The BiotimeTSH/FT3/FT4Rapid Quantitative Test is intended to quantitatively detect the concentration of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) in human serum and plasma samples on the Biotime FIA Analyzer by fluorescent immunoassay. The test is used as an adjunctive diagnosis of thyroid function.
For in vitro diagnostic use only. For professional use only.
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Specimen Types |
Serum/Plasma |
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Sample |
Serum/Plasma:50μL |
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Reaction Time |
15 min |
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Reference Interval |
TSH: 0.29-4.16mIU/L |
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FT3: 3.12-6.76 pmol/L |
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FT4: 11.80-22.47pmol/L |
Clinical Significance:
1. TSH - A Sensitive Indicator of Thyroid Function
TSH is secreted by the pituitary and regulated by negative feedback from FT3 and FT4.
Changes in TSH occur more rapidly and significantly than changes in FT3/FT4, making it a highly sensitive marker for assessing the hypothalamic‑pituitary‑thyroid axis.
Particularly valuable for diagnosing subclinical hyperthyroidism and subclinical hypothyroidism, where FT3/FT4 may still be within normal ranges.
2. Clinical Utility in Disease Differentiation
Increased TSH is seen in: primary hypothyroidism, thyroid hormone resistance syndrome, ectopic TSH syndrome, TSH‑secreting tumors, and certain drug effects (dopamine antagonists, iodine‑containing drugs).
Decreased TSH is seen in: hyperthyroidism, subclinical hyperthyroidism, prolactinoma, hypercortisolism, acromegaly, and excessive use of glucocorticoids or antithyroid drugs.
Measuring TSH helps distinguish primary hypothyroidism (high TSH) from secondary/tertiary hypothyroidism (low or inappropriately normal TSH), which is often difficult based on clinical presentation alone.
3. FT3 and FT4-Direct Markers of Thyroid Function
FT3 and FT4 are the free, physiologically active forms of thyroid hormones, unaffected by changes in thyroid hormone‑binding proteins.
They directly reflect functional thyroid status and offer higher sensitivity and specificity than total T3/T4 (TT3/TT4).
Combined with TSH, they provide the most intuitive assessment of thyroid function.
4. Synergistic Clinical Application
The three‑marker panel (TSH, FT3, FT4) is the standard for evaluating thyroid disorders, including:
Diagnosis and monitoring of hyperthyroidism and hypothyroidism
Detection of subclinical thyroid dysfunction
Differentiation between primary and central (pituitary/hypothalamic) causes of thyroid disease
Monitoring response to antithyroid or thyroid hormone replacement therapyh test).
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