COVID-19NCT05614011
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation
A study testing RT-PCR Test and Real-time PCR Test in people with COVID-19, run by QuantuMDx Group Ltd at 3 sites in United States.
Trial summary
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- RT-PCR Test and Real-time PCR Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 877 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Nov 2022to 17 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
EDP Biotech
Knoxville, Tennessee, 37919
PathAI
Memphis, Tennessee, 38125
Bright Research Center
Miami, Florida, 33144
About this study
Official title: Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Read the 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).
- Conditions
- COVID-19
- Being tested
- RT-PCR Test, Real-time PCR Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-PCR TestDiagnostic 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.
Real-time PCR TestDiagnostic test
Also called Q-POC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: RT-PCR Test; Diagnostic Test: Real-time PCR Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Nov 2022
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuantuMDx Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Day Diagnostics, PathAI, Bright Research Center
- Responsible party
- Sponsor
- Investigators
- Alice Neilson, Study director, QuantuMDx Group LtdJason Liggett, PhD, Principal investigator, New Day Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614011
- Sponsor's protocol ID
- QVTP-39
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2022
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
- ClinicalTrials.gov ID
- NCT05614011
- Acronym / sponsor ID
- QVTP-39
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- QuantuMDx Group LtdIndustry (pharma, biotech, devices)
- Collaborators
- New Day Diagnostics, PathAI, Bright Research Center
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Subjects 18+ years of age | Experimental | Diagnostic Test: RT-PCR Test, Diagnostic Test: Real-time PCR TestA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCR TestHigh 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 | Subjects 18+ years of age |
| Real-time PCR TestAlso: Q-POCMid-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. | Diagnostic test | Subjects 18+ years of age |
Primary outcome
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
Time frame: One hour
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
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test
Time frame: One hour
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Neilson study director
QuantuMDx Group Ltd
Jason Liggett, PhD principal investigator
New Day Diagnostics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-PCR Test and Real-time PCR Test in people with COVID-19, run by QuantuMDx Group Ltd at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator Test (time frame: One hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.