Project STARFISH - PRJ0002679

Study Overview
=================
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. In order to meet the minimum sample requirements, and to demonstrate performance on a range of viral strains, the prospective collection may be supplemented with banked remnant nasal and/or nasopharyngeal samples.

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.

Official Title
-----------------
IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 nasal swab collection. Individuals suspected to have respiratory tract infection and a pathogen test is requested by a healthcare provider. Subjects suspected to have respiratory tract infection for ten (10) or fewer days. Exclusion Criteria: Participants meeting the following criterion will be excluded from the study: Suspected to have respiratory tract infection for greater than ten (10) days.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2<br>50 positive samples 500 negative samples | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel<br>* 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).<br>|
| FLU A<br>50 positive samples 500 negative samples | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel<br>* 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).<br>|
| FLU B<br>30 positive samples 500 negative samples | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel<br>* 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).<br>|
| RSV<br>30 positive samples 500 negative samples | Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. The statistical analysis of minimum PPA and NPA requirements resulted in the following sample numbers: SARS-CoV-2: 70 positive samples by comparator method Influenza A, B, an RSV (A/B): 95 samples by comparator method Negative results: 193 samples by comparator method. | Between February 2023 and April 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 NPArequirements and acceptance criteria for each viral target as summarized in Table 1 of this protocol. The statistical analysis of minimum PPA and NPA requirements resulted in the following sample numbers: SARS-CoV-2: 70 positive samples by comparator method Influenza A, B, an RSV (A/B): 95 samples by comparator method Negative results: 193 samples by comparator method. | Between February 2023 and April 2023 |