Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study

Conditions
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COVID-19 Respiratory Infection, Influenza A, Influenza Type B, RSV Infection

Intervention / Treatment
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* Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presents with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19; Subject can read and understand written instructions in English; and Subject is able, in the professional opinion of the investigator, to provide up to 18.5mL of whole blood at the clinic visit. NOTE - the blood draw will be optional for subjects <12 years of age. Exclusion Criteria: no personal access to the internet and no email address Subject is 14-17 years of age and their parent or legal guardian is unable to supervise the collection of the AN swab sample from the subject; Subject is <14 years of age and their parent or legal guardian refuses to collect the AN swab sample from the subject; or Previous participation in this protocol.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Self-collection first<br>Subjects will self-collect an anterior nasal swab first | Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit<br>* 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.<br>|
| HCP-collection first<br>Subjects will have their healthcare provider collect an anterior nasal swab first | Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |