Teknisk specifikation SIS-CEN/TS :2020

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Språk: engelska/English Utgåva: 1

Teknisk specifikation

SIS-CEN/TS 17390-1:2020

Molekylärbiologisk diagnostik – Specifikationer för pre-

analytiska processer för cirkulerande tumörceller (CTC) i venöst helblod –

Del 1: Isolerat RNA

Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood –

Part 1: Isolated RNA

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Fastställd: 2020-02-07 ICS: 11.100.10

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Denna tekniska specifikation är inte en svensk standard. Detta dokument innehåller den engelska språkversionen av CEN/TS 17390-1:2020, utgåva 1.

This Technical Specification is not a Swedish Standard. This document contains the English language version of CEN/TS 17390-1:2020, edition 1.

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TECHNICAL SPECIFICATION SPÉCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION

CEN/TS 17390-1

January 2020

ICS 11.100.10

English Version

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells

(CTCs) in venous whole blood - Part 1: Isolated RNA

Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTCs) dans le

sang total veineux - Partie 1 : ARN extrait

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für

zirkulierende Tumorzellen (CTC) in venösen Vollblutproben - Teil 1: Isolierte RNA

This Technical Specification (CEN/TS) was approved by CEN on 27 October 2019 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 C O M I T É E UR O P É E N DE N O R M A L I SA T I O N E UR O P Ä I SC H E S KO M I T E E F ÜR N O R M UN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

worldwide for CEN national Members. Ref. No. CEN/TS 17390-1:2020 E

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European foreword

This document (CEN/TS 17390-1:2020) 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.

CEN/TS 17390 consists of the following parts, under the general title Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Circulating Tumor Cells (CTCs) in venous whole blood:

— Part 1: Isolated RNA

— Part 2: Isolated DNA

— Part 3: Preparations for analytical CTC staining

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.

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Introduction

Solid tumours release cells and bioanalytes into blood and other body fluids. This has opened the option of minimally-invasive tumour detection, diagnosis and characterization from venous whole blood (liquid biopsies). Liquid biopsies are expected to enable earlier detection and diagnosis of cancers and advance personalized patient treatment. These applications have become one of the fastest growing segments of the entire diagnostic market.

Circulating tumour cells (CTCs) in venous whole blood reflect the disease complexity that evolves during tumour progression, with distinct genetic, epigenetic and expression features. Besides the prognostic role of CTC identification and/or enumeration in cancer progression, CTC molecular characterization can improve e.g. disease outcome prediction, therapeutic guidance and post-treatment monitoring of the patient.

CTCs are now considered as a surrogate of tumour tissue in cancer early development, progression and metastatic phase.

Molecular characterization of CTCs can provide for example a strategy for monitoring cancer genotypes during systemic therapies [1], identification of mechanisms of disease progression, identification of novel targets for treatment [2] and to select targeted therapies. Moreover, CTC single-cell sequencing is emerging as an important tool for tumour genomic heterogeneity analysis [3] [4] [5].

CTCs are fragile and tend to degrade within a few hours when collected in conventional blood collection tubes, e.g. EDTA containing tubes, without dedicated CTC stabilizers. CTCs are extremely rare, especially in early disease, e.g. less than 10 cells per 10 ml of blood, representing a ratio of approx. 1:10⁷ CTCs to white blood cells (WBCs). This low ratio represents a significant challenge to CTC enrichment required for examination.

RNA profiles of CTCs resemble gene expression profiles of tumours. For RNA profile analysis, measures need to be taken to get rid of the WBCs in order to obtain sufficiently enriched CTC-specific RNA.

RNA profiles can change significantly after blood collection, during CTC enrichment and isolation.

Therefore, special measures need to be taken to obtain good quality CTC samples and good quality isolated RNA for gene expression analysis [4] [6].

Consequently, standardization of all steps of the pre-examination process is required. This includes blood collection and stabilization, transport, storage, CTC enrichment, CTC isolation (if required), and RNA isolation. A decision guideline for the critical steps of the CTC pre-analytical workflow for RNA isolation is provided in Annex A.

