机构名称：上海长海医院实验诊断科

机构名称：上海长海医院实验诊断科 ISO 15189 认可证书 CNAS-PD20/10-B/2 机构名称:上海长海医院实验诊断科 注册号:MT0054 地 址: A:上海市杨浦区长海路168号 获准认可能力索引 序号 地址 能力范围 评审类型 更新时间 1 授权签字人(中文) 复评 2013年04月11日 2 授权签字人(英文) 复评 2013年04月11日 A 3 授权签字人(中文) 监督 2014年06月16日 4 授权签字人(英文) 监督 2014年06月16日 5 检验能力(中文) 复评 2013年04月11日 6 检验能力(英文) 复评 2013年04月11日 A 7 检验能力(中文) 监督 2014年06月16日 8 检验能力(英文) 监督 2014年06月16日 No. CNAS MT0054 第1页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 Name:Department of Experimental Diagnosis, Shanghai Changhai Hospital Registration No.:MT0054 ADDRESS: A: No.168, Changhai Road, Yangpu District, Shanghai, China INDEX OF ACCREDITED SIGNATORIES No. Address Range Type Update date 1 Approved signatories (Chinese) Reassessment 2013-04-11 2 Approved signatories (English) Reassessment 2013-04-11 A 3 Approved signatories (Chinese) Surveillance 2014-06-16 4 Approved signatories (English) Surveillance 2014-06-16 ACCREDITED 5 Reassessment 2013-04-11 EXAMINATION(Chinese) ACCREDITED 6 Reassessment 2013-04-11 EXAMINATION(English) A ACCREDITED 7 Surveillance 2014-06-16 EXAMINATION(Chinese) ACCREDITED 8 Surveillance 2014-06-16 EXAMINATION(English) No. CNAS MT0054 第2页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 中国合格评定国家认可委员会 实 验 室 认 可 证 书 附 件 (注册号:CNAS MT0054) 名称:上海长海医院实验诊断科 地址:上海市杨浦区长海路168号 签发日期:2013年04月11日 有效期至:2016年04月10日 更新日期:2013年04月11日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(? A?B?C?Z); ?3生化学检验(?A?B?C?D? E?F?G?H?I?J?K?L?M?Z); ?4内分泌学 ?5免疫检查(?A?B?C?D?E?F?G?H?Z); 1 邓安梅 学检查(?A?B?C?D?E?F?G?H?I?J?K? Z); ?6微生物学检查(?A?B?C?Z); ?7病 理学检查(?A?B?C?D?Z); ?8其他检查(? A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(? A?B?C?Z); ?3生化学检验(?A?B?C?D? E?F?G?H?I?J?K?L?M?Z); ?4内分泌学 检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 2 李闻捷 学检查(?A?B?C?D?E?F?G?H?I?J?K? Z); ?6微生物学检查(?A?B?C?Z); ?7病 理学检查(?A?B?C?D?Z); ?8其他检查(? A?B?C?Z)。 No. CNAS MT0054 第3页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 3 周道银 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查 4 张建荣 (?A?B?C?D?E?F?G?H?Z); ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 5 方超萍 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌 6 俞靖龙 学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 No. CNAS MT0054 第4页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D? ?4内分泌学检E?F?G?H?I?J?K?L?M?Z); 7 秦琴 查(?A?B?C?D?E?F?G?H?Z); ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌 8 张鹏 学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫学 9 尚雁君 检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学 10 汪怀周 检查(?A?B?C?D?E?F?G?H?Z); ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 No. CNAS MT0054 第5页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(? ?3生化学检验(?A?B?C?D?E?FA?B?C?Z); ?G?H?I?J?K?L?M?Z); ?4内分泌学检查 11 徐德安 (?A?B?C?D?E?F?G?H?Z); ?5免疫学检 查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检 查(?A?B?C?D?Z); ?8其他检查(?A?B? C?Z)。 No. CNAS MT0054 第6页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE (Registration No. CNAS MT0054) NAME:Department of Experimental Diagnosis, Shanghai Changhai Hospital ADDRESS:No.168, Changhai Road, Yangpu District, Shanghai, China Date of Issue:2013-04-11 Date of Expiry:2016-04-10 Date of Update:2013-04-11 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(? A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D? E?F?G?H?I?J?K?Z); ?6 Clinical 1 Deng Anmei Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第7页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z); ?5 2 Li Wenjie Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(? 3 Zhou Daoyin A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?3 Clinical Biochemistry?C?Z); (?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology4 Zhang Jianrong (?A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第8页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z); ?5 5 Fang Chaopin Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?2 Clinical Hematology(?A?B??Z); C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?6 Yu Jinglong A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L ?4 Clinical Endocrinology?M?Z); 7 Qin Qin (?A?B?C?D?E?F?G?H?Z); ?5Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第9页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?8 Zhang Peng A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L ?4 Clinical Endocrinology?M?Z); 9 Shang Yangjun (?A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C?Z); ?2 Clinical Hematology(?A?B?C?Z); ?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?10 Wang Huaizhou A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第10页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry (?A?B?C?D?E?F?G?H?I?J?K 11 Xu Dean ?L?M?Z); ?4 Clinical Endocrinology (?A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D ?