Progesterone CLIA Test CE

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

In women, progesterone plays a key role in regulation of the menstrual cycle, pregnancy, and embryogenesis.  It is essential for the endometrium during the implantation and development of a fertilized egg and in normal development during pregnancy.

In men, progesterone has a direct influence on spermatogenesis, and in blocking the effects of estrogen. It also affects the function of the immune, cardiovascular, and respiratory systems, kidneys, and the nervous system.

Understanding optimal levels and accurate measurement of progesterone, therefore, is very important for both females and males. Immunoassay measurement in serum or plasma is a first-line approach in assessing progesterone 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: 0.5-191 nmol/L.

Detection Limits

Limit of Detection (LOD): 0.5 nmol/L.

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 0.5 to 191 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≤ 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 Progesterone 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 Progesterone at:
    1. 0nmol/L
    2. 5 nmol/L
    3. 100 nmol/L
  3. 2-level quality controls* containing Progesterone antigen at:
    1. 5 nmol/mL
    2. 50 nmol/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
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L1220Progesterone CLIA Test

 

60/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
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FOR EXPORT ONLY