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Many years ago I was at the AACC annual meeting attending a breakfast roundtable with a vendor representative as the speaker. She mentioned, in passing, that their lot release criteria for the immunoassay being discussed was + or - 16%, and there was an audible gasp around the table. Gary Sandberg MT(ASCP) SC Manager of Technical Operations Bellingham Laboratory PeaceHealth Laboratories Bellingham, WA USA -----Original Message----- From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Graham Jones Sent: Tuesday, February 23, 2016 4:01 PM To: [log in to unmask] Subject: Re: Reagent lot to lot variation This message originated outside of PeaceHealth's email system and contains web links. Use caution when clicking on links. VERIFY THE SENDER before opening attachments, clicking links or providing information. 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 https://mail1.peacehealth.org/enduser/classify_url.html?url=GzZs8Crqd76ilc7e/D5TJF+LqJOqtCo3po5fwc2tNmg= -----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 https://mail1.peacehealth.org/enduser/classify_url.html?url=MLSLD8gexoFiMERZrfG3zksSjAdP0HcHHCTxS1pDb2x2DLUWTasetidnzJ8dqNvG ------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. 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