A clinical performance study using an optical fluorescence test to detect SARS-CoV-2 virions in participants with and without COVID-19 and compared to participant data from PCR and viral culture

Paraytec (United Kingdom)0 sites125 target enrollmentFebruary 23, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 23, 2024

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Paraytec (United Kingdom)

•Subjects will be 18 years old and over and recruited from NHS staff and their household contacts at Sheffield Teaching Hospitals NHS Foundation Trust.
•Subjects that comply with any of the following criteria:
•1\. Asymptomatic subjects
•2\. Subjects who have tested positive for COVID\-19 via lateral flow testing or PCR testing from a specimen collected and tested within the previous 24 hours
•3\. Symptomatic subjects with 4 days or less duration of one or more COVID\-19\-related clinical symptoms including dry cough, loss of or changes in sense of taste, loss of or changes in sense of smell, fever, stuffy or runny nose, headache, fatigue, sneezing, sore throat, hoarse voice, chills, joint pain, myalgia, night sweats, skin changes, loss of concentration, dizziness, eye soreness, shortness of breath, loss of appetite, diarrhoea, nausea and vomiting.

•1\. Without the capacity or English literacy skills to give informed consent
•2\. Immunocompromised and/or taking oral or injected immunosuppressant medication such as prednisolone, cyclosporin and anticancer drugs or have stopped taking these drugs in the past four weeks
•3\. Currently taking oral antiviral drugs
•4\. Tested positive by PCR for COVID\-19 in the previous three months excluding tests taken in the previous 24 hours before informed consent for this study