CLSI EP34
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
Establish, validate, or verify a dilution scheme that will provide an extended measuring interval for specimens with concentratons above the analytical measuring interval of an in vitro diagnostic measurement procedure. This ensures that you can accurately measure higher concentrations without the need for additional, more complex procedures.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of March 2023.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical 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.
This guideline provides procedures for establishing, validating, and verifying a dilution scheme to use for obtaining results for patient specimens with measurand concentrations or activity values above a measurement procedure’s upper limit of quantitation (ULoQ). This guideline is intended to be used for measurement procedures that have an established AMI within which linearity, precision, and bias have been deemed acceptable. Guidance is provided on determining the appropriate diluent and dilution ratio for these specimens. This guideline also covers creating spiked samples for dilution recovery studies and using spiking studies to determine the suitability of a specimen type for dilution recovery studies. This guideline covers the measurement procedure after it meets design inputs and the resultant AMI has been established. The intended users of this guideline are IVD measuring system manufacturers and medical laboratory scientists, directors, and pathologists.
This guideline does not cover the process of developing a measurement procedure or determining the AMI or interval in which incremental results linearly correspond to increments in a measurand. Thus, it does not cover instituting a set of autonomous dilution steps or reflex examinations as part of the measurement procedure to create accurate results within the AMI. However, it is possible to test the performance of a measuring system’s autonomous dilution steps using the protocols described in this guideline.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
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.
This guideline provides procedures for establishing, validating, and verifying a dilution scheme to use for obtaining results for patient specimens with measurand concentrations or activity values above a measurement procedure’s upper limit of quantitation (ULoQ). This guideline is intended to be used for measurement procedures that have an established AMI within which linearity, precision, and bias have been deemed acceptable. Guidance is provided on determining the appropriate diluent and dilution ratio for these specimens. This guideline also covers creating spiked samples for dilution recovery studies and using spiking studies to determine the suitability of a specimen type for dilution recovery studies. This guideline covers the measurement procedure after it meets design inputs and the resultant AMI has been established. The intended users of this guideline are IVD measuring system manufacturers and medical laboratory scientists, directors, and pathologists.
This guideline does not cover the process of developing a measurement procedure or determining the AMI or interval in which incremental results linearly correspond to increments in a measurand. Thus, it does not cover instituting a set of autonomous dilution steps or reflex examinations as part of the measurement procedure to create accurate results within the AMI. However, it is possible to test the performance of a measuring system’s autonomous dilution steps using the protocols described in this guideline.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.