Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Exeter | OTHER |
| University of Plymouth | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
The investigators will develop novel primers to detect single virus particles in patient samples. The method involves the absorption of light by single virus particles giving a specific pattern. The investigators will develop the device to create a microdroplet of carrier fluid that is run through the trial device. The investigators will develop novel binding receptors for preferential capture of Coronavirus.
The investigators will review the results of the novel test against the standard diagnostic test and identify virus particles in test negative subjects.
The investigators will isolate the viral rna in test negative subjects and perform sequencing to find novel mutations that are not detected by the current test.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| primary arm | Experimental | There will only be one set of participants with each participants samples and results as the comparator groups. There will be within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel laser inferometry test for CORONA virus | Diagnostic Test | detection of virus particles by light absorbtion patterns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| kappa value | level of agreement between novel test and standard test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity | test of accuracy for the result versus a validated sample set | unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| clinical utility of test | timeliness of results | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Somerset NHS Foundation Trust | Taunton | Somerset | TA4 3RF | United Kingdom |
During the trial, the investigators will store a list of participants and their unique trial number on a password protected file and computer in the Clinical Research Department. After the trial has completed, and when the data is stored or used, any information that could identify an individual participant will be removed or "pseudonymised". A pseudonym is a unique identifier which does not reveal the participant's 'real world' identity.
Personal identifiable data will not be shared with any other outside organisation. The results of the tests will be shared with the collaborators using a unique trial number. Any remaining blood sample material will be frozen and stored as serum using the unique trial number in Musgrove Park Hospital's research laboratory.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
Not provided
Not provided
The participants and the primary care provider will be masked to the outcome of the test. The test will not be used to determine clinical care and the result of the original diagnostic test will be masked from the outcomes assessor of the novel test under investigation.
Not provided
| D007239 |
| Infections |