ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Development of a Reference Standard to Assign Bacterial Versus Viral Infection Etiology Using an All-inclusive Methodology for Comparison of Novel Diagnostic Tool Performance.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Effect of host-protein test (TRAIL/IP-10/CRP) on antibiotic prescription and emergency department or urgent care center return visits: The JUNO pilot randomized controlled trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2025Trial
- Reframing molecular superiority in the differential diagnosis of eczema and psoriasis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Etiological characterization of acute respiratory tract infections and associated co-infections using Biofire respiratory 2.1 Plus panel.BMC infectious diseases · 2026Article
- Diagnostic Performance of the MeMed BV Test to Distinguish Between Bacterial and Viral or Other Non-Bacterial Causes Amongst ED and Urgent Care Patients: A Systematic Review with Meta-Analysis.Diagnostics (Basel, Switzerland) · 2026Review
- Constructive Appraisal of "Real-World Study Assessing Sensitivity and Clinical Utility of a Host-Protein Test in Adult Emergency Department Patients With Blood Culture Ordered".Journal of the American College of Emergency Physicians open · 2026Article
- Real-World Study Assessing Sensitivity and Clinical Utility of a Host-Protein Test in Adult Emergency Department Patients With Blood Culture Ordered.Journal of the American College of Emergency Physicians open · 2025Article
- A Host-Protein Test for Differentiating Bacterial From Viral Infection: Diagnostic Accuracy in Elderly Patients.Journal of the American College of Emergency Physicians open · 2025Article
- Real-World Utility of the Host-Response MeMed BV Test in a Pediatric Emergency Department: A Non-Randomized Study with Optimized Antimicrobial and Diagnostic Stewardship.Children (Basel, Switzerland) · 2025Article
- Host-response testing with MeMed BV in community-acquired pneumonia: an economic evaluation from the UK NHS perspective.JAC-antimicrobial resistance · 2025Article
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Authors and funding
23 authors.
Funding
Abstract
backgroundDiagnostic test evaluation requires a reference standard. We describe an approach for creating a reference standard for acute infection using unrestricted adjudication and apply it to compare biomarker tools.
methodsAdults and children with suspected acute infection enrolled in three prospective studies at emergency departments and urgent cares were included. Adjudicators, blinded to C-reactive protein, procalcitonin, and MeMed BV (MMBV), labeled each case (bacterial/viral/non-infectious/indeterminate). Initial adjudication involved 3 adjudicators. Reference standard cohorts were defined: Microbiologically confirmed (3/3 adjudicators concur with high confidence and a concordant microbiological finding), unanimous (3/3 adjudicators concur with high confidence), suspected (3/3 adjudicators concur with high/moderate confidence or 2/3 adjudicators concur with high confidence), and all-inclusive (remaining unlabeled cases were reviewed by up to 7 additional adjudicators until reaching a leading label).
resultsAmong 1016 patients, 156 difficult-to-diagnose cases required over 3 adjudicators. The area under the receiver operating characteristic curve in the microbiologically confirmed (n = 427), unanimous (n = 565), suspected (n = 860), and all-inclusive (n = 1016) cohorts for MMBV were 0.98 (95% confidence interval .94-1.00), 0.98 (.95-1.00), 0.95 (.92-.98) and 0.90 (.87-.93), respectively, and for procalcitonin were 0.69 (.57-.81), 0.77 (.68-.86), 0.74 (.68-.80) and 0.70 (.65-.75), respectively. A delta in performance between MMBV and procalcitonin was maintained across the different cohorts.
conclusionsCreating a reference standard that includes difficult-to-diagnose cases demands an approach to addressing diagnostic uncertainty in acute infections. Tool performance depends on the reference standard applied and decreases as the difficulty to diagnose increases, highlighting the importance of using the same reference standard when comparing tools.
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