Diagnostic accuracy of a novel COVID-19 test
| ISRCTN | ISRCTN66255490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66255490 |
| IRAS number | 320705 |
| Secondary identifying numbers | RHM MED1913, CPMS 54620, IRAS 320705 |
- Submission date
- 06/02/2023
- Registration date
- 10/02/2023
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
COVID-19 diagnostic techniques and testing capacity have evolved rapidly during the pandemic. Recently, single-use analyser-free COVID tests have been undergoing development. Among these, the Veros COVID-19 test is single-use, handheld, analyser free, has no reliance on a power source, requires no dedicated user training, and uses nucleic acid amplification to provide a qualitative positive or negative result on an anterior nasal swab sample in approximately 15 minutes. This could offer scope to improve time to results and both portability and accessibility of accurate COVID-19 testing. Should the Veros COVID-19 test demonstrate acceptable accuracy when compared to the current reference standard, there is potential to improve the time to results, portability and accessibility of accurate COVID-19 testing. The study's aim is to evaluate the real-world diagnostic accuracy of the Veros COVID-19 test, and its potential clinical impact in the emergency department.
Who can participate?
Adult patients that present to the Emergency Department (ED) or Acute Medical Unit at Southampton General Hospital with symptoms of an acute respiratory illness/is a suspected case of COVID-19, and who can be recruited to the study in a timely fashion on arrival to the hospital (prior to or at the approximate time of routine point-of-care testing for COVID-19)
What does the study involve?
Potential participants will be approached by the clinical team and consented by the research team for the taking of two samples in addition to those taken as part of routine clinical care (which includes a combined nose and throat viral swab which will be tested for COVID-19 on the reference standard assay by ED staff, as is currently routine care for new presentations of possible COVID-19 infection in the ED).
The two samples required by the study will be:
1. An anterior nasal swab, to be run in the department on the Veros COVID-19 test kits by research team staff
2. A combined nose and throat swab for storage, in case later required for viral culture and other testing
Patient care will not be altered from routine clinical care as clinical staff and participants will not be informed of the results of the Veros COVID-19 tests as the Veros COVID-19 test is not yet used during routine clinical care and has not undergone local validation or verification. Patients will have received routine COVID-19 testing from the clinical team, in the form of the combined nose and throat swab run on the reference standard assay.
Questionnaires will be given to research staff using the Veros COVID-19 test to evaluate the test’s ease of use. Research team members will carry out the Veros COVID-19 tests and results will be recorded manually in ED (as the tests do not interface with NHS systems) and the reference standard test’s results will be reviewed on the participant’s EPR. Participant involvement in the study is considered to have ended once their last physical interaction with the research team has been completed, although some retrospectively collected outcome measures will be extracted from the EPR after this time. For all patients, it is intended that the final physical interaction with the research team be on the same day as enrolment, at the taking of samples. The time to result for the Veros COVID-19 test will be established by the research team member recording time from sampling to result, while the time to result for the reference standard will be recorded from sampling to the time that the result is released to the patient record. The combined nose and throat swab sample, taken for potential viral culture, will be frozen at -80°C until sent for culture if required (this will allow evaluation of the infectiousness of samples with a focus on, but not limited to, samples that return discordant COVID-19 test results).
What are the possible benefits and risks of participating?
There are no individual benefits for participating patients as the result of the Veros COVID-19 test will not be relayed to the patient or clinical team, as the main purpose of the study is to investigate diagnostic accuracy and the Veros COVID-19 test is not yet used during routine clinical care and has not yet undergone local validation or verification. However, all participants may feel that they are helping to improve NHS care for unwell patients in the future by being part of this research. No greater risk to patients enrolled in this study is anticipated than those present during routine clinical care. The harm associated with respiratory swabs is minimal and typically limited to mild and short-lived discomfort at the time the swabs are performed.
Where is the study run from?
Southampton General Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2022 to March 2024
Who is funding the study?
Sense Biodetection Limited (UK)
Who is the main contact?
