FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol

Baebies

Status: Not yet enrolling

Conditions: Influenza A; SARS CoV 2 Infection; RSV Infection; Influenza Type B

Treatments: Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

Study type: Observational

Funder types: Industry

Identifiers

NCT05928507

CSP0010

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 4 patient groups

Adult Category 1 -fresh prospective

Description:

NP swabs from the Adult population \>17 years, collected prospectively from adults presenting with symptoms of respiratory illness. Tested within 72 hours of collection.

Treatment:

Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

Pediatric Category 1 -fresh prospective

Description:

P swabs from the pediatric population \<=17 years, collected prospectively from pediatrics presenting with symptoms of respiratory illness. Tested within 72 hours of collection.

Treatment:

Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

Adult Category 2 -frozen prospective

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections

Pediatric Category 2 -frozen prospective

Description:

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.

Treatment:

Diagnostic Test: Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections