Testosterone CLIA Test CE

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

Testosterone is a steroid hormone from the androgen group that is secreted primarily by the testicles of males and the ovaries of females and, to a lesser extent, the adrenal glands.

 In males, testosterone is the principal sex hormone which plays a key role in the development of the male reproductive tissues (testes, prostate), and in normal sperm development.

In females, it functions to aid in the growth, maintenance, and repair of female reproductive tissues, bone mass and muscle, and brain function including sexual behavior.

Understanding optimal levels and accurate measurement of testosterone, therefore, is very important for both males and females. Immunoassay measurement in serum or plasma is a first-line approach in assessing testosterone levels, providing important information for diagnostic and monitoring purposes.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme catalyzed chemiluminescence detection
  • Sample volume: 100 μL

Range

Working range: 0.1 – 15 ng/mL.

Detection Limits

Limit of Detection (LOD): 0.1 ng/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 0.1 to 15 ng/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 Testosterone 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 Testosterone at:
    1. 0 ng/mL
    2. 1 ng/mL
    3. 9 ng/mL
  3. 2-level quality controls* containing Testosterone antigen at:
    1. 1 ng/mL
    2. 5 ng/mL
  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
L1210Testosterone CLIA Test

 

60/kit    S/P
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FOR EXPORT ONLY