This document describes special measures that need to be taken to obtain appropriate quality and quantity of RNA from CTC containing blood specimens for subsequent 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.

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1 Scope

This document gives guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for the examination of RNA isolated from circulating tumour cells (CTCs) 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. 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.

This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood – Part 1: Isolated cellular RNA.

This document does not cover the isolation of specific white blood cells and subsequent isolation of cellular RNA therefrom.

This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing.

NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. fetal cells).

NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 15189:2012, Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

ISO 15190, Medical laboratories — Requirements for safety

3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 15189 and the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/

• ISO Online browsing platform: available at https://www.iso.org/obp 3.1 aliquot

portion of a larger amount of homogenous material, assumed to be taken with negligible sampling error Note 1 to entry: The term is usually applied to fluids. Tissues are heterogeneous and therefore cannot be aliquoted.

Note 2 to entry: The definition is derived from References [7], [8] and [9].

[SOURCE: EN ISO 20166-3:2019, 3.1]

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3.2 ambient temperature

unregulated temperature of the surrounding air [SOURCE: EN ISO 20166-3:2019, 3.2]

3.3 analyte

component represented in the name of a measurable quantity

[SOURCE: EN ISO 17511:2003, 3.2, modified — EXAMPLE has been removed.]

3.4 analytical test performance

accuracy, precision, specificity and sensitivity of a test to measure the analyte of interest

Note 1 to entry: Other test performance characteristics such as robustness, repeatability can apply as well.

[SOURCE: EN ISO 20184-1:2018, 3.4]

3.5 blood collection set

intravenous device specialized for venipuncture consisting of a stainless steel bevelled needle and tube (tubing) with attached plastic wings and fitting connector

Note 1 to entry: The connector attaches to an additional blood collection device, e.g. a blood collection tube.

3.6 blood collection tube

tube used for blood collection, usually in a vacuum which forces blood from the vein through the needle and into the tube

3.7 backflow

flow of a liquid opposite to the usual or desired direction 3.8 circulating tumor cells

CTCs

cells present in blood, originating from a primary and/or metastatic site of a tumor 3.9 CTC enrichment

any method that is able to increase the ratio of CTCs to other cells 3.10

CTC isolation

any method resulting in a sample containing CTCs without any other cell types SIS-CEN/TS 17390-1:2020 (E)

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diagnosis

identification of a disease from its signs and symptoms, where the diagnostic process can involve examinations and tests for classification of an individual's condition into separate and distinct categories or subclasses that allow medical decisions about treatment and prognosis to be made

[SOURCE: EN ISO 20184-1:2018, 3.6]

3.12 DNase

deoxyribonuclease

enzyme that catalyzes the degradation of DNA into smaller components [SOURCE: EN ISO 20186-1:2019, 3.11]

3.13

examination analytical test

set of operations having the object of determining the value or characteristics of a property

Note 1 to entry: Processes that start with the isolated analyte and include all kinds of parameter testing or chemical manipulation for quantitative or qualitative examination.

[SOURCE: EN ISO 15189:2012, 3.7, modified — Notes to entry 1 to 3 have been removed, Note 1 to entry has been added and “analytical test” has been added as a preferred term.]

3.14

examination performance analytical test performance analytical performance

ability of an examination procedure to measure or detect a particular analyte

Note 1 to entry: Analytical performance is determined from analytical performance studies used to assess the ability of an in vitro diagnostic examination procedure to measure or detect a particular analyte.

Note 2 to entry: Analytical performance includes such characteristics as analytical sensitivity, detection limit, analytical specificity (interference and cross-reactivity), trueness, precision and linearity.

[SOURCE: ISO/TS 17822-1:2014, 3.2, modified — “analytical test performance” and “analytical performance” have been added as preferred terms.]

3.15

examination manufacturer analytical test manufacturer

group or company that provides the specific analytical test 3.16

needle holder

barrel used in routine venipuncture procedures to hold the blood collection tube in place and to protect the phlebotomist from direct contact with blood

[SOURCE: EN ISO 20186-1:2019, 3.18]

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Teknisk specifikation SIS-CEN/TS :2020