Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation

NCT05614011 | Completed Results FDA Device

• 1 other identifier: QVTP-39
• Study Type: interventional
• Target: 877
• Locations: 1 country
• Sites: 3

Brief Summary

Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test

  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

  One hour

• Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test

  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.

  One hour

Study Arms (1)

Subjects 18+ years of age

EXPERIMENTAL

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.

Diagnostic Test: RT-PCR Test; Diagnostic Test: Real-time PCR Test

Interventions

RT-PCR Test DIAGNOSTIC_TEST

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.

Subjects 18+ years of age

Real-time PCR Test DIAGNOSTIC_TEST

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.

Also known as: Q-POC

Subjects 18+ years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QuantuMDx Group Ltd: lead
• New Day Diagnostics: collaborator
• PathAI: collaborator
• Bright Research Center: collaborator

Study Sites (3)

Bright Research Center

Miami, Florida, 33144, United States

Location

EDP Biotech

Knoxville, Tennessee, 37919, United States

Location

PathAI

Memphis, Tennessee, 38125, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Alice Toomey-Smith
• Organization: QuantuMDx

alice.toomey-smith@quantumdx.com

4408708031234

Study Officials

• Alice Neilson

  QuantuMDx Group Ltd

  STUDY DIRECTOR

• Jason Liggett, PhD

  New Day Diagnostics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 14, 2022
• Study Start: November 28, 2022
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)