Method
Evaluation
•Assumptions regarding laboratory testing:
•Ulaboratory
practitioner must demonstrate competency for procedure and instrumentation.
•Ureagents,
controls, and calibrating materials used to manufacturer=s protocol.
•Ucommercially
prepared materials are being used prior to the expiration period.
•Uthe method
shows analytic linearity throughout the reporting range.
•Method
evaluation should include:
•Utesting for Arandom error (RE)@
•Utesting for Asystematic error (SE)@