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

NCT ID: NCT04537572

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-09-30

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).

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sample Collection Method

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

Group Type: OTHER

comparison of sample collection methods

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

comparison 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salveo Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen A Varvel, PhD

Role: PRINCIPAL_INVESTIGATOR

Salveo Diagnostics

Central Contacts

Stephen A Varvel, PhD

Role: CONTACT

svarvel@salveodiagnostics.com

18048364439

Other Identifiers

R2020-1002

Identifier Type: -

Identifier Source: org_study_id