Project STARFISH - PRJ0002679

Thermo Fisher Scientific

Status

Completed

Conditions

Influenza A

RSV Infection

Influenza Type B

SARS-CoV-2 Infection

Treatments

Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05727202

PCP0127284

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,909 patients

Sex

All

Volunteers

No Healthy Volunteers

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.