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Journal Articles Pediatrics Year : 2017

Validation of a Novel Assay to Distinguish Bacterial and Viral Infections

Isaac Srugo
  • Function : Author
Adi Klein
  • Function : Author
Michal Stein
  • Function : Author
Orit Golan-Shany
  • Function : Author
Nogah Kerem
  • Function : Author
Irina Chistyakov
  • Function : Author
Jacob Genizi
  • Function : Author
Oded Glazer
  • Function : Author
Liat Yaniv
  • Function : Author
Alina German
  • Function : Author
Dan Miron
  • Function : Author
Yael Shachor-Meyouhas
  • Function : Author
Ellen Bamberger
  • Function : Author
Kfir Oved
  • Function : Author
Tanya Gottlieb
  • Function : Author
Roy Navon
  • Function : Author
Meital Paz
  • Function : Author
Liat Etshtein
  • Function : Author
Olga Boico
  • Function : Author
Gali Kronenfeld
  • Function : Author
Eran Eden
  • Function : Author
Robert Cohen
  • Function : Author
Helène Chappuy
  • Function : Author
Laurence Lacroix
  • Function : Author
Alain Gervaix
  • Function : Author

Abstract

BACKGROUND: Reliably distinguishing bacterial from viral infections is often challenging, leading to antibiotic misuse. A novel assay that integrates measurements of blood-borne host-proteins (tumor necrosis factor-related apoptosis-inducing ligand, interferon γ-induced protein-10, and C-reactive protein [CRP]) was developed to assist in differentiation between bacterial and viral disease. METHODS: We performed double-blind, multicenter assay evaluation using serum remnants collected at 5 pediatric emergency departments and 2 wards from children ≥3 months to ≤18 years without (n = 68) and with (n = 529) suspicion of acute infection. Infectious cohort inclusion criteria were fever ≥38°C and symptom duration ≤7 days. The reference standard diagnosis was based on predetermined criteria plus adjudication by experts blinded to assay results. Assay performers were blinded to the reference standard. Assay cutoffs were predefined. RESULTS: Of 529 potentially eligible patients with suspected acute infection, 100 did not fulfill infectious inclusion criteria and 68 had insufficient serum. The resulting cohort included 361 patients, with 239 viral, 68 bacterial, and 54 indeterminate reference standard diagnoses. The assay distinguished between bacterial and viral patients with 93.8% sensitivity (95% confidence interval: 87.8%–99.8%) and 89.8% specificity (85.6%–94.0%); 11.7% had an equivocal assay outcome. The assay outperformed CRP (cutoff 40 mg/L; sensitivity 88.2% [80.4%–96.1%], specificity 73.2% [67.6%–78.9%]) and procalcitonin testing (cutoff 0.5 ng/mL; sensitivity 63.1% [51.0%–75.1%], specificity 82.3% [77.1%–87.5%]). CONCLUSIONS: Double-blinded evaluation confirmed high assay performance in febrile children. Assay was significantly more accurate than CRP, procalcitonin, and routine laboratory parameters. Additional studies are warranted to support its potential to improve antimicrobial treatment decisions.
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Dates and versions

hal-03944685 , version 1 (18-01-2023)

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Isaac Srugo, Adi Klein, Michal Stein, Orit Golan-Shany, Nogah Kerem, et al.. Validation of a Novel Assay to Distinguish Bacterial and Viral Infections. Pediatrics, 2017, 140 (4), ⟨10.1542/peds.2016-3453⟩. ⟨hal-03944685⟩

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