CLSI EP34

Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st Edition

Establish, validate, or verify a dilution scheme that will provide an extended measuring interval for specimens with concentrations above the analytical measuring interval of an in vitro diagnostic measurement procedure.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of March 2023. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Jeffrey R. Budd, PhD

Date of Publication: August 13, 2018

Order Code PDF: CLSI EP34Ed1E
ISBN Number: 978-1-68440-015-7

Order Code Print: CLSI EP34Ed1
ISBN Number: 978-1-68440-014-0

Edition: First

Pages: 94

CLSI EP34 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI EP34 Abstract

Clinical and Laboratory Standards Institute guideline EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking 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.