PRL CLIA Test CE

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

Prolactin has important biological and homeostatic functions, most notably in the female reproductive system. Its primary biological action is to induce and maintain lactation and mammary gland development, normal luteal function, and progesterone synthesis during pregnancy.

In addition, prolactin has been shown to influence reproductive and parental behavior and signaling pathways involving prolactin receptors in the nervous system. If prolactin concentration in the blood is high, it is known as hyperprolactinemia, which is commonly caused by pregnancy, reduction in dopamine levels, low thyroid activity, or by the presence of prolactinomas.

Accurate measurement of prolactin concentration and associated reproductive hormones are important for both males and females. The PRL CLIA test is intended to be used for monitoring purposes as well as in any person with signs and symptoms of abnormal prolactin levels, including abnormalities in lactation, fertility, menstruation, and libido.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Calibration kit follows WHO International Standard Prolactin
  • Sample volume: 70 μL

Range

Working range: 4-5000 μIU/mL

Detection Limits

Limit of Detection (LOD): 4 μIU/mL

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 between 4 and 5000 μIU/mL

Specificity

No significant cross-reactivity was observed when GH (200 ng/mL) was added to the PRL Calibrator CAL 1. The results of PRL in these samples were less than 1 μIU/mL.

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride1500 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1000 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.

Hook effect

There is no high-dose hook effect at PRL concentration up to 50,000 μIU/mL.

Reagents and Materials provided:

  1. 19-well PRL 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 Calibrators containing recombinant PRL antigen at:
    1. 0 mIU/mL
    2. 100 mIU/mL
    3. 600 mIU/mL
  3. 2-level quality controls* containing recombinant PRL antigen at:
    1. 150 mIU/mL
    2. 600 mIU/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
L1080PRL CLIA Test36/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

FOR EXPORT ONLY