Halt to patient recruitment for Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor Standard Q SARS-CoV-2)
Thanks to the amazing efforts of RAPTOR-C19 sites, the team would like to request that all sites stop using the Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor Standard Q SARS-CoV-2 assay) as we have reached sample size for this test. We would be grateful if sites could:
- Safely retain any unused Roche SARS-CoV-2 tests until further advice is provided by the RAPTOR-C19 team.
- Continue to recruit eligible patients for testing with the BD Veritor™ SARS-CoV-2 assay.
RAPTOR: Information for clinicians and test sites
- [12 Aug 21] Delay to virology and serology results: At the moment serology and virology results are being returned later than as stated in the Patient Information leaflets. This is not something in our control, and is variable at the moment, but we expect this to be resolved in the next few weeks.
- Extended expiry dates for BD Veritor™ System for Rapid Detection of SARS-CoV-2 kit, material number: 256089, lot number 0331906
BD have confirmed that it is the kit lot number that the 6-month expiry date extension applies to, and that this extends to all kit components (i.e. it is the LOT number on the box that is important!).
Please see this image to locate the kit lot number (click to expand).
These lots were originally dated with an expiry of 6 months, and data supports a 6-month extension (12 months total). The notification below lists the lot number, currently labelled kit expiry and new kit expiry date.
Click here to download the full notification (.pdf).
- For practices using the BD Veritor Plus system RAPTOR is only recruiting people who have had symptoms that started in the last five days, inline with the manufacturer's instructions for use.
- REMINDER – Roche SARS-CoV-2 Rapid Antigen Test (SD Biosensor Standard Q SARS-CoV-2) Test Product Recall:
All sites have been notified of a product recall for batch number QCO3020076. If you have any remaining stock of this batch please dispose of it appropriately. Please contact the trial team if you have any questions. This recall affects the above noted product only.
Contact us via email on email@example.com if you have any questions or comments and a member of the team will get back to you.
Serious Adverse Events (SAEs)
In the event of an SAE occurring, please contact RAPTOR@phc.ox.ac.uk for further instructions on how to report an SAE.
Please ensure no patient or patient identifiable information is included in the email.
Tips for maximising recruitment
We asked high-recruiting sites for their tips on how they go about maximising recruitment.
Got a tip? email us at firstname.lastname@example.org
All you need for your RAPTOR work
|RAPTOR Training||RAPTOR Documents|
|1.||Introduction to RAPTOR||1.||Study protocol (v5)|
|2.||Guide to recruiting to RAPTOR and interview with a recruiting practice||2.|
Patient information leaflets (and translations)
|3.||Connecting the PHC Trials Tablet to WiFI or 4G||3.||Frequently Asked Questions|
|4.||4.||Recruiting site delegation log|
RAPTOR Quick test reference
(Can be completed manually then entered into uMed later)
|Diagnostic (IVD) test training and downloads|
|ROCHE SARS-CoV-2 Rapid Antigen test|
|ROCHE 'SARS-CoV-2 Rapid antigen test' user guide and information (.zip)|
|SARS-CoV-2 Rapid antigen test video user guide (YouTube)|
|2.||BD Veritor™ Plus System for rapid COVID-19 (SARS-CoV-2) testing|
[15 Jul 2021] Uploaded Welsh and Polish translations of the Testing Centre specific Patient Information Sheets and printable CRF
[02 Jun 2021] Updated Raptor general guide to include information on where to find RAPTOR site ID and participant IDs.
[31 Mar 2021] Updates study protocol to version 5 and added Test Centre specific patient information leaflets (all English, translations coming soon).
[04 Feb 2021] Updated Study protocol to version 4
[11 Jan 2021] Updated Study protocol to version 3
[17 Nov 2020] Updated Portuguese Patient information leaflets (.zip file)
[05 Nov 2020] Updated uMed User Guide to newest version
[28 Oct 2020] Updating remain translations of Adult and young people's information leaflets in downloadable .zip files.
[21 Oct 2020] Minor update / corrections to English Adult and young people's information leaflets.
Added links to ROCHE 'SARS-CoV-2 Rapid Antigen Test' guides and video. Removed training for SD Biosensor IVD.
[23 Sept 2020] Added section with translations of patient information leaflets in Bengal, Chinese, French, Polish, Portuguese, Punjabi, Somali and Urdu.
[26 Aug 2020] Added this webpage for clinician study support resources.