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ? 8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第11页 共58页 The scope of the accreditation in Chinese remains the definitive version. ISO 15189 认可证书 CNAS-PD20/10-B/2 中国合格评定国家认可委员会 实 验 室 认 可 证 书 附 件 (注册号:CNAS MT0054) 名称:上海长海医院实验诊断科 地址:上海市杨浦区长海路168号 认可依据:ISO 15189:2007以及CNAS特定认可 签发日期:2013年04月11日 有效期至:2016年04月10日 更新日期:2013年04月11日 附件2 认可的检验能力范围 序号 检验项目 样品类型 领域代码 检验 说明 3A010-1352-0血清 双缩脲法 23-271-01 3A010-1352-01 总蛋白 血清 双缩脲法 23-271-01 3A010-1352-0血浆 双缩脲法 22-291-01 3A015-7052-0白蛋白BCG血清 23-271-01 法 3A015-7052-0白蛋白BCG2 白蛋白 血清 23-271-01 法 3A015-7052-0白蛋白BCG血浆 22-291-01 法 3B045-1352-0紫外―乳酸血清 23-272-01 脱氢酶法 丙氨酸氨基转3B045-1352-0紫外―乳酸3 血清 移酶 23-272-01 脱氢酶法 3B045-1352-0紫外―乳酸血浆 22-291-01 脱氢酶法 天冬氨酸氨基3B035-1352-0苹果酸脱氢4 血清 转移酶 23-272-01 酶法 3B035-1352-0苹果酸脱氢4 天冬氨酸氨基血清 23-272-01 酶法 No. CNAS MT0054 第12页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 转移酶 3B035-1352-0苹果酸脱氢血浆 22-291-01 酶法 3B070-1352-0AMP缓冲液血清 23-271-01 法 3B070-1352-0AMP缓冲液5 碱性磷酸酶 血清 23-271-01 法 3B070-1352-0AMP缓冲液血浆 22-291-01 法 3B090-1352-0对硝基苯胺血清 23-271-01 比色法 L-γ-谷氨酰3B090-1352-0对硝基苯胺6 血清 基转移酶 23-271-01 比色法 3B090-1352-0对硝基苯胺血浆 22-291-01 比色法 3B050-1352-0血清 乳酸速率法 23-272-01 7 乳酸脱氢酶 3B050-1352-0血清 乳酸速率法 23-272-01 3C025-1352-0酶偶联紫外血清 23-272-01 吸收法 3C025-1352-0酶偶联紫外8 尿素 血清 23-272-01 吸收法 3C025-1352-0酶偶联紫外血浆 22-291-01 吸收法 3H010-1352-0间接电位测血清 23-261-01 定法 3H010-1352-0间接电位测9 钠离子 血清 23-261-01 定法 3H010-1352-0血浆 干化学法 22-291-01 3H015-1352-0间接电位测血清 23-261-01 定法 3H015-1352-0间接电位测10 钾离子 血清 23-261-01 定法 3H015-1352-0血浆 干化学法 22-291-01 3H020-1352-0间接电位测血清 23-261-01 定法 3H020-1352-0间接电位测11 氯离子 血清 23-261-01 定法 3H020-1352-0血浆 干化学法 22-291-01 3D010-1352-0血清 氧化酶法 23-271-01 3D010-1352-0血清 氧化酶法 12 葡萄糖 23-271-01 3D010-1352-0干化学氧化血浆 22-291-01 酶法 No. CNAS MT0054 第13页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 3C015-1352-0血清 氧化酶法 23-271-01 3C015-1352-013 肌酐 血清 氧化酶法 23-271-01 3C015-1352-0干化学 氧化血浆 22-291-01 酶法 3C020-1352-0血清 酶法 23-271-01 3C020-1352-014 尿酸 血清 酶法 23-271-01 3C020-1352-0血浆 干化学 酶法 22-291-01 3F050-1352-0血清 CHOD-PAP法 23-271-01 15 总胆固醇 3F050-1352-0血清 CHOD-PAP法 23-271-01 3F015-1352-0血清 GPO-PAP法 23-271-01 16 甘油三酯 3F015-1352-0血清 GPO-PAP法 23-271-01 3F070-7142-0酶法,选择遮血清 高密度脂蛋白23-271-01 蔽法, 17 胆固醇 3F070-7142-0酶法,选择遮血清 23-271-01 蔽法, 3F077-7144-0酶法,选择遮血清 低密度脂蛋白23-271-01 蔽法, 18 胆固醇 3F077-7144-0酶法,选择遮血清 23-271-01 蔽法, 3F180-7150-0透射免疫比血清 23-061-01 浊法 19 载脂蛋白A1 3F180-7150-0透射免疫比血清 23-061-01 浊法 3F190-7154-0透射免疫比血清 23-061-01 浊法 20 载脂蛋白B 3F190-7154-0透射免疫比血清 23-061-01 浊法 3B160-1352-0血清 EPS速率法 23-271-01 3B160-1352-0血清 EPS速率法 21 淀粉酶 23-271-01 对硝基苯麦3B160-1352-0血浆 芽庚糖苷 22-291-01 ,4NP-G7,法 3B010-1352-0DGKC优化比血清 23-272-01 色法 22 肌酸激酶 3B010-1352-0DGKC优化比血清 23-272-01 色法 3H030-1352-0CALCIUM-偶23 总钙 血清 23-271-01 氮胂法 No. CNAS MT0054 第14页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 3H030-1352-0CALCIUM-偶23 总钙 血清 23-271-01 氮胂法 3H040-1352-0硫酸亚铁磷血清 23-271-01 钼蓝比色法 24 无机磷 3H040-1352-0硫酸亚铁磷血清 23-271-01 钼蓝比色法 5A010-7002-0速率散射免25 免疫球蛋白G 血清 23-061-01 疫比浊法 5A015-7003-0速率散射免26 免疫球蛋白A 血清 23-061-01 疫比浊法 5A020-7004-0速率散射免27 免疫球蛋白M 血清 23-061-01 疫比浊法 5B023-7260-0速率散射免28 血清补体3 血清 23-061-01 疫比浊法 5B024-7266-0速率散射免29 血清补体4 血清 23-061-01 疫比浊法 4A010-8216-0微粒子免疫30 卵泡刺激素 血清 23-051-01 化学发光法 4A009-8210-0微粒子免疫31 黄体生成素 血清 23-051-01 化学发光法 4A007-8224-0微粒子免疫32 催乳素 血清 23-051-01 化学发光法 总三碘甲状腺4B001-8404-0微粒子免疫33 血清 原氨酸 23-051-01 化学发光法 4B005-8406-0微粒子免疫34 甲状腺素 血清 23-051-01 化学发光法 4A014-8204-0微粒子免疫35 促甲状腺素 血清 23-051-01 化学发光法 乙肝病毒面5F016-8502-0微粒子免疫36 血清 抗原 23-051-01 化学发光法 乙肝病毒表面5F015-1352-0微粒子免疫37 血清 抗体 23-051-01 化学发光法 乙肝病毒e抗5F019-8508-0微粒子免疫38 血清 原 23-051-02 化学发光法 乙肝病毒e抗5F015-1351-0微粒子免疫39 血清 体 23-051-02 化学发光法 乙肝病毒核心5F015-1351-0微粒子免疫40 血清 抗体 23-051-02 化学发光法 抗丙肝病毒抗5F360-1430-041 血清 化学发光法 体 23-051-02 5F560-1430-042 抗HIV抗体 血清 ELISA法 23-023-04 乙型肝炎病毒5F015-1441-0荧光定量43 血清 核酸扩增荧光23-862-01 PCR法 定量检测 丙型肝炎病毒5F360-1453-0荧光定量44 血浆 核酸扩增荧光22-875-01 PCR法 定量检测 No. CNAS MT0054 第15页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 血浆凝血酶原2B030-1352-045 血浆 凝固法 时间测定 22-311-03 凝血酶原时间2B030-1352-046 血浆 计算值 国际标准化比22-311-02 值 活化部分凝血2B020-1352-047 血浆 凝固法 活酶时间测定 22-311-03 血浆纤维蛋白2B100-7180-048 血浆 凝固法 原测定 22-311-01 全血白细胞计2A010-7682-0流式细胞计49 全血 数 19-301-01 数 全血白细胞分2A010-7682-0流式细胞计50 全血 类 19-301-02 数 全血红细胞计2A020-7686-0鞘流DC检测51 全血 数 19-301-01 方法 鞘流DC和流 全血血小板计2A050-7684-052 全血 式细胞计数数 19-301-01 检测方法 全血血红蛋白2A030-1352-0SLS血红蛋53 全血 测定 19-301-01 白检测法 平均红细胞体2A060-7686-054 全血 计算值 积测定 19-301-01 平均红细胞血2A070-1352-055 全血 计算值 红蛋白量 19-301-01 平均红细胞血2A080-1352-056 全血 计算值 红蛋白浓度 19-301-01 RBC累积脉 2A040-7686-057 红细胞比积 全血 冲高度检测19-301-01 法 外周血血细胞2A160-1351-058 全血 镜检法 形态学分析 34-605-64 No. CNAS MT0054 