Standard No.:	GB/T 42216.4-2024
English Name:	Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 4: In situ detection technique
Chinese Name:	分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第4部分：原位检测技术
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
Source Content Issued by:	SAMR;SAC
Issued on:	2024-8-23
Implemented on:	2025-3-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	17000 words
Translation Price(USD):	510.0
Delivery:	via email in 1~3 business day

GB/T 42216.4-2024 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection technique 1 Scope This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for in situ examination of the morphology. This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. Note: International, national or regional regulations or requirements can also apply to specific topics covered in this document. 2 Normative references The following referenced documents are indispensable for the application 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. ISO 15189 Medical laboratories - Requirements for quality and competence IS015190, Medical laboratories - Requirements for safety Note: GB/T 22576.1-2018 Medical laboratories - Requirements for quality and competence - Part 1 : General requirements (ISO 15189:2012,IDT) ISO 15190 Medical laboratories - Requirements for safety Note: GB 19781-2005 Medical laboratories - Requirements for safety (ISO 15190:2003, IDT) 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15189 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: - ISO Online browsing platform: available at https://www.org/obp - IEC Electropedia: available at http://www.electropedia.org/ 3.1 affinity binder molecules including affibodies, peptides, antibody (3.3) fragments or other small molecules that interact with biomolecules (3.6) and structures in a cell, and can be used in in situ detection (3.27) techniques 3.2 ambient temperature unregulated temperature of the surrounding air [Source: GB/T 42216.1-2022, 3.2] 3.3 antibody protein (3.36) (immunoglobulin) produced and secreted by B lymphocytes in response to a molecule recognized as foreign (antigen (3.4)) and which is capable of binding to that specific antigen (3.4) [Source: ISO 16577:2022, 3.2.1, modified] 3.4 antigen substance that stimulates the production of antibodies (3.3) and reacts with them [Source: ISO 15089:2000, 3.5] 3.5 antigen retrieval epitope retrieval procedure(s) to unmask antigens (3.4)/epitopes (3.14) and restore their binding properties for antibodies (3.3) used in immunohistochemistry (3.25) by neutralizing the modifications introduced by formalin fixation (3.19), tissue processing (3.47) and paraffin embedding (3.33) of tissue 3.6 biomolecule organic molecule produced in living organisms that is involved in the maintenance and metabolic processes of organisms Note: The examples of organic molecule are protein (3.36), carbohydrate, lipid, or nucleic acid. 3.7 clearing process step in tissue processing (3.47) in which formalin-fixed tissue is transferred from dehydration (3.10) reagent to clearing agent (for example, xylene) to prepare the tissue for impregnation (3.26) 3.8 cold ischemia condition after removal of the tissue from the body until its stabilization or fixation [Source: GB/T 42216.1-2022, 3.5] 3.9 decalcification technique using chemical agents for removal of mineral (inorganic calcium) from bone or other calcified tissue to adjust the hard tissue components to the softness of paraffin (3.32) for sectioning 3.10 dehydration process step in tissue processing (3.47) for removal of water from formalin-fixed tissue by immersing the tissue in a series of dehydrating reagent solutions of increasing concentration finishing with water free(100%) solution 3.11 deviation departure from an approved instruction, procedure and/or method [Source: ISO 15378:2017, 3.7.5, modified] 3.12 diagnosis identification of a health or disease state from its signs and/or symptoms, where the diagnostic process can involve examinations (3.15) 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: GB/T 42216.1-2022, 3.7] 3.13 deoxy ribonucleic acid DNA polymer of deoxyribonucleotides occurring in a double-stranded or single-stranded form [Source: SN/T 2102.1-2008, 3.1.2] 3.14 epitope antibody (3.3) binding site on a biomolecule (3.6) that is an antigen (3.4) 3.15 examination analytical test set of operations with the objective of determining the value or characteristics of a property Note: Processes that start with the in situ detection (3.27) using antibodies (3.3), nucleic acid probes or dyes and include all kinds of parameter testing or chemical manipulation for quantitative or qualitative examination. [Source: GB/T 22576.1-2018, 3.7, modified] 3.16 examination manufacturer analytical test manufacturer entity that manufactures and/or produces the specific analytical test (3.15) 3.17 FFPE tissue tissue specimens (3.42)/samples (3.41) having undergone fixation in formalin (3.18, 3.19), tissue processing (3.47), and paraffin embedding (3.33) in a tissue cassette 3.18 formalin saturated aqueous formaldehyde solution which at 100 % contains 37 % formaldehyde by mass (corresponding to 40% by volume) [Source: GB/T 42216.1-2022, 3.11] 3.19 formalin fixation treatment of a sample (3.41) with standard buffered formalin solution (3.45) for stabilization [Source: GB/T 42216.1-2022, 3.12] 3.20 formalin pigment acid formalin haematin pigment acid hematin black to brown amorphous to microcrystalline granules representing an artefact in histologic sections prepared from tissues fixed in formalin (3.19) having an increased formic acid concentration, which is produced by acid acting upon haemoglobin 3.21 grossing gross examination inspection of pathology specimens (3.42) with the bare eye to obtain diagnostic information, while being processed for further microscopic examination (3.15) [Source: GB/T 42216.1-2022, 3.13] 3.22 histochemical technique(s) in situ detection (3.27) technique(s) for the visualization and characterization of biomolecules (3.6) that involves chemical reactions with specific groups, radicals, or chemical bonds in biomolecules (3.6) and provide(s) information on the biomolecules' (3.6) in situ localization in tissue sections (3.49) Note: The examples of biomolecules (3.6) are carbohydrates, lipids, other metabolites, proteins (3.36), amino acids, nucleic acids, pigments, or enzymes etc.