This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.

This document is applicable to molecular in vitro diagnostic examinations 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.

Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.

Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.

NOTE

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

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PDF Pages	PDF Title
2	undefined
8	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
15	5.1.2 Information about the patient/specimen donor 5.1.3 Specific information about the patient/specimen donor 5.1.3.1 Specific information about the patient/specimen donor for specimens from gastro-intestinal tract
16	5.1.3.2 Specific information about the patient/specimen donor for specimens from skin 5.1.3.3 Specific information about the patient/specimen donor for specimens from oral cavity, nasopharyngeal region and respiratory tract 5.1.3.4 Specific information about the patient/specimen donor for specimens from uro-genital tract
17	5.1.4 Selection of specimen collection method and device(s) 5.1.4.1 General 5.1.4.2 Selection of collection method and devices for specimens from gastro-intestinal tract
18	5.1.4.3 Selection of collection method and devices for specimens from skin 5.1.4.4 Selection of collection method and devices for specimens from oral cavity, nasopharyngeal region and respiratory tract 5.1.4.5 Selection of collection method and devices for specimens from uro-genital tract 5.1.5 Specimen collection from the patient/specimen donor and specimen stabilization 5.1.5.1 General
19	5.1.5.2 Using collection devices with stabilizers
20	5.1.5.3 Using collection devices without stabilizers 5.1.5.4 Specimen self-collection by the patient/specimen donor 5.2 Specimen storage and transport 5.2.1 General
21	5.2.2 Using collection devices with stabilizers 5.2.3 Using collection devices without stabilizers
22	6 Inside the laboratory 6.1 Specimen reception 6.2 Processing of specimens
23	6.3 Specimen storage before microbiome DNA isolation 6.4 Isolation of microbiome DNA 6.4.1 General
24	6.4.2 Using a commercial kit
25	6.4.3 Using a laboratory developed procedure 6.5 Quantity and quality assessment of isolated microbiome DNA 6.5.1 General
26	6.5.2 Quantity assessment 6.5.3 Quality assessment 6.6 Storage of isolated microbiome DNA 6.6.1 General
27	6.6.2 Microbiome DNA isolated using a commercial kit 6.6.3 Microbiome DNA isolated using a laboratory developed procedure
28	Annex A (informative)Impact of various pre-analytical variables on microbiome DNA quantity, quality and profile A.1 Introduction A.2 Result – Impact of specimen stabilization method on isolated microbiome DNA quantity A.2.1 General A.2.2 Method
29	A.2.3 Result/conclusion
30	A.3 Result – Impact of specimen to stabilizer mass/volume ratio on isolated microbiome DNA quantity and quality A.3.1 General A.3.2 Method A.3.3 Result/conclusion
31	A.4 Result – Impact of different microbiome DNA isolation methods on microbiome DNA profile A.4.1 General A.4.2 Method
32	A.4.3 Result/conclusion
33	A.5 Results – Impact of stabilization status and storage of collected specimens/samples on microbiome DNA profile A.5.1 General A.5.2 Method
34	A.5.3 Result/conclusion
35	Annex B (informative)Importance of using an in-process quality control material B.1 Introduction B.2 Results B.2.1 General B.2.2 Method
37	B.2.3 Result B.3 Conclusions

Published By	Publication Date	Number of Pages
BSI	2021	42


PDF Format	Searchable	Printable	Preview Now

Status	Definitive
Pages	42
Publication Date	2021-05-10
ISBN	978 0 539 06269 4
Standard Number	PD CEN/TS 17626:2021
Title	Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
Identical National Standard Of	CEN/TS 17626:2021
Descriptors	DNA, Humans, Microorganisms, Laboratories, Specimens (testing)
Publisher	BSI
Committee	CH/212
ICS Codes	11.100.01 - Laboratory medicine in general

BSI PD CEN/TS 17626:2021

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