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.

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