What are the sensitivity and specificity of procalcitonin (PCT) in diagnosing neonatal sepsis?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 16, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

Sensitivity and Specificity of Procalcitonin (PCT) in Diagnosing Neonatal Sepsis

The sensitivity and specificity of procalcitonin (PCT) in diagnosing sepsis have been reported to be 0.80 (95% CI, 0.69–0.87) and 0.77 (95% CI, 0.60–0.88), respectively, in adult patients 1.

  • Key points about PCT include:
    • PCT is a precursor hormone of calcitonin produced by the parafollicular cells of the thyroid gland and neuroendocrine cells of the lung and the intestine 1.
    • PCT begins to rise four hours after exposure to bacteria, reaching a maximum level after six to eight hours 1.
    • Serum levels of PCT are associated with the severity of the infection, and decrease rapidly after antibiotic treatment 1.
  • However, it's essential to note that the provided evidence does not specifically address neonatal sepsis, and the studies mentioned are focused on adult patients 1.
  • In adult patients, a systematic review and meta-analysis found that PCT had a higher diagnostic accuracy and specificity compared to C-reactive protein (CRP) for diagnosing sepsis 1.
  • The optimal cutoff values for PCT in diagnosing sepsis are not well established, but a level of less than 0.5 µg/L or a decrease of greater than or equal to 80% from peak levels may guide antibiotic discontinuation once patients stabilize 1.
  • It's crucial to consider that decisions on initiating, altering, or discontinuing antimicrobial therapy should not be made solely based on changes in PCT or CRP levels, but rather as part of a comprehensive clinical evaluation 1.

From the Research

Sensitivity and Specificity of Procalcitonin in Diagnosing Neonatal Sepsis

  • The sensitivity and specificity of procalcitonin (PCT) in diagnosing neonatal sepsis vary across different studies, with reported sensitivity ranging from 67% to 100% and specificity ranging from 17% to 95.5% 2, 3, 4, 5.
  • A study found that PCT was highly sensitive (87% to 100%) at a cut-off value of 0.5 ng/mL, although specificity varied greatly across all cut-off values reviewed 2.
  • Another study reported that at a PCT cut-off of 1.1 ng/mL, the sensitivity and specificity were 78.6% and 81.2%, respectively, for early-onset neonatal sepsis (EONS) 3.
  • A study also found that at a PCT cut-off of 1.5 ng/mL, the sensitivity and specificity were 92.9% and 85.2%, respectively, for the diagnosis of neonatal infection 4.
  • A secondary analysis of the Neonatal Procalcitonin Intervention Study reported that a PCT cutoff value of 2.8 ng/L provided a sensitivity of 100% for discriminating no sepsis vs proven sepsis within 36 hours 5.

Optimal Cut-off Values for Procalcitonin

  • The optimal cut-off values for PCT in diagnosing neonatal sepsis are not well established, with different studies reporting different cut-off values 2, 3, 4, 5.
  • A study suggested that PCT cut-off values may differ in preterm sepsis subgroups, with optimal cut-off levels of 1.1 ng/mL for EONS and 5.2 ng/mL for late-onset neonatal sepsis (LONS) 3.
  • Another study reported that a PCT cut-off value of 1.36 ng/mL provided a sensitivity of 90.8% and specificity of 83.4% for proven sepsis 3.

Comparison with Other Biomarkers

  • PCT has been compared to other biomarkers, such as C-reactive protein (CRP) and white blood count (WBC), in diagnosing neonatal sepsis 3, 4, 5.
  • A study found that PCT and CRP had similar diagnostic performances, but were more efficacious than WBC in diagnosing neonatal sepsis 3.
  • Another study reported that serial measurements of CRP and PCT within 36 hours after the start of empiric antibiotic therapy can exclude the presence of neonatal EOS with a high probability 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.