第16页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 1A035-1351-059 尿液比重测定 尿液 干化学法 03-291-12 1A035-1351-059 尿液比重测定 尿液 干化学法 03-291-12 尿液蛋白质定1A010-1351-060 尿液 干化学法 性检查 03-291-12 尿液葡萄糖定1A020-1351-061 尿液 干化学法 性检查 03-291-12 尿液亚硝酸盐1A080-1351-062 尿液 干化学法 定性检查 03-291-12 尿液胆红素定1A050-1351-063 尿液 干化学法 性检查 03-291-12 尿液尿胆原定1A040-1351-064 尿液 干化学法 性检查 03-291-12 1A035-1351-065 尿液pH测定 尿液 干化学法 03-291-12 尿液酮体定性1A060-1351-066 尿液 干化学法 检查 03-291-12 尿液白细胞检1A075-1351-067 尿液 干化学法 验 03-291-12 1A100-1351-068 尿液潜血试验 尿液 干化学法 03-291-12 1A105-1351-0尿液 手工镜检法 03-XXX-02 流式细胞计 尿有形成分分数,仪器法, 69 1A105-1352-0析 尿液 03-XXX-01 离心镜检法 ,仪器法, No. CNAS MT0054 第17页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE (Registration No. CNAS MT0054) NAME:Department of Experimental Diagnosis, Shanghai Changhai Hospital ADDRESS:No.168, Changhai Road, Yangpu District, Shanghai, China Accreditation Criteria: ISO 15189:2007 and relevant requirements of CNAS Date of Issue:2013-04-11 Date of Expiry:2016-04-10 Date of Update:2013-04-11 APPENDIX 2 ACCREDITED EXAMINATION Examination Analytical ? Sample Type Code Notes Item Method 3A010-1352-0Serum Biuret method 23-271-01 3A010-1352-01 Total protein Serum Biuret method 23-271-01 3A010-1352-0Plasma Biuret method 22-291-01 3A015-7052-0Bromocresol Serum 23-271-01 green method 3A015-7052-0Bromocresol 2 Albumin Serum 23-271-01 green method 3A015-7052-0Bromocresol Plasma 22-291-01 green method UV - lactate 3B045-1352-0Serum dehydrogenas23-272-01 e method Alkaline UV - lactate 3 3B045-1352-0phosphatase Serum dehydrogenas23-272-01 e method UV - lactate 3B045-1352-0Plasma dehydrogenas 22-291-01 e method No. CNAS MT0054 第18页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Malate 3B035-1352-0Serum dehydrogenas23-272-01 e method Asparate Malate 4 aminotransfera3B035-1352-0Serum dehydrogenasse 23-272-01 e method Malate 3B035-1352-0Plasma dehydrogenas 22-291-01 e method 3B070-1352-0AMP buffer Serum 23-271-01 method Alkaline 5 3B070-1352-0AMP buffer phosphatase Serum 23-271-01 method 3B070-1352-0AMP buffer Plasma 22-291-01 method γ- glutamyl -3- carboxyl 3B090-1352-0-4- nitro Serum 23-271-01 aniline acid substrate method γ- glutamyl -3- carboxyl Gamma glutamyl 3B090-1352-0-4- nitro 6 Serum transpeptidas 23-271-01 aniline acid substrate method γ- glutamyl -3- carboxyl 3B090-1352-0-4- nitro Plasma 22-291-01 aniline acid substrate method Rate method 3B050-1352-0Serum for lactic 23-272-01 Lactate acid 7 dehydrogenase Rate method 3B050-1352-0Serum for lactic 23-272-01 acid Enzyme 3C025-1352-0coupled UV 8 Urea Serum 23-272-01 absorption method No. CNAS MT0054 第19页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Enzyme 3C025-1352-0coupled UV Serum 23-272-01 absorption method 8 Urea Enzyme 3C025-1352-0coupled UV Plasma 22-291-01 absorption method Indirect 3H010-1352-0Serum potentiometr23-261-01 y Indirect 3H010-1352-09 Sodium Serum potentiometr23-261-01 y 3H010-1352-0Plasma Dry chemistry 22-291-01 Indirect 3H015-1352-0Serum potentiometr23-261-01 y Indirect 3H015-1352-010 Potassium Serum potentiometr23-261-01 y 3H015-1352-0Plasma Dry chemistry 22-291-01 Indirect 3H020-1352-0Serum potentiometr23-261-01 y Indirect 3H020-1352-011 Chloride Serum potentiometr23-261-01 y 3H020-1352-0Plasma Dry chemistry 22-291-01 3D010-1352-0Serum Oxidase 23-271-01 3D010-1352-0Serum Oxidase 12 Blood glucose 23-271-01 Oxidase dry 3D010-1352-0Plasma chemical 22-291-01 method 3C015-1352-0Serum Oxidase 23-271-01 3C015-1352-0Serum Oxidase 13 Creatinine 23-271-01 Oxidase dry 3C015-1352-0Plasma chemical 22-291-01 method 3C020-1352-014 Uric acid Serum Enzymatic 23-271-01 No. CNAS MT0054 第20页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 3C020-1352-0Serum Enzymatic 23-271-01 14 Uric acid Enzymatic dry 3C020-1352-0Plasma chemical 22-291-01 method 3F050-1352-0CHOD-PAP Serum 23-271-01 method 15 Cholesterol 3F050-1352-0CHOD-PAP Serum 23-271-01 method 3F015-1352-0GPO-PAP Serum 23-271-01 method 16 Triglyceride 3F015-1352-0GPO-PAP Serum 23-271-01 method Enzymatic 3F070-7142-0High density Serum (Select 23-271-01 lipoprotein masking) 17 cholesterol, Enzymatic HDL-C 3F070-7142-0Serum (Select 23-271-01 masking) Enzymatic 3F077-7144-0Low density Serum (Select 23-271-01 lipoprotein masking) 18 cholesterol, Enzymatic LDL-C 3F077-7144-0Serum (Select 23-271-01 masking) 3F180-7150-0ImmunoturbidSerum 23-061-01 imetry Apolipoprotein 19 A-1 3F180-7150-0ImmunoturbidSerum 23-061-01 imetry 3F190-7154-0ImmunoturbidSerum 23-061-01 imetry Apolipoprotein 20 B 3F190-7154-0ImmunoturbidSerum 23-061-01 imetry 3B160-1352-0EPS Rate Serum 23-271-01 method 21 Amylase 3B160-1352-0EPS Rate Serum 23-271-01 method No. CNAS MT0054 第21页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 