COVID-19CERrnaTc-19NCT05308550
Clinical Evaluation of Rapid RNA Test for Covid-19
A study testing rapid RT-LAMP test to detect SARS-COV-2 RNA in people with COVID-19, run by University of Southampton at 1 site in United Kingdom.
Trial summary
A new Rapid RNA test for Covid-19 has been developed by Professor Cui and his team at the Department of Engineering Science at the University of Oxford. This can give results in 30 minutes which is much faster than the routine PCR test, which often takes 2-3 days to produce results. 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?
- rapid RT-LAMP test to detect SARS-COV-2 RNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2020to 27 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients presenting to hospital with symptoms of Covid-19 OR who are asymptomatic but being screened for Covid-19 (including in hospital and drive-through testing centres)
- Age 18 or over
- Swab is being taken for standard PCR test of Covid-19
- Willing and able to give written informed consent
Who cannot join
- Lack of written consent
- Age under 18
- Routine PCR test not being conducted
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Watford General Hospital
Watford, Hertfordshire, WD18 0HB
About this study
A new Rapid RNA test for Covid-19 has been developed by Professor Cui and his team at the Department of Engineering Science at the University of Oxford. This can give results in 30 minutes which is much faster than the routine PCR test, which often takes 2-3 days to produce results. In this study we aim to establish the sensitivity of the rapid RNA test, which has never before been evaluated clinically. Preliminary anecdotal evidence suggests that the test is easy to use and appears to give valid results. This initial trial aims to establish whether the sensitivity of this tests is above the threshold of 90%. We aim to include at least 173 patients with symptoms of Covid-19 in Watford General Hospital.
Read the detailed description
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently, results of the standard test for the virus take 2-3 days to be reported. The University of Oxford Institute of Biomedical Engineering has designed a new test, which can produce results in 30 minutes. This uses a nasal/throat swab like the current standard test.
In the first phase of the trial, the swab was sent to the laboratory in a dry tube. In the laboratory, the swab was put into a vial of 1 mL water, and a small amount (25 µL) of the water was put into a test tube. This test tube contained materials which can detect the presence of the novel Coronavirus (SARS-CoV-2). The test tube is then simply warmed to 65°C for 30 minutes, and if the Coronavirus is present, the reagent will change colour from pink to yellow (positive). If there is no virus present in the sample, the colour remains pink (negative). This is designed to be a very simple test that does not need specialist skills or equipment, and so could be carried out in hospitals and even in primary care. In this study we aimed to evaluate the accuracy of this new test. We planned to take a second swab from patients with suspected Covid-19 at Watford General hospital (who were being tested anyway) and to use these swabs to conduct the new test (in ideal laboratory conditions) as well as the standard test. As we were not sure of the accuracy of the new test, its results were not used to make decisions about treatment for the patient. In the initial cohort of 173 patients, Discrepancies were noted with some samples when compared to reference lab results. We then investigated whether the patients who had a positive rapid RNA test, but a negative "gold standard" test, were true positives, by inviting them to have an antibody test. This revealed that 20 of 161 patients with a negative reference test had a false positive result on the rapid test. These false positives may result from interfering substances in the clinical samples, which affect the colorimetric detection based on pH changes.
In view of these first results and feedback, the Oxford team made a number of modifications to the rapid test:
- Viral inactivation - the swab is placed in saline and heated at 95°C for 5 mins - which kills the virus and makes it safe to use at the point of care
- The sample is diluted 1 in 10 to avoid interaction with saliva
- A "molecular switch" was added to avoid false positives.
The diagnostic accuracy of the modified test was then evaluated. We invited patients who were being screened, and patients who had been screened and found to be positive, to take part in this study. As the prevalence of COVID-19 amongst tested patients was lower than we had estimated when calculating the sample size (only 12 of 173 were positive on the reference test), the sample was increased by a further 300 patients. We aimed to discover rapidly whether the modified test is accurate.
The rapid RNA test has the potential to be a useful screening tool if it acquires comparable sensitivity to the current "gold standard" with a rapid and feasible approach.
- Conditions
- COVID-19
- Being tested
- rapid RT-LAMP test to detect SARS-COV-2 RNA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid RT-LAMP test to detect SARS-COV-2 RNADiagnostic test
rapid RT-LAMP test to detect SARS-COV-2 RNA
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Other | Version 1 of the rapid test:
The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a dry tube, labelled with the patient's ID, date and time of taking the sample, and was taken to the microbiology laboratory for processing.
In the laboratory, 2ml of RNase-free water was added to the tube and shaken with the swab. Twenty-five microlitres of the swab solution was transferred into a PCR tube containing the dried reagents for the rapid RNA test. This tube was then incubated for 45 minutes at 65'C, then taken out to cool down. The colour of the tube was recorded by the laboratory technician. Receives: Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNA |
| Phase 2 | Other | Version 2 of the rapid test:
The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a tube containing 1ml of normal saline (instead of a dry tube). If the patient was eligible but the standard swab had already been taken >12 hours before, we asked them for their consent to take a second standard swab alongside the swab for the rapid RNA test, to ensure that the samples were comparable.
In the laboratory, the swab was heated to 95'C for 5 minutes to inactivate the virus. Nine ml of RNase-free water was added to the tube and shaken with the swab, before transferring 25ul of the swab solution into the PCR tube containing the dried reagents. This tube was then incubated for 30 minutes at 65'C, then the colour of the tube was recorded and photographed by the laboratory technician at 30 minutes (primary reading) and 45 minutes (secondary reading). Receives: Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity compared to standard PCR
Test swab taken within 12 hours of the standard PCR swab
Measured: within 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start27 May 2020
- Primary completion27 Feb 2021
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two cohorts, the second with a modified version of the test.
