Articles and methods for preparing a surface for obtaining a patent sample

Patent metadata

Field	Value
Publication number	US-11013576-B2
Application number	US-201615535665-A
Country	US
Kind code	B2
Filing date	Oct 13, 2016
Priority date	Oct 16, 2015
Publication date	May 25, 2021
Grant date	May 25, 2021

Abstract

Articles and methods for preparing a surface for obtaining a patient sample, such as blood, are generally provided. In some embodiments, the methods involve wiping a surface of skin of a patient in preparation for obtaining a sample (e.g., a blood sample) from the patient. In some embodiments, the methods involve wiping the surface of the skin with two or more wipes. For instance, the surface of the skin may be wiped with a first wipe comprising a surfactant and a second wipe comprising an antiseptic solution. Advantageously, the use of a first wipe including a surfactant followed by a second wipe may remove a higher amount of certain contaminants (e.g., proteins, bacteria, viruses) from the surface of the skin as compared to the use of a single wipe or by hand-washing alone.

First claim

The invention claimed is:

1. A method for determining an amount of PSA protein in a patient, comprising:
wiping a surface of skin with a first wipe, the first wipe comprising a solution comprising a surfactant, wherein the surfactant is present in the solution in an amount of between about 0.1 wt % and about 15 wt % of the solution; and
wiping at least a portion of the surface with a second wipe, the second wipe comprising an antiseptic solution, wherein the first and second wipes are different,
wherein the step of wiping at least a portion of the surface with the second wipe occurs after less than or equal to about 60 seconds of contacting the surface with the first wipe;
removing at least 95% of any PSA protein from the surface of the skin after the first and second wiping steps compared to an amount of any PSA protein present on the surface before the first and second wiping steps, as determined by a tPSA assay;
forming a first blood droplet on the surface of the skin after the step of wiping at least a portion of the surface with the second wipe;
wiping away the first blood droplet with the first wipe, the second wipe, or a third wipe;
forming a second blood droplet on the surface of the skin after the step of wiping away the first blood droplet; and
determining an amount of any PSA protein present in a blood sample of the patient.

2. A method as in claim 1 , wherein the second wiping step occurs after less than or equal to about 30 seconds of the first wiping step, and wherein the method comprises collecting a blood sample from the patient at a collection site, wherein collecting the blood sample occurs after less than or equal to about 45 seconds of the second wiping step.

3. A method as in claim 1 , wherein the any PSA protein is free PSA, or a protein homologous with free-PSA.

4. A method as in claim 1 , wherein the step of wiping at least a portion of the surface of the skin with the second wipe occurs between about 1 second and about 20 seconds of contacting the surface with the first wipe.

5. A method as in claim 1 , wherein wiping with the second wipe substantially removes any surfactant present on the surface.

6. A method as in claim 1 , comprising collecting the blood sample from the patient.

7. A method as in claim 6 , wherein collecting the blood sample comprises retrieving the blood sample using a fluidic component.

8. A method as in claim 7 , wherein the fluidic component comprises at least one channel.

9. A method as in claim 8 , wherein the at least one channel has an average cross-sectional dimension of less than or equal to about 2 mm.

10. A method as in claim 8 , wherein the at least one channel has an average cross-sectional dimension of between about 300 microns and about 600 microns.

11. A method as in claim 8 , wherein the at least one channel has a length of between 1 cm and 10 cm.

12. A method as in claim 1 , wherein the surfactant is an anionic surfactant.

13. A method as in claim 1 , wherein the surfactant is sodium dodecyl sulfate.

14. A method as in claim 1 , wherein the first wipe and/or the second wipe is sterilized.

15. A method as in claim 1 , wherein the antiseptic solution comprises an alcohol.

16. A method as in claim 15 , wherein the alcohol is isopropyl alcohol.

17. A method as in claim 15 , wherein the alcohol is present in the antiseptic solution in an amount ranging between about 30 vol % and about 80 vol % of the antiseptic solution.

18. A method as in claim 1 , wherein the antiseptic solution contains an antiseptic in an amount of at least 0.01 wt % and less than or equal to about 7 wt % versus the total weight of the solution.

19. A method as in claim 1 , comprising retrieving the blood sample from either the second blood droplet or a third droplet optionally formed on the surface of the skin after wiping the second blood droplet away, by contacting a fluidic component to at least a portion of the second droplet or the third droplet.

20. A method as in claim 19 , further comprising transferring the blood sample into a channel within a fluidic component, wherein the fluidic component is arranged to be connected to a fluidic device, the fluidic device comprising at least one microfluidic channel for analyzing the blood sample.

21. A method as in claim 1 , comprising wiping the second blood droplet away, forming a third droplet on the surface of the skin after the step of wiping away the second blood droplet, retrieving the blood sample from the third droplet formed on the surface of the skin by contacting a fluidic component to at least a portion of the third droplet, connecting the fluidic component to a fluidic device comprising at least one microfluidic channel for analyzing the blood sample, and transferring at least a portion of the blood sample from the fluidic component to the fluidic device.

22. A method as in claim 1 , wherein the first wipe comprises a compound or component capable of denaturing any PSA protein.

23. A method as in claim 1 , wherein the surfactant is capable of denaturing any PSA protein.

Assignees

• Opko Diagnostics Llc

Inventors

• Taylor Jason
• Steinmiller David
• Singh Hardeep
• Wagner Rebecca
• Fagan Gary J
• Linder Vincent

Classifications

• A61B5/150022 Primary

  for capillary blood or interstitial fluid · CPC title

• A61B5/150343

  Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045) · CPC title

• C11D17/049

  Cleaning or scouring pads; Wipes · CPC title

• A61B5/150358

  Strips for collecting blood, e.g. absorbent · CPC title

• A61L2/186

  Peroxide solutions · CPC title