Additive preparation and method of use thereof

• US 6,534,016 B1
• Filed: 11/21/2000
• Issued: 03/18/2003
• Est. Priority Date: 04/30/1997
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cohen, Richmond, Dastane, Ajit N.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/717,417
• Time in Patent Office: 847 Days
• Field of Search: 436/8, 436/17, 436/18, 436/69, 436/74, 436/174, 436/175, 436/177, 252/408.1, 422/99, 422/101, 422/102, 424/44, 424/466
• US Class Current: 422/549
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• 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 2300/16 Surface properties and coatings
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: G01N 2496/35 Polyvinylpyrrolidone, e.g. PVP
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G01N 33/5002 Partitioning blood components
• CPC Class Codes: G01N 33/5094 for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

The present invention is an additive preparation which contains an additive, an organic acid, a metal carbonate compound, and a surfactant agent which is capable of rendering the surface of a collection device to have properties that cause the surface to repel the adsorption of components of a body fluid sample. The preparation effervesces when in contact with a body fluid sample, thereby efficiently dispersing the additive and surfactant in a body fluid sample.

Claims

1. An assembly for collecting a body fluid, comprising

a container, and

a additive preparation in the container, the additive preparation comprising an organic acid, a metal carbonate compound, a surfactant, and an additive selected from the group consisting of a clot activator, an anticoagulant, and a urine preservation compound.

2. The assembly of claim 1 wherein the surfactant reduces the surface tension of a body fluid to about 50 dynes/cm.

3. The assembly of claim 2 wherein the body fluid is blood.

4. The assembly of claim 1 wherein the surfactant reduces the surface tension of a body fluid from about 30 dynes/cm to about 45 dynes/cm.

5. The assembly of claim 1 wherein the surfactant is a silicone.

6. The assembly of claim 5 wherein the silicone surfactant comprises a hydrophobic backbone of polydimethylsiloxane and a hydrophilic tail of polyalkylether.

7. The assembly of claim 5 wherein the silicone surfactant is present at about 2 weight percent to about 10 weight percent of the preparation.

8. The assembly of claim 1 further comprising a binding agent in the additive preparation.

9. The assembly of claim 8 wherein the binding agent is selected from the group consisting of polyvinylpyrrolidone, polyvinyl-alcohol, polyethylene glycol, carboxymethyl cellulose and corn starch.

10. The assembly of claim 1 wherein the organic acid is selected from the group consisting of citric acid, tartaric acid, malic acid, maleic acid, fumaric acid, succinic acid, ascorbic acid, and mixtures thereof.

11. The assembly of claim 1 wherein the metal carbonate compound is an alkali metal salt.

12. The assembly of claim 11 wherein the alkali metal salt is selected from the group consisting of sodium bicarbonate, sodium carbonate, sodium sesquicarbonate, potassium carbonate, cadmium carbonate, calcium carbonate, potassium bicarbonate, sodium benzoate, sodium phosphate monobasic and sodium glycine carbonate.

13. The assembly of claim 10 wherein the alkali metal salt is sodium bicarbonate.

14. The assembly of claim 1, wherein the preparation contains about 40 to about 90 weight percent of the additive.

15. The assembly of claim 1, wherein the container is an evacuated tube.

16. An assembly for collecting a body fluid, comprising

a container, and

an additive preparation in the container, the additive preparation comprising:

(a) from about 40 weight percent to about 90 weight percent of an additive selected from the group consisting of a clot activator, an anticoagulant, and a urine preservation material;

(b) from about 5 weight percent to about 30 weight percent of an organic acid;

(c) from about 5 weight percent to about 30 weight percent of a metal carbonate compound; and

(d) from about 2 weight percent to about 10 weight percent of a surfactant.

17. The assembly of claim 16 wherein the surfactant is a silicone.

18. The assembly of claim 17 wherein the silicone surfactant comprises a hydrophobic backbone of polydimethylsiloxane and a hydrophilic tail of polyalkylether.

19. The assembly of claim 16, wherein the preparation further comprises about 1 weight percent to about 30 weight percent of a binding agent.

20. The assembly of claim 16 wherein the organic acid is selected from the group consisting of citric acid, tartaric acid, malic acid, maleic acid, fumaric acid, succinic acid, ascorbic acid and mixtures thereof.

21. The assembly of claim 16 wherein the metal carbonate compound is an alkali metal salt.

22. The assembly of claim 16, wherein the container is an evacuated tube.