Validation of a membrane-based immunoassay to test for SARS-CoV-2 [COVID-19]
Research type
Research Study
Full title
Validation of a membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2 (RAPG-COV-019)
IRAS ID
281788
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Richmond Research Institute
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
The RAPG-COV-019 kit is a small testing cartridge developed by Biopanda that can detect if an individual has or has been infected by the novel coronavirus (SARS-CoV-2). It does this by using a spot of the person’s blood and displays these results in 10 minutes. \n\nThis is a screening study to validate this new test and check that it is accurate. An already established, polymerase chain reaction (PCR) based laboratory test is available that detects SARS-CoV-2, and though accurate, it is expensive and time consuming. Furthermore, it requires highly trained staff and laboratory facilities. The RAPG-COV-019 kit can be used by non-experts and provide results within minutes. Such a test would allow rapid, inexpensive diagnosis of infection with SARS-CoV-2 which is currently a worldwide pandemic.\n\nThis study is designed to test all staff and visitors as they enter the Richmond Pharmacology unit in London, UK. They will be tested with the new RAPG-COV-019 kit as well as the established PCR test. The results will be compared to enable determination of whether the RAPG-COV-019 kit can make a reliable diagnosis. Collecting this data also allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence and information on asymptomatic carriers. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission. \n
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0106
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion