Back to resultsQ-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RT-PCR Test
Real-time PCR Test
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria: Participants must be over the age of 18 years. Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset. Participants must have capacity to give informed consent. Exclusion Criteria: Participant is under the age of 18 years. Participant does not have symptoms of SARS-CoV-2 infection. Participant lacks capacity to give informed consent.
Sites / Locations
- Bright Research CenterRecruiting
- EDP BiotechRecruiting
- PathAIRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects 18+ years of age
Arm Description
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril. Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.
Outcomes
Primary Outcome Measures
Positive Percent Agreement
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Negative Percent Agreement
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
Secondary Outcome Measures
Full Information
NCT ID
NCT05614011
First Posted
November 10, 2022
Last Updated
April 4, 2023
Sponsor
QuantuMDx Group Ltd
Collaborators
EDP Biotech, PathAI, Bright Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05614011
Brief Title
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
Official Title
Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QuantuMDx Group Ltd
Collaborators
EDP Biotech, PathAI, Bright Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Detailed Description
The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.
The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective clinical study enrolling adult patients with signs and symptoms that are consistent with SARS-CoV-2. Positive and negative specimens will be run on the Q-POC SARS-CoV-2 Assay in comparison with an FDA-approved reference standard to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity)
Masking
None (Open Label)
Allocation
N/A
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects 18+ years of age
Arm Type
Experimental
Arm Description
A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's (IFU) in one nostril. Mid-turbinate swab samples will be taken from the opposite nostril using Copan FLOQ Swabs and placed into MSwab buffer (Q14-116-P02), for the candidate test. In instances where opposite nostrils cannot be swabbed for both the comparator and the test under investigation, a 15-minute wait period to allow for viral reloading must occur between collecting both the comparator and the test samples on the same nostril.
Comparator RT-PCR samples will be shipped overnight with ice packs and processed for testing within 48 hours of collection. Candidate test samples will tested as soon as possible following collection, however if time is required between specimen collection and testing, the samples must be stored at 2-8 °C for up to 24 hours. Test samples must also be stored at 2-8 °C whilst the Q-POC test is running.
Intervention Type
Diagnostic Test
Intervention Name(s)
RT-PCR Test
Intervention Description
High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril.
Intervention Type
Diagnostic Test
Intervention Name(s)
Real-time PCR Test
Other Intervention Name(s)
Q-POC
Intervention Description
Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample.
Primary Outcome Measure Information:
Title
Positive Percent Agreement
Description
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Time Frame
3 months
Title
Negative Percent Agreement
Description
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be over the age of 18 years.
Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.
Participants must have capacity to give informed consent.
Exclusion Criteria:
Participant is under the age of 18 years.
Participant does not have symptoms of SARS-CoV-2 infection.
Participant lacks capacity to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Wilson, BS
Phone
8652996250
Email
ryanwilson@edpbiotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Liggett, PhD
Phone
8652996250
Email
jasonliggett@edpbiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Neilson
Organizational Affiliation
QuantuMDx Group Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jason Liggett, PhD
Organizational Affiliation
EDP Biotech
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bright Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Mendez-Mulet, MD
Phone
786-870-5487
First Name & Middle Initial & Last Name & Degree
Sukie Hernandez, MS
Phone
7868705487
Email
shernandez@brclinical.com
First Name & Middle Initial & Last Name & Degree
luis Mendez-Mulet, MD
Facility Name
EDP Biotech
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Liggett, PhD
Phone
865-299-6250
Email
jasonliggett@edpbiotech.com
First Name & Middle Initial & Last Name & Degree
Ryan Wilson
Phone
8652996250
Email
ryanwilson@edpbiotech.com
First Name & Middle Initial & Last Name & Degree
Jason liggett, PhD
Facility Name
PathAI
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anami Patel, PhD
Phone
901-526-1912
Email
anami.patel@pathai.com
First Name & Middle Initial & Last Name & Degree
Jennifer Lasseter, PharmD
Phone
9015261912
Email
jennifer.lasseter@pathai.com
First Name & Middle Initial & Last Name & Degree
Anami Patel, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
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