This test is currently outside of our scope of UKAS/ISO 15189:2012 accreditation. The antibody has been verified in HSL Advanced Diagnostics, to reflect clinical use. However the expected staining characteristics have not been formally validated by the manufacturer.
We are committed to using CE-IVD or FDA-approved methodologies whenever possible and update our antibody stock when these become available. New tests that come on line will be assessed as part of the next assessment cycle and will form part of our updated UKAS accreditation scope following successful assessments.