Coronavirus, Diagnoses Disease
Conditions
Brief summary
Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTNovel laser inferometry test for CORONA virus
detection of virus particles by light absorbtion patterns.
Sponsors
University of Exeter
University of Plymouth
Somerset NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* clinical suspicion of coronavirus or staff member having a coronavirus test
Exclusion criteria
* unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| kappa value | 6 months | level of agreement between novel test and standard test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity | unknown this will require a centrally validated test set for known positives and negatives to be available estimated 1 year | test of accuracy for the result versus a validated sample set |
Other
| Measure | Time frame | Description |
|---|---|---|
| clinical utility of test | 3 months | timeliness of results |
Countries
United Kingdom
Outcome results
None listed