Rapid diagnostic assay

• US 20060178568A1
• Filed: 11/04/2005
• Published: 08/10/2006
• Est. Priority Date: 11/04/2004
• Status: Abandoned Application

• Current Assignee: Allan I. Krauter, Andrew Jay Kugler, Dominick Danna, Richard W. Newman, Wendy Marie Scinta
• Original Assignee: Allan I. Krauter, Andrew Jay Kugler, Dominick Danna, Richard W. Newman, Wendy Marie Scinta
• Inventors: Newman, Richard W., Danna, Dominick, Krauter, Allan I., Kugler, Andrew Jay, Scinta, Wendy Marie
• Application Number:
  US11/267,647
• Publication Number:
  US 20060178568A1
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/565 Seals in general F16L
• CPC Class Codes: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 33/56944 Streptococcus
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/56994 Herpetoviridae, e.g. cytomegalovirus, Epstein-Barr virus

Abstract

Disclosed is a rapid and easy to use diagnostic tool that a point-of-care practitioner can use to specifically identify the cause of a disease, such as the upper respiratory infection (URI) pharyngitis. Such a disease has multiple potential causative pathogens and has a number of combined clinical manifestations. The diagnostic tool is rapid in order to provide the busy point-of-care practitioner with an assay result within a time that does not affect patient flow. The time usually available to such a practitioner is optimally less than 10 minutes, so that an assay that detects multiple pathogens rapidly is regarded as one that does so in less than 10 minutes. The diagnostic tool can be operated with minimal training and within the confines of said practitioner'"'"'s environment. The diagnostic tool has specificity and sensitivity above those of the prior art devices. The tool is self-contained, which thereby helps to control the spread of infection and eases the burden of disposal of used equipment. The tool includes a diagnostic card configured to enable a plurality of nucleic acid diagnostic assays for rapidly detecting the presence or absence of multiple pathogens at the point-of-care. The tool includes a device that interacts with the card and that contains assay analysis means.

Claims

1. A network for assessing medical conditions comprising:

means for guiding inquiry into a patient'"'"'s observable symptoms which will provide an affirmative signal if conditions are met to provide a biological sample;

a diagnostic card configured to enable at least one nucleic acid diagnostic assay for rapidly detecting the presence or absence of multiple pathogens at the point-of-care; and

means for instructing said diagnostic card to test said sample to identify the specific pathogens present in said sample.

2. The network of claim 1 wherein the network has further means for adding a patient'"'"'s vital signs.

3. The network of claim 1 wherein said observable symptoms include fever, swollen glands, and a sore throat.

4. The network of claim 1 wherein said multiple pathogens share a common clinical manifestation.

5. The network of claim 1 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite and at least a second pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite.

6. The network of claim 5 wherein the network has further means to provide the identity of said detected pathogens to a physician.

7. A diagnostic system comprising:

a diagnostic card configured to enable at least one nucleic acid diagnostic assay for rapidly detecting the presence or absence of multiple pathogens at the point-of-care.

8. The system of claim 7 wherein said multiple pathogens share a common clinical manifestation.

9. The system of claim 7 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite and at least a second pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite.

10. The system of claim 7 further comprising a device that communicates with said diagnostic card.

11. The system of claim 10 further comprising analyses means to analyze data from said diagnostic card.

12. The system of claim 11 wherein a treatment regimen is included.

13. The system of claim 11 further comprising communication means to a network to provide test results to a medical practitioner so that said practitioner may provide diagnosis.

14. The system of claim 11 further comprising communication means to a network to provide test results to a medical practitioner so that said practitioner may provide a treatment regimen.

15. A method of diagnosing the underlying cause of a common clinical manifestation, said method comprising:

providing a diagnostic card configured to enable at least one nucleic acid diagnostic assay for rapidly detecting multiple pathogens at the point-of-care;

introducing at least one sample into said card;

interacting said card with a device; and

means connected to said diagnostic card wherein said means are capable of instructing said diagnostic card to test said sample to identify the specific pathogens present in said sample.

16. The method of claim 15 wherein said device has analyzing means for determining the results of said diagnostic assay.

17. The method of claim 15 wherein said multiple pathogens share a common clinical manifestation.

18. The method of claim 15 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite and at least a second pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite.

19. A method of diagnosing the underlying cause of a common clinical manifestation, said method comprising:

providing a diagnostic card configured to enable at least one nucleic acid diagnostic assay for rapidly detecting multiple pathogens at the point-of-care;

introducing at least one sample into said card.

20. The method of claim 19 wherein said multiple pathogens share a common clinical manifestation.

21. The method of claim 19 wherein said multiple pathogens include at least a first pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite and at least a second pathogen selected from the group consisting of a virus, a bacterium, a fungus, and a parasite.

22. The method of claim 19 wherein said assays comprise DNA assays.

23. The method of claim 19 wherein said assays comprise RNA assays.

24. The method of claim 19 wherein said nucleic acid assays include an amplification phase.

25. The method of claim 24 wherein said amplification phase comprises polymerase chain reaction.

26. The method of claim 19 wherein said nucleic acid assays include a positive control and a negative control for each of said multiple pathogens.

27. The method of claim 20 wherein said common clinical manifestation comprises at least one of a sore throat, swollen lymph nodes, and fever.

28. The method of claim 27 wherein said assays are designed to detect the presence of at least two of the group consisting of Streptococcus Pyogenes, Influenza A, Influenza B, and Epstein-Barr Virus.

29. The method of claim 19 further comprising a sample port that is sealed after a sample is introduced to said diagnostic card.

30. The method of claim 19 wherein said card utilizes at least one sample to detect the presence or absence of any of said pathogens.

31. The method of claim 30 wherein said at least one sample is introduced into said card by a sample collection device.

32. The method of claim 19 wherein at least one reagent for said assays is contained on board said card.

33. The method of claim 32 wherein said at least one reagent selected from the group consisting of a lysis reagent, an elution reagent, a rehydrating fluid, air, and polymerase chain reaction reagents for said nucleic acid assay is contained on board said card.

34. The method of claim 19 further comprising a chamber configured to allow for rapid thermal cycling for conducting polymerase chain reaction.