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Self-sampling for the Study of COVID-19

NCT04447495 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2021-12-23

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

iAMP 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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Juan Felix, M.D. · Medical College of Wisconsin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447495 on ClinicalTrials.gov