FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Purpose
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
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
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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. |
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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. |
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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. |
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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. |
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Recruiting Locations
More Details
- NCT ID
- NCT05928507
- Status
- Not yet recruiting
- Sponsor
- Baebies, Inc.