FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
NCT ID: NCT05928507
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2500 participants
OBSERVATIONAL
2023-10-02
2024-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
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.
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.
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
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.
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.
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
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.
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.
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
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.
Interventions
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Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
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
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Baebies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Candice Prowse
Role: STUDY_DIRECTOR
Baebies, Inc.
Locations
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Wake Med
Raleigh, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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CSP0010
Identifier Type: -
Identifier Source: org_study_id
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