Thyroid Related Markers - CLIA
Tests for quantitative determination of thyroid related markers in human specimen by microplate enzyme immunoassay, chemiluminescence.
Part #: Refer to the respective IFUs
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Description
Thyroid gland produces Tri-iodothyronine (T3) and Thyroxine (T4) hormones and releases them into the bloodstream. T3 & T4 regulates various metabolism and helps in the mental development. T3 and T4 exist in two forms: free form and bound form. Bound form is bound to carrier proteins e.g. Thyroxine Binding Globulin (TBG). Those which are not bound exist in free state such as free T3 (fT3) and free T4 (fT4). The free hormones are biologically active form. The production of T3 & T4 is regulated by Thyroid Stimulating Hormone (TSH) which is produced by pituitary gland. The abnormal levels of any of these analytes may result in various thyroid disorders namely hyperthyroidism or hypothyroidism.
Tg (Thyroglobulin) is a vital protein made by your thyroid gland, acting as a "storage tank" for iodine and a precursor for thyroid hormones (T3/T4) that control metabolism. Measurements of thyroid hormones (fT3, fT4 and TSH) are generally regarded as invaluable in-vitro diagnostic tests for assessing thyroid function.
Anti-thyroid peroxidase (Anti-TPO) and anti-thyroglobulin (Anti-Tg) are autoantibodies produced against thyroid-specific antigens and are important markers of autoimmune thyroid disease. Thyroid peroxidase is an enzyme essential for thyroid hormone synthesis, while thyroglobulin is a precursor protein for thyroid hormones. Elevated anti-TPO and anti-Tg levels are most associated with Hashimoto’s thyroiditis and may also be seen in Graves’ disease. Measurement of anti-TPO and anti-Tg helps in evaluating the cause of thyroid dysfunction and in monitoring disease progression.
Technical specifications
| Analyte | Principle | Calibrator Concentration | Measurement Range | Assay Time |
| T3 | Competitive assay | 0, 0.5, 1, 2.5, 5, 7.5 ng/mL | 0.126 – 7.5 ng/mL | 50 minutes |
| T3 (VAST kit) | Competitive assay | 0, 0.5, 1, 2.5, 5, 7.5 ng/mL | 0.02 – 7.5 ng/mL | 50 minutes |
| T4 | Competitive assay | 0, 2, 5, 10, 15, 25 µg/dL | 0.318 – 25 µg/dL | 50 minutes |
| T4 (VAST kit) | Competitive assay | 0, 2, 5, 10, 15, 25 µg/dL | 0.2 – 25 µg/dL | 50 minutes |
| fT3 | Competitive assay | 0, 1.5, 3.2, 6.5, 15, 20 pg/mL | 0.742 – 20 pg/mL | 50 minutes |
| fT3 (VAST kit) | Competitive assay | 0, 1.3, 3, 8, 12, 22 pg/mL | 0.04 – 22 pg/mL | 50 minutes |
| fT4 | Competitive assay | 0, 0.4, 1, 1.85, 3.5, 7.2 ng/dL | 0.28 – 7.2 ng/dL | 50 minutes |
| fT4 (VAST kit) | Competitive assay | 0, 0.5, 1.2, 2.4, 4.2, 7.6 ng/dL | 0.04 – 7.6 ng/dL | 50 minutes |
| TSH | Sandwich assay | 0, 0.5, 2.5, 5, 10, 20, 40 µIU/mL | 0.0062 – 40 µIU/mL | 55 minutes |
| TSH (VAST kit) | Sandwich assay | 0, 0.5, 2.5, 10, 20, 40 µIU/mL | 0.05 – 40 µIU/mL | 50 minutes |
| Tg | Sandwich assay | 0, 2, 10, 40, 100, 250 ng/mL | 0.031 – 250 ng/mL | 125 minutes |
| Anti-TPO | Sandwich assay | 0, 25, 50, 100, 250, 500 IU/mL | 1 – 500 IU/mL | 65 minutes |
| Anti-Tg | Sandwich assay | 0, 50, 125, 500, 1000, 2000 IU/mL | 1.95 – 2000 IU/mL | 65 minutes |
Refer to the product Instruction-For-Use (IFU) for complete details.