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- West Hertfordshire Hospitals NHS Trust, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Michael Moore, FRCGP, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308550
- Sponsor's protocol ID
- 56505
- Other IDs
- 283408
- Acronym
- CERrnaTc-19
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Rapid RNA Test for Covid-19
- ClinicalTrials.gov ID
- NCT05308550
- Acronym / sponsor ID
- CERrnaTc-19 / 56505
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- West Hertfordshire Hospitals NHS Trust, University of Oxford
- Study start
- 27 May 2020 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new Rapid RNA test for Covid-19 has been developed by Professor Cui and his team at the Department of Engineering Science at the University of Oxford. This can give results in 30 minutes which is much faster than the routine PCR test, which often takes 2-3 days to produce results. In this study we aim to establish the sensitivity of the rapid RNA test, which has never before been evaluated clinically. Preliminary anecdotal evidence suggests that the test is easy to use and appears to give valid results. This initial trial aims to establish whether the sensitivity of this tests is above the threshold of 90%. We aim to include at least 173 patients with symptoms of Covid-19 in Watford General Hospital.
Detailed description
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently, results of the standard test for the virus take 2-3 days to be reported. The University of Oxford Institute of Biomedical Engineering has designed a new test, which can produce results in 30 minutes. This uses a nasal/throat swab like the current standard test.
In the first phase of the trial, the swab was sent to the laboratory in a dry tube. In the laboratory, the swab was put into a vial of 1 mL water, and a small amount (25 µL) of the water was put into a test tube. This test tube contained materials which can detect the presence of the novel Coronavirus (SARS-CoV-2). The test tube is then simply warmed to 65°C for 30 minutes, and if the Coronavirus is present, the reagent will change colour from pink to yellow (positive). If there is no virus present in the sample, the colour remains pink (negative). This is designed to be a very simple test that does not need specialist skills or equipment, and so could be carried out in hospitals and even in primary care. In this study we aimed to evaluate the accuracy of this new test. We planned to take a second swab from patients with suspected Covid-19 at Watford General hospital (who were being tested anyway) and to use these swabs to conduct the new test (in ideal laboratory conditions) as well as the standard test. As we were not sure of the accuracy of the new test, its results were not used to make decisions about treatment for the patient. In the initial cohort of 173 patients, Discrepancies were noted with some samples when compared to reference lab results. We then investigated whether the patients who had a positive rapid RNA test, but a negative "gold standard" test, were true positives, by inviting them to have an antibody test. This revealed that 20 of 161 patients with a negative reference test had a false positive result on the rapid test. These false positives may result from interfering substances in the clinical samples, which affect the colorimetric detection based on pH changes.
In view of these first results and feedback, the Oxford team made a number of modifications to the rapid test:
- Viral inactivation - the swab is placed in saline and heated at 95°C for 5 mins - which kills the virus and makes it safe to use at the point of care
- The sample is diluted 1 in 10 to avoid interaction with saliva
- A "molecular switch" was added to avoid false positives.
The diagnostic accuracy of the modified test was then evaluated. We invited patients who were being screened, and patients who had been screened and found to be positive, to take part in this study. As the prevalence of COVID-19 amongst tested patients was lower than we had estimated when calculating the sample size (only 12 of 173 were positive on the reference test), the sample was increased by a further 300 patients. We aimed to discover rapidly whether the modified test is accurate.
The rapid RNA test has the potential to be a useful screening tool if it acquires comparable sensitivity to the current "gold standard" with a rapid and feasible approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohorts, the second with a modified version of the test.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Other | Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNAVersion 1 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a dry tube, labelled with the patient's ID, date and time of taking the sample, and was taken to the microbiology laboratory for processing. In the laboratory, 2ml of RNase-free water was added to the tube and shaken with the swab. Twenty-five microlitres of the swab solution was transferred into a PCR tube containing the dried reagents for the rapid RNA test. This tube was then incubated for 45 minutes at 65'C, then taken out to cool down. The colour of the tube was recorded by the laboratory technician. |
| Phase 2 | Other | Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNAVersion 2 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a tube containing 1ml of normal saline (instead of a dry tube). If the patient was eligible but the standard swab had already been taken >12 hours before, we asked them for their consent to take a second standard swab alongside the swab for the rapid RNA test, to ensure that the samples were comparable. In the laboratory, the swab was heated to 95'C for 5 minutes to inactivate the virus. Nine ml of RNase-free water was added to the tube and shaken with the swab, before transferring 25ul of the swab solution into the PCR tube containing the dried reagents. This tube was then incubated for 30 minutes at 65'C, then the colour of the tube was recorded and photographed by the laboratory technician at 30 minutes (primary reading) and 45 minutes (secondary reading). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting to hospital with symptoms of Covid-19 OR who are asymptomatic but being screened for Covid-19 (including in hospital and drive-through testing centres)
- Age 18 or over
- Swab is being taken for standard PCR test of Covid-19
- Willing and able to give written informed consent
Key exclusion criteria (3 listed)
- Lack of written consent
- Age under 18
- Routine PCR test not being conducted
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 |
|---|---|---|
| rapid RT-LAMP test to detect SARS-COV-2 RNArapid RT-LAMP test to detect SARS-COV-2 RNA | Diagnostic test | Phase 1, Phase 2 |
Primary outcome
Sensitivity and specificity compared to standard PCR
Time frame: within 12 hours
Test swab taken within 12 hours of the standard PCR swab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- 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.
Michael Moore, FRCGP principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid RT-LAMP test to detect SARS-COV-2 RNA in people with COVID-19, run by University of Southampton at 1 site in United Kingdom.
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 4 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity compared to standard PCR (time frame: within 12 hours). 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 4 Apr 2022.