Sepsis is the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure and death.1 In the United States, one person is diagnosed with sepsis every 20 seconds.1 In total, 1.6 million people are diagnosed with sepsis each year.1
For in vitro diagnostics use only.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.1Anyone affected by an infection can progress to sepsis conditions but some vulnerable populations such as elderly people, pregnant women, neonates, hospitalized patients, and people with HIV/AIDS, are at higher risk.2
In sepsis, organ dysfunction can be identified as an acute change in total SOFA (Sequential [Sepsis-related] Organ Failure Assessment) score ≥2 points consequent to the infection. A SOFA score ≥2 refelct an overall mortality risk of approximately 10% in a general hospital population with suspected infection.1
It is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalitites are profound enough to substantially increase mortality. Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP (Mean Arterial Pressure) ≥65 mmHg and having a serum lactate level ≥2 mmol/L (18mg/dL) despite adequate volume resuscitation. With these criteria, hospital mortality is in excess of 40%.1
For In Vitro Diagnostic Use Only
CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.
For complete assay information, see the assay specific package insert.
ARCHITECT B∙R∙A∙H∙M∙S PCT
Intended Use: The ARCHITECT B∙R∙A∙H∙M∙S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT i System.
Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT B∙R∙A∙H∙M∙S PCT assay is intended for use as an:
Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock.
Warning: The ARCHITECT B∙R∙A∙H∙M∙S PCT 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 PCT 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 PCT values and should be considered as potentially confounding clinical factors when interpreting PCT values. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydophila pneumoniae and Mycoplasma pneumoniae.
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. 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. ARCHITECT B∙R∙A∙H∙M∙S PCT results should not be used interchangeably with other methods for PCT determinations for monitoring patients.
PCT is an inflammatory biomarker that is highly specific to bacterial infection and helps differentiate bacterial from viral infections. Additionally it:
PCT is a more accurate diagnostic parameter for sepsis, a better predictor of mortality and a more reliable marker than other biomarkers, including C-reactive (CRP), Interleukins and Lactate levels. 5
Recent studies indicate the value of PCT testing for patients diagnosed with COVID-19.
When making critical decisions, early diagnosis means life-saving treatment for your patients.
Abbott is committed to increasing awareness about sepsis and has developed several educational resources to help clinicians and laboratorians learn more about sepsis.
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1. Third International Consensus Definition of Sepsis2. https://www.who.int/news-room/fact-sheets/detail/sepsis (Last accessed January 2020) 3. https://www.worldsepsisday.org/toolkits/ 4. Thermo Scientific B-R-A-H-M-S PCT Improving infection management https://www.procalcitonin.com/images/downloads/brahms-pct-procalcitonin-clinical-guide-en.pdf5. Shiferaw, at al. The Role of Procalcitonin as a Biomarker in Sepsis. J Infect Dis Epidemiology. 2016; 2:006 Vol 2. 6. Procalcitonin OUS Package Insert
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