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NCT05928507 | NOT YET RECRUITING | Influenza A

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

Baebies, Inc.

Brief 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.

Condition or disease

Influence

Influenza Type B

SARS CoV 2 Infection

RSV Infection

Intervention/treatment

Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

Study Type : OBSERVATIONAL
Estimated Enrollment : 2500 participants
Official Title : CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Actual Study Start Date : 2023-10-02
Estimated Primary Completion Date : 2024-02-29
Estimated Study Completion Date : 2024-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

Location Details

NCT05928507

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

Wake Med

Raleigh, North Carolina, United States, 27610