Point of care diagnostic systems

• US 20060014302A1
• Filed: 09/02/2005
• Published: 01/19/2006
• Est. Priority Date: 02/03/1998
• Status: Abandoned Application

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Hussa, Robert, Senyei, Andrew, Anderson, Emory V., Marzolf, Gail, Nemec, Edward, Martinez, Ricardo R., Pong, Ronald, Jones, Lynn, Lapointe, Jerome P., Desieno, Duane
• Application Number:
  US11/219,216
• Publication Number:
  US 20060014302A1
• Time in Patent Office: Days
• US Class Current: 436/518
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2333/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10S 436/814 Pregnancy

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.

Claims

1. A method for determining results from an immunoassay, comprising:

(a) testing a patient sample for the presence of a target analyte indicative of a condition or risk of having the condition by reacting the sample with antibodies specific for the analyte in a sandwich assay performed on a test strip, in which one of the antibodies is labeled with a detectable label; and

(b) detecting a reflectance signal produced by the label in a reflectance reader, wherein;

the reflectance reader includes a reader head that comprises;

(i) a reader head body;

(ii) a light emitting diode (LED);

(iii) a first fiberoptic bundle optically coupled to the light emitting diode;

(iv) a photodetector;

(v) a second fiberoptic bundle optically coupled to the photodetector; and

(vi) an aperture in the reader head body,

wherein fiberoptic conductor ends of the first fiberoptic bundle and fiberoptic conductor ends of the second fiberoptic bundle are arranged in a substantially co-planar relationship to form a planar surface, and the planar surface is substantially parallel to a plane at an upper surface of the test strip during reflectance signal detection, whereby light is conducted by fiberoptic bundles to the photodetector, which generates the reflectance signal indicative of an amount of reflected light; and

the reflectance signal is indicative of the presence of the analyte.

2. The method of claim 1, wherein the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle are arranged in a sigmoidal distribution in the aperture.

3. The method of claim 1, wherein the reader head further comprises a third fiberoptic bundle optically connected to a second light emitting diode, wherein fiberoptic conductor ends of the third fiberoptic bundle are arranged in a substantially coplanar relationship with the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle.

4. The method of claim 3, wherein the fiberoptic conductor ends of the first fiberoptic bundle and the fiberoptic conductor ends of the second fiberoptic bundle and the fiberoptic conductor ends of the third fiberoptic bundle are arranged in a sigmoidal distribution in the aperture.

5. The method of claim 1, wherein the target analyte is fetal fibronectin.