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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561102
• Other study ID #: COVD-B07-002
• Status: Completed
• Start date: September 11, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2022
• Source: Illumina, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. "

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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."

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
United States	Rollins College Alfonds Sports Center	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Illumina, Inc.	Helix OpCo, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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