3B160-1352-0Plasma 4NP-G7 method 22-291-01 DGKC 3B010-1352-0Serum optimized 23-272-01 Creatine assay 22 kinase DGKC 3B010-1352-0Serum optimized 23-272-01 assay 3H030-1352-0CALCIUM-arseSerum 23-271-01 nazo method 23 Calcium 3H030-1352-0CALCIUM-arseSerum 23-271-01 nazo method Phosphorus molybdenum 3H040-1352-0Serum blue method 23-271-01 of ferrous sulfate Inorganic 24 phosphate Phosphorus molybdenum 3H040-1352-0Serum blue method 23-271-01 of ferrous sulfate Rate immune Immunoglobulin 5A010-7002-025 Serum scatter G 23-061-01 turbidimetry Rate immune Immunoglobulin 5A015-7003-026 Serum scatter A 23-061-01 turbidimetry Rate immune Immunoglobulin 5A020-7004-027 Serum scatter M 23-061-01 turbidimetry Rate immune 5B023-7260-028 Complement 3 Serum scatter 23-061-01 turbidimetry R Rate immune 5B024-7266-029 Complement 4 Serum scatter 23-061-01 turbidimetry Follicle 4A010-8216-0Chemilumines30 Serum stimulating 23-051-01 cent hormone, FSH Luteinizing 4A009-8210-0Chemilumines31 Serum hormone, LH 23-051-01 cent 4A007-8224-0Chemilumines32 Prolactin, PRL Serum 23-051-01 cent Triiodothyroni4B001-8404-0Chemilumines33 Serum ne 23-051-01 cent 4B005-8406-0Chemilumines34 Thyroxine Serum 23-051-01 cent No. CNAS MT0054 第22页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Thyroid 4A014-8204-0Chemilumines35 stimulating Serum 23-051-01 cent hormone 5F016-8502-0Serum CMIA Hepatitis B 23-051-01 36 surface antigen 5F016-8502-0Serum CMIA 23-051-01 5F015-1352-0Serum CMIA Hepatitis B 23-051-01 37 surface antibody 5F015-1352-0Serum CMIA 23-051-01 5F019-8508-0Serum CMIA 23-051-02 Hepatitis B e 38 antigen 5F019-8508-0Serum CMIA 23-051-02 5F015-1351-0Serum CMIA 23-051-02 Hepatitis B e 39 antibody 5F015-1351-0Serum CMIA 23-051-02 5F015-1351-0Serum CMIA 23-051-02 Hepatitis B c 40 antibody 5F015-1351-0Serum CMIA 23-051-02 Hepatitis C 5F360-1430-0Chemilumines41 Serum antibody 23-051-02 cent Human Immnnodeficien5F560-1430-042 Serum ELISA cy virus 23-023-04 antibody No. CNAS MT0054 第23页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 5F015-1441-043 HBV-DNA Serum Real-time PCR 23-862-01 5F360-1453-044 HCV-RNA Plasma Real-time PCR 22-875-01 Prothrombin 2B030-1352-045 Plasma Clot-based time 22-311-03 International 2B030-1352-046 Plasma Caculation Normalized 22-311-02 Ratio Actived partial 2B020-1352-047 Plasma Clot-based thromboplastin 22-311-03 time Plasma 2B100-7180-048 Plasma Clot-based fibrinogen 22-311-01 Flow White blood 2A010-7682-049 Whole blood Cytometry cell count 19-301-01 Method White blood Flow cell 2A010-7682-050 Whole blood Cytometry differential 19-301-02 Method count RF/DC Red blood cell 2A020-7686-051 Whole blood Detection count 19-301-01 Method RF/DC Detection and 2A050-7684-052 Platelet count Whole blood Flow 19-301-01 Cytometry Method No. CNAS MT0054 第24页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 2A030-1352-0SLS-Hemoglob53 Hemoglobin Whole blood 19-301-01 in Method 2A030-1352-0SLS-Hemoglob53 Hemoglobin Whole blood 19-301-01 in Method Mean 2A060-7686-054 corpusclar Whole blood Caculation 19-301-01 volume Mean 2A070-1352-055 corpuscular Whole blood Caculation 19-301-01 hemoglobin Mean corpuscular 2A080-1352-056 Whole blood Caculation hemoglobin 19-301-01 concentration RBC Cumulative 2A040-7686-057 Haematocrit Whole blood Pulse Height 19-301-01 Detection Method No. CNAS MT0054 第25页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Manual Micro 2A160-1351-058 Blood picture Whole blood Examination 34-605-64 Method Urine specific 1A030-1351-0Dry chemistry 59 Urine gravity 03-291-12 analysis Urine specific 1A030-1351-0Dry chemistry 59 Urine gravity 03-291-12 analysis 1A010-1351-0Dry chemistry 60 Urine protein Urine 03-291-12 analysis 1A020-1351-0Dry chemistry 61 Urine glucose Urine 03-291-12 analysis 1A080-1351-0Dry chemistry 62 Urine nitrite Urine 03-291-12 analysis Urine 1A050-1351-0Dry chemistry 63 Urine bilirubin 03-291-12 analysis No. CNAS MT0054 第26页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 1A040-1351-0Dry chemistry 64 Urobilinogen Urine 03-291-12 analysis 1A035-1351-0Dry chemistry 65 Urine PH Urine 03-291-12 analysis 1A060-1351-0Dry chemistry 66 Urine ketones Urine 03-291-12 analysis Urine 1A075-1351-0Dry chemistry 67 leucocyte Urine 03-291-12 analysis count No. CNAS MT0054 第27页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Urine occult 1A100-1351-0Dry chemistry 68 Urine blood test 03-291-12 analysis Urine occult 1A100-1351-0Dry chemistry 68 Urine blood test 03-291-12 analysis 1A105-1351-0Urine Manual test 03-XXX-02 Flow Cytometry Urine formed 69 element analysis 1A105-1351-0Urine 03-XXX-01 Centrifugal microscopic examination No. CNAS MT0054 第28页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 中国合格评定国家认可委员会 实 验 室 认 可 证 书 附 件 (注册号:CNAS MT0054) 名称:上海长海医院实验诊断科 地址:上海市杨浦区长海路168号 签发日期:2013年04月11日 有效期至:2016年04月10日 更新日期:2014年06月16日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 1 一般检查(?A?B?C?Z); 2 血液学检查(? A?B?C?Z); 3 生化学检验(?A?B?C?D?E ?F?G?H?I?J?K?L?M?Z); 4 内分泌学检 查(?A?B?C?D?E?F?G?H?Z); ?5免疫学 1 邓安梅 检查(?A?B?C?D?E?F?G?H?I?J?K?Z); 6 微生物学检查(?A?B?C?Z); 7 病理学检查 (?A?B?C?D?Z); 8 其他检查(?A?B?C ?