COVID-19
Conditions
Brief 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).
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.
Sponsors
Salveo Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies * \>17 years old
Exclusion criteria
* Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG) | testing will be performed within 2 days of collection |
Contacts
Primary ContactStephen A Varvel, PhD
Outcome results
None listed