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

NCT ID: NCT04561089

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 763 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2021-02-28

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 asymptomatic population

COVID-19 asymptomatic Illumina personnel

COVIDSeq Test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

COVIDSeq Test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helix OpCo, LLC

UNKNOWN

Sponsor Role: collaborator

Illumina, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Illumina Laboratory Services

Foster City, California, United States

Illumina Hayward

Hayward, California, United States

Illumina Laboratory Services

San Diego, California, United States

Countries

United States

Other Identifiers

COVD-B07-001

Identifier Type: -

Identifier Source: org_study_id