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BSI PD CEN/TS 17742:2022

BSI PD CEN/TS 17742:2022

$142.49

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma

Published By Publication Date Number of Pages
BSI 2022 28
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This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations 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. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood – Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for venous whole blood – Part 1: Isolated cellular RNA. 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 considerations
13 5 Outside the laboratory
5.1 Specimen collection
5.1.1 General
5.1.2 Information about the patient/specimen donor
14 5.1.3 Selection of the venous whole blood collection tube by the laboratory
5.1.4 Venous whole blood specimen collection from the patient/donor
15 5.2 Specimen storage and transport
5.2.1 General
5.2.2 Storage and transport using blood collection tubes with stabilizers
16 5.2.3 Storage and transport using blood collection tubes without stabilizers
6 Inside the laboratory
6.1 Specimen reception
6.2 Storage requirements for blood specimens
17 6.3 Plasma preparation
6.4 Storage requirements for plasma samples
18 6.5 Isolation of ccfRNA
6.5.1 General
6.5.2 Using a commercial ccfRNA isolation kit intended for diagnostic use
19 6.5.3 Using a laboratory developed ccfRNA isolation procedure
6.6 Quantity and quality assessment of isolated ccfRNA
6.6.1 General
20 6.6.2 Quantity assessment
6.6.3 Quality assessment
6.7 Storage of isolated ccfRNA
22 Annex A (informative)Impact of pre-examination process steps on circulating cell free RNA profiles in venous whole blood plasma
A.1 Influence of blood storage on targeted ccfRNA levels, isolated from blood plasma, collected into tubes with and without ccfRNA profile stabilizer

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BSI PD CEN/TS 17742:2022
$142.49