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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza A; RSV Infection; SARS CoV 2 Infection; Influenza Type B
• Intervention / Treatment: Diagnostic test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Candice Prowse; Phone Number: 7038632530; Email: clinical@baebies.com
• Study Contact Backup: Name: Nikisha Harwani; Phone Number: 206.475.3260; Email: clinical@baebies.com

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Wake Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult Category 1 -fresh prospective; NP swabs from the Adult population >17 years, collected prospectively from adults presenting with symptoms of respiratory illness. Tested within 72 hours of collection.	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.
Pediatric Category 1 -fresh prospective; P swabs from the pediatric population <=17 years, collected prospectively from pediatrics presenting with symptoms of respiratory illness. Tested within 72 hours of collection.	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.
Adult Category 2 -frozen prospective; 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.	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.
Pediatric Category 2 -frozen prospective; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	within 72 hours of collection of NP swab

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baebies, Inc.
• Investigators: Study Director: Candice Prowse, Baebies, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections; Pneumovirus Infections; COVID-19; Infections; Communicable Diseases; Influenza, Human; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: CSP0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data. The data is in support of a 510K

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No