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Sepsis & Antibiotic Stewardship 

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Sepsis may result due to an overwhelming life-threatening response to an infection. The B∙R∙A∙H∙M∙S Procalcitonin (PCT) assay aids in diagnosis of Sepsis and patient management to allow for timely antibiotic therapy, helping prevent serious medical complications.

For in vitro diagnostic use.

Challenges

More than 1.7 million people are diagnosed with sepsis each year leading to an estimated 270,000 adults deaths in the U.S.1

Aggregate hospital costs for sepsis stays in the U.S reached $36.9 billion in both 2020 and 2021.2

Sepsis

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.3 Anyone 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.4

In sepsis, organ dysfunction can be identified as an acute change in total SOFA (Sequential [Sepsis-related] Organ failure Assessment) score ≥ 2 reflect an overall mortality risk of approximately 10% in a general hospital population with suspected infection.3

Septic shock

It is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities 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 ≥ 65mm Hg and having a serum lactate level ≥ 2mmol/L (18mg/dL) despite adequate volume resuscitation. With these criteria, hospital mortality is in excess of 40%.3

 

PROCALCITONIN AND SEPSIS5,6

PCT is an inflammatory biomarker that is highly specific to bacterial infection and helps differentiate bacterial infection from other causes of inflammation such as that caused by viral infection. Additionally, it:

  • Helps determine how severe the infection is
  • Helps determine if the patient is responding to treatment (or not)9

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 protein (CRP), Interleukins and Lactate levels.7 

Recent studies suggest the value of PCT testing among COVID-19 patients as some patients may experience bacterial infections. This testing will help indicate who may benefit from antibiotics as part of their treatment.8

ABBOTT's B·R·A·H·M·S PCT

When making critical decisions, early diagnosis may help you select the best treatment for your patients. 

  • Provide clinicians a risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression of sepsis to septic shock.5,6 
  • Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.5,6
  • Excellent clinical sensitivity with a Limit of Quantitation (LoQ) of 0.01ng/mL allowing for early indication, antibiotic stewardship, and negative predictive values.5,6

Click here for the full INTENDED USE AND IMPORTANT SAFETY INFORMATION

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INTENDED USE AND IMPORTANT SAFETY INFORMATION

The ARCHITECT and Alinity i 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 iSystem and Alinity i analyzer respectively. 

Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT and Alinity i 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. 
  • 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. 
  • 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 or an emergency department.
  • Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Important Safety Information 
Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. 

This product contains sodium azide. Contact with acids liberates very toxic gas. Dispose of contents/container in accordance with local regulations. 

CAUTION: This product requires the handling of human specimens. It is recommended that all human-sourced materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents.

United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.

Warnings And Precautions – Test Interpretation

  • The ARCHITECT and Alinity i 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 preexisting patient risk factors and clinical course.
  • The need to continue ICU care at Day 4 and other covariates (e.g., age and Sequential Organ Failure Assessment [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. 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 pro-inflammatory Cytokines
    • Patients with invasive fungal infections
    • Patients with acute attacks of Plasmodium falciparum malaria
    • 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 acute or chronic viral hepatitis, or medullary C-cell carcinoma of the thyroid
  • 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 and Alinity i B·R·A·H·M·S PCT results should not be used interchangeably with other methods for PCT determinations for monitoring patients.
References
  1. Rhee C, et al. “Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014.” JAMA. 2017;318(13):1241-1249. http://jamanetwork.com/journals/jama/fullarticle/2654187 (accessed Aug 8, 2024).
  2. Owens et al., Overview of Outcomes for Inpatients Stays Involving Sepsis, 2016-2021. Agency for healthcare research and quality. https://hcup-us.ahrq.gov/reports/statbriefs/sb306-overview-sepsis-2016-2021.pdf (Last accessed April 2024).
  3. Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. PMID: 26903338; PMCID: PMC4968574.
  4. Sepsis (who.int) https://www.who.int/news-room/fact-sheets/detail/sepsis. doi:https://doi.org/10.3390/cancers13112621 (Last accessed March 12, 2024).
  5. Alinity i B∙R∙A∙H∙M∙S PCT Instructions for Use, G99806R02., April 2024.
  6. ARCHITECT B∙R∙A∙H∙M∙S PCT Instructions for Use, G10601R03., January 2022.
  7. Shiferaw, et al. The Role of Procalcitonin as a Biomarker in Sepsis. J Infect Dis Epidemiology. 2016; 2:006 Vol 2. 
  8. Hessels LM, Speksnijder E, Paternotte N, van Huisstede A, Thijs W, Scheer M, van der Steen-Dieperink M, Knarren L, van Den Bergh JP, Winckers K, Henry R, Simsek S, Boersma WG; COVID Predict Study Group. Procalcitonin-Guided Antibiotic Prescription in Patients With COVID-19: A Multicenter Observational Cohort Study. Chest. 2023 Sep;164(3):596-605. doi: 10.1016/j.chest.2023.04.032. Epub 2023 Apr 26. PMID: 37116748; PMCID: PMC10132833.
  9. Kumar, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.

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