SARS CoV 2 Infection Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 2500 |
| Est. completion date | March 30, 2024 |
| Est. primary completion date | February 29, 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Wake Med | Raleigh | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Baebies, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |