PCT CLIA Test CE

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

Sepsis is a serious medical condition characterized by an overwhelming systemic immune response to an infection caused by bacteria or other microbes. If untreated, severe sepsis can lead to organ failure and drop in blood pressure that can progress into a life-threatening septic shock condition.

In healthy people, PCT levels in the blood are low (~0.05 ng/mL), but increase rapidly in response to a systemic bacterial infection1. The concentration of PCT in the blood correlates with both bacterial load and severity of infection. The half-life of circulating PCT is short, only 25-30 hours. Therefore, PCT is a good biomarker for the specific detection of a systemic bacterial infection.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range: 0.02-100 ng/mL.

Detection Limits

Limit of Detection (LOD): 0.02 ng/mL.

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Linearity

Linearity between 0.02 and 100 ng/mL.

Specificity

No significant cross-reactivity was observed when calcitonin (10 ng/mL), Katacalcin (30 ng/mL), α-CGRP (10 μg/mL) or β-CGRP (10 μg/mL) were spiked to zero PCT serum sample. The results of PCT in these samples were less than 0.02 ng/mL.

Interference

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

SubstanceConcentration
Hemoglobin900 mg/dL
Bilirubin25 mg/dL
Triglyceride1500 mg/dL
Total Protein4 g/dL
Rheumatoid Factor1500 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 PCT concentration up to 1000 ng/mL.

Reagents and materials provided

  1. 19-well PCT 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 PCT at:
    1. 0 ng/mL
    2. 1 ng/mL
    3. 50 ng/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials may be required and not provided

  1. Commercial controls

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
L0400PCT CLIA Test60/kitS/P
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