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

Not Applicable

• Conditions: COVID-19
• Interventions: Diagnostic Test: comparison of sample collection methods

• Registration Number: NCT04537572
• Lead Sponsor: Salveo Diagnostics

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Study First Posted: 2020-09-03
• Last Update Posted: 2020-09-03
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sample Collection Method	comparison of sample collection methods	All subjects will provide samples via traditional phlebotomy, finger-stick, and saliva collection.

Primary Outcome Measures

Name	Time	Method
Laboratory determination of presence of anti-SARS-COV2 antibodies (IgM, IgA, and IgG)	testing will be performed within 2 days of collection