COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection

Not Applicable

• Conditions: Diagnoses Disease; Coronavirus
• Interventions: Diagnostic Test: Novel laser inferometry test for CORONA virus

• Registration Number: NCT04401644
• Lead Sponsor: Somerset NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-22
• Last Update Submitted: 2020-05-22
• Study First Posted: 2020-05-26
• Last Update Posted: 2020-05-26
• Study Start: 2020-06
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• clinical suspicion of coronavirus or staff member having a coronavirus test

Exclusion Criteria

• unable to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
primary arm	Novel laser inferometry test for CORONA virus	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.

Primary Outcome Measures

Name	Time	Method
kappa value	6 months	level of agreement between novel test and standard test

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Somerset NHS Foundation Trust; 🇬🇧 Taunton, Somerset, United Kingdom