Project STARFISH - PRJ0002679

Thermo Fisher Scientific, Inc1,909 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,909

Conditions

SARS-CoV-2 Infection Influenza A Influenza Type B RSV Infection

Interventions

The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select PanelDIAGNOSTIC_TEST

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (17)

Women's Health Care Research

San Diego, California, United States

Medical Center for Clinical Research

San Diego, California, United States

Outcomes

Primary Outcomes

Primary Endpoint

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.

Time frame: Between February 2023 and April 2024

Secondary Outcomes

Secondary Endpoint

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.

Time frame: Between February 2023 and April 2024

Data from ClinicalTrials.gov

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