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(? A?B?C?Z); ?3生化学检验(?A?B?C?D? E?F?G?H?I?J?K?L?M?Z); ?4内分泌学 检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 2 李闻捷 学检查(?A?B?C?D?E?F?G?H?I?J?K? Z); ?6微生物学检查(?A?B?C?Z); ?7病 理学检查(?A?B?C?D?Z); ?8其他检查(? A?B?C?Z)。 No. CNAS MT0054 第29页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 3 周道银 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 4 张建荣 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 5 方超萍 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 6 俞靖龙 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 7 秦琴 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 No. CNAS MT0054 第30页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 姓 名 授权签字领域 备 注 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 8 汪怀周 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 9 徐德安 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 10 张薇薇 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 11 张鹏 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 ?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 12 尚雁君 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。 No. CNAS MT0054 第31页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE (Registration No. CNAS MT0054) NAME:Department of Experimental Diagnosis, Shanghai Changhai Hospital ADDRESS:No.168, Changhai Road, Yangpu District, Shanghai, China Date of Issue:2013-04-11 Date of Expiry:2016-04-10 Date of Update:2014-06-16 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(? 1 Deng Anmei A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第32页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?2 Li Wenjie A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?3 Zhou Daoyin A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?4 Zhang Jianrong A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第33页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?5 Fang Chaopin A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?6 Yu Jinglong A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology7 Qin Qin (?A?B?C?D?E?F?G?H?Z); ?5Clinical Immunology(?A?B?C?D ?E?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ? 8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第34页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?8 Wang Huaizhou A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?9 Xu Dean A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?10 Zhang Weiwei A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第35页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 ? Name Authorized Scope of Signature Notes ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?11 Zhang Peng A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); ?2 Clinical Hematology(?A?B ?C?Z); ?3 Clinical Biochemistry(?A ?B?C?D?E?F?G?H?I?J?K?L ?M?Z); ?4 Clinical Endocrinology(?12 Shang Yangjun A?B?C?D?E?F?G?H?Z); ?5 Clinical Immunology(?A?B?C?D?E ?F?G?H?I?J?K?Z); ?6 Clinical Microbiology(?A?B?C?Z); ?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 No. CNAS MT0054 第36页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 中国合格评定国家认可委员会 实 验 室 认 可 证 书 附 件 (注册号:CNAS MT0054) 名称:上海长海医院实验诊断科 地址:上海市杨浦区长海路168号 认可依据:ISO 15189:2007以及CNAS特定认可要求 签发日期:2013年04月11日 有效期至:2016年04月10日 更新日期:2014年06月16日 附件2 认可的检验能力范围 序号 检验项目 样品类型 领域代码 检验方法 说明 3A010-1352-0血清 双缩脲法 23-271-01 3A010-1352-01 总蛋白 血清 双缩脲法 23-271-01 3A010-1352-0血浆 双缩脲法 22-291-01 3A015-7052-0白蛋白BCG血清 23-271-01 法 3A015-7052-0白蛋白BCG2 白蛋白 血清 23-271-01 法 3A015-7052-0白蛋白BCG血浆 22-291-01 法 3B045-1352-0紫外―乳酸血清 23-272-01 脱氢酶法 丙氨酸氨基转3B045-1352-0紫外―乳酸3 血清 移酶 23-272-01 脱氢酶法 3B045-1352-0紫外―乳酸血浆 22-291-01 脱氢酶法 No. CNAS MT0054 第37页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 3B035-1352-0苹果酸脱氢血清 23-272-01 酶法 天冬氨酸氨基3B035-1352-0苹果酸脱氢4 血清 转移酶 23-272-01 酶法 3B035-1352-0苹果酸脱氢血浆 22-291-01 酶法 3B070-1352-0AMP缓冲液血清 23-271-01 法 3B070-1352-0AMP缓冲液5 碱性磷酸酶 血清 23-271-01 法 3B070-1352-0AMP缓冲液血浆 22-291-01 法 3B090-1352-0对硝基苯胺血清 23-271-01 比色法 γ-谷氨酰基3B090-1352-0对硝基苯胺6 血清 转移酶 23-271-01 比色法 3B090-1352-0对硝基苯胺血浆 22-291-01 比色法 3B050-1352-0血清 乳酸速率法 23-272-01 7 乳酸脱氢酶 3B050-1352-0血清 乳酸速率法 23-272-01 3C025-1352-0酶偶联紫外血清 23-272-01 吸收法 3C025-1352-0酶偶联紫外8 尿素 血清 23-272-01 吸收法 