Reduction of false positives in oral-fluid based immunoassays

• US 5,871,905 A
• Filed: 09/04/1996
• Issued: 02/16/1999
• Est. Priority Date: 09/04/1996
• Status: Expired due to Term

• Current Assignee: Orasure Technologies Incorporated
• Original Assignee: Epitope, Inc. (Orasure Technologies Incorporated)
• Inventors: Thieme, Thomas, Klimkow, Nanette
• Primary Examiner(s): Smith, Lynette F.
• Assistant Examiner(s): NELSON, BRETT L
• Application Number:
  US08/707,446
• Time in Patent Office: 895 Days
• Field of Search: 435/5, 435/6, 435/7, 128/760, 128/771
• US Class Current: 435/5
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding

Abstract

This invention relates to the use and composition of materials which, when added to oral fluid samples, make such samples suitable for use with microparticle-based immunoassays. In one embodiment, this invention provides a method of reducing false positives in assays for the detection of an analyte in an oral fluid sample. The method involves providing an oral fluid sample combined with a bile acid or salt where the bile acid or salt is present in a concentration sufficient to reduce the rate of occurrence of false positives in said oral fluid based immunoassays.

Claims

1. A method of reducing false positives in assays for the detection of an analyte in an oral fluid sample, said method comprising the step of providing an oral fluid sample combined with a bile acid bile or salt;

wherein said bile acid bile or salt is present in a concentration sufficient to reduce the rate of occurrence of false positives in said assays; and

wherein said assays are characterized by the use of a particulate moiety as a detectable label.

2. The method of claim 1, wherein said bile acid bile or salt is selected from the group consisting of deoxycholic acid (deoxycholate salt), cholic acid (cholate salt), chenodeoxycholic acid (chenodeoxycholate salt), glycodeoxycholic acid (glycodceoxycholate salt), and taurodeoxycholic acid (taurodeoxycholate salt).

3. The method of claim 2, wherein said bile acid or bile salt is deoxycholic acid or deoxycholate salt.

4. The method of claim 1, wherein said bile acid or bile salt ranges in concentration from about 0.1 weight percent to about 1.0 weight percent of the oral fluid/bile salt or bile acid combination.

5. The method of claim 1, further comprising contacting a chelator of divalent cations with said oral fluid sample.

6. The method of claim 5, wherein said chelator is selected from the group consisting of EDTA, EGTA, NTA, CDTA, sodium citrate, and a chelating resin.

7. The method of claim 6, wherein said chelator is EDTA.

8. The method of claim 1, wherein said assay is an immunoassay that use a particulate detectable label.

9. The method of claim 8, wherein said assay is an immunochromatography assay.

10. The method of claim 1, wherein said providing comprises using a collection means selected from the group consisting of a sponge, an absorbent pad, a salt-impregnated absorbent pad, an aspirator, and a mouth rinse to collect said oral fluid sample.

11. The method of claim 1, wherein said oral fluid sample is predominantly mucosal transudate.

12. The method of claim 1, wherein said analytes are selected from the group consisting of antibodies to antigens of infectious diseases, antigens of infections diseases, hormones, growth factors, therapeutic drugs, drugs of abuse and products of the metabolism of drugs of abuse.

13. The method of claim 12, wherein said antigens are antigens of hepatitis B and said antibodies are selected from the group consisting of antibodies to HIV, antibodies to HTLV, antibodies to Helicobacter pylon, antibodies to hepatitis, antibodies to measles, antibodies to mumps, and antibodies to rubella.

14. The method of claim 13, wherein said analyte is an antibody to HIV.

15. The method of claim 12, wherein said therapeutic drugs and drugs of abuse or products of the metabolism of drugs of abuse are selected from the group consisting of tetrahydrocannabinol, nicotine, ethanol, theophylline, phenytoin, acetaminophen, lithium, diazepam, nortryptyline, secobarbital, phenobarbitol.

16. The method of claim 12, wherein said hormones are selected from the group consisting of testosterone, estradiol, 17-hydroxyprogesterone, progesterone, thyroxine, thyroid stimulating hormone, follicle stimulating hormone, and luteinizing hormone.

17. The method of claim 1, wherein said method further comprises contacting said oral fluid sample with a chelator of divalent cations and said oral fluid sample is assayed in a lateral flow immunochromatography assay.

18. The method of claim 17, wherein

said bile salt or bile acid is deoxycholic acid or deoxycholate salt;

said chelator is EDTA.