A biomarker assay to risk-stratify patients with symptoms of respiratory tract infection.

Humans COVID-19 / diagnosis ROC Curve Biomarkers Emergency Service, Hospital Respiratory Tract Infections Interleukin-6

Journal

The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460

Informations de publication

Date de publication:
12 2022
Historique:
received: 08 03 2022
accepted: 25 07 2022
pubmed: 15 9 2022
medline: 20 12 2022
entrez: 14 9 2022
Statut: epublish

Résumé

Patients who present to an emergency department (ED) with respiratory symptoms are often conservatively triaged in favour of hospitalisation. We sought to determine if an inflammatory biomarker panel that identifies the host response better predicts hospitalisation in order to improve the precision of clinical decision making in the ED. From April 2020 to March 2021, plasma samples of 641 patients with symptoms of respiratory illness were collected from EDs in an international multicentre study: Canada (n=310), Italy (n=131) and Brazil (n=200). Patients were followed prospectively for 28 days. Subgroup analysis was conducted on confirmed coronavirus disease 2019 (COVID-19) patients (n=245). An inflammatory profile was determined using a rapid, 50-min, biomarker panel (RALI-Dx (Rapid Acute Lung Injury Diagnostic)), which measures interleukin (IL)-6, IL-8, IL-10, soluble tumour necrosis factor receptor 1 (sTNFR1) and soluble triggering receptor expressed on myeloid cells 1 (sTREM1). RALI-Dx biomarkers were significantly elevated in patients who required hospitalisation across all three sites. A machine learning algorithm that was applied to predict hospitalisation using RALI-Dx biomarkers had a mean±sd area under the receiver operating characteristic curve of 76±6% (Canada), 84±4% (Italy) and 86±3% (Brazil). Model performance was 82±3% for COVID-19 patients and 87±7% for patients with a confirmed pneumonia diagnosis. The rapid diagnostic biomarker panel accurately identified the need for inpatient care in patients presenting with respiratory symptoms, including COVID-19. The RALI-Dx test is broadly and easily applicable across many jurisdictions, and represents an important diagnostic adjunct to advance ED decision-making protocols.

Sections du résumé

BACKGROUND
Patients who present to an emergency department (ED) with respiratory symptoms are often conservatively triaged in favour of hospitalisation. We sought to determine if an inflammatory biomarker panel that identifies the host response better predicts hospitalisation in order to improve the precision of clinical decision making in the ED.
METHODS
From April 2020 to March 2021, plasma samples of 641 patients with symptoms of respiratory illness were collected from EDs in an international multicentre study: Canada (n=310), Italy (n=131) and Brazil (n=200). Patients were followed prospectively for 28 days. Subgroup analysis was conducted on confirmed coronavirus disease 2019 (COVID-19) patients (n=245). An inflammatory profile was determined using a rapid, 50-min, biomarker panel (RALI-Dx (Rapid Acute Lung Injury Diagnostic)), which measures interleukin (IL)-6, IL-8, IL-10, soluble tumour necrosis factor receptor 1 (sTNFR1) and soluble triggering receptor expressed on myeloid cells 1 (sTREM1).
RESULTS
RALI-Dx biomarkers were significantly elevated in patients who required hospitalisation across all three sites. A machine learning algorithm that was applied to predict hospitalisation using RALI-Dx biomarkers had a mean±sd area under the receiver operating characteristic curve of 76±6% (Canada), 84±4% (Italy) and 86±3% (Brazil). Model performance was 82±3% for COVID-19 patients and 87±7% for patients with a confirmed pneumonia diagnosis.
CONCLUSIONS
The rapid diagnostic biomarker panel accurately identified the need for inpatient care in patients presenting with respiratory symptoms, including COVID-19. The RALI-Dx test is broadly and easily applicable across many jurisdictions, and represents an important diagnostic adjunct to advance ED decision-making protocols.

Identifiants

DOI: 10.1183/13993003.00459-2022 PMID: 36104292 PMC: PMC9753477
pubmed: 36104292
pii: 13993003.00459-2022
doi: 10.1183/13993003.00459-2022
pmc: PMC9753477
pii:
doi:

Substances chimiques

Biomarkers 0
Interleukin-6 0

Types de publication

Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : CIHR
ID : FRN 440205
Pays : Canada

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright ©The authors 2022.