3C025-1352-0酶偶联紫外血浆 22-291-01 吸收法 3H010-1352-0间接电位测血清 23-261-01 定法 3H010-1352-0间接电位测9 钠离子 血清 23-261-01 定法 3H010-1352-0血浆 干化学法 22-291-01 3H015-1352-0间接电位测血清 23-261-01 定法 3H015-1352-0间接电位测10 钾离子 血清 23-261-01 定法 3H015-1352-0血浆 干化学法 22-291-01 3H020-1352-0间接电位测血清 23-261-01 定法 3H020-1352-0间接电位测11 氯离子 血清 23-261-01 定法 3H020-1352-0血浆 干化学法 22-291-01 3D010-1352-012 葡萄糖 血清 氧化酶法 23-271-01 No. CNAS MT0054 第38页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 3D010-1352-0血清 氧化酶法 23-271-01 12 葡萄糖 3D010-1352-0干化学氧化血浆 22-291-01 酶法 3C015-1352-0血清 氧化酶法 23-271-01 3C015-1352-013 肌酐 血清 氧化酶法 23-271-01 3C015-1352-0干化学 氧化血浆 22-291-01 酶法 3C020-1352-0血清 酶法 23-271-01 3C020-1352-014 尿酸 血清 酶法 23-271-01 3C020-1352-0血浆 干化学 酶法 22-291-01 3F050-1352-0血清 CHOD-PAP法 23-271-01 15 总胆固醇 3F050-1352-0血清 CHOD-PAP法 23-271-01 3F015-1352-0血清 GPO-PAP法 23-271-01 16 甘油三酯 3F015-1352-0血清 GPO-PAP法 23-271-01 3F070-7142-0酶法,选择遮血清 高密度脂蛋白23-271-01 蔽法, 17 胆固醇 3F070-7142-0酶法,选择遮血清 23-271-01 蔽法, 3F077-7144-0酶法,选择遮血清 低密度脂蛋白23-271-01 蔽法, 18 胆固醇 3F077-7144-0酶法,选择遮血清 23-271-01 蔽法, 3F180-7150-0透射免疫比血清 23-061-01 浊法 19 载脂蛋白A1 3F180-7150-0透射免疫比血清 23-061-01 浊法 3F190-7154-0透射免疫比血清 23-061-01 浊法 20 载脂蛋白B 3F190-7154-0透射免疫比血清 23-061-01 浊法 3B160-1352-0血清 EPS速率法 23-271-01 3B160-1352-0血清 EPS速率法 21 淀粉酶 23-271-01 对硝基苯麦3B160-1352-0血浆 芽庚糖苷22-291-01 ,4NP-G7,法 No. CNAS MT0054 第39页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 3B010-1352-0DGKC优化比22 肌酸激酶 血清 23-272-01 色法 3B010-1352-0DGKC优化比22 肌酸激酶 血清 23-272-01 色法 3H030-1352-0CALCIUM-偶血清 23-271-01 氮胂法 3H030-1352-0CALCIUM-偶23 总钙 血清 23-271-01 氮胂法 3H030-1352-0CALCIUM-偶血浆 22-291-01 氮胂法 3H040-1352-0硫酸亚铁磷血清 23-271-01 钼蓝比色法 24 无机磷 3H040-1352-0硫酸亚铁磷血清 23-271-01 钼蓝比色法 5A010-7002-0速率散射免血清 23-061-01 疫比浊法 25 免疫球蛋白G 5A010-7002-0速率散射免血清 23-061-01 疫比浊法 5A015-7003-0速率散射免血清 23-061-01 疫比浊法 26 免疫球蛋白A 5A015-7003-0速率散射免血清 23-061-01 疫比浊法 5A020-7004-0速率散射免血清 23-061-01 疫比浊法 27 免疫球蛋白M 5A020-7004-0速率散射免血清 23-061-01 疫比浊法 5B023-7260-0速率散射免血清 23-061-01 疫比浊法 28 血清补体3 5B023-7260-0速率散射免血清 23-061-01 疫比浊法 5B024-7266-0速率散射免血清 23-061-01 疫比浊法 29 血清补体4 5B024-7266-0速率散射免血清 23-061-01 疫比浊法 4A010-8216-0微粒子免疫30 卵泡刺激素 血清 23-051-01 化学发光法 4A009-8210-0微粒子免疫31 黄体生成素 血清 23-051-01 化学发光法 4A007-8224-0微粒子免疫32 催乳素 血清 23-051-01 化学发光法 总三碘甲状腺4B001-8404-033 血清 电化学发光 原氨酸 23-051-01 No. CNAS MT0054 第40页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 4B005-8406-034 甲状腺素 血清 电化学发光 23-051-01 4A014-8204-035 促甲状腺素 血清 电化学发光 23-051-01 乙肝病毒表面5F016-8502-0微粒子免疫36 血清 抗原 23-051-01 化学发光法 乙肝病毒表面5F015-1352-0微粒子免疫37 血清 抗体 23-051-01 化学发光法 乙肝病毒e抗5F019-8508-0微粒子免疫38 血清 原 23-051-02 化学发光法 乙肝病毒e抗5F015-1351-0微粒子免疫39 血清 体 23-051-02 化学发光法 乙肝病毒核心5F015-1351-0微粒子免疫40 血清 抗体 23-051-02 化学发光法 抗丙肝病毒抗5F360-1430-041 血清 化学发光法 体 23-051-02 5F560-1430-042 抗HIV抗体 血清 ELISA法 23-023-04 乙型肝炎病毒5F015-1441-0荧光定量43 血清 核酸扩增荧光23-862-01 PCR法 定量检测 丙型肝炎病毒5F360-1453-0荧光定量44 血浆 核酸扩增荧光22-875-01 PCR法 定量检测 血浆凝血酶原2B030-1352-045 血浆 凝固法 时间测定 22-311-03 凝血酶原时间 2B030-1352-046 国际标准化比血浆 计算值 22-311-02 值 活化部分凝血2B020-1352-047 血浆 凝固法 活酶时间测定 22-311-03 No. CNAS MT0054 第41页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 血浆纤维蛋白2B100-7180-048 血浆 凝固法 原测定 22-311-01 全血白细胞计2A010-7682-0流式细胞计49 全血 数 19-301-01 数 全血白细胞分2A010-7682-0流式细胞计50 全血 类 19-301-02 数 全血红细胞计2A020-7686-0鞘流DC检测51 全血 数 19-301-01 方法 鞘流DC和流全血血小板计2A050-7684-052 全血 式细胞计数数 19-301-01 检测方法 全血血红蛋白2A030-1352-0SLS血红蛋53 全血 测定 19-301-01 白检测法 平均红细胞体2A060-7686-054 全血 计算值 积测定 19-301-01 平均红细胞血2A070-1352-055 全血 计算值 红蛋白量 19-301-01 平均红细胞血2A080-1352-056 全血 计算值 红蛋白浓度 19-301-01 No. CNAS MT0054 第42页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 序号 检验项目 样品类型 领域代码 检验方法 说明 RBC累积脉 2A040-7686-057 红细胞比积 全血 冲高度检测19-301-01 法 RBC累积脉2A040-7686-057 红细胞比积 全血 冲高度检测 19-301-01 法 外周血血细胞2A160-1351-058 全血 镜检法 形态学分析 34-605-64 1A035-1351-059 尿液比重测定 尿液 干化学法 03-291-12 尿液蛋白质定1A010-1351-060 尿液 干化学法 性检查 03-291-12 尿液葡萄糖定1A020-1351-061 尿液 干化学法 性检查 03-291-12 尿液亚硝酸盐1A080-1351-062 尿液 干化学法 定性检查 03-291-12 尿液胆红素定1A050-1351-063 尿液 干化学法 性检查 03-291-12 尿液尿胆原定1A040-1351-064 尿液 干化学法 性检查 03-291-12 1A035-1351-065 尿液pH测定 尿液 干化学法 03-291-12 尿液酮体定性1A060-1351-066 尿液 干化学法 检查 03-291-12 尿液白细胞检1A075-1351-067 尿液 干化学法 验 03-291-12 1A100-1351-068 尿液潜血试验 尿液 干化学法 03-291-12 1A105-1351-0尿液 手工镜检法 03-XXX-02 尿有形成分分流式细胞计69 析 数,仪器法, 1A105-1352-0尿液 03-XXX-01 离心镜检法 ,仪器法, No. CNAS MT0054 第43页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE (Registration No. CNAS MT0054) NAME:Department of Experimental Diagnosis, Shanghai Changhai Hospital ADDRESS:No.168, Changhai Road, Yangpu District, Shanghai, China Accreditation Criteria: ISO 15189:2007 and relevant requirements of CNAS Date of Issue:2013-04-11 Date of Expiry:2016-04-10 Date of Update:2014-06-16 APPENDIX 2 ACCREDITED EXAMINATION Examination Analytical ? Sample Type Code Notes