PD ISO/TS 16393:2019 Molecular biomarker analysis. Determination of the performance characteristics of qualitative measurement methods and validation of methods

PD ISO/TS 16393:2019

Molecular biomarker analysis. Determination of the performance characteristics of qualitative measurement methods and validation of methods

Status : Current   Published : March 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies methods that yield a binary result and are used for the determination in food or food products (including seeds of food crops) of the presence of molecular biomarkers. These methods are typically used where the measurand is expected to be present in very small amounts and concentrations at the limit of detection (LOD).

Methods are validated in terms of the probability of detection (POD) and of the precision of the POD. They do not rely on the concept of false positive/false-negative results, or the concept of LOD. However, inferences about the precision of the classical LOD can be made.

This document describes the extent of method validation. The annexes provide different statistical models that can be considered depending on the analytical method, structure of data and statistical experience.

This document does not apply to quantitative methods that are used to make a detection decision by comparing the value of a response to a cut-off value using a quantitative method, where the methods are validated by using quantitative statistics on the responses. This document also does not apply to microbiological test methods, starch, essential oils or quantitative methods.




Standard NumberPD ISO/TS 16393:2019
TitleMolecular biomarker analysis. Determination of the performance characteristics of qualitative measurement methods and validation of methods
StatusCurrent
Publication Date05 March 2019
Normative References(Required to achieve compliance to this standard)ISO 5725-1:1994, ISO 5725-2:2019, BS ISO 5725-2:2019
Informative References(Provided for Information)ISO 5725 (all parts), ISO 3534-2
International RelationshipsISO/TS 16393:2019
DescriptorsFood, Measurement, Performance characteristics, Performance, Analysis
ICS67.050
Title in FrenchAnalyse de biomarqueurs moléculaires. Détermination des caractéristiques de performance des méthodes de mesure qualitatives et validation des méthodes
CommitteeAW/275
ISBN978 0 580 88197 8
PublisherBSI
FormatA4
DeliveryYes
Pages38
File Size3.319 MB
Price£214.00


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