ISO/TC 69/SC 6

Project No.ISO/TS 27878:2023
Title<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document provides statistical techniques for the determination of the reproducibility of the level of detection for</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">a)<span style="mso-tab-count: 1;">    </span>binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">b)<span style="mso-tab-count: 1;">    </span>binary (qualitative) test methods for discrete measurands, e.g. the number of RNA copies in a sample.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">The reproducibility precision is determined according to </span><span class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;"> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5725</span></span></span> (</span><span class="stddocPartNumber"><span lang="EN-GB" style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">all parts</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">).</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">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 </span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">LOD</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;"> reproducibility precision, but also for the standard error of the estimates.</span></p>
Registration number (WIID)71614
Scope<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">This document provides statistical techniques for the determination of the reproducibility of the level of detection for</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">a)<span style="mso-tab-count: 1;">    </span>binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">b)<span style="mso-tab-count: 1;">    </span>binary (qualitative) test methods for discrete measurands, e.g. the number of RNA copies in a sample.</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">The reproducibility precision is determined according to </span><span class="stdpublisher"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;"> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5725</span></span></span> (</span><span class="stddocPartNumber"><span lang="EN-GB" style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">all parts</span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">).</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;">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 </span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">LOD</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho'; mso-fareast-theme-font: minor-fareast;"> reproducibility precision, but also for the standard error of the estimates.</span></p>
StatusStandarts spēkā
ICS group17.020
03.120.30