Item Method 3A010-1352-0Serum Biuret method Reagent 23-271-01 Company 3A010-1352-0Change Serum Biuret method 23-271-01 1 Total protein Analytic al 3A010-1352-0Plasma Biuret method Instrume22-291-01 nt Model Change 3A015-7052-0Bromocresol Serum Reagent 23-271-01 green method Company 3A015-7052-0Bromocresol Change Serum 23-271-01 green method 2 Albumin Analytic al 3A015-7052-0Bromocresol Plasma Instrume22-291-01 green method nt Model Change UV - lactate Alkaline 3B045-1352-03 Serum dehydrogenasphosphatase 23-272-01 e method No. CNAS MT0054 第44页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method UV - lactate 3B045-1352-0Serum dehydrogenas23-272-01 e method Alkaline Analytic3 phosphatase UV - lactate al 3B045-1352-0Plasma dehydrogenasInstrume22-291-01 e method nt Model Change Malate 3B035-1352-0Serum dehydrogenas23-272-01 e method Malate 3B035-1352-0Serum dehydrogenasAsparate 23-272-01 4 aminotransferae method se Analytic Malate al 3B035-1352-0Plasma dehydrogenasInstrume22-291-01 e method nt Model Change 3B070-1352-0AMP buffer Serum 23-271-01 method 3B070-1352-0AMP buffer Serum 23-271-01 method Alkaline 5 Analyticphosphatase al 3B070-1352-0AMP buffer Plasma Instrume22-291-01 method nt Model Change γ- glutamyl -3- carboxyl 3B090-1352-0-4- nitro Serum 23-271-01 aniline acid substrate method γ- glutamyl -3- carboxyl Gamma glutamyl 3B090-1352-0-4- nitro 6 Serum transpeptidas 23-271-01 aniline acid substrate method γ- glutamyl Analytic-3- carboxyl al 3B090-1352-0-4- nitro Plasma Instrume22-291-01 aniline acid nt Model substrate Change method No. CNAS MT0054 第45页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Rate method 3B050-1352-0Serum for lactic 23-272-01 Lactate acid 7 dehydrogenase Rate method 3B050-1352-0Serum for lactic 23-272-01 acid Enzyme 3C025-1352-0coupled UV Serum 23-272-01 absorption method Enzyme 3C025-1352-0coupled UV Serum 23-272-01 absorption 8 Urea method AnalyticEnzyme al 3C025-1352-0coupled UV Plasma Instrume22-291-01 absorption nt Model method Change Indirect 3H010-1352-0Serum potentiometr23-261-01 y Indirect 3H010-1352-0Serum potentiometr23-261-01 y 9 Sodium Analytic al 3H010-1352-0Plasma Dry chemistry Instrume22-291-01 nt Model Change Indirect 3H015-1352-0Serum potentiometr 23-261-01 y Indirect 3H015-1352-0Serum potentiometr23-261-01 y 10 Potassium Analytic al 3H015-1352-0Plasma Dry chemistry Instrume22-291-01 nt Model Change Indirect 3H020-1352-0Serum potentiometr 23-261-01 y 11 Chloride Indirect 3H020-1352-0Serum potentiometr 23-261-01 y No. CNAS MT0054 第46页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Analytic al 3H020-1352-011 Chloride Plasma Dry chemistry Instrume22-291-01 nt Model Change 3D010-1352-0Serum Oxidase 23-271-01 3D010-1352-0Serum Oxidase 23-271-01 12 Blood glucose Analytic Oxidase dry al 3D010-1352-0Plasma chemical Instrume22-291-01 method nt Model Change 3C015-1352-0Serum Oxidase 23-271-01 3C015-1352-0Serum Oxidase 23-271-01 13 Creatinine Analytic Oxidase dry al 3C015-1352-0Plasma chemical Instrume22-291-01 method nt Model Change 3C020-1352-0Serum Enzymatic 23-271-01 3C020-1352-0Serum Enzymatic 23-271-01 14 Uric acid Analytic Enzymatic dry al 3C020-1352-0Plasma chemical Instrume22-291-01 method nt Model Change 3F050-1352-0CHOD-PAP Serum 23-271-01 method 15 Cholesterol 3F050-1352-0CHOD-PAP Serum 23-271-01 method 3F015-1352-0GPO-PAP Serum 23-271-01 method 16 Triglyceride 3F015-1352-0GPO-PAP Serum 23-271-01 method Enzymatic 3F070-7142-0Serum (Select High density 23-271-01 masking) lipoprotein 17 cholesterol, Enzymatic HDL-C 3F070-7142-0Serum (Select 23-271-01 masking) No. CNAS MT0054 第47页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Enzymatic 3F077-7144-0Low density Serum (Select 23-271-01 lipoprotein masking) 18 cholesterol, Enzymatic LDL-C 3F077-7144-0Serum (Select 23-271-01 masking) 3F180-7150-0ImmunoturbidAnalyticSerum 23-061-01 imetry Apolipoprotein al 19 A-1 reagent changes 3F180-7150-0ImmunoturbidSerum 23-061-01 imetry 3F190-7154-0ImmunoturbidAnalyticSerum 23-061-01 imetry Apolipoprotein al 20 B reagent changes 3F190-7154-0ImmunoturbidSerum 23-061-01 imetry 3B160-1352-0EPS Rate Serum 23-271-01 method 3B160-1352-0EPS Rate Serum 23-271-01 method 21 Amylase Analytic al 3B160-1352-0Plasma 4NP-G7 method Instrume22-291-01 nt Model Change DGKC 3B010-1352-0Serum optimized 23-272-01 Creatine assay 22 kinase DGKC 3B010-1352-0Serum optimized 23-272-01 assay 3H030-1352-0CALCIUM-arseSerum 23-271-01 nazo method 3H030-1352-0CALCIUM-arseSerum 23-271-01 nazo method 23 Calcium New CALCIUM-arseAnalytic3H030-1352-0nazo dry Plasma al 22-271-01 chemical Instrumemethod nt Add No. CNAS MT0054 