NCT04561089

Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel

Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 763 (actual)
• Sponsor: Illumina, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

"This is a prospective, multi-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. Positive results from COVIDSeq Test using saliva and/or the comparator EUA test will be provided to subjects so participants can be referred for further evaluation (outside the study). No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	COVIDSeq Test	The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19

Timeline

• Start date: 2020-02-13
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2020-09-23
• Last updated: 2022-01-21

Locations

3 sites across 1 country: United States