异种移植用无指定病原体（ Designated Pathogen Free, DPF ）医用供体猪 第2部分：微生物、寄生虫学等级与监测DB43/T95—2023 9.243 湖南省地方标准 发 布 湖南省市场监督管理局2023-1 1发布-09 2024-02实施-0 9代替 DB43/T 95.2—2014 9 Medical grade DPF donor pig for xenotransplantation Part 2:mircrobiological parasitological standards and surveillanceICS CCS 70.080 B 44 DB43/T 959.2—2023 I 目 次 前言 ································ ································ ································ ························ Ⅲ 引言 ································ ································ ································ ························ Ⅴ 1 范围 ································ ································ ································ ····················· 1 2 规范性引用文件 ································ ································ ································ ······ 1 3 术语和定义 ································ ································ ································ ············ 1 4 微生物学等级 ································ ································ ································ ········· 3 5 检测要求 ································ ································ ································ ··············· 3 6 检测程序 ································ ································ ································ ··············· 3 7 检测方法 ································ ································ ································ ··············· 3 8 检测规则 ································ ································ ································ ··············· 5 9 结果判定 ································ ································ ································ ··············· 6 10 判定结论 ································ ································ ································ ·············· 6 11 样本保存 ································ ································ ································ ·············· 6 附录A（规范性） 牛分枝杆菌 PCR检测方法 ································ ································ ···· 7 附录B（规范性） 细胞内鸟型分枝杆菌 PCR检测方法 ································ ························ 8 附录C（规范性） 新型隐球菌 DNA实时荧光定量 PCR检测 ································ ·················· 9 附录D（规范性） 抗荚膜组织胞浆菌抗体 ELISA检测方法 ································ ················ 10 附录E（规范性） 猪兰氏类圆线虫病镜检法诊断 ································ ···························· 11 附录F（规范性） 布氏姜片吸虫镜检法诊断 ································ ································ ·· 12 附录G（规范性） 猪脑心肌炎病毒间接 ELISA检测 ································ ························· 13 附录H（规范性） 人流感病毒多重 PCR检测 ································ ································ ·· 14 附录I（规范性） 猪巨细胞病毒 FQ-PCR检测 ································ ································ · 15 附录J（规范性） 疱疹病毒核酸检测 ································ ································ ··········· 17 附录K（规范性） 猪急性腹泻综合征冠状病毒（ SADS‐CoV）RT‐PCR检测 ·························· 19 附录L（规范性） 猪呼吸道冠状病毒（ PRCV）巢式PCR检测 ································ ············· 20 附录M（规范性） 猪血凝性脑脊髓炎 病毒检测 ································ ······························· 21 附录N（规范性） 猪内源性逆转录病毒 C（PERV-C）PCR检测 ································ ··········· 24 附录O（规范性） 猪嗜淋巴细胞疱疹病毒 3型TaqMan荧光定量 PCR检测 ···························· 25 附录P（规范性） 新型冠状病毒肺炎防控方案（第七版） ································ ················ 26 DB43/T 959.2—2023 II DB43/T 959.2—2023 III 前 言 本文件按照 GB/T 1.1 —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 DB43/T 95 9《异种移植用无指定病原体（ Designated Pathogen Free, DPF ）医用供体猪》 的第2部分。DB43/T 95 9已发布了以下部分： ——第1部分：遗传质量控制； ——第2部分：微生物、寄生虫学 等级与监测 ； ——第3部分：配合饲料； ——第4部分：病理学诊断规范； ——第5部分：环境与设施。 本文件替代 DB43/T 95 9.2—2014《异种移植用无指定病原体（ Designated Pathogen Free, DPF ） 医用供体猪 第2部分：微生物学 等级与监测 》，与DB43/T 95 9.2—2014相比，除结构调整和编辑性改动 外，主要技术变化如下： a） 将本文件“标题”由“异种移植用无指定病原体（ Designated Pathogen Free, DP