CEN/TS 17688-1:2021
(Main)Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
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.
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre RNA
Dieses Dokument gibt Leitlinien für die Handhabung, Dokumentation, Lagerung und Verarbeitung von Feinnadelaspiraten (FNAs) zur RNA Untersuchung während der präanalytischen Phase vor Beginn der molekularen Analyse.
Dieses Dokument ist anzuwenden für molekulare in vitro-diagnostische Untersuchungen, wozu auch laboreigene Prüfungen zählen, die von medizinischen Laboratorien und Laboratorien der molekularen Pathologie zur Untersuchung der aus FNAs isolierten RNA durchgeführt werden. Es soll auch von Laborkunden, Entwicklern und Herstellern von In vitro-Diagnostika, Biobanken, Einrichtungen und kommerziellen Organisationen, die in der biomedizinischen Forschung tätig sind, sowie Aufsichtsbehörden angewendet werden.
Für die Entnahme, die Stabilisierung, den Transport und die Lagerung von Stanzbiopsien (FNA Biopsie oder FNA B) werden verschiedene spezielle Maßnahmen ergriffen, die nicht in diesem Dokument, sondern in EN ISO 20184 1, Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für gefrorene Gewebeproben — Teil 1: Isolierte RNA und EN ISO 20166 1, Molekularanalytische in vitro-diagnostische Verfahren — Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)-Gewebeproben — Teil 1: Isolierte RNA behandelt werden.
Dieses Dokument ist nicht anzuwenden für RNA Untersuchungen durch In situ-Detektion.
ANMERKUNG Zu bestimmten Bereichen, die in diesem Dokument behandelt werden, können auch internationale, nationale oder regionale Bestimmungen oder Anforderungen gelten.
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus préanalytiques pour les ponctions à l’aiguille fine - Partie 1 : ARN cellulaire extrait
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne procese pri aspiraciji s tanko iglo (FNA) - 1. del: Izolirana celična RNK
Ta dokument podaja smernice za obravnavo, dokumentiranje, shranjevanje in obdelavo aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo (FNA), namenjenih za pregled RNK med predpreiskovalno fazo, preden se izvede molekularna preiskava.
Ta dokument se uporablja za molekularne diagnostične preiskave in vitro, vključno z laboratorijsko razvitimi preskusi, ki jih izvajajo v medicinskih laboratorijih in laboratorijih za molekularno patologijo, kjer preiskujejo RNK, izolirano iz aspiratov, pridobljenih z aspiracijsko biopsijo s tanko iglo. Namenjen je tudi temu, da ga uporabljajo laboratorijske stranke, razvijalci in proizvajalci diagnostike in vitro, biobanke, institucije in komercialne organizacije, ki izvajajo biomedicinske raziskave, ter regulativni organi.
Za zbiranje, stabiliziranje, prevoz in shrambo aspiratov, pridobljenih z aspiracijsko biopsijo z debelo iglo (FNA B) se uporabljajo drugačni namenski ukrepi, ki niso zajeti v tem dokumentu, temveč v standardih ISO 20184-1, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za zamrznjena tkiva – 1. del: Izolirani RNK in ISO 20166-1, Molekularne diagnostične preiskave in vitro – Specifikacije za predpreiskovalne procese za tkiva, ki so fiksirana v formalinu ter položena v parafin – 1. del: Izolirani RNK.
RNK v patogenih v aspiratu ni zajeta v tem dokumentu.
