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

NCT04561089 | Completed

• 1 other identifier: COVD-B07-001
• Study Type: observational
• Target: 763
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

COVID-19 asymptomatic population

COVID-19 asymptomatic Illumina personnel

Diagnostic Test: COVIDSeq Test

Interventions

COVIDSeq Test DIAGNOSTIC_TEST

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

COVID-19 asymptomatic population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Illumina personnel

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

• Illumina, Inc.: lead
• Helix OpCo, LLC: collaborator

Study Sites (3)

Illumina Laboratory Services

Foster City, California, 94404, United States

Location

Illumina Hayward

Hayward, California, 94545, United States

Location

Illumina Laboratory Services

San Diego, California, 92122, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva \& nasal swab medium

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 23, 2020
• Study Start: February 13, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

US (3)