1. Prof Tristan W Clark (Chief Investigator), t.w.clark@soton.ac.uk
2. Dr Mary Chapman (Co-investigator), mary.chapman@uhs.nhs.uk
Contact information
Principal Investigator
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0001-6026-5295 |
|---|---|
| Phone | +44 02381 208410 |
| t.w.clark@soton.ac.uk |
Scientific
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381 208410 |
|---|---|
| t.w.clark@soton.ac.uk |
Public
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381 208410 |
|---|---|
| t.w.clark@soton.ac.uk |
Scientific
Clinical Research Fellow
Study Co-investigator
LF100
South Academic Block
Southampton General Hospital
Romsey Road
Southampton
SO16 6YD
United Kingdom
| mary.chapman@uhs.nhs.uk |
Study information
| Study design | Single-centre diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 43169_ICF_v2.0_14Dec2022.pdf |
| Scientific title | A prospective study to evaluate the real-world diagnostic accuracy and potential clinical impact of the Veros COVID-19 test in adults presenting to the Emergency Department with suspected COVID-19: ED-POC |
| Study acronym | ED-POC |
| Study hypothesis | This study aims to evaluate the real-world diagnostic accuracy of the Veros COVID-19 test and its potential clinical impact in the Emergency Department. COVID-19 will remain a burden on healthcare services and their patients for years to come. Diagnostic techniques and COVID-19 testing capacity have evolved rapidly during the pandemic. Recently, single-use analyser-free COVID tests have been undergoing development. Among these, the Veros COVID-19 test is single-use, handheld, analyser free, has no reliance on a power source, requires no dedicated user training, and uses nucleic acid amplification to provide a qualitative positive or negative result on an anterior nasal swab sample in approximately 15 minutes. This could offer scope to improve time to results and both portability and accessibility of accurate COVID-19 testing. Should the Veros COVID-19 test demonstrate diagnostic accuracy comparable to the current reference standard, it could offer scope to improve time to results, and both portability and accessibility of accurate COVID-19 testing. |
| Ethics approval(s) | Approved 28/11/2022, North East - Tyne & Wear South Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 104 8282; tyneandwearsouth.rec@hra.nhs.uk) ref: 22/NE/0225 |
| Condition | The real-world diagnostic accuracy of the Veros COVID-19 test |
| Intervention | This study will consist of a diagnostic accuracy study of the Veros COVID-19 test, in the form of a prospectively recruited study. Adult patients presenting to the ED with suspected COVID-19 and/or symptoms of acute respiratory infection will be recruited and tested at the point of care using the Veros COVID-19 test kit (a second swab will be taken and stored for potential further tests in form of viral culture if required). They will also be receiving testing from the clinical team in the ED as part of their routine clinical care which will be run on the Cepheid GeneXpert Xpress SARS-CoV-2 assay (a component of the Cepheid GeneXpert Xpress SARS-CoV-2/Flu/RSV test). The result of the GeneXpert SARS-CoV-2 assay, as part of their routine clinical care, will be available to clinical staff to facilitate decision-making for patients. The results of the Veros COVID-19 test will not be disclosed to clinical staff or participating patients. Active patient participation in the study will end after sample collection. Due to the low risk and brief nature of patient involvement in the study, and that no deviations from routine clinical care are planned, observation and follow-up of patients post active participation are not planned. Sensitivity, specificity, positive predictive value (PPV), and negative predictive values (NPV) (with 95% confidence intervals) of the Veros COVID-19 test can then be calculated using the GeneXpert SARS-CoV-2 result as the reference standard. Secondary objectives will consist of evaluating the time to results of the Veros COVID-19 test compared to the reference standard, the reliability of the Veros COVID-19 test, the ease-of-use of the Veros COVID-19 test and the relationship between viral load and Veros COVID-19 test result. Viral culture will be used to evaluate the infectiousness of samples, with a focus on samples that return discordant results from the Veros COVID-19 test and the reference standard. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Veros COVID-19 test |
| Primary outcome measure | Diagnostic accuracy of the Veros COVID-19 test measured using the GeneXpert SARS-CoV-2 result as the reference standard as defined by the manufacturer's instructions at comparable timepoints |
| Secondary outcome measures | 1. Time to result for the Veros COVID-19 test compared to the reference standard assessed at comparable timepoints at the point of care 2. Proportionate failure rate of the Veros COVID-19 test (with the failure to provide a valid result after the use of a test denoting a failed test) assessed at one timepoint at the point of care 3. Ease-of-use measured using quantitative data from the ‘Veros COVID-19 Test Kits – Ease of Use’ Questionnaire provided to users assessed at one timepoint at the point of care 4. Proportion of positive discordant results measured using viral culture of the stored sample at one timepoint after the final physical interaction with the participant 5. The performance of the Veros COVID-19 test across high, medium and low viral loads as determined by cycle threshold (Ct) value bins (with a Ct value of <25 indicating high levels of virus, Ct>25<30 medium levels of virus and Ct>30 low levels of virus) as calculated by the GeneXpert SARS-CoV-2 test at one timepoint |
| Overall study start date | 30/08/2022 |
| Overall study end date | 03/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Participant inclusion criteria | 1. Is a patient in the ED or AMU at Southampton General Hospital, UHS 2. Aged ≥18 years old 3. Can be recruited into the study on arrival to the hospital at the time of/prior to routine point-of-care testing for COVID-19, and 3.1. Has an acute respiratory illness, or 3.2. Does not have an acute respiratory illness but is a suspected case of COVID-19 according to the current PHE case definition 4. Has the capacity to consent to the study |
| Participant exclusion criteria | 1. Not fulfilling all inclusion criteria 2. Declines nasal/pharyngeal swabbing |
| Recruitment start date | 09/01/2023 |
| Recruitment end date | 03/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 (0)2381 203920 |
|---|---|
| sponsor@uhs.nhs.uk | |
| Website | http://www.uhs.nhs.uk/home.aspx |
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 03/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in high-impact peer reviewed journals 2. Disseminated via medical conference posters and presentations |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Professor Tristan Clark (CI) from 03/03/2024. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 14/12/2022 | 09/02/2023 | No | Yes |
| Participant information sheet | version 2.0 | 14/12/2022 | 09/02/2023 | No | Yes |
| Protocol file | version 1.0 | 20/09/2022 | 09/02/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 05/09/2024 | 28/01/2025 | Yes | No |
Additional files
Editorial Notes
28/01/2025: Publication reference and total final enrolment added.
21/03/2023: Internal review.
09/02/2023: Trial's existence confirmed by the North East - Tyne & Wear South Research Ethics Committee.
