A Prospective, Multi-Center U.S. Clinical Trial to ......A Prospective, Multi-Center U.S. Clinical...
1
A Prospective, Multi-Center U.S. Clinical Trial to Determine Accuracy of FebriDx Point-of-Care Testing for Acute Upper Respiratory Infections With and Without a Confirmed Fever Robert Sambursky, MD (RPS Diagnostics); Wesley H. Self, MD, MPH (Vanderbilt University School of Medicine Department of Emergency Medicine); Jeff Rosen, MD (Clinical Research of South Florida); Stephan C. Sharp, MD (Clinical Research Associates); Michael Filbin, MD (Massachusetts General Hospital Department of Emergency Medicine); Peter Hou, MD (Brigham and Women’s Hospital Emergency Department); Amisha Parekh, MD (New York Methodist Hospital); Michael Kurz, MD (University of Alabama Department of Emergency Medicine); Nathan I. Shapiro, MD, MPH (Beth Israel Deaconess Medical Center) BACKGROUND FebriDx is a 10 minute disposable point-of-care (POC) test designed to identify clinically significant systemic host immune responses and aid in the differentiation of viral and bacterial respiratory infection by simultaneously detecting C-reactive protein (CRP) and myxovirus resistance protein A (MxA) from a fingerstick blood sample. METHODS A prospective, multicenter, cross-sectional study of primarily adults with acute upper respiratory tract infections (URIs), with and without a confirmed fever at the time of enrollment, was performed to evaluate the diagnostic accuracy of FebriDx (RPS Diagnostics; Sarasota, FL) to identify clinically significant bacterial infection with host response and acute pathogenic viral infection. URI was defined as rhinosinusitis, pharyngitis, nonspecific URI, and bronchitis and the reference method consisted of an algorithm that included throat bacterial cell culture, respiratory PCR panels for viral and atypical pathogens, procalcitonin (PCT), white blood cell count, and bandemia. The algorithm also utilized the Centor criteria and allowed for physician override. FINDINGS CONCLUSIONS Robert Sambursky, MD • RPS Diagnostics • 7227 Delainey Court, Sarasota, FL 34240 USA • [email protected] Among 220 patients enrolled, 15% (34/220) were classified as bacterial, 56% (124/220) were classified as viral, and 28% (62/220) negative by the reference standard. 100% reported fever ≥ 100.5 within the last 72 hours while 55% (121/220) had a confirmed fever at the time of enrollment. FebriDx test’s sensitivity for bacterial infection was higher in the patients confirmed to have a fever (95%) compared with the overall population (85%). Across the entire population, the FebriDx test was found to have a 97% NPV. Of 124 patients with a microbiologically confirmed viral infection, 23% (29) had PCT ≥ 0.1 ng/ml, 9% (11) had PCT ≥ 0.25 ng/ml and 56% (70) had a CRP ≥ 20 mg/L. Independently, neither MxA nor CRP alone is sensitive or specific at identifying both viral and bacterial infection but in combination, these biomarkers can aid in the diagnosis of acute respiratory infection. FebriDx’s 97-99% NPV may help to identify clinically significant bacterial URI’s and supports outpatient antibiotic decisions. Global use of POC testing to rapidly distinguish between immune response to viral and bacterial infection may reduce antibiotic overuse, reduce antibiotic resistance, and lower healthcare costs.
Transcript of A Prospective, Multi-Center U.S. Clinical Trial to ......A Prospective, Multi-Center U.S. Clinical...
A Prospective, Multi-Center U.S. Clinical Trial to Determine Accuracy of FebriDx Point-of-Care Testing for Acute Upper Respiratory Infections With and Without a Confirmed Fever
Robert Sambursky, MD (RPS Diagnostics); Wesley H. Self, MD, MPH (Vanderbilt University School of Medicine Department of Emergency Medicine); Jeff Rosen, MD (Clinical Research of South Florida); Stephan C. Sharp, MD (Clinical Research Associates); Michael Filbin, MD (Massachusetts General Hospital Department of Emergency Medicine); Peter Hou, MD (Brigham and Women’s Hospital Emergency Department);
Amisha Parekh, MD (New York Methodist Hospital); Michael Kurz, MD (University of Alabama Department of Emergency Medicine); Nathan I. Shapiro, MD, MPH (Beth Israel Deaconess Medical Center)
BACKGROUND
FebriDx is a 10 minute disposable point-of-care (POC)test designed to identify clinically significant systemichost immune responses and aid in the differentiation ofviral and bacterial respiratory infection bysimultaneously detecting C-reactive protein (CRP) andmyxovirus resistance protein A (MxA) from a fingerstickblood sample.
METHODSA prospective, multicenter, cross-sectional study ofprimarily adults with acute upper respiratory tractinfections (URIs), with and without a confirmed fever atthe time of enrollment, was performed to evaluate thediagnostic accuracy of FebriDx (RPS Diagnostics;Sarasota, FL) to identify clinically significant bacterialinfection with host response and acute pathogenic viralinfection. URI was defined as rhinosinusitis, pharyngitis,nonspecific URI, and bronchitis and the referencemethod consisted of an algorithm that included throatbacterial cell culture, respiratory PCR panels for viraland atypical pathogens, procalcitonin (PCT), whiteblood cell count, and bandemia. The algorithm alsoutilized the Centor criteria and allowed for physicianoverride.
FINDINGS
CONCLUSIONS
Robert Sambursky, MD • RPS Diagnostics • 7227 Delainey Court, Sarasota, FL 34240 USA • [email protected]
Among 220 patients enrolled, 15% (34/220) were classifiedas bacterial, 56% (124/220) were classified as viral, and28% (62/220) negative by the reference standard. 100%reported fever ≥ 100.5 within the last 72 hours while 55%(121/220) had a confirmed fever at the time of enrollment.FebriDx test’s sensitivity for bacterial infection was higherin the patients confirmed to have a fever (95%) comparedwith the overall population (85%). Across the entirepopulation, the FebriDx test was found to have a 97% NPV.Of 124 patients with a microbiologically confirmed viralinfection, 23% (29) had PCT ≥ 0.1 ng/ml, 9% (11) had PCT ≥0.25 ng/ml and 56% (70) had a CRP ≥ 20 mg/L.
Independently, neither MxA nor CRP alone is sensitive orspecific at identifying both viral and bacterial infection butin combination, these biomarkers can aid in the diagnosis ofacute respiratory infection. FebriDx’s 97-99% NPV may helpto identify clinically significant bacterial URI’s and supportsoutpatient antibiotic decisions. Global use of POC testing torapidly distinguish between immune response to viral andbacterial infection may reduce antibiotic overuse, reduceantibiotic resistance, and lower healthcare costs.
