Serum analysis of clinical samples designated for testing in laboratories outside UK

Dear experts,

We are preparing to submit a CTA for an AAV gene therapy program for the Dilated Cardiomyopathy indication. As part of the protocol’s inclusion and exclusion criteria, we plan to collect serum samples at the UK clinical site and ship them to the United States for Neutralizing Antibody (NAb) testing.
The assay’s performance evaluation has been completed, and the FDA has granted an Investigational Device Exemption (IDE) and IND to support its use in the study.
We would like to confirm whether clinical serum samples collected in the UK may be shipped to the United States for screening. If there are any applicable guidance documents or regulatory references regarding the export of human clinical samples for analysis outside the UK, we would greatly appreciate your direction.

Thank you!
Srini