Wayne, Pennsylvania, USA—The Clinical and Laboratory Standards Institute announces the publication of EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st ed. EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure’s upper limit of quantitation.
Guidance is provided on determining, validating, and verifying the appropriate diluent and dilution ratio to be used for such specimens. This guideline also covers creating spiked samples for use during dilution recovery studies and using spiking to determine the suitability of a sample matrix for dilution recovery studies. The intended users of this guideline are manufacturers of in vitro diagnostic tests and medical laboratory scientists, directors, and pathologists.
Jeffrey R. Budd, PhD, Chairholder of EP34 said, "It is often a medical necessity for laboratories to accommodate patients whose assay results are higher than the typical (analytical) measuring interval of that assay. EP34 describes methods for creating an extended measuring interval within which such results can be accurately measured. These reproducible methods for diluting and spiking patient specimens are used to establish, validate and verify this newly extended measuring interval."
Guidance is provided on:
For more information about EP34, visit https://clsi.org/standards/products/method-evaluation/documents/ep34/ or contact Patrick McGinn at firstname.lastname@example.org or +1.484.588.5933.
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