Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing

Status:Enrolling by invitation
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Age Range:Any
Start Date:October 5, 2017
End Date:December 30, 2019

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The purpose of this study is two-fold. In the first phase, the goal is to characterize the
stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and
stool (raw stool and rectal swab) specimens collected using various standard, medically
established procedures with and without transport media and tested at various time points and
under different temperature conditions, and also to look at variation between repeat sampling
events. The intention is for these data to support decisions made by BioFire regarding the
appropriate specimen type and handling guidelines for future tests. In the second phase of
the study, collection and transport conditions identified in Phase 1 will be used to collect
specimens for pilot performance evaluations of a new molecular diagnostic test.

This evaluation will be initiated at several sites in the US. In the first phase of the
study, multiple specimens will be collected from each subject and tested using various
pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each
specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or
other post-collection variables. In the second phase of the study only two specimens will be
collected from each subject: one for testing with the new test (using handling procedures
identified in Phase 1) and another for testing with the reference method. Up to 2,000
subjects will be enrolled across all sites in each phase (up to 4,000 subjects total).
Enrollment is expected to last approximately 18 months to cover both phases of the study. All
specimens and subject data will be de-identified and coded. Prior to study initiation, each
participating site will have the necessary Institutional Review Board (IRB) reviews.
Specimens in both phases will be tested at the study site using various BioFire test
platforms and cartridges.

Inclusion Criteria:

- Subject presents with signs/symptoms of respiratory infection including but not
limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache,
chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea,
vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days

- If age 18 or over, subject provides written informed consent

- If under the age of 18, parental permission and assent (as appropriate) is obtained

- Subject is willing and able to provide at least two (up to three) specimens: any
combination of NS, NPS, or TS OR rectal swab or stool

Exclusion Criteria:

- Subject is unable to provide consent or parental permission and assent (as
appropriate) cannot be obtained

- Subject is unable or unwilling to provide two specimens

- Subject's health care provider determines that specimen collection represents an
unacceptable risk
We found this trial at
Saint Louis, Missouri 63110
Saint Louis, MO
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