BSI PD CEN/TS 17688-2:2021

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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) – Isolated proteins

Published By	Publication Date	Number of Pages
BSI	2021	30

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Categories: 11.100.10 - In vitro diagnostic test systems, BSI

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This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for protein examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine proteins isolated from FNAs. 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. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-2, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 2: Isolated proteins and EN ISO 20166-2, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue – Part 2: Isolated proteins. This document is not applicable for protein examination by immunohistochemistry. 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
13	4 General considerations
14	5 Outside the laboratory 5.1 Specimen collection 5.1.1 General 5.1.2 Information about the specimen donor/patient
15	5.1.3 Information about the specimen 5.1.4 Selection of the primary FNA collection device 5.1.5 FNA specimen collection and processing from the donor/patient 5.1.5.1 General
16	5.1.5.2 FNA specimen/sample collection with stabilizers 5.1.5.3 FNA specimen/sample collection without stabilizers
17	5.2 Specimen storage and transport 6 Inside the laboratory 6.1 Specimen reception 6.2 Specimen/sample storage after transport and reception 6.2.1 General
18	6.2.2 Storage of FNA specimen/samples using collection devices with stabilizer 6.2.3 Storage of FNA specimen/samples using collection devices without stabilizers 6.3 Specimen/sample processing for cytological examination prior to protein isolation 6.3.1 General
19	6.3.2 Handling of cell suspension
20	6.3.3 Preparation of paraffin-embedded cell blocks
21	6.3.4 Preparation of cell suspension slides 6.4 Evaluation of the pathology of the specimen or sample(s)
22	6.5 Processed sample storage, transport and reception 6.5.1 General 6.5.2 Storage and transport of cell suspension 6.5.3 Storage and transport of paraffin-embedded cell blocks
23	6.5.4 Storage and transport of cell suspension slides 6.6 Isolation of protein 6.6.1 General 6.6.2 Using a commercial protein isolation kit intended for diagnostic use
24	6.6.3 Using the laboratory’s own protein isolation procedure 6.6.4 Isolation of proteins from specific sample types 6.6.4.1 Isolation of protein from cell suspension 6.6.4.2 Isolation of protein from paraffin-embedded cell blocks
25	6.6.4.3 Isolation of protein from slides 6.7 Quantity and quality assessment of isolated proteins 6.8 Storage of isolated proteins