Point of care diagnostic systems

• US 7,270,970 B2
• Filed: 06/25/2004
• Issued: 09/18/2007
• Est. Priority Date: 02/03/1998
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Prenatal Products Corp. (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
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): Jung; Unsu
• Application Number:
  US10/877,122
• Publication Number:
  US 20040241752A1
• Time in Patent Office: 1,180 Days
• Field of Search: 435/4, 435/7.1, 435/7.94, 436/518, 436/510, 436/164, 436/46, 436/172, 422 8205- 8208, 356/446
• US Class Current: 435/7.94
• 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;

(b) transmitting light onto the surface of the test strip, wherein the transmitted light is transmitted at an angle normal to the surface;

(c) detecting the signal produced by the label in a reflectance reader containing a reader head, wherein the surface for detection of reflected signal in the reader head is positioned parallel to the surface of the test strip to detect light reflected normally from the surface; and

(d) processing the data obtained from the reflectance signal obtained from reading the test strip into a result indicative of the presence or absence of analyte or of a predetermined concentration of analyte in a sample.

4. The method of claim 1, wherein the results are qualitative.

5. The method of claim 1, wherein the results are quantitative.

6. The method of claim 1, wherein the data is input into a neural network trained for assessing risk related to or diagnosing the condition.

7. The method of claim 6, wherein the analyte is fetal fibronectin (fFN).

8. The method of claim 7, wherein the condition is pregnancy-related or the method assesses fertility status.

9. The method of claim 7, wherein the condition is a fertility-related disorder.

10. The method of claim 7, wherein the risk of ectopic pregnancy, pre-eclampsia, infertility, preterm labor, imminent delivery, term induction or fetal membrane rupture is assessed.

11. The method of claim 1, wherein the immunoassay detects fetal fibronectin (fFN) in a sample.

12. The method claim 1, wherein the reflectance reader contains a charge coupled device (CCD).

13. The method claim 1, wherein the processing step further comprises a step of forming an array of points containing a number of rows (n) corresponding to the number of points at which readings were taken along the test strip, and a number of columns (m) corresponding to the number of reflectance readings taken at each point.

2. 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;

(b) transmitting light onto the surface of the test strip, wherein the light is transmitted at an angle normal to the surface;

(c) detecting the signal produced by the label in a reflectance reader containing a reader head, wherein the surface for detection in the reader head is positioned parallel to the surface of the test strip, wherein;

the detecting step includes measuring light reflected normally from the surface; and

the reflected light measurement is indicative of the presence of the analyte; and

(d) processing the data obtained from the reflectance signal obtained from reading the test strip into a result indicative of the presence or absence of analyte or of a predetermined concentration of analyte in a sample.

15. The method of claim 2, wherein the results are qualitative.

16. The method of claim 2, wherein the results are quantitative.

17. The method of claim 2, wherein the data is input into a neural network trained for assessing risk related to or diagnosing the condition.

18. The method of claim 17, wherein the analyte is fetal fibronectin (fFN).

19. The method of claim 18, wherein the condition is pregnancy-related or the method assesses fertility status.

20. The method of claim 18, wherein the condition is a fertility-related disorder.

21. The method of claim 18, wherein the risk of ectopic pregnancy, pre-eclampsia, infertility, preterm labor, imminent delivery, term induction or fetal membrane rupture is assessed.

22. The method of claim 2, wherein the immunoassay detects fetal fibronectin (fFN) in a sample.

23. The method of claim 2, wherein the reader head contains two fiberoptic bundles that form a coplanar surface.

3. 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;

(b) uniformly illuminating the surface of the test strip, wherein the illuminating is at an angle normal to the surface;

(c) detecting the signal produced by the label in a reflectance reader containing a reader head, wherein the surface for detection in the reader head is positioned parallel to the surface of the test strip, wherein;

the detecting step includes measuring light reflected normally from the surface; and

the reflected light measurement is indicative of the presence of the analyte; and

(d) processing the data obtained from the reflectance signal obtained from reading the test strip into a result indicative of the presence or absence of analyte or of a predetermined concentration of analyte in a sample.

14. The method of claim 3, wherein:

the processing step further converts the array into a result indicative of the presence or absence of analyte or of a predetermined concentration of an analyte in a sample; and

conversion is effected by data processing software employing data reduction and curve fitting algorithms.