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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04561089
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
Helix OpCo, LLC
Information provided by (Responsible Party):
Illumina, Inc.

Study Description
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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. "


Condition or disease Intervention/treatment
SARS-CoV-2 Diagnostic Test: COVIDSeq Test

Study Design
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Study Type : Observational
Actual Enrollment : 763 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel
Actual Study Start Date : February 13, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Saliva & nasal swab medium

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Illumina personnel
Criteria

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."
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561089


Locations
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United States, California
Illumina Laboratory Services
Foster City, California, United States, 94404
Illumina Hayward
Hayward, California, United States, 94545
Illumina Laboratory Services
San Diego, California, United States, 92122
Sponsors and Collaborators
Illumina, Inc.
Helix OpCo, LLC
More Information
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Responsible Party: Illumina, Inc.
ClinicalTrials.gov Identifier: NCT04561089    
Other Study ID Numbers: COVD-B07-001
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No