COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection

Study Overview
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Brief Summary
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Using Laser light to detect COVID 19 virus particles in deep throat swab / nasal swab samples.

Detailed Description
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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.

Official Title
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Laser Interferometry of Single Virus Particles Flowing Through Glass Microcapillaries to Detect Novel Coronavirus COVID-19

Conditions
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Diagnoses Disease, Coronavirus

Intervention / Treatment
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* Diagnostic Test: Novel laser inferometry test for CORONA virus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical suspicion of coronavirus or staff member having a coronavirus test Exclusion Criteria: unable to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: within group comparison of methods of detection of virus by two test methodologies. Post hoc validation of test performance against reference set.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: primary arm<br>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. | Diagnostic Test: Novel laser inferometry test for CORONA virus<br>* detection of virus particles by light absorbtion patterns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kappa value | level of agreement between novel test and standard test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |