Procalcitonin

Purpose:
Procalcitonin (PCT) has developed into a promising biomarker for identifying serious bacterial infections, to distinguish between bacterial and non-bacterial conditions and to guide antibiotic treatment. The diagnostic accuracy of procalcitonin in detecting infection was found to be useful for early diagnosis of sepsis and subsequent reduction of mortality in critically ill patients.

PCT concentrations in the diagnosis of systemic bacterial infection or generalised sepsis are as follows:

Systemic infection unlikely: PCT < 0.5 ng/mL.
Systemic infection possible: PCT ≥ 0.5– < 2 ng/mL.
Systemic infection likely: PCT ≥ 2 ng/mL.
Severe sepsis or septic shock likely: PCT ≥ 10 ng/mL.

Evidence suggests that PCT to guide antibiotic treatment in patients with acute respiratory infections (ARI) reduces antibiotic exposure and side-effects, and improves survival. More recently PCT has been used as part of the management of patients with COVID-19. Increased PCT levels has been associated with disease severity, reflecting the likelihood of pneumonia and useful in identifying those COVID-19 patients who may require more intensive care. In addition, serial PCT measurements may also be useful in predicting the prognosis.

Scope:
Three liquid human serum samples are distributed monthly, with a minimum of 36 samples distributed over the year covering a wide clinically relevant range. The samples consist of a panel of 6 linearly related samples produced from donations from healthy volunteers spiked with a highly purified source of recombinant PCT to provide an extended clinical range. The programme assesses both laboratory and method performance, including bias, within and between batch imprecision and linearity.

Key Features:

Samples provided to cover range of Procalcitonin concentrations seen in both LRTI and systemic bacterial infection or severe sepsis.
Samples suitable for Laboratory and POCT applications.
Panel of linearly related samples produced from donations from healthy volunteers spiked with procalcitonin.
The linearly related samples are distributed on a number of occasions over the year to assess both laboratory and method performance, including linearity, bias, within and between batch imprecision.