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Article Dans Une Revue Pediatrics Année : 2017

Validation of a Novel Assay to Distinguish Bacterial and Viral Infections

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

Résumé

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 et versions

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

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Citer

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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