DIN CEN/TS 17811:2022-08
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA; German version CEN/TS 17811:2022 / Note: To be replaced by DIN EN ISO 18704 (2024-12).
| Fecha edición: |
2022-08-01
En Vigor
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| Idiomas disponibles: | Alemán |
| Resumen: | This document gives guidelines on the handling, storage, processing and documentation of body fluid specimens intended for human cell-free DNA (cfDNA) examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination 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 organisations performing biomedical research, and regulatory authorities.This document does not cover the pre-examination processes for examination of DNA in body fluid derived nucleated cells and for examination of microbial derived DNA. Different dedicated measures are taken for preserving circulating cell-free DNA (ccfDNA) from blood. These are not described in this document, but are covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document. |
| Keywords: | Analysis|Analysis methods|Body fluids|Definitions|Deoxyribonucleic acid|Diagnosis|DNA|In vitro|In-vitro diagnostic|Laboratories|Laboratory method|Medical sciences|Molecular biological methods|Urine |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica CEN/TS 17811:2022 |
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