IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,909
- 试验地点
- 15
- 主要终点
- Primary Endpoint
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Endpoint
时间窗: 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.
次要结局
- Secondary Endpoint(Between February 2023 and April 2024)