Evaluation of the diagnostic performance of the Rapid SARS-CoV-2 Antigen Test Card for COVID-19

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN12682933
• Lead Sponsor: Sante Group LLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-31
• Study Start: 2023-08-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Diagnostic performance differences (if any) in relation to:<br>1. Age<br>2. Gender<br>3. Symptomatic or asymptomatic<br>4. Days from symptom onset or Days from contact (if applicable)<br>5. CT value of RT-PCR results<br>All measured using statistical analysis (chi-squared test or Fisher exact test, as appropriate) at the end of recruitment period.