Orlef Bella COVID-19
Research type
Research Study
Full title
Orlef Bella Covid-19. Validation of a single line, single track lateral flow combined immunoassay qualitative test for IgM and IgG antibodies to SARS CoV-2 virus (COVID-19 virus) antigen in plasma and whole blood.
IRAS ID
282813
Contact name
Justin CT Pepperell
Contact email
Sponsor organisation
Orlef Ltd
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
282813, 282813
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study is to validate the utility of the Orlef Bella COVID-19 test in a real world clinical setting. The Orlef Bella test has completed laboratory validation.
This study will test the practical delivery of the test in terms of time constraints and error rates and the objective performance compared to the current standard diagnostic test for COVID-19 and against a proven serological antibody positive cases when suitable reference tests become available.
We will recruit patients having a SARS CoV-2 PCR test and additionally test them with the Orlef Bella test in parallel. We aim to study 250 patients on this site. The results WILL NOT be used to guide clinical decision making. Patients having a COVID-19 PCR test will be asked to read the patient information sheet and if they would like to participate. The patients will have no additional samples or interventions.
Written informed consent will be taken for whole blood or plasma left over from any routine clinical sample to be used for the Orlef Bella test and for the remainder to be stored as anonymised samples for future testing once a reference source becomes available.
We will report results of the on site clinical diagnostic test and the Orlef Bella test with the number of the kit used, the Buffer solution and test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of onset, symptoms and immunodeficiency status or significant conditions.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/HRA/1882
Date of REC Opinion
22 Apr 2020
REC opinion
Unfavourable Opinion