TSH CLIA Test CE

The Thyroid Stimulating Hormone (TSH) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of TSH in human serum or plasma (sodium heparin, K2EDTA or K3EDTA) using the ALTA CLIAlyzer.

Human TSH is synthesized by the basophilic cells (thyrotropes) of the anterior pituitary. TSH stimulates the production and secretion of the metabolically active thyroid hormones, thyroxine (T4) and triiodothyronine (T3).

Most physicians consider TSH levels > 5-10 μIU/mL as evidence of mild or subclinical hypothyroidism, and TSH levels < 0.2-0.4 μIU/mL as evidence of hyperthyroidism. However, it is important for each facility to establish its own TSH reference interval based on representative sampling of the local population.

Combining the measurement of TSH with the thyroid hormones (T3/T4) can provide more information for the determination of thyroid status.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range:  0.01-100 μIU/mL.

Detection Limits

Limit of Detection (LOD): 0.01 μIU/mL.

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Accuracy

Accuracy of ± 10% in comparison to the control

Linearity

Linearity between 0.01 and 100 μIU/mL.

Specificity

No significant cross-reactivity was observed when FSH (200 mIU/mL), LH (200 mIU/mL), or hCG (1000 mIU/mL) were added to the TSH Calibrator CAL 1, respectively. The results of TSH in these samples were less than 0.01 μIU/mL.

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride1500 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1500 IU/mL

 

HAMA Interference 

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values.  Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook

There is no high-dose hook effect at TSH concentration up to 1000 µIU/mL.

Reagents and Materials provided:

  1. 19-well TSH reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Liquid calibrators containing TSH at:
    1. 0 µIU/mL
    2. 3 µIU/mL
    3. 15 µIU/mL
  3. 2-level quality controls* containing TSH antigen at:
    1. 1 µIU/mL
    2. 15 µIU/mL
  4. Registration card
  5. Calibrator card
  6. Quality Control Sheet
  7. Instructions for Use

*Quality control values are lot specific and refer to the quality control sheet.

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L1030TSH CLIA Test                    60/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

FOR EXPORT ONLY