Validation of IVD Assays at External Clinical Laboratories
Research type
Research Study
Full title
Validation of In Vitro Diagnostic Assays at External Clinical Laboratories
IRAS ID
309506
Contact name
Stephen Walker
Contact email
Sponsor organisation
The Binding Site
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The aim of this study is to obtain data required for the validation of in vitro diagnostic assays developed by The Binding Site Group Limited in a clinical laboratory setting. The selected residual clinical samples will be run anonymised, by the study site, to produce the validation data required.
The study will consist of selection of residual clinical samples, anonymised testing of samples for the purposes of assay validation and release of data to The Binding Site.
The data generated will be used by The Binding Site Group Limited in publications and in regulatory submissions. Data provided to The Binding Site Group Limited will include information such as original test results for which the sample was selected and other relevant results, sample date, patient age, patient sex, patient ethnicity (if available) and admission diagnosis. No data that allows the identification of individual patients will be released to The Binding Site Group Limited.
The data generated will be used by The Binding Site Group Limited, as part of the regulatory submissions required for approval and use of the assays. This will enable The Binding Site Group Limited to release to the market assays that can both aid clinicians in diagnosis and help to monitor the treatment of patients.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0043
Date of REC Opinion
7 Mar 2022
REC opinion
Further Information Favourable Opinion