Detection of SARS-CoV-2 virions in infected participants Infections and Infestations
Conditions
Interventions
This study is a prospective single-centre non-blinded cross-sectional study of anonymised clinical specimens from staff and their household contacts presenting for SARS-CoV-2 clinical testing.
Parti
Sponsors
Paraytec (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Detection of the presence or absence of the SARS-CoV-2 virus in test specimens measured using the CX300 device compared with the results of quantitative polymerase chain reaction (qPCR) as a reference standard on the day of the test specimens being taken 2. The sensitivity and specificity to detect the presence or absence of the SARS-CoV-2 virus measured using the CX300 device and compared with the results of qPCR as a reference standard on the day of the test specimens being taken | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Repeatability and reproducibility (intermediate precision) to detect the presence or absence of the SARS-CoV-2 virus measured using the CX300 device compared with the results of quantitative polymerase chain reaction (qPCR) as a reference standard on the day of the test specimens being taken 2. The relationship between signal strength and viral titre measured using the CX300 device compared with the results of qPCR as a reference standard in nasal/oropharyngeal swab samples cultured on the day of the test specimens being taken | — |
Countries
England, United Kingdom
Contacts
Public ContactSue Hagan
Outcome results
None listed