FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

Status unconfirmed

Conditions studied: Influenza A, Influenza Type B, SARS CoV 2 Infection, RSV Infection

In brief

The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness. The main question it aims to answer are: • the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.

Key facts

Study ID

NCT05928507

Run by

Baebies, Inc.

People needed

2500

Starts

2023-10-02

Expected to finish

2024-03-30

Last updated by the study team

2023-07-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
• The samples are obtained from individuals exhibiting respiratory signs and symptoms.
• These samples are collected as part of standard differential diagnostic procedures.
• A minimum sample volume of 1.5 mL is required for testing purposes.

You may not qualify if…

• de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
• Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
• The sample with a volume is less than 1.5 mL

Where it is running

• Wake Med — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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