COVID-19NCT04537572
A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing
A study testing comparison of sample collection methods in people with COVID-19, run by Salveo Diagnostics.
Trial summary
The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- comparison of sample collection methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2022
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
- >17 years old
Who cannot join
- Refusal or inability to provide informed consent
Trial locations and contacts
No sites are listed yet.
About this study
The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).
- Conditions
- COVID-19
- Being tested
- comparison of sample collection methods
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of sample collection methodsDiagnostic test
Samples will be collected via finger-stick, saliva collection, and traditional phlebotomy to determine effects on COVID-19 antibody test results.
| Study group | Role | What they receive |
|---|---|---|
| Sample Collection Method | Other | All subjects will provide samples via traditional phlebotomy, finger-stick, and saliva collection. Receives: Diagnostic Test: comparison of sample collection methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)
Measured: testing will be performed within 2 days of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salveo Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen A Varvel, PhD, Principal investigator, Salveo Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537572
- Sponsor's protocol ID
- R2020-1002
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing
- ClinicalTrials.gov ID
- NCT04537572
- Acronym / sponsor ID
- R2020-1002
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Salveo DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Sep 2020 (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.
The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample Collection Method | Other | Diagnostic Test: comparison of sample collection methodsAll subjects will provide samples via traditional phlebotomy, finger-stick, and saliva collection. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
- >17 years old
Key exclusion criteria (1 listed)
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| comparison of sample collection methodsSamples will be collected via finger-stick, saliva collection, and traditional phlebotomy to determine effects on COVID-19 antibody test results. | Diagnostic test | Sample Collection Method |
Primary outcome
Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)
Time frame: testing will be performed within 2 days of collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Stephen A Varvel, PhD principal investigator
Salveo Diagnostics
Questions about this trial
What is this clinical trial studying?
A study testing comparison of sample collection methods in people with COVID-19, run by Salveo Diagnostics.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen A Varvel, PhD (18048364439, svarvel@salveodiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG) (time frame: testing will be performed within 2 days of collection). 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 3 Sep 2020; AzTrials last refreshed its copy on 1 Nov 2026.