- Individual ready-to-use cartridges
- Combines competitive immunoassay technique with enzyme catalyzed chemiluminescence detection
- Sample volume: 70 μL
Free T4 CLIA Test CE
The free Thyroxine (fT4) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of free 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.
Generally, and depending on the status of the individual’s TSH concentration, elevated fT4 results may indicate hyperthyroidism, and low fT4 results may indicate hypothyroidism. Free T4 tests are also commonly used to monitor pregnancy and certain treatments for thyroid disorder, pituitary disease, and thyroid cancer. Combining fT4 with other thyroid hormone results and any other necessary test results will help provide enough information for the healthcare provider to design a proper plan of care.
Working range: 2.0-77.2 pmol/L.
Limit of Detection (LOD): 2.0 pmol/L.
CV less than 10%
CV less than 15%
Accuracy of ± 10% in comparison to the control
Linearity from 2.0 and 77.2 pmol/L.
The cross-reactivity fT4 CLIA was less than 0.1% for the below mentioned cross reactive compounds at given concentration
|Triiodothyronine (T3)||10 ng/mL|
|Reverse triiodothyronine (rT3)||10 ng/mL|
No significant interference was detected up to the concentrations mentioned below:
|Total Protein||≤10 g/dL|
|Rheumatoid Factor||≤1000 IU/mL|
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:
- 19-well fT4 reagent cartridge
- Sample well (1st well)
- Reading well for chemiluminescent signal (19th well)
- Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
- 3 Liquid calibrators containing T4 antigen at:
- 0 pmol/L
- 10 pmol/L
- 50 pmol/L
- 2-level quality controls* containing T4 antigen at:
- 10 pmol/L
- 30 pmol/L
- Registration card
- Calibrator card
- Quality Control Sheet
- Instructions for Use
*Quality control values are lot specific and refer to the quality control sheet.
Materials required but not provided:
- Pipette with disposable tip to dispense up to 100 μL
- For other specific materials and disposables, refer to CLIAlyzer user manual
- CLIAlyzer instrument
- Powderless gloves
|L1026||Free T4 CLIA Test||60/kit||S/P|
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|MATERIALS REQUIRED BUT NOT PROVIDED:|
FOR EXPORT ONLY