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, lahko veljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pri aspiraciji s tanko iglo (FNA) - 1. del: Izolirana celična RNK
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre RNA
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus
préanalytiques pour les ponctions à l’aiguille fine - Partie 1 : ARN cellulaire extrait
Ta slovenski standard je istoveten z: CEN/TS 17688-1:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TS 17688-1
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
December 2021
TECHNISCHE SPEZIFIKATION
ICS 11.100.10
English Version
Molecular in vitro diagnostic examinations - Specifications
for pre-examination processes for Fine Needle Aspirates
(FNAs) - Part 1: Isolated cellular RNA
Analyses moléculaires de diagnostic in vitro - Molekularanalytische in-vitro-diagnostische Verfahren
Spécifications pour les processus préanalytiques pour - Spezifikationen für präanalytische Prozesse für
les ponctions à l'aiguille fine - Partie 1 : ARN cellulaire Feinnadelaspiration (FNA) - Teil 1: Isolierte zelluläre
extrait RNA
This Technical Specification (CEN/TS) was approved by CEN on 15 November 2021 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17688-1:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General considerations . 12
5 Outside the laboratory . 13
5.1 Specimen collection . 13
5.1.1 General . 13
5.1.2 Information about the patient/specimen donor . 13
5.1.3 Information about the specimen . 14
5.1.4 Selection of the primary FNA collection device . 14
5.1.5 FNA specimen collection and stabilization from the donor/patient . 14
5.2 Specimen storage and transport . 16
6 Inside the laboratory . 16
6.1 Specimen reception . 16
6.2 Specimen/sample storage after transport and reception . 16
6.2.1 General . 16
6.2.2 Storage of FNA specimen/samples using collection devices with stabilizer . 17
6.2.3 Storage of FNA specimen/samples using collection devices without stabilizers . 17
6.3 Specimen/sample processing for cytological examination prior to RNA isolation . 17
6.3.1 General . 17
6.3.2 Handling of cell suspension . 18
6.3.3 Preparation of paraffin-embedded cell blocks. 19
6.3.4 Preparation of cell suspension slides . 20
6.4 Evaluation of the pathology of the specimen or sample(s) . 20
6.5 Processed sample storage, transport and reception . 21
6.5.1 General . 21
6.5.2 Storage and transport of cell suspension . 21
6.5.3 Storage and transport of paraffin-embedded cell blocks . 21
6.5.4 Storage and transport of cell suspension slides . 22
6.6 Isolation of RNA . 22
6.6.1 General . 22
6.6.2 Using a commercial RNA isolation kit intended for diagnostic use . 22
6.6.3 Using a laboratory developed RNA isolation procedure. 23
6.6.4 Further specifications . 23
6.7 Quantity and quality assessment of isolated RNA . 24
6.7.1 General . 24
6.7.2 Quantity assessment . 25
6.7.3 Quality assessment . 25
6.8 Storage of isolated RNA . 25
6.8.1 General . 25
6.8.2 RNA isolated using commercially available kits . 26
6.8.3 RNA isolated using a laboratory developed procedure . 26
Annex A (informative) Impact of pre-analytical variables on FNA sample quality, RNA
quantity and quality . 27
A.1 Introduction. 27
A.2 Method – FNA model sample . 27
A.3 Result - Impact of specimen stabilization method on FNA cell quality . 28
A.3.1 General . 28
A.3.2 Method . 28
A.3.3 Result/conclusion. 30
A.4 Result – Impact of FNA sample stabilization on isolated RNA quality . 31
A.4.1 General . 31
A.4.2 Method . 31
A.4.3 Result/conclusion, part 1 . 31
A.4.4 Result/conclusion, part 2 . 33
A.4.5 Result/conclusion, part 3 . 34
A.5 Conclusions . 36
Bibliography . 37
European foreword
This document (CEN/TS 17688-1:2021) has been prepared by Technical Committee CEN/TC 140 “In
vitro diagnostic medical devices”, the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is expected
by new technologies analysing profiles of nucleic acids, proteins, and metabolites in human tissues and
body fluids. However, the profiles of these molecules can change drastically during the pre-examination
process, including the specimen collection, transport, storage and processing.
Examination of RNA is commonly used in clinical practice. This includes e.g. prognostic and predictive
biomarker examinations. This is a fast growing field in molecular diagnostics.
Fine needle aspiration is a non-surgical procedure that uses a thin, hollow-bore needle and syringe to
collect a specimen from patients for cytopathological and molecular investigation. As a minimally-
invasive technique, fine needle aspirates (FNAs) are commonly used to diagnose and monitor for example
a range of cancer types, e.g. breast, lung and thyroid cancer, and other diseases, such as inflammatory
diseases. FNAs also provide the opportunity to sample metastatic sites (e.g. lymph nodes) an
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