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

NCT04537572 | Unknown

• 1 other identifier: R2020-1002
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  testing will be performed within 2 days of collection

Study Arms (1)

Sample Collection Method

OTHER

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

Diagnostic Test: comparison of sample collection methods

Interventions

comparison of sample collection methods DIAGNOSTIC_TEST

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

Sample Collection Method

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Salveo Diagnostics: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stephen A Varvel, PhD

  Salveo Diagnostics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen A Varvel, PhD

CONTACT

18048364439; svarvel@salveodiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 3, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share