It is often medically necessary to provide results for specimens with concentrations above the analytical measuring interval of an in vitro diagnostic measurement procedure. This guideline helps manufacturers and laboratory scientists with establishing, validating, or verifying a dilution scheme that will provide an extended measuring interval for such specimens.
CLSI EP34 (R2023)
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Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st Edition, EP34Ed1E
Clinical and Laboratory Standards Institute , 08/13/2018