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Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population

NCT04561102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 644

Last updated 2022-01-21

No results posted yet for this study

Summary

"This is a prospective, single-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis.

Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Conditions

Interventions

DIAGNOSTIC_TEST

Diagnostic test for detection of SARS-CoV-2

The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19

Sponsors & Collaborators

  • Helix OpCo, LLC

    collaborator UNKNOWN

  • Illumina, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04561102 on ClinicalTrials.gov