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
1 other identifier
observational
2,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedJuly 3, 2023
June 1, 2023
5 months
June 26, 2023
June 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
CLIA Waived results and clinical laboratory result
within 72 hours of collection of NP swab
Study Arms (4)
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.
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.
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.
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.
Interventions
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.
Eligibility Criteria
The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baebies, Inc.lead
Study Sites (1)
Wake Med
Raleigh, North Carolina, 27610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Candice Prowse
Baebies, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 3, 2023
Study Start
October 2, 2023
Primary Completion
February 29, 2024
Study Completion
March 30, 2024
Last Updated
July 3, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
No plan to share data. The data is in support of a 510K