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

Not yet recruiting

• Conditions: SARS CoV 2 Infection; Influenza A; RSV Infection; Influenza Type B
• Interventions: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

• Registration Number: NCT05928507
• Lead 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Study Start: 2023-10-02
• Primary Completion: 2024-02-29
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric Category 1 -fresh prospective	Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections	P swabs from the pediatric population \<=17 years, collected prospectively from pediatrics presenting with symptoms of respiratory illness. Tested within 72 hours of collection.
Adult Category 1 -fresh prospective	Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections	NP swabs from the Adult population \>17 years, collected prospectively from adults presenting with symptoms of respiratory illness. Tested within 72 hours of collection.
Adult Category 2 -frozen prospective	Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections	NP swabs from the Adult population \>17 years, were collected prospectively from adults presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be Tested at a later time point approximately 3 months.
Pediatric Category 2 -frozen prospective	Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections	NP swabs from the pediatric population \>17 years, were collected prospectively from pediatrics presenting with symptoms of respiratory illness. Frozen following CLSI guidelines to be tested at a later time point approximately 3 months.

Primary Outcome Measures

Name	Time	Method
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)	within 72 hours of collection of NP swab	Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes) in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider.for adults and pediatrics when compared to a known FDA cleared assay/ instrument combination.

Secondary Outcome Measures

Name	Time	Method
CLIA Waived results and clinical laboratory result	within 72 hours of collection of NP swab	Characterization of the performance of the FINDER device when used at a CLIA-waived location and when used in a clinical laboratory location.

Trial Locations

Locations (1)

Wake Med; 🇺🇸 Raleigh, North Carolina, United States