2023. 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
Session: Poster Abstract Session: Diagnostics: Biomarkers and Novel Approaches
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • 18-0915_Sambursky, Robert _IDWeek 2018 Poster_Final.pdf (8.5 MB)
  • Background: FebriDx is a 10 minute disposable point-of-care 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 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, white blood cell count, and bandemia. The algorithm also utilized the Centor criteria and allowed for physician over-ride.

    Results: Among 220 patients enrolled, 100% reported fever ≥ 100.5 within the last 72 hours while 55% (121/220) had a confirmed fever at the time of enrollment. Of the total enrolled patients, 15% (34/220) were classified as bacterial, 56% (124/220) were classified as viral, and 28% (62/220) negative by the reference standard.

    Sample Size (n)

    Confirmation of Fever

    Diagnosis

    Sensitivity

    %

    and

    [95% CI]

    Specificity

    %

    and

    [95% CI]

    Positive Predictive Value (PPV)

    %

    and

    [95% CI]

    Negative Predictive Value (NPV)

    %

    and

    [95% CI]

    220

    Reported within last

    3 days

    Bacterial

    85

    (29/34)

    [69-95]

    93

    (183/196)

    [89-96]

    69

    (29/42 )

    [56-79]

    97

    (183/188)

    [94-99]

    Viral

    90

    (111/124)

    [83-94]

    76

    (73/96)

    [66-84]

    83

    (111/134)

    [77-87]

    85

    (73/86)

    [77-90]

    121

    Exhibited on enrollment

    Bacterial

    95

    (19/20)

    [77-100]

    94

    (95/101)

    [88-98]

    76

    (19/25)

    [59-87]

    99

    (95/96)

    [93-100]

    Viral

    90

    (72/80)

    [81-96]

    78

    (32/41)

    [62-89]

    89

    (72/81)

    [82-93]

    80

    (32/40)

    [67-89]

    Conclusion: When comparing clinical accuracy of diagnostic tests, performance values should be determined in febrile patients. FebriDx’s 97-99% NPV may help to identify clinically significant bacterial URI’s and supports outpatient antibiotic decisions.

    Robert Sambursky, MD, Rapid Pathogen Screening, Inc., Sarasota, FL, Wesley Self, MD, Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, Jeffrey Rosen, MD, Clinical Research of South Florida, Coral Gables, FL, Stephan Sharp, MD, Clinical Research Associates, Nashville, TN, Michael Filbin, MD, Emergency Department, Massachusetts General Hospital, Boston, MA, Peter Hou, MD, Emergency Medicine, Brigham and Womens, Boston, MA, Amisha Parekh, MD, Emergency Medicine, New York Methodist Hospital, Brooklyn, NY, Michael Kurz, MD, Emergency Medicine, University of Alabama, Birmingham, AL and Nathan Shapiro, MD, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA

    Disclosures:

    R. Sambursky, Rapid Pathogen Screening, Inc: Board Member , Employee and Shareholder , Salary .

    W. Self, None

    J. Rosen, None

    S. Sharp, None

    M. Filbin, None

    P. Hou, None

    A. Parekh, None

    M. Kurz, None

    N. Shapiro, None

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