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

NCT05928507 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2023-07-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Baebies, Inc.

    lead INDUSTRY

Principal Investigators

  • Candice Prowse · Baebies, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-02-29
Completion
2024-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928507 on ClinicalTrials.gov