CEN/TS 17688-2:2021

SLOVENSKI STANDARD
01-februar-2022
Molekularne diagnostične preiskave in vitro - Specifikacije za predpreiskovalne
procese pri aspiraciji s tanko iglo (FNA) - 2. del: Izolirani proteini
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes
for Fine Needle Aspirates (FNAs) - Part 2: Isolated proteins
Molekularanalytische in‐vitro‐diagnostische Verfahren - Spezifikationen für
präanalytische Prozesse für Feinnadelaspirate - Teil 2: Isolierte Proteine
Analyses moléculaires de diagnostic in vitro - Spécifications pour les processus
préanalytiques pour les ponctions à l’aiguille fine - Partie 2 : Protéines extradites
Ta slovenski standard je istoveten z: CEN/TS 17688-2:2021
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 17688-2
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 2: Isolated proteins
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 2 : Protéines Feinnadelaspirate - Teil 2: Isolierte Proteine
extradites
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 17688-2:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General considerations . 11
5 Outside the laboratory . 12
5.1 Specimen collection . 12
5.1.1 General . 12
5.1.2 Information about the specimen donor/patient . 12
5.1.3 Information about the specimen . 13
5.1.4 Selection of the primary FNA collection device . 13
5.1.5 FNA specimen collection and processing from the donor/patient . 13
5.2 Specimen storage and transport . 15
6 Inside the laboratory . 15
6.1 Specimen reception . 15
6.2 Specimen/sample storage after transport and reception . 15
6.2.1 General . 15
6.2.2 Storage of FNA specimen/samples using collection devices with stabilizer . 16
6.2.3 Storage of FNA specimen/samples using collection devices without stabilizers . 16
6.3 Specimen/sample processing for cytological examination prior to protein isolation . 16
6.3.1 General . 16
6.3.2 Handling of cell suspension . 17
6.3.3 Preparation of paraffin-embedded cell blocks. 18
6.3.4 Preparation of cell suspension slides . 19
6.4 Evaluation of the pathology of the specimen or sample(s) . 19
6.5 Processed sample storage, transport and reception . 20
6.5.1 General . 20
6.5.2 Storage and transport of cell suspension . 20
6.5.3 Storage and transport of paraffin-embedded cell blocks . 20
6.5.4 Storage and transport of cell suspension slides . 21
6.6 Isolation of protein . 21
6.6.1 General . 21
6.6.2 Using a commercial protein isolation kit intended for diagnostic use . 21
6.6.3 Using the laboratory’s own protein isolation procedure . 22
6.6.4 Isolation of proteins from specific sample types . 22
6.7 Quantity and quality assessment of isolated proteins. 23
6.8 Storage of isolated proteins . 23
Bibliography . 25

European foreword
This document (CEN/TS 17688-2:2021) 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 proteins 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) and otherwise
non-resectable tissues.
Besides cytological assessment, molecular biological analysis of FNAs is expected to become increasingly
used for cancer and other disease diagnostics, including companion diagnostics.
One of the challenges facing molecular analysis of FNA samples is their small size and diversity in
composition (cells, blood, body fluid). The low cellular content of FNAs means that the yield of isolated
proteins is typically towards the lower end of detection for molecular examination. Therefore, the protein
isolation procedure should provide a sufficient amount of protein as required by the specific examination.
Protein profiles, protein integrities, and protein–protein interactions in FNAs can change drastically
during and after collection (due to, e.g. gene induction, gene down regulation, protein degradation and
modification). Protein species amounts can change differently in different donors’/patients’ FNAs.
Therefore, standardization of the entire process from specimen collection to protein examination is
needed to minimize protein degradation and protein profile changes during and after FNA collection. This
document describes special measures which need to be taken to obtain good quality FNA
specimens/samples and isolated protein therefrom for molecular examination.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 15189, Me
...