Thanks Ian for the useful comments.
Re biotin interference, just one comment - all avidin-biotin based Roche assays have an interference statement about biotin in the package inserts. For example the B12 pack insert says: "Samples should not be taken from patients receiving therapy with high biotin doses (i.e. >5 mg/day) until at least 8 hrs following the last biotin administration."
So "maybe this is [NOT] the only one they looked at"...:-)
Re the question how do we know if patients are on biotin - well we do not...Possible solutions, for example: Pop-up info in eMR when the relevant test is ordered, and the lab manual that describes sample requirements can also have this alert to inform users and phlebotomists? Std comments on reports on all potential interferences might be an overkill...and would most likely cause comment inertia (mind you often pop-up alerts do too...)
So, overall it is not easy of course.
Kind regards, Rita
Prof. Andrea Rita Horvath, MD, PhD, EurClinChem, FRCPath, FRCPA
Past President of the European Federation of Clinical Chemistry and Laboratory Medicine
Clinical Director, SEALS North, Department of Clinical Chemistry
Level 4, Campus Centre, Prince of Wales Hospital
Barker Street, Randwick, NSW 2031, Sydney, Australia
Tel: (+612)-9382 9078
Fax: (+612)-9382 9099
Mobile No: (+61)-404 027 843
-----Original Message-----
From: IAN WATSON [mailto:[log in to unmask]]
Sent: Tuesday, 14 May 2013 8:32 PM
To: Rita Horvath; [log in to unmask]
Subject: Decrypt: RE: Roche crosslaps assay
Thanks for this post Rita. I was at an MHRA [UK Notified Body] yesterday to discuss the EU IVD Directive and this very point was made: MHRA and Notified Bodies in other countries rely on users reporting problems. Reports are to raise awareness and are not punitive and the NB will seek clarification/explanation from the manufacturer/supplier to resolve the issue. It is within the NB's authority to withdraw unsatisfactory products from the market and they can and will do so, but this is, I think, subject to subsidiarity.
While a parallel organisation to the EMA for IVDs may sound attractive this is only ever likely to happen if there were to be an organisation for all medical devices as most IVDs are not in themselves inherently potentially dangerous to patients as e.g. cardiac valves are.
EFLM have urged all our National Societies to engage with their NB to ensure a more effective IVD Regulation results from the current revision of the IVD Directive. Primary matters of concern are: POCT and in-house testing and class D exemptions. The Chair of the EFLM Quality and Regulations Committee, Dr Wim Huisman, would be interested to learn of national developments, he can be contacted through the EFLM web-site [ http://efcclm.eu/ ].
Ian
Dr Ian D Watson PhD FRCPath Eur.Clin.Chem.
President
European Federation of Clinical Chemistry
& Laboratory Medicine
Consultant Biochemist & Toxicologist
Liverpool Clinical Laboratories
Dept Clinical Biochemistry
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
UK
-----Original Message-----
From: Rita Horvath [mailto:[log in to unmask]]
Sent: 14 May 2013 00:24
To: IAN WATSON; [log in to unmask]
Subject: RE: Decrypt: RE: Roche crosslaps assay
Indeed and whilst each EU country has a competent authority which operates such postmarket surveillance and feedback system on IVD failures, they are not very well known and utilized by ourselves. Maybe some more training and education at EU conferences on how various systems work would raise more awareness of their availability and processes?
Whilst these bodies have a common European voice, we as a profession in Europe would be better served by a central European repository where all these observations and notifications could go to so that labs all over Europe could see that it is "not just their lab" which had a problem with a particular IVD - a comment so often heard from manufacturers when labs file a complaint or an observation to them. The FDA IVD notification system seems to work more efficiently and I often go to their website to see if there are reports on failed or troublesome IVD lots and devices. The UK site is very helpful too, but as said, it would be best to have a common repository. Something we might have to discuss in EFLM's IVD working group, Ian?
On this website http://www.meddev.info/_documents/ca_vig.htm all EU authorities are seen and the map is quite blank in Central-Eastern Europe or they have only internal rudimentary and thus hardly used systems in place - so undoubtedly these counteries are potentially more vulnerable when manufacturers sell some lots or products that may not be up to the highest stds? This was seen in the past decades with POCT devices that they could not sell in more advanced parts of Europe and which were dumped on not even labs (!) but non-vigilant GP offices, using government funds to support (the politically correct agenda, i.e.) primary care.
This easy to read article sums up the EU situation and the typical procedures, but this mostly places reporting into the hands of the manufacturer and incident reports mostly tackle serious failures that caused harm to patients and near miss scenarios all of which are seemingly underreported: http://www.emergogroup.com/resources/articles/reporting-incidents-europe
How much do labs all over Europe (and elsewhere) use their own authority's reporting system?
Best regards, Rita
________________________________
From: Clinical biochemistry discussion list [[log in to unmask]] On Behalf Of IAN WATSON [[log in to unmask]]
Sent: Tuesday, 14 May 2013 3:25 AM
To: [log in to unmask]
Subject: Decrypt: RE: Roche crosslaps assay
We have long had a duty to do so!
Dr Ian D Watson
Clinical Director
Consultant Biochemist & Toxicologist
Clinical Laboratories
University Hospital Aintree
LIVERPOOL
L9 7AL
UK
Tel +44 151 529 3575
Fax +44 151 529 3310
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of GIFFORD BATSTONE
Sent: 13 May 2013 11:23
To: [log in to unmask]
Subject: Re: Roche crosslaps assay
Perhaps we as a pathology community should be reporting our concerns re assays to MHRA - I note recent report on Siemens HbA1c Gifford
Dr Gifford Batstone
MBBS, BSc, FRCPath, MSc
Tel 01962 860761
Mob 0791 285 9344
--- On Wed, 8/5/13, Reynolds Tim (RJF) BHFT <[log in to unmask]<mailto:[log in to unmask]>> wrote:
From: Reynolds Tim (RJF) BHFT <[log in to unmask]<mailto:[log in to unmask]>>
Subject: Re: Roche crosslaps assay
To: [log in to unmask]<mailto:[log in to unmask]>
Date: Wednesday, 8 May, 2013, 17:08
It is probably the only assay where they have looked!
Most assays using a biotin-avidin linkage system will have a similar interference - but the manufacturers have been careful not to look...
The same sort of issue affects statins: Rosuvastatin can only be used in asians in half the caucasian dose because of a drug metabolism effect.
Have the other drug compoanies done similar tests? It's doubtful because if they had they would have been using the data in marketing - they have simply buried their heads in the sand and been careful not to look too far beneath the surface...
************************************************************************
**************
Prof. Tim Reynolds
Consultant Chemical Pathologist / Clinical Director - Diagnostics / R&D Lead, Burton Hospitals NHS Foundation Trust work tel: 01283 511511 ext 4035 work fax: 01283 593064 work email: [log in to unmask]<[log in to unmask]" target="_blank">http:[log in to unmask]>
work URL: www.burtonhospitals.nhs.uk<http://www.burtonhospitals.nhs.uk>
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-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]<[log in to unmask]" target="_blank">http:[log in to unmask]>] On Behalf Of Gerald Cox
Sent: 08 May 2013 4:44 PM
To: [log in to unmask]<[log in to unmask]" target="_blank">http:[log in to unmask]>
Subject: Roche crosslaps assay
A recent urgent field safety notice arrived stating a reducded stability from 8 hrs to 6 hrs for serum and a reduced level biotin interference, from 368 nmol/L to 123 nmol/L. My question is how do we know who is on biotin and who measures biotin routinely?
Second question is why is it only beta crosslaps the only immunoassay affected?
Thanks
Gerry
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