COVID-19: Laser Interferometry for Rapid Single Coronavirus Detection (COLIDE)

Somerset NHS Foundation Trust

Status: Unknown

Conditions: Diagnoses Disease; Coronavirus

Treatments: Diagnostic Test: Novel laser inferometry test for CORONA virus

Study type: Interventional

Funder types: Other

Identifiers

NCT04401644

RBA20203

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• unable to give written informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

primary arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Novel laser inferometry test for CORONA virus