Test Code LAB129 Thyroid-Stimulating Hormone (TSH), Plasma or Serum
Reporting Title
TSH 3rd Generation
Methodology
Roche Diagnostics, Electrochemiluminescence Immunoassay-RMH, GMC, DH, DMH, GMH, WECC, PMH, GCMH, BH, OBH, MGH, MH, HMH, SH
Used as a primary test for differential diagnosis of thyroid disease and as an aid in monitoring adequacy of thyroid hormone replacement therapy.
VWH Lab Only:
The Access TSH(3rd IS) assay is a two-site immunoenzymatic (“sandwich”) assay. A sample is added to a reaction vessel with mouse anti-hTSH-alkaline phosphatase conjugate, buffered protein solution, and paramagnetic particles coated with immobilized mouse monoclonal anti-hTSH antibody The hTSH binds to the immobilized monoclonal anti-hTSH on the solid phase while the goat anti-hTSH-alkaline phosphatase conjugate reacts with a different antigenic site on the hTSH. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of human thyroid-stimulating hormone in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.
Performing Laboratory
OhioHealth Laboratory Services - RMH, GMC, DH ,DMH, MGH, GMH, HMH, OBH, MH, SH, WECC, GCMH, BH, PMH and VWH Core Laboratories
Specimen Requirements
Collection Instructions:
1. Serum and Plasma gel tubes should be centrifuged within 2 hours of collection.
2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.
Submit only 1 of the following specimens:
Preferred:
Serum
Draw blood in a gold-top serum gel tube(s). Spin down and send 0.5 mL of serum refrigerated.
Note:
1. A speckled-top serum gel tube (s) or a plain, red-top tube(s) is also acceptable.
2. Heterophile antibodies may interfere with this assay.
3. Indicate serum on request form.
4. Label specimen appropriately (serum).
Alternate (Preferred for VWH Lab):
Plasma
Draw blood in a mint green-top (heparin) gel tube(s). Spin down and send 0.5 mL of heparinized plasma refrigerated.
Note:
1. Heterophile antibodies may interfere with this assay.
2. Indicate plasma on request form.
3. Label specimen appropriately (plasma).
VWH Lab:
4. Store samples tightly stoppered at room temperature (15 to 30°C) for no longer than 18 hours. If the assay will not be completed within 18 hours, refrigerate the samples at 2 to 8°C for up to 48 hrs.
Roche Specimen Stability Information
Specimen Type | Temperature | Time |
---|---|---|
Serum or plasma | Refrigerated | 14 days |
Ambient | 8 days | |
Frozen | 24 months |
Specimen Transport Temperature
Refrigerate/Frozen/Ambient -All OK
Reference Values
0-5 d: 0.7-15.2 microIU/mL
6d-2 mo: 0.7-11.0
3-11 mo: 0.7-8.4
1-5 y: 0.7-6.0
6-10 y: 0.6-4.8
11-18 y: 0.5-4.3
≥ 19 y:
0.27-4.2 microIU/mL (euthyroid)
<0.1 microIU/mL (hyperthyroid)
>7.1 microIU/mL (hypothyroid)
VWH Lab Only:
0-1 month: 0.520-16.000mIU/mL
1 month-6 years: 0.550-7.100 mIU/mL
6 yrs-18-yrs: 0.370-6.000 mIU/mL
18yrs and older: 0.490-4.670 mIU/mL
Day(s) Test Set Up
Monday through Sunday; Continuously
Test Classification and CPT Coding
84443