Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population

January 20, 2022 updated by: Illumina, Inc.

Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From an Asymptomatic Population

"This is a prospective, single-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.

Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

644

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Winter Park, Florida, United States, 32789
        • Rollins College Alfonds Sports Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Rollins College community

Description

Subject Inclusion Criteria:

An individual must meet the criteria below to be eligible.

  • Individual is attending or invited to visit a participating collection site.
  • Individual is 18 years or older at the time of consent.
  • Individual is feeling well at the time of consent or specimen collection and does not have any of the following symptoms of COVID-19 per the current CDC guidance such as 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.
  • 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 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. [5]
  • Individual had symptoms of COVID-19 less than 10 days before time of consent or specimen collection."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 asymptomatic population
COVID-19 asymptomatic Rollins College community
Diagnostic test: Diagnostic test for detection of SARS-CoV-2
The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19
Other Names:
  • COVIDSeq Test

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
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Illumina, Inc.

Collaborators

Helix OpCo, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 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-B07-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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