Validating biomarkers

Although plasma biomarkers of inflammation, lung epithelial and endothelial injury may facilitate early identification of patients with ARDS,9 10 the utility of plasma biomarkers for diagnosis of ARDS in patients with traumatic injuries has not been systematically investigated in large cohorts of patients.

Only one prior study has examined plasma biomarkers for ARDS diagnosis among trauma patients, a small, single-center case–control study limited by discordant timing of plasma sampling and ARDS diagnosis.11 To rigorously examine the diagnostic performance of plasma biomarkers for ARDS among adult trauma patients, we evaluated 11 previously described biomarkers of inflammation and epithelial or endothelial injury in three prospective observational cohorts of patients with severe traumatic injury.

All biomarkers were measured in duplicate in plasma that was collected at enrollment on the morning of ICU day 2, using commercially available enzyme immunoassay kits or radioimmunoassay: plasminogen activator inhibitor-1, American Diagnostica (Stamford, CT); von Willebrand factor antigen (VWF), Diagnostica Stago (Parsippany, NJ); procollagen peptide-III, Cis Bioscience International (Bedford, MA); club cell-16 protein (CC16), Bio Vendor (Chandler, NC); B-type natriuretic peptide, Bachem Bioscience (King of Prussia, PA); surfactant protein-D (SP-D), Yamasa Corporation (Tokyo, Japan); and angiopoietin-2 (Ang-2), interleukin-8 (IL-8), soluble receptor for advanced glycation endproducts (RAGE), R&D Systems (Minneapolis, MN).

For the ACIT validation cohort, Ang-2 and RAGE were measured in plasma that was collected 24 hours after presentation to the emergency department using the assay kits from the same manufacturers.

Background Acute respiratory distress syndrome (ARDS) is common after severe traumatic injuries but is underdiagnosed and undertreated.

We hypothesized that a panel of plasma biomarkers could be used to diagnose ARDS in severe trauma.

Clinical application of this model could improve both diagnosis and treatment of ARDS in patients with severe trauma.However, the clinical diagnosis of ARDS is frequently delayed or missed,7 8 contributing to belated, inadequate or inappropriate treatment.Plasma biomarkers are commonly used in conditions such as myocardial infarction and congestive heart failure to aid in clinical diagnosis and facilitate rapid application of appropriate therapies.To test this hypothesis, we derived and validated a biomarker panel in three independent cohorts and compared the diagnostic performance to clinician recognition of ARDS.Methods Eleven plasma biomarkers of inflammation, lung epithelial and endothelial injury were measured in a derivation cohort of 439 severe trauma patients.

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