Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candice Prowse | Contact | 7038632530 | clinical@baebies.com | |
| Nikisha Harwani | Contact | 206.475.3260 | clinical@baebies.com |
| Name | Affiliation | Role |
|---|---|---|
| Candice Prowse | Baebies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Med | Raleigh | North Carolina | 27610 | United States |
No plan to share data. The data is in support of a 510K
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |