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I think in labs we have shifted towards not reporting issues with a perception [probably incorrect] that our reporting issues will not change anything. Probably worth noting that MHRA do rely on users to flag potential problems, they are not psychic. One report may not change anything, but if several labs are independently reporting same problem............... dj From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of IAN WATSON Sent: 13 May 2013 18:26 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]<mailto:[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]<http:[log in to unmask]> work URL: www.burtonhospitals.nhs.uk<http://www.burtonhospitals.nhs.uk> This e-mail, and any files transmitted with it, are confidential and intended solely for the use of the individual to whom it is addressed. If you are not the intended recipient please destroy this message, delete any copies held on your systems, and notify the sender immediately. You should not retain copy or use this e-mail for any purpose, nor disclose all or any part of its content to any other person. If you have received this e-mail in error, please notify me on 01283 511511 Ext 4035 [Picture of tree not available] Please consider the environment before printing this e-mail -----Original Message----- From: Clinical biochemistry discussion list [mailto:[log in to unmask]<http:[log in to unmask]>] On Behalf Of Gerald Cox Sent: 08 May 2013 4:44 PM To: [log in to unmask]<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 ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk<http://www.acb.org.uk/> Green Laboratories Work http://www.laboratorymedicine.nhs.uk<http://www.laboratorymedicine.nhs.uk/> List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk<http://www.acb.org.uk/> Green Laboratories Work http://www.laboratorymedicine.nhs.uk<http://www.laboratorymedicine.nhs.uk/> List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ This message contains confidential information and is intended only for the individual named. If you are not the named addressee you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately by e-mail if you have received this e-mail in error and delete this e-mail from your system. If you are not the intended recipient you are notified that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited. ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk Green Laboratories Work http://www.laboratorymedicine.nhs.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/