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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