Self-sampling for the Study of COVID-19

NCT04447495 | Completed FDA Device

• 1 other identifier: 20-001
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not require RNA extraction. The investigators will compare the sensitivity and specificity of the iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal swab.

Conditions

Coronavirus

Outcome Measures

Primary Outcomes (1)

• Validate iAMP testing kit

  Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.

  1 month

Study Arms (2)

SARS-CoV-2 positive

We will enroll patients within a larger clinical validation study of the iAMP® test against the gold standard (the CDC-recommended test) until we have prospectively collected a total of 100 positive cases.

Diagnostic Test: iAMP test

Controls

Current SARS-CoV-2 positivity in the region is approximately 20%, therefore, approximately 400 negative control samples will be needed.

Diagnostic Test: iAMP test

Interventions

iAMP test DIAGNOSTIC_TEST

The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.

Controls; SARS-CoV-2 positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SARS-CoV-2 positive and negative participants

You may qualify if:

• Subjects older than 18 presenting for COVID-19 testing
• Subject able to tolerate nasopharyngeal swabs
• Subjects able to follow instructions for self-collection.

You may not qualify if:

• Subjects younger than 18
• Subjects unable to tolerate nasopharyngeal swabs
• Subjects unable to follow instructions
• Subjects unable or unwilling to provide informed consent and/or reliable contact information.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Mooreland Reserve Health Center

New Berlin, Wisconsin, 53151, United States

Location

Biospecimen

Retention: NONE RETAINED

A dry swab will be collected from two of the three iAMP® self-sample sites - mid-turbinate and anterior nares.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Juan Felix, M.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)