TSH is recognized as a sensitive indicator of thyroid status and thus the TSH assay has been widely adopted as the front-line thyroid function test (1,2,3). A normal TSH result excludes suspected thyroid disease in ambulatory patients with intact hypothalamic and pituitary function. Whereas elevated and suppressed TSH results are diagnostic of hypo- and hyperthyroidism (4). Functional sensitivity of 0.11 mIU/L and as such can be classified as a 2nd generation assay. It is able to differentiate between hyperthyroid and euthyroid conditions.
|Premature Infants (28-36 weeks)||0.7 - 27.0 mIU/L|
|Term Infants (>37 weeks)||1-4 days||1.00 - 39.00 mIU/L|
|2-20 weeks||1.70 - 9.10 mIU/L|
|5 months - 20 years||0.70 - 6.40 mIU/L|
|Adults||21-54 years||0.40 - 4.20 mIU/L|
|55-87 years||0.50 - 8.90 mIU/L|
|Pregnancy||First Trimester||0.30 - 4.50 mIU/L|
|Second Trimester||0.50 - 4.60 mIU/L|
|Third Trimester||0.80 - 5.20 mIU/L|
As a guide, the following ranges were determined. The euthyroid reference interval for IB10 sphingotest® TSH was determined as the central 95% of the measurements with human plasma samples collected from 265 apparently healthy individuals.
Whole Blood vs. Plasma Comparison
All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.
(1) Surks et al. (1990), American Thyroid Association Guidelines for the use of laboratory tests in thyroid disorders, JAMA, DOI: 10.1001/jama.1990.03440110095035
(2) Keffer (1996), Preanalytical considerations in testing thyroid function, Clin Chem, DOI: 10.1093/clinchem/42.1.125.
(3) John et al. (1988), Evaluation of a new strategy for detection of thyroid dysfunction in the routine laboratory, Clin Chem, DOI: 10.1093/clinchem/34.6.1110
(4) Nicoloff et al. (1990), The use and misuse of the sensitive thyrotropin assays, J Clin Endocrinol Metab, DOI: 10.1210/jcem-71-3-553