Reference number
ISO/TS 27878:2023
Technical Specification
ISO/TS 27878:2023
Reproducibility of the level of detection (LOD) of binary methods in collaborative and in-house validation studies
Edition 1
2023-01
Technical Specification
Read sample
ISO/TS 27878:2023
71614
Published (Edition 1, 2023)
This publication was last reviewed and confirmed in 2026. Therefore this version remains current.

ISO/TS 27878:2023

ISO/TS 27878:2023
71614
Language
Format
CHF 100

Abstract

This document provides statistical techniques for the determination of the reproducibility of the level of detection for

a)    binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and

b)    binary (qualitative) test methods for discrete measurands, e.g. the number of RNA copies in a sample.

The reproducibility precision is determined according to ISO 5725 (all parts).

Precision estimates are subject to random variability. Accordingly, it is important to determine the uncertainty associated with each estimate, and to understand the relationship between this uncertainty, the number of participants and the experimental design. This document thus provides not only a description of statistical tools for the calculation of the LOD reproducibility precision, but also for the standard error of the estimates.

General information

  •  : Published
     : 2023-01
    : International Standard confirmed [90.93]
  •  : 1
     : 16
  • ISO/TC 69/SC 6
    17.020  03.120.30 
  • RSS updates

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