Standard No.:	GB/T 43279.2-2023
English Name:	Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA
Chinese Name:	分子体外诊断检验 静脉全血检验前过程的规范 第2部分：分离基因组DNA
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Issued by:	SAMR; SAC
Issued on:	2023-11-27
Implemented on:	2024-6-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	255.0
Delivery:	via email in 1~3 business day

GB/T 43279.2-2023 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA 1 Scope This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination 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 stabilizing blood cell free circulating DNA, which are not described in this document. Note: Circulating cell free DNA in blood is covered in GB/T 43279.3-2023. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. DNA in pathogens present in blood is not covered by 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. GB/T 22576.1-2018, Medical laboratories - Requirements for quality and competence - Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ——ISO Online browsing platform: available at https://www.iso.org/obp ——IEC Electropedia: available at http://www.electropedia.org/ 3.1 analyte component represented in the name of a measurable quantity [SOURCE: GB/T 21415-2008, 3.2, modified.] 3.2 backflow flow of a liquid opposite to the usual or desired direction 3.3 blood collection set intravenous device specialized for venepuncture consisting of a stainless steel bevelled needle and tube (tubing) with attached plastic wings and fitting connector Note: The connector attaches to an additional blood collection device, e.g. a blood collection tube (3.4). 3.4 blood collection tube tube used for blood collection, usually in a vacuum which forces blood from the vein through the needle into the tube 3.5 blood genomic DNA stabilizers compounds, solutions or mixtures that are designed to minimize degradation and fragmentation of genomic DNA (3.12) in blood 3.6 closed system non-modifiable system provided by the vendor including all necessary components for the examination (i.e. hardware, software, procedures and reagents) 3.7 deoxyribonucleic acid; DNA polymer of deoxyribonucleotides occurring in a double-stranded (dsDNA) or single-stranded (ssDNA) form [SOURCE: SN/T 2102.1-2008, 3.1.2] 3.8 deoxyribonuclease; DNase enzyme that catalyses the degradation of DNA into smaller components 3.9 examination analytical test set of operations having the object of determining the value or characteristics of a property Note: Processes that start with the isolated analyte (3.1) and include all kinds of parameter testing or chemical manipulation for quantitative or qualitative examination. [SOURCE: GB/T 22576.1-2018, 3.7, modified.] 3.10 examination performance analytical test performance analytical performance ability of an examination procedure to measure or detect a particular analyte (3.1) Note 1: 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: Analytical performance includes such characteristics as analytical sensitivity, detection limit, analytical specificity (interference and cross-reactivity), trueness, precision and linearity. [SOURCE: GB/T 39367.1-2020, 3.2, modified.] 3.11 examination provider analytical test provider entity that provides the specific analytical test 3.12 genomic DNA DNA from the nuclear and mitochondrial genomes containing all coding (exon) and non-coding (intron and other) sequences Note: In this document, reference is only made to genomic DNA present in cells in blood, excluding circulating cell free DNA. 3.13 high molecular weight DNA; HMW DNA DNA with an average double strand size larger than 50 kb on a pulsed field electrophoresis gel for the purpose of this document 3.14 interfering substances endogenous or exogenous substances in clinical specimens (3.17)/samples (3.23) that can alter an examination result Note 1: Examples of endogenous substances are blood components and acidic polysaccharides. Note 2: Examples of exogenous substances are talc and anticoagulant. 3.15 needle holder barrel used in routine venepuncture procedures to hold the blood collection tube (3.4) in place and to protect the phlebotomist from direct contact with blood 3.16 pre-examination processes preanalytical phase preanalytical workflow processes that start, in chronological order, from the clinician’s request and include the examination request, preparation and identification of the patient, collection of the primary sample(s) (3.17), transportation to and within the medical laboratory, isolation of analytes, and end when the analytical examination begins Note: The pre-examination phase includes preparative processes, e.g. DNA isolation procedures, which influence the outcome of the intended examination. [SOURCE: GB/T 22576.1-2018, 3.15, modified.]