CRO Custom Services

Clinical Assay Validation

We are able to provide full clinical evaluation services including sourcing of clinical samples, limit of detection calculations using reference material and performance comparisons against a gold standard to determine assay sensitivity and specificity.  At PeploBio we specialise in genomic and immunoassay technologies.

Our team is experienced in delivering validation studies to meet various testing requirements such as:

Covid-19 Testing Devices Approval (CTDA)

list of testing kits using government approved comparator assays.

CE IVDR marking

1. GOV.UK. 2022. COVID-19 test validation approved products. [online] Available at: <https://www.gov.uk/government/publications/covid-19-test-validation-approved-products> [Accessed 3 May 2022].

2. EUR-Lex. 2017. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ). [online] Available at: <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746> [Accessed 4 May 2022].