Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2023

Publisher

Clinical Laboratory Standards Institute

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).

DocumentType	Standard
ISBN	978-1-68440-014-0
Pages	94
PublisherName	Clinical Laboratory Standards Institute
Status	Current
Supersedes	CLSI EP34:2018

ISO 5725-1:2023	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 15193:2009	In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
CLSI EP17 A2 : 2ED 2012	EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
ISO 18153:2003	In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 17511:2020	In vitro diagnostic medical devices Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
ISO 15195:2018	Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures
ISO 18113-1:2022	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements