Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 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. "

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Key information

Conditions

SARS-CoV-2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rollins College Alfonds Sports Center

Winter Park, Florida, 32789, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

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

Other names: COVIDSeq Test

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Illumina, Inc.

Industry

Collaborators

Helix OpCo, LLC

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 23, 2020
Registry last updated: Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed