# US 2007/0178604 A1 · Multi-analyte diagnostic test for thyroid disorders

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- Number: US 2007/0178604 A1
- Document ID: US20070178604A1
- Status: Published application
- Kind: A1
- Application number: 11/726,856
- Filed: 2007-03-22
- Published: 2007-08-02
- Earliest claimed: 1999-04-30
- Assignees: Bio-Rad Laboratories, Inc.
- Inventors: Michael Watkins; Suknan Chang; Renato Del Rosario; Patricia Miranda; Timothy Knight; Richard Edwards
- Web page: https://patentgrep.com/patent/US20070178604A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/76: Human chorionic gonadotropin {including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors}
- G01N 33/78: Thyroid gland hormones {, e.g. T3, T4, TBH, TBG or their receptors}
- G01N 2800/046: Thyroid disorders
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Immunological assays for several biological markers for thyroid disorders in a biological sample are performed in a single test with a combination of sandwich-type, sequential competitive, and serological assays by the use of particles classified into groups that are distinguishable by flow cytometry, one group for the assay of each marker. Each group of particles is coated with a different immunological binding member, and coating densities, co-coating materials, and special buffer solutions are used to adjust for differences in the sensitivities and dynamic ranges of each of the markers in the typical sample.

## Claims

### Claim at position 1

1-28. (canceled)

### Claim 29

A composition for analyzing a single sample to simultaneously determine levels of four biological markers indicative of thyroid disorders, said composition comprising a mixture of particles comprised of groups (i) through (iv):
(i) particles coated with anti-thyroid stimulating hormone,
(ii) particles coated with anti-triiodothyronine,
(iii) particles coated with anti-thyroxine, and
(iv) particles coated with a mixture of a diluting agent and a member selected from the group consisting of thyroid peroxidase and anti-human IgG,
the particles of each group distinguishable from the particles of each other group by a flow cytometry distinguishable characteristic that is independent of the coatings of subparagraphs (i), (ii), (iii), and (iv).

### Claim 30

A test system for analyzing a single sample to simultaneously determine levels of four biological markers indicative of thyroid disorders, said test system comprising
(a) a mixture of particles comprised of groups (i) through (iv):
(i) particles coated with anti-thyroid stimulating hormone,
(ii) particles coated with anti-triiodothyronine,
(iii) particles coated with anti-thyroxine, and
(iv) particles coated with a mixture of a diluting agent and a member selected from the group consisting of thyroid peroxidase and anti-human IgG, the particles of each group distinguishable from the particles of each other group by a flow cytometry distinguishable characteristic that is independent of the coatings of subparagraphs (i), (ii), (iii), and (iv); and
(b) a mixture of label binding members comprising:
(1) labeled anti-thyroid stimulating hormone,
(2) a labeled analog composition toward which anti-triiodothyronine and anti-thyroxine have immunological binding affinity, but in which said immunological binding affinity is less than that of anti-triiodothyronine toward triiodothyronine and of anti-thyroxine toward thyroxine, and
(3) either labeled anti-human IgG when particles of group (iv) are coated with thyroid peroxidase, or labeled thyroid peroxidase when particles of group (v) are coated with anti-human IgG;
said diluting agent being inert toward said biological markers and said labeled binding members.