Useful For

For information regarding the testing algorithm and result interpretation, consult the AsanteNet policy 400-LAB-0006: Procalcitonin (PCT) Guide

Used in conjunction with other laboratory findings and clinical assessments, LIAISON® BRAHMS PCT® II GEN intended for use as follows:

• To aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock

• To aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time

• To aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting

• To aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis

Warnings and Precautions-Test Interpretation

• LIAISON® BRAHMS PCT® II GEN ASSAY is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence.

• Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations.

• PCT results should always be interpreted in the context of the clinical status of the patient and other laboratory results.

Changes in PCT levels for the prediction of mortality, and overall mortality, are strongly dependent on many factors, including pre-existing patient risk factors and clinical course.

• The need to continue ICU care at Day 4 and other covariates (e.g., age and SOFA score) are also significant predictors of 28-day cumulative mortality risk.

• Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values.

• Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock.

• PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae.

• The safety and performance of PCT-guided therapy for individuals younger than age 18 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials.

• Low PCT levels do not always indicate absence of bacterial infection. Falsely low PCT levels in the presence of bacterial infection may occur during the early course of infections, in localized infections, and in subacute infectious endocarditis.

• Increased PCT levels may not always be related to systemic bacterial infection. There are a few situations where PCT levels may be elevated by non-bacterial causes. These include, but are not limited to, the following:

• Neonates at < 48 hours of life (physiological elevation)

• Severe illness such as polytrauma, burns, major surgery, and prolonged or cardiogenic shock

• Treatment with OKT3 (muromonab-CD3) antibodies and other drugs stimulating the release of proinflammatory cytokines

• Patients with invasive fungal infections

• Patients with acute attacks of Plasmodium falciparum malaria3

• Patients receiving peritoneal dialysis or hemodialysis treatment

• Patients with biliary pancreatitis, chemical pneumonitis, or heat stroke

• Patients with small cell lung cancer, severe liver cirrhosis and chronic or acute viral hepatitis, or medullary C-cell carcinoma of the thyroid