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Validate the Fibrinogen Assay

Because in Romania we don’t have books, guidance or procedures about validation I want to know if for the fibrinogen validation it is necessary to establish the lower limit of detection (LLD) and if the manufacturer does not provide information about the CV% for precision and accuracy what can I do? Best regards, Monica Truta, Clinical Laboratory Technician.

Hello, Monica, and thank you for your question. Yes, I do recommend you establish LLD, and also precision and accuracy data. You may find everything you need at theWestgard QC web site. Also, our audio modules 3 and 4, Method Validation 1 and 2,contain the information you are looking for. Thirdly, Dave McGlasson and I have recently published Quick Guide to Laboratory Statistics and Quality Control, 2012, AACC Press. Perhaps you will be able to order this online from AACC, or even Amazon. If not, please contact me again with a physical address and I can arrange for you to receive a copy.

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