Thermo Fisher SCIENTIFIC 900760.2 Ultra Low Refrigerated Circulators User Guide

Thermo Fisher SCIENTIFIC 900760.2 Ultra Low Refrigerated Circulators

Product Specifications

• Product Name: Procalcitonin Test

• Usage: Antibiotic therapy initiation and discontinuation for
  lower respiratory tract infections

• Measurement: PCT (Procalcitonin) levels in ng/mL

• Monitoring Frequency: Follow-up samples are recommended every 1-2 days

• Sample Type: Serum or Plasma (Do not use citrate plasma tubes)

Initiating Antibiotic Therapy

When to consider antibiotic therapy

• Regardless of PCT result, consider antibiotic therapy if the patient is clinically unstable, at high risk for adverse outcomes,  shows strong evidence of bacterial infection, or clinical context warrants it.
• If antibiotics are initially withheld, reassess if symptoms persist or worsen within 6-24 hours.

Important Note: PCT levels may not be elevated in infections caused by certain atypical pathogens.

Discontinuing Antibiotics

• Consider discontinuing antibiotics if there is a decline of PCT level >80% from peak PCT and/or there is clinical improvement.
• If clinical picture does not improve and PCT remains high,re-evaluate for treatment failure or other causes.

Important Note: PCT values may be elevated in certain conditions unrelated to bacterial infections.

Monitoring and Interpretation
Follow-up samples should be tested every 1-2 days to assess treatment success and support decisions regarding antibiotic therapy continuation or discontinuation.

B·R·A·H·M·S PCT (Procalcitonin)

Initiating antibiotic therapy for patients with suspected or confirmed lower respiratory tract infection (LRTI)1

PCT (ng/mL) Ongoing Infection?

Interpretation

Important Considerations:

• Antibiotic therapy should be considered regardless of PCT result if the patient is clinically unstable, is at high risk for adverse outcome, has strong evidence of bacterial pathogen, or the clinical context indicates antibiotic therapy is warranted. If antibiotics are withheld, reassess if symptoms persist/worsen and/or repeat PCT measurement within 6-24 hours.
•  In order to assess treatment success and to support a decision to discontinue antibiotic therapy, follow up samples should be tested once every 1-2 days, based upon physician discretion taking into account patient’s evolution and progress.
• PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydophila pneumoniae and Mycoplasma pneumoniae 2.

Discontinuing antibiotics for patients with lower respiratory tract

infection (LRTI), or suspected or confirmed sepsis5,6

Important Considerations: If clinical picture has not improved and PCT remains high, re-evaluate and consider treatment failure or other causes.
PCT values may be elevated in certain conditions independent of bacterial infection. These include, but are not limited to: 3,4,8

• Injuries including major trauma, burns and heat stroke∙ Acute medical conditions such as biliary pancreatitis, chemical pneumonitis, viral hepatitis and /or decompensated severe cirrhosis (Child-Pugh Class C), prolonged or severe cardiogenic shock, prolonged severe organ perfusion anomalies, and post-cardiac arrest
• Active medullary C-cell carcinoma, small cell lung carcinoma, and bronchial carcinoid
• Invasive fungal infections and acute Plasmodium falciparum malaria
• Following interventions such as surgery with extra-corporeal circulation, treatment with drugs stimulating release of proinflammatory cytokines or resulting in anaphylaxis, peritoneal or hemodialysis

PCT values rise in relation to sepsis severity, providing clinicians with a valuable tool for assessing patients suspected of sepsis.7-9

PCT can be measured on serum or plasma; the liquid chosen should be consistent throughout a patient’s clinical course. Do not use citrate plasma tubes for specimen collection.

PCT Plasma Concentration (ng/mL)
Possible Interpretations

Please Note: PCT levels below 0.5 ng/mL do not exclude an infection, because localized infections (without systemic signs) may also be associated with such low levels.
If the PCT measurement is done very early after the systemic infection process has started (usually <6 hours), these values may still be low.

The PCT reference ranges are valuable guidelines for the clinician but they should always be interpreted in context of the patient’s clinical condition. PCT serum concentrations are elevated in clinically relevant bacterial infections and continue to rise with the increasing severity of the disease. However, as an expression of individually different immune responses and different clinical situations, the same focus of infection may be associated with varying individual elevations in PCT concentrations. Antibiotic treatment should be started/continued on suspicion of infection, particularly in high- risk patients.
Thermo Scientific™ B·R·A·H·M·S PCT™ results should be evaluated in context of all clinical and laboratory findings. If results do not agree with clinical finding, additional testing should be performed.

References

1. Schuetz P., et al., Role of procalcitonin in managing adult patients with respiratory tract infections. CHEST 2012; 141(4):1063–1073.

2. Krueger S., Welte T., Biomarkers in community-acquired pneumonia. Expert Rev. Respir. Med. 2012; 6(2): 203–214.

3. Meisner M. et al., Postoperative plasma concentrations of procalcitonin after different types of surgery. Intensive Care Med. 1998; 24: 680-684.

4. Reith H.B., Procalcitonin in early detection of postoperative complications. Dig Surg 1998; 15: 260-265.

5. Schuetz P., Christ-Crain M. et al., Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. Jama 2009; 302(10): 1059-1066.
   6. Bouadma L., Luyt C. E. et al., Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010; 375(9713): 463-474.

6. Harbarth et al., Diagnostic Value of Procalcitonin, Interleukin-6, and Interleukin-8 in Critically Ill Patients Admitted with Suspected Sepsis. Am
   J. Respir Crit Care Med 2001; 164: 396-402.

7. Meisner M., Procalcitonin – Biochemistry and Clinical Diagnosis,
   ISBN 978-3-8374-1241-3, UNI-MED, Bremen 2010.

8. Müller B. et al., Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med 2000, 28 (4): 977-983.

9. Schuetz et al., Serial Procalcitonin Predicts Mortality in Severe Sepsis Patients: Results From the Multicenter Procalcitonin MOnitoring SEpsis (MOSES) Study. Crit Care Med 2017; 45(5):781-789.

10. Morgenthaler N.G. et al., Detection of procalcitonin (PCT) in healthy controls and patients with local infection by a sensitive ILMA. Clin Lab 2002;48 (5-6):263-270.

Learn more at thermoscientific.com/procalcitonin or email us at info.pct@thermofisher.com

Not all products are CE marked or have 510(k) clearance for sale in the U.S. Availability of products in each country depends on local regulatory marketing authorization status. © 2023 Thermo Fisher Scientific Inc. All rights reserved.
B·R·A·H·M·S PCT and all other trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Patents: www.brahms.de/patents. 900760.2

References

• Patents

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