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PCR Test

Subjects 18+ years of age for COVID-19

N/A
Waitlist Available
Led By Jason Liggett, PhD
Research Sponsored by QuantuMDx Group Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour
Awards & highlights

Study Summary

This trial tested performance of a Q-POC SARS-CoV-2 PCR test to detect COVID-19 in respiratory samples.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects 18+ years of ageExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RT-PCR Test
2022
N/A
~1600
Real-time PCR Test
2022
N/A
~880

Find a Location

Who is running the clinical trial?

New Day DiagnosticsNETWORK
3 Previous Clinical Trials
531 Total Patients Enrolled
3 Trials studying COVID-19
531 Patients Enrolled for COVID-19
Bright Research CenterUNKNOWN
EDP BiotechNETWORK
3 Previous Clinical Trials
531 Total Patients Enrolled
3 Trials studying COVID-19
531 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this scientific trial still ongoing?

"According to the records hosted on clinicaltrials.gov, this trial is not presently seeking participants. It was initially listed on November 1st 2022 and last updated two weeks later. Despite this study's temporary pause in recruitment, there are over a thousand other medical trials which are enrolling volunteers at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
2022. "Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05614011.
~376 spots leftby Apr 2025
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