Clinical Evaluation of Rapid RNA Test for Covid-19 (CERrnaTc-19)
COVID-19
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Patients presenting to hospital with symptoms of Covid-19 OR who are asymptomatic but being screened for Covid-19 (including in hospital and drive-through testing centres)
- Age 18 or over
- Swab is being taken for standard PCR test of Covid-19
- Willing and able to give written informed consent
Exclusion Criteria:
- Lack of written consent
- Age under 18
- Routine PCR test not being conducted
Sites / Locations
- Watford General Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
Phase 1
Phase 2
Version 1 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a dry tube, labelled with the patient's ID, date and time of taking the sample, and was taken to the microbiology laboratory for processing. In the laboratory, 2ml of RNase-free water was added to the tube and shaken with the swab. Twenty-five microlitres of the swab solution was transferred into a PCR tube containing the dried reagents for the rapid RNA test. This tube was then incubated for 45 minutes at 65'C, then taken out to cool down. The colour of the tube was recorded by the laboratory technician.
Version 2 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a tube containing 1ml of normal saline (instead of a dry tube). If the patient was eligible but the standard swab had already been taken >12 hours before, we asked them for their consent to take a second standard swab alongside the swab for the rapid RNA test, to ensure that the samples were comparable. In the laboratory, the swab was heated to 95'C for 5 minutes to inactivate the virus. Nine ml of RNase-free water was added to the tube and shaken with the swab, before transferring 25ul of the swab solution into the PCR tube containing the dried reagents. This tube was then incubated for 30 minutes at 65'C, then the colour of the tube was recorded and photographed by the laboratory technician at 30 minutes (primary reading) and 45 minutes (secondary reading).