Abbott ARCHITECT Sepsis Testing

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The treatment of sepsis incurs the highest hospitalization costs in the U.S., with annual expenses of more than $24 billion. The measurement of procalcitonin (PCT) levels has been used as a more accurate diagnostic parameter for sepsis; it better predicts mortality and is a more reliable marker than C-reactive protein, interleukins and lactate levels. One healthcare system study showed that implementing a sepsis protocol that employs the clinical utility of PCT reduced the occurrence of Clostridium difficile infections by 54%.

The Abbott™ ARCHITECT™ B∙R∙A∙H∙M∙S PCT Assay is an automated procedure with excellent clinical sensitivity. Its limit of quantitation (LoQ) of 0.0077ng/mL allows for early indication, antibiotic stewardship and negative predictive values.

  • ARCHITECT B∙R∙A∙H∙M∙S package inserts, G1-0601 R01, June 2017.
  • Shiferaw, et al. The Role of Procalcitonin as a Biomarker in Sepsis. J Infect Dis Epidemiology. 2016; 2:006 Vol 2.
  • “Sepsis in the Rural Setting: Early Recognition and Management”, a presentation by Mike Broyles, BS Pharm, PD, PharmD, Director of Pharmacy and Laboratory Services, Five Rivers Medical Center, Pocahontas, AR.

ARCHITECT B∙R∙A∙H∙M∙S PCT

Intended Use and Safety Information

For In Vitro Diagnostic Use

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 iSystem. 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 assessment of critically ill patients for the risk of progression to severe sepsis and septic shock from their first day of an intensive care unit (ICU) admission.
  • Aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU, in the emergency department or in other medical wards prior to ICU admission.
  • Aid in antibiotic therapy decision-making for inpatients or emergency room patients with suspected or confirmed lower respiratory tract infections (LRTI); this includes community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
  • Aid in the decision to discontinue antibiotics for patients with suspected or confirmed sepsis.

Limitations

  • The ARCHITECT B∙R∙A∙H∙M∙S PCT Assay is not to be used as a stand-alone diagnostic assay and should always 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 levels.
  • 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 morbidity or mortality are strongly dependent on many factors, including pre-existing patient risk factors and the course of clinical care.
  • 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.
  • The severity of renal failure or insufficiency and other patient characteristics may influence PCT values and should be considered as factors when interpreting PCT values.
  • PCT levels may not be elevated in patients infected by Chlamydophila pneumonia, Mycoplasma pneumoniae or other atypical pathogens.
  • Low PCT levels do not always indicate absence of bacterial infection; falsely low PCT levels in the presence of bacterial infection may occur during early infections, localized infections, and in subacute infectious endocarditis.
  • Increased PCT levels may not always be related to systemic bacterial infection.
  • The supportive clinical trials did not include the formal analysis of the safety and performance of PCT-guided therapy for individuals younger than age 18 years, pregnant women,  immunocompromised individuals or those receiving immunomodulatory agents.
  • Results from ARCHITECT B∙R∙A∙H∙M∙S PCT tests should not be used interchangeably with other methods for PCT determinations.
  • If PCT results are inconsistent with clinical evidence, additional testing is recommended.
  • Carefully follow the package insert instructions. The reliability of assay results cannot be guaranteed if there are any deviations from the package insert instructions.

Important Safety Information: This product contains sodium azide, which has been reported to form lead or copper azide on laboratory plumbing. These azides can explode upon percussion, such as hammering. To prevent formation of lead or copper azide, flush drains thoroughly with water after disposing of solutions containing sodium azide.  

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