NCT04561102

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 644 (actual)
• Sponsor: Illumina, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• SARS-CoV-2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2020-09-23
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States