COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Two swabs will be provided to the participant, who will perform self-swabbing:
1. An anterior nasal swab for RT-PCR (on Cepheid GeneXpert Xpert® Xpress SARS-CoV-2)
2. An anterior nasal swab for latera
Sponsors
Sante Group LLP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Three groups of participants will be recruited. Group A This group consists of COVID-19-suspected NHS staff members who either have symptoms compatible with COVID-19 or have been in recent contact with someone who has COVID-19 1. This group consists of COVID-19-suspected NHS staff members who: 1.1. Have symptoms compatible with COVID-19 or 1.2. Have been in recent contact with someone who has COVID-19 2. Age =18 years 3. Within 10 days of onset of symptoms or within 10 days of contact with a confirmed COVID-19 case 4. Voluntarily presents to the Airedale swabbing centre for RT-PCR swabbing Group B This group consists of patients who have confirmed COVID-19 infection (with a positive PCR test result) 1. This group consists of patients in hospital who have confirmed COVID-19 infection (with a positive PCR test result) and 1.1. Admitted to hospital for >24 hours and 1.2. The medical team feels that the patient can give valid consent and 1.3. Does not require respiratory support other than supplementary nasal oxygen (i.e., participants on non-invasive ventilation such as CPAP, and intubated patients are excluded) 2. Age =18 years 3. Within 10 days of onset of symptoms, or if asymptomatic, within 10 days of the date of PCR test Group C This group consists of NHS staff members who are asymptomatic for COVID-19, have had no known COVID-19 contact in the past 10 days, and volunteering for the study 1. This group consists of NHS staff members who: 1.1. Are asymptomatic for COVID-19 1.2. Have no known COVID-19 contact in the past 10 days 2. Age =18 years 3. Voluntarily presents to the Airedale laboratory for swabbing
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Demographic data not available or not provided Sample rejection criteria: 1. Samples received without the corresponding pair 2. Anterior nasal swabs received >8 hours from the time of collection 3. Improperly stored swabs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of the SARS-CoV-2 Antigen Test Card compared with Cepheid RT-PCR: sensitivity, specificity, accuracy, and confidence intervals calculated by comparing the results of the Rapid SARS-CoV-2 Antigen Test Card with the results of the standard reference comparator Cepheid® Xpert® Xpress SARS-CoV-2 RT-PCR. Measured at end of recruitment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic performance differences (if any) in relation to: 1. Age 2. Gender 3. Symptomatic or asymptomatic 4. Days from symptom onset or Days from contact (if applicable) 5. CT value of RT-PCR results All measured using statistical analysis (chi-squared test or Fisher exact test, as appropriate) at the end of recruitment period. | — |
Countries
England, United Kingdom
Contacts
Public ContactMarco Lee
Outcome results
None listed