Thyrotropin (TSH) in Human Serum with Roche c502

Detection of Thyrotropin (TSH) in Human Serum with Roche c502

Test Name: Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma.
Method Name: The Elecsys TSH assay employs monoclonal antibodies specifically directed against human TSH. The antibodies labeled with ruthenium complex consist of a chimeric construct from human and mouse specific components. As a result, interfering effects due to HAMA (human anti mouse antibodies) are largely eliminated.
Results: Technical Range: 0.005-100 µIU/mL
Reportable Range: 0.298-25 µIU/mL
Reference Ranges: Age Female Male
0-5 days 0.700-15.200 0.700-15.200
6-60 days 0.700-11.000 0.700-11.000
3-11 months 0.700-8.400 0.700-8.400
1-5 years 0.700-6.000 0.700-6.000
6-10 years 0.600-4.800 0.600-4.800
11-17 years 0.500-4.300 0.500-4.300
18-999 years 0.358-3.740 0.358-3.740
Clinical Significance: Thyroid stimulating hormone (TSH, thyrotropin) is a glycoprotein having a molecular weight of approximately 30000 daltons and consisting of two subunits. The β subunit carries the TSH specific immunological and biological information, whereas the α chain carries species specific information and has an identical amino acid sequence to the α chains of LH, FSH and hCG.

TSH is formed in specific basophil cells of the anterior pituitary and is subject to a circadian secretion sequence. The hypophyseal release of TSH (thyrotropic hormone) is the central regulating mechanism for the biological action of thyroid hormones. TSH has a stimulating action in all stages of thyroid hormone formation and secretion; it also has a proliferative effect.

The determination of TSH serves as the initial test in thyroid diagnostics. Even very slight changes in the concentrations of the free thyroid hormones bring about much greater opposite changes in the TSH level. Accordingly, TSH is a very sensitive and specific parameter for assessing thyroid function and is particularly suitable for early detection or exclusion of disorders in the central regulating circuit between the hypothalamus, pituitary, and thyroid.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    24 months at -20°C
14 days at 2-8°C
8 days at 20-25 °C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.