- Individual ready-to-use cartridges
- Combines competitive immunoassay technique with enzyme catalyzed chemiluminescence detection
- Sample volume: 75 μL
Total T3 CLIA Test CE
The Total Triiodothyronine (T3) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of T3 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.
Thyroid stimulating hormone (TSH) controls the production of the thyroid hormones thyroxine (T4) and 3, 5, 3’ triiodothyronine (T3), which play an important role in the regulation of metabolism.
Thus, testing of thyroid function commonly encompasses TSH and a combination of the thyroid hormone (T3/T4, fT3/fT4) assays.
Range
Working range: 0.3-10 nmol/L.
Detection Limits
Limit of Detection (LOD): 0.3 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 0.3 and 10 nmol/L.
Specificity
No significant cross-reactivity was observed when T4 (500 ng/mL) or rT3 (50 ng/mL) were added to the T3 Calibrator CAL1 respectively. The results of T3 in these samples were less than 3.072 nmol/L.
Interference
No significant interference was detected up to the concentrations mentioned below:
Substance | Concentration |
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:
- 19-well T3 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 T3 at:
- 0 nmol/L
- 1 nmol/L
- 8 nmol/L
- 2-level quality controls* containing T3 antigen at:
- 1nmol/L
- 5 nmol/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
CATALOG # | PRODUCT | QUANTITY | SPECIMEN | |
L1015 | Total T3 CLIA Test
| 60/kit | S/P | |
OTHER PRODUCTS YOU MIGHT BE INTERESTED IN… | ||||
CATALOG # | PRODUCT | QUANTITY | SPECIMEN | |
L1016 | Free T3 CLIA Test | 60/kit | S/P | |
L1025 | Total T4 CLIA Test | 60/kit | S/P | |
L1026 | Free T4 CLIA Test | 60/kit | S/P | |
L1030 | TSH CLIA Test | 60/kit | S/P | |
MATERIALS REQUIRED BUT NOT PROVIDED: | ||||
CLIA-1 | CLIAlyzer |
FOR EXPORT ONLY