Estradiol (E2) CLIA Test CE

The Estradiol (E2) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence based immunoassay for the quantitative detection of Estradiol in human serum or plasma (sodium heparin or K2EDTA or K3EDTA) using the ALTA CLIAlyzer.

E2 is the predominant form of estrogen. It is a steroid hormone and is the most important sex hormone in females.

E2 also plays an essential in male sexual function. Optimal levels of E2 in males are essential for healthy regulation of sex drive, erectile function, spermatogenesis, and testicular maintenance.

Optimal levels of E2 are also needed to support growth and maintenance of bone and liver, and to support healthy neurological and cardiovascular function.

Understanding optimal levels and accurate measurement of estradiol, therefore, is very important for both females and males. Immunoassay measurement in serum or plasma is a first-line approach.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme catalyzed chemiluminescence detection
  • Sample volume: 80 μL

Range

Working range:  15-3000 pg/mL.

Detection Limits

Limit of Detection (LOD): 15 pg/mL.

Precision

Intra-lot Precision

CV less than 10%

Inter-lot Precision

CV less than 15%

Accuracy

Accuracy of ± 10% in comparison to the control

Linearity

Linearity from 15 to 3000 pg/mL.

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≤ 1000 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 E2 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 Estradiol at:
    1. 0 pg/mL
    2. 100 pg/mL
    3. 1500 pg/mL
  3. 2-level quality controls* containing E2 antigen at:
    1. 100 pg/mL
    2. 500 pg/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
L1230Estradiol (E2) CLIA Test60/kit                S/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

FOR EXPORT ONLY