Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Recruiting
Observational Study
CoronavirusRespiratory InfectionCOVID
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
1,500 (estimated)
Sponsor
BioFire Defense LLC · Industry
Who this trial is looking for
This trial is looking for patients who have leftover samples from COVID-19 testing. Participants will help evaluate the accuracy of a new test for detecting coronaviruses.
Are You a Good Fit for This Trial?
You may be able to join if
I have a leftover sample from a standard respiratory test.
My sample has been stored properly within time limits.
I have at least 1.7 mL of sample left after testing.
You may not be able to join if
My sample cannot be tested because it wasn't stored correctly.
My sample does not have enough volume for testing.
I do not know the type of transport medium my sample is in.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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 b…
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
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