We would perform our own validation above the manufacturer's recommendation. ISO15189 simply requires that you perform your own studies if you need to deviate from manufacturer's recommendations. There is often a need to this for tumour markers in order to ensure that the service meets the clinical need.
Lesley Tetlow FRCPath
Consultant Clinical Biochemist
Director of Newborn Screening & Clinical Director (Paediatrics) for Laboratory Medicine
Paediatric Pathology, 4th Floor
Royal Manchester Children’s Hospital
Oxford Road, Manchester, M13 9WL
T: 0161 701 1268
E: [log in to unmask]
PA T: 0161 701 5167
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www.mft.nhs.uk
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Rebecca Beresford-Green
Sent: 25 October 2019 15:12
To: [log in to unmask]
Subject: [EXTERNAL] Roche CA 15-3 reporting limit
WARNING: This message originated from an external source. Please exercise caution when opening any attachments or clicking on links.
Hi All,
According to the kit insert, the upper limit of the Roche CA 15-3 immunoassay after dilution is 3,000 kU/L. Despite us explaining that the accuracy of the assay is unknown above this point, we have a clinician insisting that we report higher than this so that he can make chemotherapy decisions.
Please could you advise what other labs are doing in this or similar situations?
Best wishes,
Rebecca
Clinical Scientist
Northampton General Hospital
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