Blood and biological sample collection device and method

• US 9,986,944 B2
• Filed: 11/18/2016
• Issued: 06/05/2018
• Est. Priority Date: 05/08/2014
• Status: Active Grant

• Current Assignee: Sedia Biosciences Corporation
• Original Assignee: Sedia Biosciences Corporation
• Inventors: Piacentini, Stephen Carl, Mink, Ronald William, Smith, Paul Robert
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US15/356,226
• Publication Number:
  US 20170065215A1
• Time in Patent Office: 564 Days
• Field of Search: 436 63, 436169, 436170, 436174, 436175, 436177, 436178, 436180, 422408, 422419, 422420, 422421, 422422, 422527, 4352877, 4352878, 4352883, 600573, 600578
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 1/28 Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Qmounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 ; laboratory gas handling apparatus B01L5/00
• CPC Class Codes: G01N 2001/4088 filtration
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Specially designed collection strips and their processing. By using specially designed collection strips, having a backer and one or more absorbent pads, in conjunction with a unique processing method, the processes of analyzing biological samples such as blood, or the like, may be done efficiency with the elimination of cross contamination risk. Identification of the sample stays with the sample throughout the process as it resides on the collection strip. The strip absorbs a known volume. The sample with identification is placed directly in an elution solution, without mechanically separating the sample from its identification information. Elimination of the need for mechanical separation tends to reduce cross contamination, as well as reducing sample processing time.

Claims

1. A blood collection device that does not require punching, or folding to obtain a sample for processing comprising:

a flat rectangular elongated backer having a first end and a second end;

a planar label area disposed on the first end upon which identifying information of a collected sample is recorded; and

a separate absorbent pad selected from the group consisting of, polyester, and glass fiber, attached at the second end of the flat rectangular elongate backer on a top surface thereof, wherein the absorbent pad is configured to receive a blood sample and dry the blood sample for later processing, the identifying information is configured to stay affixed to the dried blood-sample until later processing of the sample, the blood collection device is configured to be placed into a titertube containing an elution buffer for elution of the dried blood sample into the elution buffer without folding, punching out or detachment of a portion of the blood collection device containing the dried blood sample, and wherein the absorbent pad is configured to remain on the flat elongated backer after elution of the dried blood sample into the elution buffer.

2. The blood collection device of claim 1, in which the absorbent pad is fused to the flat elongate backer.

3. The blood collection device of claim 1, in which the absorbent pad is attached to the flat elongate backer with an adhesive.

4. The blood collection device of claim 1, in which the absorbent pad has a thickness, a width, a height and an absorbance that is selected to define a sample volume collected.

5. The blood collection device of claim 1, in which the absorbent pad is treated with a detergent.

6. The blood collection device of claim 1, in which the absorbent pad is treated with a surfactant.

7. The blood collection device of claim 1, in which the absorbent pad is treated with a blocking agent.

8. The blood collection device of claim 1, in which the absorbent pad is rectangular in shape.

9. The blood collection device of claim 1, in which the elongate backer is made from plastic.

10. The blood collection device of claim 1, in which the elongate backer is a rectangular flat strip.

11. A blood collection device comprising:

a flat elongated rectangular backer having a first end where identifying information is disposed;

a first absorbent pad that does not dissolve in an elution buffer into which the blood collection device is inserted selected from the group consisting of, polyester, and glass fiber disposed at a second end of the flat rectangular elongated backer on a top surface thereof, wherein the first absorbent pad is configured to receive a blood sample and dry the blood sample for later processing, the identifying information is configured to stay affixed to the dried blood-sample until later processing of the sample, the blood collection device is configured to be placed into a titertube containing an elution buffer for elution of the dried blood sample into the elution buffer without folding, punching out or detachment of a portion of the blood collection device containing the dried blood sample, and wherein the absorbent pad is configured to remain on the flat elongated backer after elution of the dried blood sample into the elution buffer; and

a second absorbent pad that does not dissolve in an elution buffer into which the blood collection device is inserted selected from the group consisting of, polyester, and glass fiber on the top surface thereof disposed between the first absorbent pad and the first end of the flat elongated rectangular backer and in end to end abutting, without overlapping contact with the first absorbent pad so that a blood sample is first applied to the first absorbent pad and then flows into the second absorbent pad.

12. The blood collection device of claim 11, in which the first absorbent pad provides filtering of the sample flowing onto the second absorbent pad.

13. The blood collection device of claim 11, in which the first absorbent pad is pretreated.

14. The blood collection device of claim 11, in which the first absorbent pad is treated with a clotting agent and thrombin.

15. A method for processing a blood sample comprising:

applying a blood sample to a first absorbent collection pad contained on a collection strip, wherein the collection strip is constructed in the form of a flat rectangular elongated backer comprising a plurality of absorbent collection pads attached thereto at a first end that abut each other end to end without overlapping, and identification information attached directly on the collection strip at a second end, wherein at least one absorbent collection pad is selected from the group consisting of cellulose, polyester and glass fiber;

allowing the blood sample to flow from the first absorbent collection pad to a second absorbent collection pad that abuts the first absorbent collection pad on the collection strip, wherein unwanted entities in the blood sample remain in the first absorbent collection pad;

drying the blood sample on the absorbent collection pads of the collection strip;

tearing off the first absorbent pad containing the unwanted entities of the blood sample from the collection strip prior to testing the blood sample so that the unwanted entities are removed from the collection strip;

placing the collection strip into a titertube containing an elution buffer so that the dried blood sample on the second absorbent collection pad is eluted into the elution buffer, wherein the second absorbent collection pad remains on the flat elongated backer of the collection strip after elution;

removing the collection strip from the titertube with the second absorbent collection pad remaining on the collection strip; and

testing the eluted blood sample produced in the titertube.

16. The method for processing a blood sample of claim 15, further comprising pre-processing by filtering the blood sample prior to applying it to the first absorbent pad.

17. The method for processing a blood sample of claim 16, in which filtering is performed by disposing on the collection strip a filtering absorbent pad between the blood sample and the first absorbent pad.

18. The method for processing a blood sample of claim 17, in which the filtering absorbent pad is treated.

19. The method for processing a blood sample of claim 18, in which the filtering absorbent pad is a selective or exclusionary material membrane, whereby red blood cells are extracted from the sample in the filtering absorbent pad.

20. The method for processing a blood sample of claim 18, in which the treatment is thrombin, whereby retention and clotting of any previously un-clotted fibrinogen is caused.