A biomarker assay to risk-stratify patients with symptoms of respiratory tract infection.
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Husain Shahid, Sage Andrew T, Del Sorbo Lorenzo, Cypel Marcelo, Martinu Tereza, Juvet Stephen C, Mariscal Andrea, Wright Julie, Chao Bonnie T, Shamandy Alaa A, Mousavi S Hossein, Ma Jin, Wang Bo, Valero Jerome, Liu Mingyao, Landes Megan, Balachandran Sharaniyaa, Hudson Kimberley, Ngai Michelle, Capuano Marialessia, Gelardi Maria, Lupia Enrico, Marinowic Daniel R, Friedrich Frederico O, Schmitz Carine R R, Dos Santos Leticya S M, Barbe-Tuana Florencia M, Jones Marcus H, Kain Kevin C, Mazzulli Tony, Sabbah Sam, Keshavjee Shaf
Аннотация
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.