Influenza A, Influenza Type B, RSV Infection, SARS-CoV-2 Infection
Conditions
Brief summary
This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.
Detailed description
The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as Starfish Test) aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.
Interventions
DIAGNOSTIC_TESTThe Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
A multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
Sponsors
NAMSA
Thermo Fisher Scientific, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study. * Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection. * All-comers phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days. * Enrichment phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive PCR test result within three (3) days.
Exclusion criteria
* Participants meeting the following criterion will be excluded from the study: * Suspected to have respiratory tract infection for greater than seven (7) days. * Patients not suspected of having a respiratory tract infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | Between February 2023 and April 2024 | The primary endpoint of this clinical performance study is to meet the minimum sample positivity requirements for nasopharyngeal samples as defined by relevant regulatory guidance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | Between February 2023 and April 2024 | The secondary endpoint of this study is to complete the clinical performance evaluation of the Starfish Test compared with that of a predicate device using Anterior nasal specimens and meet the minimum PPA and NPA requirements and acceptance criteria for each viral target as summarized in the protocol. |
Countries
United States
Outcome results
None listed