IP Library Granted Patent US 10,000,742
Granted Patent B2
US 10,000,742 · App. 14/945,483 · Granted Jun 19, 2018

Device and method of collection for RNA viruses

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Quick Facts
Patent No.
US 10,000,742
App. No.
14/945,483
Granted
Jun 19, 2018
Kind
B2
Abstract

The present disclosure generally relates to a method and device for inactivation and dry storage, under ambient conditions, of a biological sample containing RNA virus. Methods for collecting and recovering RNA from a biological sample and subsequent analysis for a virus are also provided.

Claims (35)

1. A method of inactivation and dry storage of a biological sample containing an RNA virus, the method comprising:

providing a non-dissolvable, dry, solid matrix incorporated with a composition, the composition comprising at least one protein denaturant, at least one acid or acid-titrated buffer reagent impregnated therein in a dry state to provide an acidic pH on hydration;

contacting the biological sample with the non-dissolvable, dry, solid matrix to effectively lyse cells of the biological sample to extract RNA from the lysed cells and preserve the extracted RNA in an intact state;

drying the biological sample on the solid matrix; and

storing the biological sample on the solid matrix in a dry state under ambient conditions,

wherein the biological sample is rendered non-infectious within 30 minutes of being subjected to the drying step, and wherein the acidic pH is in a range from 2 to 7.

2. The method of claim 1 , wherein the acid comprises acetic acid, citric acid, tartaric acid, phosphoric acid, hydrochloric acid, Tris(2-carboxyethyl) phosphine-hydrochloric acid (TCEP-HCl), oxidized Tris(2-carboxyethyl) phosphine-hydrochloric acid (TCEP-O-HCl), sulfuric acid, nitric acid, vanillic acid, 3-(N-morpholino)propanesulfonic acid or combinations thereof.

3. The method of claim 1 , wherein the composition further comprises a UV protectant, a free-radical scavenger, a chelator, a reducing agent or combinations thereof.

4. The method of claim 1 , wherein the composition further comprises an RNase inhibitor.

5. The method of claim 4 , wherein the RNase inhibitor comprises at least one of a triphosphate salt, pyrophosphate salt, vanadyl ribonucleoside complex (VCR), or sodium pyrophosphate.

6. The method of claim 3 , wherein the reducing agent is selected from the group consisting of dithiothreitol (DTT), 2-mercaptoethanol (2-ME), tris(2-carboxyethyl)phosphine (TCEP), tris(2-carboxyethyl)phosphine hydrochloride (TCEP-HCl), and combinations thereof.

7. The method of claim 1 , wherein the extracted and preserved RNA has an RNA integrity number (RIN) of greater than 5.

8. The method of claim 1 , wherein the RNA virus is a blood-borne virus.

9. The method of claim 8 , wherein the blood-borne virus is Ebolavirus, Hepatitis virus, Arenavirus, Filovirus, Lentivirus, or a related subgroup.

10. The method of claim 1 , wherein the method further comprises recovering the RNA from the non-dissolvable, dry, solid matrix.

11. The method of claim 10 , wherein recovering the RNA comprises extracting the RNA by rehydrating the non-dissolvable, dry, solid matrix, solid phase extraction, electroelution, or combinations thereof.

12. The method of claim 11 , wherein rehydrating comprises using an aqueous solution, a buffer solution, an organic solution, or combinations thereof.

13. A method for testing a biological sample for presence of an RNA virus, the method comprising:

providing a non-dissolvable, dry, solid matrix incorporated with a composition, the composition comprising at least one protein denaturant, at least one acid or acid-titrated buffer reagent impregnated therein in a dry state to provide an acidic pH on hydration;

applying the biological sample comprising RNA to the non-dissolvable, dry, solid matrix;

drying the biological sample on the non-dissolvable, dry, solid matrix to preserve the RNA in an intact state;

recovering the RNA of the biological sample from the non-dissolvable, dry, solid matrix; and

analyzing the recovered RNA for the presence of a viral RNA to determine the presence of the RNA virus,

wherein the biological sample is rendered non-infectious within 30 minutes of being subjected to the drying step, and wherein the acidic pH is in a range from 2 to 7.

14. The method of claim 13 , wherein the recovering step comprises extracting the RNA by rehydrating the non-dissolvable, dry, solid matrix, electroelution, solid phase extraction, adding a portion of the solid matrix directly into an amplification reaction, or combinations thereof.

15. The method of claim 14 , wherein rehydrating comprises using an aqueous solution, a buffer solution, an organic solution, or combinations thereof.

16. The method of claim 13 , wherein the acid comprises acetic acid, citric acid, tartaric acid, phosphoric acid, hydrochloric acid, Tris(2-carboxyethyl) phosphine-hydrochloric acid (TCEP-HCl), oxidized Tris(2-carboxyethyl) phosphine-hydrochloric acid (TCEP-O-HCl), sulfuric acid, nitric acid, vanillic acid, 3-(N-morpholino)propanesulfonic acid, or combinations thereof.

17. The method of claim 13 , wherein the composition further comprises a UV protectant, a free-radical scavenger, a chelator, a reducing agent or combinations thereof.

18. The method of claim 13 , wherein the composition further comprises an RNase inhibitor.

19. The method of claim 18 , wherein the RNase inhibitor comprises at least one of a triphosphate salt, pyrophosphate salt, vanadyl ribonucleoside complex (VCR), or sodium pyrophosphate.

20. The method of claim 17 , wherein the reducing agent is selected from the group consisting of dithiothreitol (DTT), 2-mercaptoethanol (2-ME), tris(2-carboxyethyl)phosphine (TCEP), tris(2-carboxyethyl)phosphine hydrochloride (TCEP-HCl) and combinations thereof.

21. The method of claim 13 , wherein the biological sample is blood.

22. The method of claim 13 , wherein the RNA virus is a blood-borne virus.

23. The method of claim 22 , wherein the blood-borne virus is Ebolavirus, Hepatitis virus, Arenavirus, Filovirus, Lentivirus, or a related subgroup.

24. The method of claim 13 , further comprising prolonged storing the RNA in an intact form under a dry format and ambient conditions, wherein any virus present in the biological sample is rendered inactive.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 7, 2020
From: GE HEALTHCARE UK LIMITED
To: GLOBAL LIFE SCIENCES SOLUTIONS OPERATIONS UK LTD
Reel/Frame 054300/0369 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 5, 2020
From: GENERAL ELECTRIC COMPANY
To: GE HEALTHCARE UK LIMITED
Reel/Frame 053981/0329 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 19, 2015
From: KVAM, ERIK LEEMING; DUTHIE, ROBERT SCOTT; NELSON, JOHN RICHARD
To: GENERAL ELECTRIC COMPANY
Reel/Frame 037082/0930 →