It's good to see labs reporting such concerns directly to the MHRA (who actively encourage such reporting)
dj
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Philip Monaghan
Sent: 16 August 2016 15:32
To: [log in to unmask]
Subject: Re: TnI-Ultra
Thanks Eric
An eye-opening report. As with everything we do, appreciation of the clinical use of test results and potential impact on patients is critical. In my institution (tertiary oncology setting), the use of troponin testing is relatively low, therefore limiting the data available to assess lot-to-lot bias in this instance (my findings are mainly based on EQA results; ? matrix-issues).
We know that Troponin results are interpreted in the context of clinical symptoms of ischaemia, ECG changes, etc. Nonetheless, I have discussed this issue with the manufacturer and last week escalated to the MHRA (who have now asked Siemens to investigate), and logged internally via Medical Devices Committee for review.
Best wishes
Phil
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