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BSI PD CEN/TS 17811:2022

BSI PD CEN/TS 17811:2022

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA

Published By Publication Date Number of Pages
BSI 2022 28
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This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 1 Scope
2 Normative references
3 Terms and definitions
12 4 General requirements
13 5 Outside the laboratory
5.1 Specimen collection
5.1.1 Information about the patient or specimen donor
14 5.1.2 Selection of the body fluid collection device by the laboratory
5.1.3 Body fluid specimen collection from the patient/donor and stabilization procedures
5.1.3.1 General
15 5.1.3.2 Body fluid collection with cfDNA stabilizers
5.1.3.3 Body fluid collection without addition of cfDNA stabilizers
16 5.1.4 Information about the specimen storage requirements at the body fluid collection facility/site
5.1.4.1 General
5.1.4.2 Storage of body fluid collected with cfDNA stabilizers
5.1.4.3 Storage of body fluid collected without cfDNA stabilizers
17 5.2 Transport requirements
5.2.1 General
5.2.2 Transport using body fluid collection devices with cfDNA stabilizers
5.2.3 Transport using body fluid collection devices without cfDNA stabilizers
18 6 Inside the laboratory
6.1 General
6.2 Specimen reception
6.3 Specimen storage after transport and reception
6.4 Body fluid specimen/sample processing prior to cfDNA isolation
19 6.5 Storage requirements for body fluid samples after processing
6.6 Isolation of body fluid cfDNA
6.6.1 General
20 6.6.2 Using commercial kit
6.6.3 Using a laboratory developed isolation procedure
21 6.7 Quantity and quality assessment of isolated cfDNA
6.7.1 General
6.7.2 Quantity assessment of cfDNA
6.7.3 Quality assessment of cfDNA
22 6.8 Storage of isolated body fluid cfDNA
6.8.1 General
6.8.2 Storage of isolated body fluid cfDNA, isolated with a commercially available kit
23 6.8.3 Storage of isolated body fluid cfDNA, isolated with the laboratory’s own procedure

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BSI PD CEN/TS 17811:2022
$142.49