reflected from the position of the surface that comprises the image;
transmitting light of a first wavelength onto the position of the surface at an angle normal to the surface, and measuring a second amount of light reflected normally from the surface;
transmitting light of a second wavelength onto the position of the surface at an angle normal to the surface, and measuring a third amount of light reflected normally from the surface;
moving the reader head in a stepwise fashion to a plurality of positions over the test device, wherein three light measurements are made at each of the plurality of positions, whereby the device is scanned and and data indicative of the presence or amount of fFN in the sample is obtained.
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Specification