Biological sample storage device and method for biological sample contamination testing

• US 20040209353A1
• Filed: 12/12/2003
• Published: 10/21/2004
• Est. Priority Date: 12/12/2002
• Status: Abandoned Application

• Current Assignee: Novartis Vaccines And Diagnostics Incorporated (Novartis Ag)
• Original Assignee: Chiron Corporation (Bayer AG)
• Inventors: Chien, David, Phelps, Bruce H.
• Application Number:
  US10/733,766
• Publication Number:
  US 20040209353A1
• Time in Patent Office: Days
• US Class Current: 435/287.1
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• 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 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures

Abstract

The present invention is directed to a method for screening blood and blood products that utilizes a specialized blood and blood products storage device useful for storing and testing blood or blood products comprising a container having at least one compartment with one or more sections for storing and testing the blood or blood products for a target molecule. The method utilizes a homogeneous testing system that employs ribozymes, DNAzymes or catalytic antibodies.

Claims

1. A biological sample storage device for storing and testing blood or blood products, comprising:

a container for receiving and storing blood or blood products; and

at least one compartment for testing the blood or blood products, wherein said compartment comprises;

at least a first section for holding a portion of the blood or blood products, and optionally for testing the portion of the blood or blood products.

2. The device according to claim 1, wherein the first section is arranged contiguous to the container so that the blood products can flow from the container to the first section.

3. The device according to claim 2, wherein the first section is designed such that the first section can be sealed from the container so that the blood products sealed into the first section can be used for testing.

4. The device according to claim 2, further comprising at least one additional section for testing the portion of the blood or blood products held in the first section, said additional section being arranged in sealed contact with another portion of the first section, different from a portion of the first section in contact with the container.

5. The device according to claim 4, wherein the additional section comprises a pressure sensitive seal between the first section and the additional section that can broken by the application of pressure, such that breaking the seal in the additional section allows mixing of the contents of the first and additional sections.

6. The device according to claim 1, wherein the container comprises a plurality of compartments.

7. The device according to claim 1, wherein each of the compartments is arranged as a protruding element from the container.

8. The device according to claim 7, wherein the first section is arranged contiguous to the container so that the blood products can flow from the container to the first section.

9. The device according to claim 8, wherein the first section is designed such that the first section can be sealed from the container so that the blood products sealed into the first section can be used for testing.

10. The device according to claim 4, wherein the at least one additional section comprises a second and a third section, the second section being arranged in sealed contact with another portion of the first section, different from a portion of the first section in contact with the container, and wherein the third section being arranged in sealed contact with another portion of the second section, different from a portion of the second section in sealed contact with the first section.

11. The device according to claim 10, wherein the second and third sections comprise pressure sensitive seals that can broken by the application of pressure such that breaking the seal in the second section allows mixing of the contents of the first and second sections and breaking of the seal in the third section allows transfer of the mixed contents of the first and second sections into the third sections.

12. The device according to claim 11, wherein the second section contains a buffer, wherein said buffer is a lysis buffer or an isotonic buffer.

13. The device according to claim 11, wherein the third section contains test reagents for testing the transferred mixed contents from the first and second sections.

14. The device according to claim 13, wherein the test reagents are a catalytic molecule and a reporter sequence.

15. The device according to claim 14, wherein said catalytic molecule is an inactivated ribozyme, a DNAzyme or a catalytic antibody.

16. The device according to claim 14, wherein the test reagents are an inactivated ribozyme and an RNA reporter sequence.

17. The device according to claim 14, wherein at least one of the catalytic molecule and reporter sequence is immobilized to a solid support.

18. The device according to claim 14, wherein at least one of the catalytic molecule and reporter sequence is in a lyophilized form.

19. The device according to claim 1, wherein the blood products comprise blood platelets.

20. A method of testing a blood or blood product for a target molecule indicative of contamination in said blood or blood product, comprising

providing a sample of a blood product in a compartment of the storage device for storing and testing blood or blood products, comprising:

a container for receiving and storing blood or blood products; and

at least one compartment for testing the blood or blood products, wherein said compartment comprises;

at least a first section for holding a portion of the blood or blood products, and optionally testing the portion of the blood or blood products;

contacting the blood product in the compartment with a lysing buffer;

releasing the target molecule from the cells and protein in the blood product; and

detecting the presence of the target molecule.

21. The method according to claim 20, wherein the target molecule is a 16S ribosomal RNA or a nucleic acid associated with a pathogen.

22. The method according to claim 20 or 21, wherein the detecting step employs test reagents comprising a catalytic molecule and a reporter sequence.

23. The method according to claim 22, wherein said catalytic molecule is an inactivated ribozyme, a DNAzyme or a catalytic antibody.

24. The method according to claim 22, wherein said test reagents are an inactivated ribozyme and an RNA reporter sequence.

25. The method according to claim 24, wherein the inactivated ribozyme binds to the target molecule, which activates the ribozyme that cleaves the RNA reporter sequence and releases a detectable sequence.

26. A method of testing a blood or blood product for a target molecule indicative of contamination in said blood or blood product, comprising

providing a sample of a blood product in a compartment of the storage device for storing and testing blood or blood products, comprising:

a container for receiving and storing blood or blood products; and

at least one compartment for testing the blood or blood products, wherein said compartment comprises;

at least a first section for holding a portion of the blood or blood products, and optionally testing the portion of the blood or blood products;

contacting the blood product in the compartment with a buffer to dilute the sample; and

detecting the presence of the target molecule.

27. The method according to claim 26, wherein the target molecule is a protein associated with a pathogen.

28. The method according to claim 26 or 27, wherein the detecting step employs test reagents comprising a catalytic molecule and a reporter sequence.

29. The method according to claim 28, wherein said catalytic molecule is an inactivated ribozyme or catalytic antibody.

30. The method according to claim 28, wherein said test reagents are an inactivated ribozyme and an RNA reporter sequence.

31. The method according to claim 30, wherein the inactivated ribozyme binds to the target molecule which activates the ribozyme that cleaves the RNA reporter sequence and releases a detectable sequence.