B-277 Analytical Validation of Whole Blood Suitability for MeMed BV, A Host-protein Test for Differentiating Between Bacterial and Viral Infection

Abstract Background MeMed BV® is an FDA-cleared test for differentiating bacterial and viral infections. It based on computational integration of serum levels TNF-related apoptosis-induced ligand (TRAIL), interferon gamma-induced protein-10 (IP-10), C-reactive protein (CRP). The result a score between 0 100 that correlates with increasing likelihood infection (or co-infection). Here, we assessed the analytical performance BV using whole blood (WB). Methods Precision each analyte were 3 clinical WB samples representing bacterial, equivocal scores. Each specimen was analyzed in four runs five Key® analyzers accordance CLSI EP05-A3 Evaluation Quantitative Measurement Procedures. For matrix comparison study, paired collected from patients suspected acute bacterial/viral infection. study performed EP35Ed1E Assessment Equivalence or Suitability Specimen Types. Limit Quantitation established EP17-A2 Detection Capability Clinical Laboratory Results results passed pre-determined acceptance criteria analytes score. precision coefficient variation range 4.6%–6.9%, 3.1%–5.8%, 4.0%–12.0% TRAIL, IP-10 CRP, respectively. standard deviation 0.0–3.0 units. 216 recruited, aged 1–92 years (median 42.0) 45.8% female. Passing-Bablok regression analysis scores vs yielded slope 1.00 (95% confidence interval, CI 0.99–1.00) intercept 0.00 (95%CI 0.00–0.06) fulfilling pre-defined (Fig. 1). to be 1mg/L, pg/mL, 15 pg/mL respectively, same values as serum.Fig. 1. Conclusion demonstrated.