Dear Rachel and others,
On the issue of lot to lot variation I think a useful approach is to ask the manufacturer for their lot release criteria. If the change between lots fails to meeting this criteria they should replace the lot or otherwise assist. In an ideal world you would know this information at the time of purchasing a kit or method, then you purchase this kit aware of the possible limitations. If we purchase knowing the possible lot to lot variation, and they meet this criteria, we cannot complain, but at least we know what could happen even when their quality system is operating as planned.
Regards,
graham
Graham Jones
Staff Specialist in Chemical Pathology
St Vincent’s Hospital, Sydney
(02) 8382-9160
www.sydpath.com.au
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Rachel Brixey-McCann
Sent: Wednesday, 24 February 2016 4:05 AM
To: [log in to unmask]
Subject: Reagent lot to lot variation
Dear All,
We have had a couple of issues recently with lot to lot variation for a few of our reagents and would be interested to hear what acceptance criteria you use in your departments, if any, to assess this variation?
Do you use the same criteria for both chemistry and immunoassay reagents?
Many thanks for your help
Rachel
Rachel Brixey-McCann DPhil
Senior Clinical Biochemist
Medical Biochemistry & Immunology
University Hospital of Wales
Cardiff, UK
029 2074 8346
http://www.cardiff-mbit.wales.nhs.uk
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