{"id":375331,"date":"2024-10-20T02:43:06","date_gmt":"2024-10-20T02:43:06","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-cen-ts-176262021\/"},"modified":"2024-10-26T04:45:25","modified_gmt":"2024-10-26T04:45:25","slug":"bsi-pd-cen-ts-176262021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-cen-ts-176262021\/","title":{"rendered":"BSI PD CEN\/TS 17626:2021"},"content":{"rendered":"

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.<\/p>\n

This document is applicable to molecular in vitro<\/i> diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro<\/i> diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.<\/p>\n

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.<\/p>\n

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<\/span><\/span>, Molecular in vitro diagnostic examinations \u2014 Specifications for pre-examination processes for saliva \u2014 Isolated DNA<\/i>.<\/p>\n

\n
\n NOTE\n <\/div>\n

International, national or regional regulations or requirements can also apply to specific topics covered in this document.<\/p>\n<\/div>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
8<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 General considerations <\/td>\n<\/tr>\n
14<\/td>\n5 Outside the laboratory
5.1 Specimen collection
5.1.1 General <\/td>\n<\/tr>\n
15<\/td>\n5.1.2 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 <\/td>\n<\/tr>\n
16<\/td>\n5.1.3.2 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 <\/td>\n<\/tr>\n
17<\/td>\n5.1.4 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 <\/td>\n<\/tr>\n
18<\/td>\n5.1.4.3 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 <\/td>\n<\/tr>\n
19<\/td>\n5.1.5.2 Using collection devices with stabilizers <\/td>\n<\/tr>\n
20<\/td>\n5.1.5.3 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 <\/td>\n<\/tr>\n
21<\/td>\n5.2.2 Using collection devices with stabilizers
5.2.3 Using collection devices without stabilizers <\/td>\n<\/tr>\n
22<\/td>\n6 Inside the laboratory
6.1 Specimen reception
6.2 Processing of specimens <\/td>\n<\/tr>\n
23<\/td>\n6.3 Specimen storage before microbiome DNA isolation
6.4 Isolation of microbiome DNA
6.4.1 General <\/td>\n<\/tr>\n
24<\/td>\n6.4.2 Using a commercial kit <\/td>\n<\/tr>\n
25<\/td>\n6.4.3 Using a laboratory developed procedure
6.5 Quantity and quality assessment of isolated microbiome DNA
6.5.1 General <\/td>\n<\/tr>\n
26<\/td>\n6.5.2 Quantity assessment
6.5.3 Quality assessment
6.6 Storage of isolated microbiome DNA
6.6.1 General <\/td>\n<\/tr>\n
27<\/td>\n6.6.2 Microbiome DNA isolated using a commercial kit
6.6.3 Microbiome DNA isolated using a laboratory developed procedure <\/td>\n<\/tr>\n
28<\/td>\nAnnex A (informative)Impact of various pre-analytical variables on microbiome DNA quantity, quality and profile
A.1 Introduction
A.2 Result \u2013 Impact of specimen stabilization method on isolated microbiome DNA quantity
A.2.1 General
A.2.2 Method <\/td>\n<\/tr>\n
29<\/td>\nA.2.3 Result\/conclusion <\/td>\n<\/tr>\n
30<\/td>\nA.3 Result \u2013 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 <\/td>\n<\/tr>\n
31<\/td>\nA.4 Result \u2013 Impact of different microbiome DNA isolation methods on microbiome DNA profile
A.4.1 General
A.4.2 Method <\/td>\n<\/tr>\n
32<\/td>\nA.4.3 Result\/conclusion <\/td>\n<\/tr>\n
33<\/td>\nA.5 Results \u2013 Impact of stabilization status and storage of collected specimens\/samples on microbiome DNA profile
A.5.1 General
A.5.2 Method <\/td>\n<\/tr>\n
34<\/td>\nA.5.3 Result\/conclusion <\/td>\n<\/tr>\n
35<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
37<\/td>\nB.2.3 Result
B.3 Conclusions <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":375340,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[160,2641],"product_tag":[],"class_list":{"0":"post-375331","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/375331","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/375340"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=375331"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=375331"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=375331"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}