NCT05928507

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

CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Baebies, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections	The FINDER FLU A/B, RSV, SARS-CoV-2 Test real-time RT-PCR test for the qualitative detection of viral RNA from RSV, FLU A, FLU B and SARS-CoV-2 in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider. Nucleic acids from respiratory viruses identified by this test are typically detectable in nasopharyngeal swabs (NP) during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals signs is an indication of the presence of the identified microorganism and assist in the diagnosis of respiratory infection when considered alongside other clinical and epidemiological information.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-02-29
• Completion: 2024-03-30
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study