COVID-19 Respiratory InfectionNCT06008457
Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit
An observational study of COVID-19 Respiratory Infection and Influenza A, run by Sequenom, Inc. at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 2 to 89 years
- Conditions the study is for
- COVID-19 Respiratory Infection, Influenza A, Influenza Type B
- What is being tested?
- Labcorp COVID-19+Flu+RSV Test Home Collection Kit
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 31 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study
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).
- Being tested
- Labcorp COVID-19+Flu+RSV Test Home Collection Kit
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labcorp COVID-19+Flu+RSV Test Home Collection KitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-collection first | Subjects will self-collect an anterior nasal swab first Receives: Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit | |
| HCP-collection first | Subjects will have their healthcare provider collect an anterior nasal swab first Receives: Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start17 Apr 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Responsible party
- Sponsor
- Investigators
- Graham McLennan, MS, Study director, Laboratory Corporation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008457
- Sponsor's protocol ID
- SQNM-VIR-403
- Status last verified
- Jun 2025
- First submitted
- 21 Aug 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share data
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study
- ClinicalTrials.gov ID
- NCT06008457
- Acronym / sponsor ID
- SQNM-VIR-403
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-collection first | – | Device: Labcorp COVID-19+Flu+RSV Test Home Collection KitSubjects will self-collect an anterior nasal swab first |
| HCP-collection first | – | Device: Labcorp COVID-19+Flu+RSV Test Home Collection KitSubjects will have their healthcare provider collect an anterior nasal swab first |
Who may qualify
- Ages
- 2 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labcorp COVID-19+Flu+RSV Test Home Collection KitThe 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. | Device | HCP-collection first, Self-collection first |
Primary outcome
Collection method comparison
Time frame: 1 day
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 secondary outcome
Whole blood specimen collection
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No. There are no plans to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham McLennan, MS study director
Laboratory Corporation of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection and Influenza A, run by Sequenom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection method comparison (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.