PeploBio provides a streamlined approach for obtaining Coronavirus Test Device Approvals (CTDA) for COVID-19 molecular and antigen assays, where excellence in sample logistics, processing, data management and technology are necessary.
A full evaluation of clinical performance including sensitivity, specificity, and limit-of-detection (LOD) will be provided along with data from a gold standard comparator assay. Established partnerships enable our laboratory to source retrospective or prospective samples that meet the Ct stratification requirements, at a timescale that meets your project timeline.
Our scientists are experts in both molecular and serology-based tests, ensuring that you are fully informed and confident that your project will be managed by professionals who understand the science. A detailed study plan, describing all aspects of the study design, regulatory compliance, methodology, data, acquisition, analysis, and reporting will be provided prior to study initiation. Due to our SOP-driven processes, we are able to manage large scale studies whilst maintaining the necessary quality, sample management and tracking procedures.
To find out more about this service or to request a service proposal, please get in touch with our R&D team at development@peplobio.co.uk and provide a copy of your Instructions For Use (IFU) documentation.
PeploBio is a UKAS accredited Medical Laboratory No. 22998. Our UKAS accredited ISO:15189 laboratory has robust quality processes in place, essential for supporting drug and vaccine discovery, validation, and development.
We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.