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

NCT05614011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 877

Last updated 2024-02-28

Study results available
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Summary

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

Conditions

Interventions

DIAGNOSTIC_TEST

RT-PCR 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.

DIAGNOSTIC_TEST

Real-time PCR 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.

Sponsors & Collaborators

  • New Day Diagnostics

    collaborator NETWORK

  • PathAI

    collaborator INDUSTRY

  • Bright Research Center

    collaborator INDUSTRY

  • QuantuMDx Group Ltd

    lead INDUSTRY

Principal Investigators

  • Alice Neilson · QuantuMDx Group Ltd

  • Jason Liggett, PhD · New Day Diagnostics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614011 on ClinicalTrials.gov