Clinical trial NCT04561089: Evaluation of the COVIDSeq Test in Saliva Specimens From COVID-19 Asymptomatic Illumina Personnel
Official title: Evaluation of the COVIDSeq Test in Saliva Specimens From Illumina Personnel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Helix OpCo, LLC
First posted: 2020-09-23
Enrollment: 763
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Illumina personnel

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. "


Eligibility 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."

Primary outcomes:
measure: 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
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Foster City
country: United States
facility: Illumina Laboratory Services
state: California
city: Hayward
country: United States
facility: Illumina Hayward
state: California
city: San Diego
country: United States
facility: Illumina Laboratory Services
state: California
Study officials:
References: