Process for realising a device for collecting and transferring samples for molecular biology

• US 9,504,452 B2
• Filed: 03/08/2011
• Issued: 11/29/2016
• Est. Priority Date: 01/05/2011
• Status: Active Grant

• Current Assignee: Copan Italia SpA
• Original Assignee: Copan Italia SpA
• Inventors: Triva, Daniele
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): TAVARES, JULIE L
• Application Number:
  US13/043,175
• Publication Number:
  US 20120171712A1
• Time in Patent Office: 2,093 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 1/02 Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A process for realizing a device (1) for collecting and transferring samples for molecular biology, the device including at least: a support body (2) having at least a first portion (2a), and a plurality of fibers (6) attached and arranged on the first portion (2a) of the support body (2) by flocking, such as to define a flocked collecting portion (3) destined to collect, on the said collecting portion, (3) a quantity of the sample for molecular biology, the process including at least a step of pre-treating the plurality of fibers (6) with a surfactant, the step of pre-treating the plurality of fibers (6) with a surfactant being performed after application of the fibers on the support body (2) by flocking and/or before application of the fibers (6) on the body (2) by flocking and/or wherein the surfactant is added to the fiber (6) during production of the fiber (6).

Claims

1. A method for collecting, conserving and transferring samples of DNA or RNA for molecular biology, the method comprising:

collecting a sample of DNA or RNA for molecular biology on at least a flocked collecting portion (3) of a collecting device (1) having a support body (2), the collecting portion (3) comprising a first portion (2a) of the support body (2) and a plurality of fibres (6) attached and arranged on the first portion (2a) of the support body (2) by flocking;

conserving the integrity of the DNA or RNA samples collected by the device sufficiently to enable subsequent use of said samples in laboratory examinations of analytic or diagnostic type, wherein the sample is conserved and preserved on the collecting portion for a predetermined period of time of at least twenty-four hours; and

releasing the sample of DNA or RNA for molecular biology from the collecting portion (3) in order to enable performance of operation of molecular biology on the sample; and

wherein conserving comprises pretreating the plurality of fibres (6) with a surfactant, wherein the surfactant is a mixture of chlorides of alkyl-benzyl-dimethyl ammonium, in which the alkyl group varies from octile (C₈H₁₇—

) to octadecyl (C₁₈H₃₇—

), wherein the pre-treated plurality of fibers (6) conserve the integrity of the DNA or RNA samples collected by the device on said collecting portion during said predetermined period of time.

2. The method of claim 1 wherein said step of conserving the sample is carried out by conserving the sample on the flocked collecting portion (3) for a period of time of at least forty-eight hours.

3. The method of claim 1 wherein said step of conserving the sample is carried out by conserving the sample on the flocked collecting portion (3) for a period of time of at least three days.

4. The method of claim 1 wherein said step of conserving the sample is carried out by conserving the sample on the flocked collecting portion (3) for a period of time of at least five days.

5. The method of claim 1 wherein said step of conserving the sample is carried out by conserving the sample on the flocked collecting portion (3) for a period of time of at least one week.

6. The method of claim 1, wherein the flocked collecting portion (3) collects a substantially known quantity of the sample or collects a quantity of between 5 and 1000 microliters, or between 10 microliters and 500 microliters, or between 50 and 200 microliters, or between 80 and 120 microliters of the sample and/or collects a quantity of sample of at least 0.5 μ

l per mm², or at least 0.6 μ

l per mm², or at least 0.7 μ

l per mm², or at least 0.75 μ

l per mm².

7. The method of claim 1, comprising:

arranging the fibres (6) on the first portion (2a) of the support body (2) in a substantially ordered way and to form a substantially continuous layer on the collecting portion (3) and/or arranging the fibres (6) on the collecting portion (3) in such a way as to define a plurality of capillary interstices (9) destined to absorb the sample by capillary action.

8. The method of claim 1, comprising arranging the fibres (6) with a yarn count of between 1.7 and 3.3 Dtex, and/or a length of between 0.6 and 3 mm.

9. The method of claim 1, comprising arranging the fibres (6) made of at least one of nylon or of a material selected from:

polyamide, rayon, polyester, carbon fibre, alginate, natural fibre.

10. The method of claim 1, comprising collecting the sample of DNA or RNA for molecular biology on said collecting portion (3) exhibiting a surface density of the fibres (6) on the collecting portion (3) of between 50 and 500 fibres per mm² or between 100 and 200 fibres per mm².

11. A method for performing operations of molecular biology on a sample, comprising:

performing the method for collecting, conserving and transferring samples of DNA or RNA for molecular biology according to claim 1; and

performing operations of molecular biology on the sample.

12. The method of claim 11, performing polymerisation reactions or chain reactions of the polymerase on the DNA or RNA samples released.

13. The method of claim 1, further comprising the step of drying at least the collecting portion (3) provided with the sample.

14. The method of claim 13, wherein the step of drying is performed by drying in a forced-ventilation oven.

15. The method of claim 1, further comprising the step of inserting the collecting portion (3) in a hermetic container during the step of drying.

16. A method for collecting, conserving and transferring samples of DNA or RNA for molecular biology, the method comprising:

collecting a sample of DNA or RNA for molecular biology on at least a flocked collecting portion (3) of a collecting device (1) having a support body (2), the collecting portion (3) comprising a first portion (2a) of the support body (2) and a plurality of fibres (6) attached and arranged on the first portion (2a) of the support body (2) by flocking, said collecting portion (3) exhibiting a surface density of the fibres (6) on the collecting portion (3) of between 50 and 500 fibres per mm² or between 100 and 200 fibres per mm²;

conserving the integrity of the DNA or RNA samples collected by the device sufficiently to enable subsequent use of said samples in laboratory examinations of analytic or diagnostic type, wherein the sample is conserved and preserved on the collecting portion for a predetermined period of time of at least twenty-four hours; and

releasing the sample of DNA or RNA for molecular biology from the collecting portion (3) in order to enable performance of operation of molecular biology on the sample; and

wherein conserving comprises pretreating the plurality of fibres (6) with a surfactant, wherein the pre-treated plurality of fibers (6) conserve the integrity of the DNA or RNA samples collected by the device on said collecting portion during said predetermined period of time.

17. A method for collecting, conserving and transferring samples of DNA or RNA for molecular biology, the method comprising:

collecting a sample of DNA or RNA for molecular biology on at least a flocked collecting portion (3) of a collecting device (1) having a support body (2), the collecting portion (3) comprising a first portion (2a) of the support body (2) and a plurality of fibres (6) attached and arranged on the first portion (2a) of the support body (2) by flocking;

conserving the integrity of the DNA or RNA samples collected by the device sufficiently to enable subsequent use of said samples in laboratory examinations of analytic or diagnostic type, wherein the sample is conserved and preserved on the collecting portion for a predetermined period of time of at least twenty-four hours; and

releasing the sample of DNA or RNA for molecular biology from the collecting portion (3) in order to enable performance of operation of molecular biology on the sample; and

wherein conserving comprises pretreating the plurality of fibres (6) with a surfactant, wherein the pre-treated plurality of fibers (6) conserve the integrity of the DNA or RNA samples collected by the device on said collecting portion during said predetermined period of time;

further comprising the step of drying at least the collecting portion (3) provided with the sample, wherein the step of drying is performed by drying in a forced-ventilation oven.