<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination is performed.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers, and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p>
Registration number (WIID)
82829
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination is performed.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers, and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research, and regulatory authorities.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2.</span></p>
<p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;"> </span>The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells).</span></p>
<p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;"> </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p>
