Total T4 CLIA Test CE

The Total Thyroxine (T4) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of Total Thyroxine in human serum or plasma (Sodium heparin or K2EDTA, or K3EDTA) using the ALTA CLIAlyzer. 

Thyroid disease is very common on a global level and studies have shown that the prevalence of undiagnosed thyroid disorder is high. Thus, quantification of markers that reflect thyroid function is very important.

Testing of thyroid function commonly incorporates TSH testing along with a combination of T3, T4, fT3, and fT4 assays.

T4 tests can be used to aid in the detection and diagnosis of thyroid disease including hyperthyroidism, hypothyroidism, and Graves’ disease, and to monitor pregnancy and treatment for thyroid disorder, pituitary disease, and thyroid cancer. T4 measurements are generally employed in conjunction with results from other members of the thyroid function panel as well as a measurement or estimate of binding protein levels such as TBG to give the most accurate measurement of thyroid status possible.

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

Range

Working range: 6.44-320 nmol/L.

Detection Limits

Limit of Detection (LOD): 6.44 nmol/L.

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 15%

Accuracy

Accuracy of ± 10% in comparison to the control

Linearity

Linearity from 6.44 to 320 nmol/L.

Specificity

Cross-reactivity was evaluated by spiking zero serum samples with cross-reactive compounds. The results of this study are shown as following table:

SubstanceConcentration Test Result
T3500 ng/mL<19.3 nmol/L
rT350 ng/mL<19.3 nmol/L

Interference

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

SubstanceConcentration
Hemoglobin≤500 mg/dL
Bilirubin≤20 mg/dL
Triglyceride≤1500 mg/dL
Total Protein≤10 g/dL
Rheumatoid Factor≤1500 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.

Reagents and Materials provided:

  1. 19-well T4 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 T4 at:
    1. 0 nmol/L
    2. 50 nmol/L
    3. 200 nmol/L
  3. 2-level quality controls* containing T4 antigen at:
    1. 60 nmol/L
    2. 160 nmol/L
  1. Registration card
  2. Calibrator card
  3. Quality Control Sheet
  4. 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
L1025Total T4 CLIA Test                           

 

60/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

 

FOR EXPORT ONLY