Method and apparatus for preserving human saliva for testing

• US 6,291,178 B1
• Filed: 08/30/1999
• Issued: 09/18/2001
• Est. Priority Date: 11/26/1997
• Status: Expired due to Fees

• Current Assignee: David R. Schneider
• Original Assignee: David R. Schneider
• Inventors: Schneider, David R.
• Primary Examiner(s): Campbell, Eggerton A.
• Assistant Examiner(s): Chunduru, Suryaprabha
• Application Number:
  US09/385,171
• Time in Patent Office: 750 Days
• Field of Search: 435/6, 536/23.7, 424/150.1, 424/237.1
• US Class Current: 435/6.16
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 2400/0672 Swellable plugs
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: C12Q 1/32 involving dehydrogenase

Abstract

A method and apparatus for the preservation of a saliva sample for use in subsequent quantitative chemical assays. The method involves collecting a saliva sample at a location, directly into a specimen cup. The specimen cup contains a predetermined volume of aqueous solution of pH buffered saline and enzymatic inhibitor and is optionally adapted with a constituent compound specific, qualitative test unit.

Claims

1. An assay sample collection kit for the direct collection and preservation of a saliva sample for subsequent assay of a biologic therein comprising:

a) an ionic solute that upon dilution to a preselected volume in water yields a solution with an osmality of a normal physiological body fluid; and

b) an enzymatic inhibitor of an enzyme capable of utilizing said biologic as a substrate, said enzyme being present in the saliva sample.

2. The kit of claim 1 wherein said ionic solute is a salt and protein matrix that has at least one constituent concentration of a normal body fluid.

3. The kit of claim 2 further comprising a buffer to maintain said solution as a predetermined pH between 7 and 8 following introduction of the saliva sample.

4. The kit of claim 1 wherein said body fluid is plasma or urine.

5. The kit of claim 1 wherein said biologic is selected from a group consisting of:

virus infected cells, bacteria, carbohydrates, nucleic acids, lipids, fatty acids, melanin, hormones, steroids, cholesterol, insulin, glucogen, antibodies, polypeptides, blood groups, proteins, neurotransmitters, prostaglandin and metabolites thereof.

6. The kit of claim 5 wherein said virus infecting cells is selected from the group consisting of:

human immunodeficiency virus (HIV), hepatitis, herpes, influenza, rhinoviruses, adenoviruses, enteroviruses and picornaviruses.

7. The kit of claim 5 wherein said bacteria are selected from a group consisting of:

tuberculosis bacilli, Pneumococcae, Klebsiella bacilli, Streptococci, Staphlococcae, Mycobacteria, Bordetellae, Corynebacteria, Clostridia, Fusobacteria, Escherichae, Spirochetae, Salmonellae, Enterobacteria, Shigellae, and Brucella.

8. The kit of claim 5 wherein said hormones are selected from a group consisting of:

growth hormone releasing factor, endocrine, hypothalamus, pituitary and adrenal gland produced hormones, sex hormones and gastrointestinal hormones.

9. The kit of claim 2 wherein said salt and protein matrix contains substances selected from the groups consisting of:

bicarbonate, calcium, chloride, phosphate, potassium, sodium, sulfate, sulfite, albumins, amino acids, bilirubin, nucleotides, nucleosides, urea, creatine, citrate, formate and lactate.

10. The kit of claim 1 wherein said enzymatic inhibitor is selected from the group consisting of:

2-deoxyglucose;

rotenone;

reduced glutathione (GSH);

octaoate;

β

-NADH;

hydrogen peroxide H₂O₂ and Fe⁺⁺⁺;

iodoacetate;

iodoacetamide;

soluble cyanides;

aluminum metal;

chlorhexidine;

soluble azides;

butylparabens;

cyclohexyladenosine;

alpha-cyano-4-hydroxycinnamate;

alpha-cyano-beta (1-phenylindol-3-yl)acrylate;

glycerol;

paraquat;

mannoheptulose;

3-bromopyruvate;

glucose 1, 6-bisphosphate;

Cibacron Blue 3G-A;

3-deoxyhglucosone (3-DG);

actinomycin D;

cycloheximide;

Mg₂ citrate;

oxalates;

glutamates;

soluble fluorides and nitroprussides.

11. The kit of claim 1 further comprising:

a bactericide present in a concentration from about 0.1 to 10 mole percent.

12. The kit of claim 1 further comprising:

a fungicide present in a concentration from about 0.1 to 10 mole percent.

13. A method for determining the presence of a biologic in body plasma comprising the steps of:

a) collecting a saliva sample at a first location directly into a specimen cup, said specimen cup containing a measured aqueous solution consisting essentially of;

pH buffered saline, and an enzymatic inhibitor;

b) scaling said specimen cup against spillage and tampering;

c) transporting said specimen cup to a second location; and

d) assaying by conventional techniques said sample and solution subsequently for said biologic at said second location.

14. The method of claim 13 wherein said biologic is selected from a group consisting of:

virus infected cells, bacteria, carbohydrates, nucleic acids, lipids, fatty acids, melanin, hormones, steroids, cholesterol, insulin, glucogen, antibodies, polypeptides, blood groups, proteins, neurotransmitters, prostaglandin and metabolites thereof.

15. The method of claim 13 wherein said measured said aqueous solution has a volume ranging from between 10 and 40 milliliters.

16. The method of claim 13 wherein said measured solution further consists essentially of:

a salt and protein matrix simulating a body fluid composition.

17. The method of claim 13 wherein said matrix is a quantitative assay standard.

18. The method of claim 13 wherein said measured solution further consists essentially of a fungicide.

19. The method of claim 13 wherein said measured solution further consists essentially of a bactericide.

20. A method of assaying for a biological comprising the step of sampling a saliva preservative solution to detect a biologic therein selected from a group consisting of:

virus infected cells, bacteria, carbohydrates, nucleic acids, lipids, fatty acids, melanin, hormones, steroids, cholesterol, insulin, glucogen, antibodies, polypeptides, blood groups, proteins, neurotransmitters, prostaglandin and metabolites thereof.