BSI PD CEN/TS 17688-1:2021

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

Published By	Publication Date	Number of Pages
BSI	2021	42

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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 RNA 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 and molecular pathology laboratories that examine RNA 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 20184-1, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue – Part 1: Isolated RNA. This document is not applicable for RNA examination by in situ detection. 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
8	1 Scope 2 Normative references 3 Terms and definitions
14	4 General considerations
15	5 Outside the laboratory 5.1 Specimen collection 5.1.1 General 5.1.2 Information about the patient/specimen donor
16	5.1.3 Information about the specimen 5.1.4 Selection of the primary FNA collection device 5.1.5 FNA specimen collection and stabilization from the donor/patient 5.1.5.1 General
17	5.1.5.2 FNA specimen/sample collection with stabilizers 5.1.5.3 FNA specimen/sample collection without stabilizers
18	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
19	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 RNA isolation 6.3.1 General
20	6.3.2 Handling of cell suspension
21	6.3.3 Preparation of paraffin-embedded cell blocks
22	6.3.4 Preparation of cell suspension slides 6.4 Evaluation of the pathology of the specimen or sample(s)
23	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
24	6.5.4 Storage and transport of cell suspension slides 6.6 Isolation of RNA 6.6.1 General 6.6.2 Using a commercial RNA isolation kit intended for diagnostic use
25	6.6.3 Using a laboratory developed RNA isolation procedure 6.6.4 Further specifications 6.6.4.1 Isolation of RNA from cell suspension 6.6.4.2 Isolation of RNA from paraffin-embedded cell blocks
26	6.6.4.3 Isolation of RNA from slides 6.7 Quantity and quality assessment of isolated RNA 6.7.1 General
27	6.7.2 Quantity assessment 6.7.3 Quality assessment 6.8 Storage of isolated RNA 6.8.1 General
28	6.8.2 RNA isolated using commercially available kits 6.8.3 RNA isolated using a laboratory developed procedure
29	Annex A (informative)Impact of pre-analytical variables on FNA sample quality, RNA quantity and quality A.1 Introduction A.2 Method – FNA model sample
30	A.3 Result – Impact of specimen stabilization method on FNA cell quality A.3.1 General A.3.2 Method
32	A.3.3 Result/conclusion
33	A.4 Result – Impact of FNA sample stabilization on isolated RNA quality A.4.1 General A.4.2 Method A.4.3 Result/conclusion, part 1
35	A.4.4 Result/conclusion, part 2
36	A.4.5 Result/conclusion, part 3
38	A.5 Conclusions