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| Name | Class |
|---|---|
| Labcorp Corporation of America Holdings, Inc | INDUSTRY |
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To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or SARS-CoV-2 (C-19).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-collection first | Subjects will self-collect an anterior nasal swab first |
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| HCP-collection first | Subjects will have their healthcare provider collect an anterior nasal swab first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labcorp COVID-19+Flu+RSV Test Home Collection Kit | Device | The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R&D using the comparator assays. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection method comparison | To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Whole blood specimen collection | The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients ≥2 years of age who present to the participating study clinics with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19 and who meet all study inclusion criteria and no exclusion criteria will be considered for enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Graham McLennan, MS | Laboratory Corporation of America | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exer Urgent Care | Pasadena | California | 91107 | United States |
There are no plans to share data
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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Remnant swab samples from all subjects (positive and negative) and isolated viral DNA will be maintained for future related research. No human DNA will be maintained.
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| D014777 | Virus Diseases |
| D007239 | Infections |