Thyroid analyte detection and measurement

• US 8,012,769 B2
• Filed: 11/09/2009
• Issued: 09/06/2011
• Est. Priority Date: 11/12/2008
• Status: Active Grant

• Current Assignee: Hemopet
• Original Assignee: Hemopet
• Inventors: Ongchangco, Ferdie S., Dodds, W. Jean
• Primary Examiner(s): Yu; Melanie J
• Assistant Examiner(s): Counts; Gary W
• Application Number:
  US12/615,121
• Publication Number:
  US 20100120169A1
• Time in Patent Office: 666 Days
• Field of Search: None
• US Class Current: 436/500
• CPC Class Codes: G01N 33/78 Thyroid gland hormones , e.g. T3, T4, TBH, TBG or their receptors

Abstract

A non-radioisotopic method of detecting thyroid analytes comprising detecting T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in a sample of a non-human species. Each one of these analytes in an assay profile includes non-radio isotopic measurement of T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in the sample from the non-human species. A non-radioisotopic method detects T3AA and T4AA thyroid autoantibodies in a sample from a non-human species such as the canine species. Antibodies and autoantibodies are bound, and a precipitated or bound antigen-antigen or antibody-autoantibody complex is formed. The supernatant or surrounding fluid of the bound or precipitated antigen-antigen or antibody-autoantibody complex is then removed. The thyroid activity of the bound complex, precipitate, supernatant or surrounding fluid is measured. The thyroid analyte is at least one of T3, Free T3, T4 or Free T4. A dialysis cell can be used to separate by dialysis the T3AA or T4AA from their respective T3AA or T4AA fractions without radioisotopes. A non-radioisotopic method detects Free T3 and/or Free T4 in a sample of a non-human species.

Claims

1. A non-radioisotopic method of detecting thyroid activity of a canine sample using a profile of thyroid analytes consisting of measuring T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in a sample of a canine species and wherein each one of these analytes in an assay profile consists of a non-radio isotopic measurement of each of the analytes T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in the sample from the canine species, and wherein the measurement of the T3, Free T3, T4, Free T4 and thyroglobulin autoantibody analytes in the profile collectively is indicative of thyroid activity.

2. The method as claimed in claim 1 wherein, for the canine species, an r-squared value of T4 relative to Free T4 is between about 0.75 and about 0.99, and wherein the r-squared value is a measure of diagnostic specificity of the analytes T4 and Free T4.

3. The method as claimed in claim 1 consisting of adding a sample to a luminescence reaction assay for measuring T3, Free T3, T4 and Free T4 in the canine species, and measuring the amount of luminescence from a reaction of the sample with a reactant in the assay, and thereby determining the amount of T3, Free T3, T4 and Free T4 in the canine species, including employing a luminescent detector and microparticles as a solid phase for measuring T3, Free T3, T4, Free T4 in the canine species.

4. The method of claim 1 comprising applying a luminescent detector and microparticles as a solid phase.

5. The method as claimed in claim 4 wherein, for the canine species, a r-squared value of T4 relative to Free T4 is between about 0.75 and about 0.99, and wherein the r-squared value is a measure of diagnostic specificity of the analytes T4 and Free T4.

6. The method of claim 1 including applying chemiluminesence.

7. The method of claim 1 including measuring Free T4 by applying a luminescent detector and microparticles as a solid phase, and effecting the measurement with a sensitivity of about 1 femtogram per mL.

8. The method of claim 1 including measuring Free T4 by chemiluminesence, and having an incubation period for less than 90 minutes.

9. The method of claim 1 including measuring T3 by applying a luminescent detector and microparticles as a solid phase, and having an incubation period for less than 90 minutes.

10. The method of claim 1 including measuring T3 by chemiluminesence, and effecting the measurement with a sensitivity of about 1 femtogram per mL.

11. The method of claim 1 including measuring Free T3 by applying a luminescent detector and microparticles as a solid phase.

12. The method of claim 1 including measuring Free T3 by chemiluminesence.

13. The method as claimed in claim 6 wherein, for the canine species, a r-squared value of T4 relative to Free T4 is between about 0.75 and about 0.99, and wherein the r-squared value is a measure of diagnostic specificity of the analytes T4 and Free T4.

14. A non-radioisotopic method of detecting thyroid activity of a canine sample using a profile of thyroid analytes consisting of measuring T3, Free T3, T4, Free T4 and thyroglobulin autoantibody in a sample of biological fluid from a canine species, and wherein each one of these analytes consists of measuring by a non-radioisotopic measurement for each of the analytes T3, Free T3, T4, and Free T4 and thyroglobulin autoantibody in the sample of biological fluid from the canine species, adding the sample to a non-radioisotopic luminescence reaction assay for measuring each of T3, Free T3, T4 and Free T4 and thyroglobulin antibody in the canine species, measuring the amount of non radioisotopic luminescence from a reaction of the sample with a reactant in the assay, and measuring thyroglobulin autoantibody in the sample by a non-radioisotopic immunoassay thereby determining the amount of each of T4, Free T4, T3 and Free T3 and thyroglobulin autoantibody in the canine species, and wherein the measurement of the T3, Free T3, T4, Free T4 and thyroglobulin autoantibody analytes in the profile collectively is indicative of thyroid activity.