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

Salveo Diagnostics

Status: Unknown

Conditions: COVID-19

Treatments: Diagnostic Test: comparison of sample collection methods

Study type: Interventional

Funder types: Industry

Identifiers

NCT04537572

R2020-1002

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

Sample Collection Method

Other group

Description:

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

Treatment:

Diagnostic Test: comparison of sample collection methods