Multi-analyte diagnostic test for thyroid disorders

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).

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.