Déclaration de conflit d'intérêts

Conflict of interest: S. Keshavjee serves as Chief Medical Officer of Traferox Technologies and receives personal fees from Lung Bioengineering, outside the submitted work. A.T. Sage, M. Cypel, L. del Sorbo, B. Wang, J. Valero and S. Keshavjee are inventors of a patent licensed to SQI Diagnostics. The inventors fully adhere to a number of policies in place at the University Health Network that ensure academic integrity and management of potential conflicts of interest between authors and industry partners. For the purposes of regulatory application, SQI Diagnostics provided funding to support Brazil data collection and the work performed by D.R. Marinowic, F.O. Friedrich, C.R.R. Schmitz, L.S.M. dos Santos, F.M. Barbe-Tuana and M.H. Jones, but remained arms-length and blinded from the data analysis included in this study. All other authors report no conflicts of interest.

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Auteurs

Shahid Husain (S)

Division of Infectious Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Andrew T Sage (AT)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Lorenzo Del Sorbo (L)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Interdepartmental Division of Critical Care Medicine, Medical and Surgical Intensive Care Unit, University Health Network, University of Toronto, Toronto, ON, Canada.

Marcelo Cypel (M)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Institute of Medical Science, University of Toronto, Toronto, ON, Canada.
Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada.

Tereza Martinu (T)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Institute of Medical Science, University of Toronto, Toronto, ON, Canada.
Division of Respirology, Department of Medicine, University of Toronto, Toronto, ON, Canada.

Stephen C Juvet (SC)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Institute of Medical Science, University of Toronto, Toronto, ON, Canada.
Division of Respirology, Department of Medicine, University of Toronto, Toronto, ON, Canada.
ORCID: 0000-0002-7243-556X

Andrea Mariscal (A)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Julie Wright (J)

Tropical Disease Unit, Department of Medicine, University of Toronto, Sandra Rotman Centre for Global Health, University Health Network, Toronto General Hospital, Toronto, ON, Canada.

Bonnie T Chao (BT)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.

Alaa A Shamandy (AA)

Department of Computer Science, University of Toronto, Toronto, ON, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
ORCID: 0000-0001-7074-437X

S Hossein Mousavi (SH)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.

Jin Ma (J)

Biostatistics Research Unit, University Health Network, Toronto, ON, Canada.

Bo Wang (B)

Department of Computer Science, University of Toronto, Toronto, ON, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Vector Institute, Toronto, ON, Canada.

Jerome Valero (J)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Mingyao Liu (M)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Institute of Medical Science, University of Toronto, Toronto, ON, Canada.

Megan Landes (M)

Department of Emergency Medicine, University Health Network, Toronto, ON, Canada.
Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.

Sharaniyaa Balachandran (S)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Kimberley Hudson (K)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.

Michelle Ngai (M)

Tropical Disease Unit, Department of Medicine, University of Toronto, Sandra Rotman Centre for Global Health, University Health Network, Toronto General Hospital, Toronto, ON, Canada.

Marialessia Capuano (M)

Division of Emergency Medicine and High Dependency Unit, Cittá della Salute e della Scienza di Torino Hospital-Molinette Site, Department of Medical Sciences, University of Turin, Turin, Italy.

Maria Gelardi (M)

Division of Emergency Medicine and High Dependency Unit, Cittá della Salute e della Scienza di Torino Hospital-Molinette Site, Department of Medical Sciences, University of Turin, Turin, Italy.

Enrico Lupia (E)

Division of Emergency Medicine and High Dependency Unit, Cittá della Salute e della Scienza di Torino Hospital-Molinette Site, Department of Medical Sciences, University of Turin, Turin, Italy.

Daniel R Marinowic (DR)

School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.

Frederico O Friedrich (FO)

School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.

Carine R R Schmitz (CRR)

Biochemistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.

Leticya S M Dos Santos (LSM)

School of Health, Sciences and Life, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.

Florencia M Barbe-Tuana (FM)

School of Health, Sciences and Life, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.

Marcus H Jones (MH)

School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.

Kevin C Kain (KC)

Tropical Disease Unit, Department of Medicine, University of Toronto, Sandra Rotman Centre for Global Health, University Health Network, Toronto General Hospital, Toronto, ON, Canada.

Tony Mazzulli (T)

Department of Microbiology, Mount Sinai Hospital, Toronto, ON, Canada.

Sam Sabbah (S)

Department of Emergency Medicine, University Health Network, Toronto, ON, Canada.
Division of Emergency Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.

Shaf Keshavjee (S)

Toronto Lung Transplant Program and Latner Thoracic Research Laboratories, Toronto General Hospital Research Institute, University Health Network, University of Toronto, Toronto, ON, Canada shaf.keshavjee@uhn.ca.
Ajmera Transplant Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Institute of Medical Science, University of Toronto, Toronto, ON, Canada.
Division of Thoracic Surgery, Department of Surgery, University of Toronto, Toronto, ON, Canada.
ORCID: 0000-0003-4547-8094

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