Specimen collecting, processing and analytical assembly

• US 20050232813A1
• Filed: 04/16/2004
• Published: 10/20/2005
• Est. Priority Date: 04/16/2004
• Status: Active Grant

• Current Assignee: Savvipharm Incorporated
• Original Assignee: Savvipharm Incorporated
• Inventors: Karmali, Rashida A.
• Granted Patent: US 7,378,054 B2
• Time in Patent Office: Days
• US Class Current: 422/58
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150343 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 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: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis

Abstract

A specimen collecting, processing and analytical assembly, designed for testing small volumes of body fluids, substances and secretions, said assembly comprising a one piece barrel assembly with a volumetrically graduated capillary tube having an open end, and optionally coated internally with an anticoagulant, a stabilizer or a preservative. The barrel assembly includes a filter membrane fitted above the capillary end at the junction of the barrel assembly and the capillary tube, a support means at the barrel'"'"'s second open end, and an analytical testing means disposed there between. The invention also provides a sealed vial containing an analytical testing reagent, the vial being substantially airtight and sealed with a pierceable material, a first tip cap for closing the open end of the capillary tube, a second cap to close sealably the second open end of the barrel container and a lancet to induce capillary skin punctures.

Claims

1. A specimen collecting and analytical assembly comprising in combination:

a. a one piece barrel container having an open top and a capillary tube with an open end, with a chamber disposed there between,

b. the chamber having a support means at the distal end and a filter membrane at the proximal end, wherein the capillary tube is volumetrically graduated and internally coated with an agent including a buffer, anticoagulant, detergent, stabilizer or a preservative, and

c. wherein the top of the barrel houses a vial containing a suitable reagent therein.

2. The specimen collecting and analytical assembly of claim 1 further comprising an analytical means housed between the support means and the filter membrane.

3. The specimen collecting and analytical assembly of claim 1, wherein the barrel container is made of a material selected from the group consisting glass, quartz, plastic, polypropylene, polyolefin, nylon, polyethylene terephthalate, polyethylene naphthalate polyvinyl chloride or copolymers thereof.

4. The specimen collecting and analytical assembly of claim 1 wherein said capillary tube comprises a diameter of about 0.1 to 5.0 mm, a length of about 5.0 to about 20 mm, and an interior volume of about 1 to about 2000 μ

l.

5. The specimen collecting and analytical assembly of claim 1 further comprising a tip cap sealable fitted to the open capillary end.

6. The specimen collecting and analytical assembly of claim 1, further comprising a second cap sealably fitted to close the top end of the barrel container.

7. The specimen collecting and analytical assembly of claim 1 wherein said vial has a penetrable foil seal.

8. The specimen collecting and analytical assembly of claim 7 wherein said barrel container includes means to form an air tight seal and said penetrable foil upon receipt of said capillary tube.

9. The specimen collecting and analytical assembly of claim 8, wherein said barrel container has an inwardly extending portion, said inwardly extending portion engageable with an opening in said penetrable foil to form an airtight seal between said barrel container and said vial.

10. The specimen collecting and analytical assembly of claim 2, wherein said support means defines the location of one end of the analytical means housed in the chamber.

12. A plurality of specimen collecting and analytical assemblies according to claim 1, housed in a packaging tray, wherein the assemblies comprise color coded graduated volumetric capillary tubes, color coded tip caps and color coded second caps, all corresponding to the coating applied internally in the capillary tube, including green for heparin, purple for EDTA, blue for sodium citrate, red for serum, yellow for stabilizer and black for preservative.

11. A specimen collecting assembly kit comprising:

a. a lancet;

b. a barrel container housing an analytical means, a filter membrane and a support means, and having an open capillary tube end;

c. a vial sealed by a penetrable foil placed on top of the barrel container, and d. a first tip cap to sealably fit the end of the open capillary tube end, and a second cap to sealably fit the open top of the barrel when the vial is removed.

13. A method of collecting a specimen of a fluid, said method comprising the steps of:

a. bringing into contact with a fluid specimen to be tested an open capillary tube end of a barrel container,

b. drawing said specimen into said capillary tube end to scavenge the desired volume of specimen,

c. mixing said fluid specimen with the agent coating the capillary tube; and

d. sealingly covering the open end of the capillary tube with a tip cap.

14. A method of collecting a specimen of a fluid, said method comprising the steps of:

a. bringing into contact with a fluid specimen to be tested an open capillary tube end of a barrel container,

b. drawing said specimen into said capillary tube end to scavenge the desired volume of specimen,

c. mixing said fluid specimen with the agent coating the capillary tube;

d. placing said capillary tube end into a vial containing an analytical reagent and forcing said reagent into said open end,

e. mixing said fluid specimen with said reagent in said capillary tube end;

f. closing the top open end of the barrel container with a second cap, and

g. inverting the barrel container to draw said fluid specimen and said reagent through said capillary tube and into said chamber whereby said fluid specimen and said reagent filter through a filter membrane and collect into the chamber of the barrel container, ready to be stored.

15. A method of collecting a specimen of a fluid, said method comprising the steps of:

a. bringing into contact with a fluid specimen to be tested an open capillary tube end of a barrel container,

b. drawing said specimen into said capillary tube end to scavenge the desired volume of specimen,

c. mixing said fluid specimen with the agent coating the capillary tube;

d. placing said capillary tube end into a vial containing an analytical reagent and forcing said reagent into said open end,

e. mixing said fluid specimen with said reagent in said capillary tube end;

f. drawing said fluid specimen and said reagent mixture through said capillary tube end through the filter membrane into said chamber whereby the mixture contacts the analytical testing means, and

g. observing color change on the analytical testing means to record the test result.