CClinicalTrials.gg
Status unknownNCT04537572Updated Sep 3, 2020

A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing

An interventional study of comparison of sample collection methods in COVID-19, sponsored by Salveo Diagnostics. Status unknown. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Salveo Diagnostics · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • COVID-19
03

In context

Lead sponsor

This is the only study on the registry with Salveo Diagnostics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
  • >17 years old

Exclusion criteria

Exclusion Criteria:

  • Refusal or inability to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Sample Collection Method

    All subjects will provide samples via traditional phlebotomy, finger-stick, and saliva collection.

    Diagnostic Test: comparison of sample collection methods

Interventions

  • Diagnostic testcomparison of sample collection methods

    Samples will be collected via finger-stick, saliva collection, and traditional phlebotomy to determine effects on COVID-19 antibody test results.

06

What researchers measure

Primary outcomes

  1. Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)

    Time frame: testing will be performed within 2 days of collection

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04537572
Lead sponsor
Salveo Diagnostics
Responsible party
Sponsor
First posted
Sep 3, 2020
Start date
Sep 2020 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Sep 3, 2020

Study contacts

Stephen A Varvel, PhD
Contact
svarvel@salveodiagnostics.com
18048364439
Stephen A Varvel, PhD
principal investigator · Salveo Diagnostics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion