Immunoluminometric assay (ILMA) for the quantitative determination of Procalcitonin (PCT) in human serum and plasma

Assay characteristics

• One-step immunoluminescence assay using coated tube systemwith two monoclonal antibodies (sandwich principle)
• Sample matrix: Serum or plasma
• Sample volume: 20 μL
• Incubation time: 1 hour at room temperature (18-25 °C)
• Measuring range: 0.1-500 μg/L
• Functional assay sensitivity: 0.3 μg/L
• High-dose hook: No high-dose hook effect detectable up to 900 μg/L

Assay procedure

• Pipette 20 μL sample plus 250 μL tracer into the coated tube
• Incubate for 1 hour at room temperature (18-25 °C)
• Remove excess tracer by thorough washing and subsequently remove the remaining liquid (put tube upside down on filter paper for 5-10 min)
• Measure luminescence for 1 sec in a luminometer
• Calculate results from the standard curve

Reproducibility

The inter-assay precision in the clinically relevant range is between 6 and 10% CV. The functional assay sensitivity, defined as the smallest value with an inter-assay precision of 20% CV, is 0.3 μg/L.