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

SARS-CoV-2 Clinical Trial

Official title:
Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From an Asymptomatic Population

Clinical Trial 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. "

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04561102
Study type Observational
Source Illumina, Inc.
Contact
Status Completed
Phase
Start date September 11, 2020
Completion date February 28, 2021
View Details
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