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

"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. "

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Diagnostic test: COVIDSeq Test

• Study Type: Observational
• Enrollment (Actual): 763

Contacts and Locations

Study Locations

• United States
  • California
    • Foster City, California, United States, 94404
      • Illumina Laboratory Services
    • Hayward, California, United States, 94545
      • Illumina Hayward
    • San Diego, California, United States, 92122
      • Illumina Laboratory Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Illumina personnel

Description

Subject Inclusion Criteria:

An individual must meet the criteria below to be eligible.

• Individual is Illumina US personnel (eg, employee, contractor, consultant) and was invited to participate in the study.
• Individual is 18 years or older at the time of consent.
• Individual is feeling well and, at the time of consent or specimen collection, does not have any of the following symptoms of COVID-19: cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea. [1]
• Individual is willing to participate in study procedures and able to provide written informed consent in the English language.

Subject Exclusion Criteria:

An individual cannot meet the below criteria.

• Individual is confirmed to have COVID-19 and continues to require home isolation in accordance with current CDC guidelines at the time of consent or specimen collection.
• Individual is asymptomatic but suspected to have COVID-19 due to recent close contact (as currently defined by the CDC) with a person with COVID-19 and continues to require quarantine in accordance with current CDC guidelines at the time of consent or specimen collection. [4]
• Individual had symptoms of COVID-19 less than 10 days before time of consent or less than 10 days before time of any subsequent specimen collection visit."

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 asymptomatic population; COVID-19 asymptomatic Illumina personnel	Diagnostic test: COVIDSeq Test; The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive percent agreement (PPA) and negative percent agreement (NPA) between the COVIDSeq Test and a comparator EUA test for the detection of SARS-CoV-2 RNA	1 month

Collaborators and Investigators

• Sponsor: Illumina, Inc.
• Collaborators: Helix OpCo, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: COVD-B07-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No