This study is a prospective accuracy observational study to evaluate the performance ofthe Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medicaldevice panel and generate performance data. The precision of results will be evaluated inconcordance with the comparator predicate device panel BioFire Respiratory Panel 2.1(RP2.1).
This study is a prospective accuracy observational study to evaluate the performance of
the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical
device panel and generate performance data. The precision of results will be evaluated in
concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1
(RP2.1). This study will utilise prospective sample respiratory swabs from individuals
with paired test data, presenting with influenza-like symptoms (e.g., cough, nasal
congestion, rhinorrhoea, sore throat, fever, headache, myalgia), as well as asymptomatic
individuals. To meet the target number of 400 positive samples (50 samples per target; 8
targets in total), a required sampling size of 1000 participants will need to be screened
to account for unviable samples and screen failures. Prospective respiratory samples will
include nasopharyngeal swabs as described in Intended Use of the product.
Diagnostic Test: SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel
The SARS-CoV-2, Influenza and RSV PCR test is multiplex-tandem polymerase chain reaction
(MT-PCR) based on qualitive in vitro diagnostic testing for the detection and
identification of pathogens in nucleic acid extracts.
Diagnostic Test: BioFire Respiratory Panel 2.1
The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test
intended for use with the BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch Systems
for the simultaneous qualitative detection and identification of multiple respiratory
viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals
suspected of respiratory tract infections.
Inclusion Criteria:
- The sample is derived from an individual who has the ability to provide consent or
from a legally acceptable representative, parent(s), or legal guardian and have
consented for their sample and demographic information to be taken
- The sample is a nasopharyngeal swab
- The sample is collected in universal transport media (UTM) or viral transport media
(VTM), using FDA approved swabs
- The sample is collected from an individual who has a presumptive diagnosis or is
presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea,
sore throat, fever, headache, myalgia) or is suspected to be asymptomatic.
Exclusion Criteria:
- Sample does not meet acceptable specimen criteria in that is not a nasopharyngeal
swab
- The sample is collected using swabs with wood shafts or other materials known to
inhibit growth of influenza viruses
Not Provided
Joanna Haydar
+61 432 683 964
Joanna.Haydar@ausdx.com
Not Provided