The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2Test to an FDA-cleared device. The study will utilize prospectively collectedde-identified nasopharyngeal samples obtained from both pediatric and adult populationsfrom subjects presenting with symptoms of respiratory illness.The main question it aims to answer are:• the study is to validate that the device intended use in terms that the device'sperformance meets the criteria for substantial equivalence with a predicate and satisfiesthe statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.
Not Provided
Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
The FINDER FLU A/B, RSV, SARS-CoV-2 Test real-time RT-PCR test for the qualitative
detection of viral RNA from RSV, FLU A, FLU B and SARS-CoV-2 in nasopharyngeal (NP)
specimens from individuals suspected of respiratory tract infection by their healthcare
provider.
Nucleic acids from respiratory viruses identified by this test are typically detectable
in nasopharyngeal swabs (NP) during the acute phase of infection. The detection and
identification of specific viral nucleic acids from individuals signs is an indication of
the presence of the identified microorganism and assist in the diagnosis of respiratory
infection when considered alongside other clinical and epidemiological information.
Inclusion Criteria:
- Nasopharyngeal samples will be collected using swabs and placed in liquid transport
media.
- The samples are obtained from individuals exhibiting respiratory signs and symptoms.
- These samples are collected as part of standard differential diagnostic procedures.
- A minimum sample volume of 1.5 mL is required for testing purposes.
Exclusion Criteria:
- de-identified samples that have not been stored in accordance with CDC
recommendations for nasopharyngeal (NP) sample storage.
- Samples obtained from subjects who do not exhibit signs or symptoms of respiratory
illness.
- The sample with a volume is less than 1.5 mL
Wake Med
Raleigh, North Carolina, United States
Candice Prowse
7038632530
clinical@baebies.com
Nikisha Harwani
206.475.3260
clinical@baebies.com
Candice Prowse, Study Director
Baebies, Inc.