Hello George, I am trying to find an article that tells how often I have to calculate the uncertainty for coagulation assay (fibrinogen, PT, APTT). Can you give me a resource for information or any further help with this?
Best regards, Monica Truta, Clinical Laboratory Technician, Infectious Diseases Hospital “Dr. Victor Babes,” Romania.
Hello, Ms. Truta, and thank you for your question. I went to my friend and colleague, Dr. Ali Sadeghi-Khomami, scientist at Precision BioLogic Inc for his expertise. His response is that every time a new instrument, new assay or new lot number of a previously used assay or reagent is received by a lab they need to verify the manufacturer’s claims on its precision If the manufacturer provides no data for a specific instrument or reagent, the lab needs to run a precision study as part of their validation effort which is more detailed compared to verification efforts. Dr. Ali recommends the Clinical and Laboratory Standards Institute Guideline EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition. Also, if you will pardon the self-reference, you may find this information in Fritsma GA, McGlasson DL. Quick Guide to Laboratory Statistics and Quality Control, AACC Press, 2012. I hope this is helpful.
Dr. Larry Brace, a Fritsma Factor technical advisor, sent this helpful June 2015 AACC Briefs definition of uncertainty calculations by Anders Kallner, MD, PhD.