GB/T 42216.4-2024 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

ICS11.100.10

CCSC30

中华人民共和国国家标准

GB/T42216.4—2024/ISO20166-4：2021

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

Molecularinvitrodiagnosticexaminations—Specificationsfor

pre⁃examinationprocessesforformalin⁃fixedandparaffin-

embedded（FFPE）tissue—Part4：Insitudetectiontechnique

（ISO20166⁃4：2021，IDT）

2024⁃08⁃23发布2025⁃03⁃01实施

国家市场监督管理总局

发布

国家标准化管理委员会

GB/T42216.4—2024/ISO20166⁃4:2021

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4通则·······················································································································7

5实验室外部··············································································································8

5.1标本采集···········································································································8

5.1.1概述············································································································8

5.1.2标本供体/患者的信息·····················································································8

5.1.3标本信息······································································································8

5.1.4标本处理······································································································9

5.2运送要求···········································································································9

6实验室内部··············································································································9

6.1标本接收···········································································································9

6.2福尔马林固定标本/样品······················································································10

6.3标本的病理学评估和样品的选择············································································11

6.3.1概述··········································································································11

6.3.2大体评估····································································································11

6.3.3样品的选择·································································································11

6.4术中冷冻样品的后固定························································································12

6.5样品脱钙/软化··································································································12

6.6组织处理及石蜡包埋···························································································12

6.6.1通用要求····································································································12

6.6.2脱水和透明·································································································13

6.6.3浸蜡和石蜡包埋···························································································13

6.7FFPE组织块贮存······························································································13

6.8FFPE组织块的切片及载玻片切片的贮存································································13

6.9载玻片切片的脱蜡和再水化··················································································14

6.10用于原位检测技术的载玻片切片的预处理······························································15

6.10.1概述·········································································································15

6.10.2基于抗体或其他亲和结合剂的原位检测技术的预处理··········································15

6.10.3基于杂交的原位检测技术的预处理··································································15

6.10.4其他原位检测技术的预处理···········································································15

6.11原位检测分析前阶段的质量评估··········································································15

附录A（资料性）有关实验室开发的原位检测试验的验证和确认的建议··································17

附录B（资料性）组织处理的操作指南示例······································································18

参考文献····················································································································19

Ⅰ

GB/T42216.4—2024/ISO20166⁃4:2021

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件是GB/T42216《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》的

第4部分。GB/T42216已经发布了以下部分：

——第1部分：分离RNA；

——第2部分：分离蛋白质；

——第3部分：分离DNA；

——第4部分：原位检测技术。

本文件等同采用ISO20166⁃4：2021《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》。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由国家药品监督管理局提出。

本文件由全国医用临床检验实验室和体外诊断系统标准化技术委员会（SAC/TC136）归口。

本文件起草单位：北京医院、北京大学人民医院、中日友好医院、北京市医疗器械检验研究院（北京

市医用生物防护装备检验研究中心）、广州金域医学检验集团股份有限公司、杭州迪安医学检验中心有

限公司、北京中杉金桥生物技术有限公司。

本文件主要起草人：肖飞、钟定荣、邹丽辉、赵晓涛、代蕾颖、陈皇、张淑正、张爱龙、马慧宁。

Ⅲ

GB/T42216.4—2024/ISO20166⁃4:2021

引言

分子体外诊断（包括分子病理学）技术的出现使医学取得了重大进展。然而，分子体外诊断结果的

准确性受诸多因素的影响，包括检验前过程的不规范操作。如在标本采集、运送、贮存及处理过程中的

不规范操作可能造成这些分子的含量和/或完整性发生显著变化，后续的检验分析会受到检验前过程

人为因素的影响，不能完全反映患者的真实状态，使得诊断或研究的结果受到影响。因此，需要对从标

本采集到检测的整个检验前过程进行标准化。

GB/T42216《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》规定了福尔

马林固定和石蜡包埋组织的分子体外诊断检验的检验前操作步骤的标准化要求，拟由4个部分组成。

——第1部分：分离RNA。目的在于规范福尔马林固定和石蜡包埋组织的RNA检验的标准化检

验前操作步骤，减少RNA谱的变化和修饰，保障后续检验结果的有效性和可靠性。

——第2部分：分离蛋白质。目的在于规范福尔马林固定和石蜡包埋组织的蛋白质检验的标准化

检验前操作步骤，减少蛋白质谱的变化和修饰对后续检验的影响。

——第3部分：分离DNA。目的在于规范福尔马林固定和石蜡包埋组织的DNA检验的标准化

检验前操作步骤，减少DNA谱的变化和修饰对后续检验的影响。

——第4部分：原位检测技术。目的在于规范福尔马林固定和石蜡包埋组织原位检测的标准化检

验前操作步骤，减少相关试验因素对原位检测结果的影响。

Ⅳ

GB/T42216.4—2024/ISO20166⁃4:2021

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

1范围

本文件提供了在进行分子分析之前的检验前阶段，用于原位检测的福尔马林固定及石蜡包埋

（FFPE）组织标本处理、记录、贮存及取材的指南。

本文件适用于分子体外诊断检验，包括医学实验室和分子病理学实验室进行的实验室自建检测项

目；本文件还适用于实验室客户、体外诊断开发者和制造商、生物样本库、从事生物医学研究的机构和

商业组织以及监管机构。

本文件不适用于从FFPE组织中分离RNA、蛋白质和DNA的检验前阶段。

注：国际、国家及区域法规要求同样适用于本文件涉及的特定内容。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用于

本文件。

ISO15189医学实验室质量和能力的要求（Medicallaboratories—Requirementsforqualityand

competence）

注：GB/T22576.1—2018医学实验室质量和能力的要求第1部分：通用要求（ISO15189：2012，IDT）

ISO15190医学实验室安全要求（Medicallaboratories—Requirementsforsafety）

注：GB19781—2005医学实验室安全要求（ISO15190：2003，IDT）

3术语和定义

ISO15189界定的以及下列术语和定义适用于本文件。

ISO和IEC维护的用于标准化的术语数据库，地址如下：

——ISO在线浏览平台：http：//www.iso.org/obp；

——IEC电子百科：http：//www.electropedia.org/。

3.1

亲和配体affinitybinder

包括亲和体、多肽、抗体（3.3）片段或其他生物分子（3.6），能与细胞结构分子相互作用，从而用于原

位检测（3.27）技术。

3.2

环境温度ambienttemperature

未经调节的周围空气的温度。

[来源：GB/T42216.1—2022，3.2]

1