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

NCT04561102 | Completed

• 1 other identifier: COVD-B07-002
• Study Type: observational
• Target: 644
• Locations: 1 country
• Sites: 1

Brief Summary

"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. "

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 Rollins College community

Diagnostic Test: Diagnostic test for detection of SARS-CoV-2

Interventions

Diagnostic test for detection of SARS-CoV-2 DIAGNOSTIC_TEST

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

Also known as: COVIDSeq Test

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

Rollins College community

You may qualify if:

• 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.

You may not qualify if:

• 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."

Sponsors & Collaborators

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

Study Sites (1)

Rollins College Alfonds Sports Center

Winter Park, Florida, 32789, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva \& nasal swab medium

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

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: September 11, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

US (1)