Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses

Purpose

The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium. This study aims to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highly sensitive and specific for the detection of the coronaviruses included on the panel.

Conditions

  • Coronavirus
  • Respiratory Infection
  • COVID

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Specimen is residual NPS in transport medium (VTM or UTM) left over from standard of care testing under clinician order for respiratory pathogen analysis. - Specimen has been held at room temperature for less than or equal to 4 hours or 4°C for less than or equal to 72 hours before enrollment. - At least 1.7 mL of specimen is remaining after standard of care testing and available for use in the study

Exclusion Criteria

  • Specimen is unable to be tested within the defined storage parameters - Insufficient specimen volume for testing - Transport medium type is unknown

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Suspected respiratory infection NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider
  • Device: Investigational IVD for coronaviruses
    Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.
    Other names:
    • BIOFIRE ECoV Panel

Recruiting Locations

Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921 90027
Contact:
Jenn Dien Bard, PhD D(ABMM) F(CCM)
(323) 361-5443
jdienbard@chla.usc.edu

George Washington University
Washington D.C. 4140963, District of Columbia 4138106 20037
Contact:
Aileen Chang, MD MSPH FACP
(202) 677-6562
chang@gwu.edu

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30032
Contact:
Colleen Kraft, MD MSc
(404) 712-8889
Colleen.kraft@emory.edu

More Details

NCT ID
NCT07221097
Status
Recruiting
Sponsor
BioFire Defense LLC

Study Contact

Brittany C Collins, PhD
801-262-3592
brittany.collins@biofiredefense.com

Detailed Description

The primary objective of this observational, non-interventional study is to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel when used to test NPS obtained from individuals with signs and/or symptoms of respiratory infection. Multiple geographically distinct clinical sites in the U.S. will participate in testing. Enrollment will consist of residual, coded NPS specimens leftover from standard of care testing for a suspected respiratory infection as determined by a health care provider. Concordance between the BioFire ECoV Panel assays and comparator methods will be measured using positive and negative percent agreement (PPA and NPA).