CLSI EP34:2018(R2023)
Current
Current
The latest, up-to-date edition.
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
€416.67
Excluding VAT
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 |
| 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 |
| CLSI EP05-A3:2014(R2019) | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition |
| 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 |
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