第48页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Phosphorus molybdenum Inorganic 3H040-1352-024 Serum blue method phosphate 23-291-01 of ferrous sulfate Phosphorus molybdenum Inorganic 3H040-1352-024 Serum blue method phosphate 23-271-01 of ferrous sulfate the Same Rate immune Model 5A010-7002-0Serum scatter Analytic23-061-01 Immunoglobulin turbidimetry al 25 G Instrume nt Add and Rate immune 5A010-7002-0Change Serum scatter 23-061-01 turbidimetry the Same Rate immune Model 5A015-7003-0Serum scatter Analytic23-061-01 Immunoglobulin turbidimetry al 26 A Instrume nt Add and Rate immune 5A015-7003-0Change Serum scatter 23-061-01 turbidimetry the Same Rate immune Model 5A020-7004-0Serum scatter Analytic23-061-01 Immunoglobulin turbidimetry al 27 M Instrume nt Add and Rate immune 5A020-7004-0Change Serum scatter 23-061-01 turbidimetry No. CNAS MT0054 第49页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method the Same Rate immune Model 5B023-7260-0Serum scatter Analytic23-061-01 turbidimetry al 28 Complement 3 Instrume nt Add and Rate immune 5B023-7260-0Change Serum scatter 23-061-01 turbidimetry the Same R Rate immune Model 5B024-7266-0Serum scatter Analytic23-061-01 turbidimetry al 29 Complement 4 Instrume nt Add and R Rate immune 5B024-7266-0Change Serum scatter 23-061-01 turbidimetry Follicle 4A010-8216-0Chemilumines30 Serum stimulating 23-051-01 cent hormone, FSH Luteinizing 4A009-8210-0Chemilumines31 Serum hormone, LH 23-051-01 cent 4A007-8224-0Chemilumines32 Prolactin, PRL Serum 23-051-01 cent Analytic al Triiodothyroni4B001-8404-0ChemiluminesInstrume33 Serum ne 23-051-01 cent nt Company Change Analytic al 4B005-8406-0ChemiluminesInstrume34 Thyroxine Serum 23-051-01 cent nt Company Change Analytic al Thyroid 4A014-8204-0ChemiluminesInstrume35 stimulating Serum 23-051-01 cent nt hormone Company Change No. CNAS MT0054 第50页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method 5F016-8502-0Serum CMIA 23-051-01 5F016-8502-0Serum CMIA Hepatitis B 23-051-01 36 surface the same antigen Model 5F016-8502-0AnalyticSerum CMIA 23-051-01 al Instrume nt Add 5F015-1352-0Serum CMIA 23-051-01 5F015-1352-0Serum CMIA Hepatitis B 23-051-01 37 surface the same antibody Model 5F015-1352-0AnalyticSerum CMIA 23-051-01 al Instrume nt Add 5F019-8508-0Serum CMIA 23-051-02 5F019-8508-0Serum CMIA 23-051-02 Hepatitis B e the same 38 antigen Model 5F019-8508-0AnalyticSerum CMIA 23-051-02 al Instrume nt Add 5F015-1351-0Serum CMIA 23-051-02 5F015-1351-0Serum CMIA 23-051-02 Hepatitis B e the same 39 antibody Model 5F015-1351-0AnalyticSerum CMIA 23-051-02 al Instrume nt Add 5F015-1351-0Serum CMIA 23-051-02 Hepatitis B c 40 antibody 5F015-1351-0Serum CMIA 23-051-02 No. CNAS MT0054 第51页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method the same Model 5F015-1351-0AnalyticSerum CMIA 23-051-02 al Instrume nt Add Hepatitis C 5F360-1430-0Chemilumines41 Serum antibody 23-051-02 cent Human Immnnodeficien5F560-1430-042 Serum ELISA cy virus 23-023-04 antibody 5F015-1441-043 HBV-DNA Serum Real-time PCR 23-862-01 5F360-1453-044 HCV-RNA Plasma Real-time PCR 22-875-01 the same Model Prothrombin 2B030-1352-045 Plasma Clot-based Analytictime 22-311-03 al Instrume nt Change the same International 2B030-1352-0Model 46 Normalized Plasma Caculation 22-311-02 AnalyticRatio al Instrume nt Change Actived the same partial 2B020-1352-047 Plasma Clot-based Model thromboplastin 22-311-03 Analytictime al Instrume nt Change Plasma 2B100-7180-048 Plasma Clot-based fibrinogen 22-311-01 No. CNAS MT0054 第52页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method the same Model Analytic al Instrume nt Change Flow White blood 2A010-7682-049 Whole blood Cytometry cell count 19-301-01 Method Analytic al Instrume nt Model Flow Change White blood 2A010-7682-049 Whole blood Cytometry Analyticcell count 19-301-01 Method al Instrume nt Company Change Analytic al White blood Flow Instrumecell 2A010-7682-050 Whole blood Cytometry nt Model differential 19-301-02 Method Change count Analytic al Instrume nt Company Change RF/DC Red blood cell 2A020-7686-0Analytic51 Whole blood Detection count 19-301-01 al Method Instrume nt Model Change No. CNAS MT0054 第53页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Analytic al Instrume nt Company Change RF/DC Detection and 2A050-7684-052 Platelet count Whole blood Flow 19-301-01 Cytometry Method Analytic al Instrume nt Model RF/DC Detection and Change 2A050-7684-052 Platelet count Whole blood Flow Analytic19-301-01 Cytometry al Method Instrume nt Company Change Analytic al Instrume nt Model 2A030-1352-0SLS-Hemoglob53 Hemoglobin Whole blood Change 19-301-01 in Method Analytic al Instrume nt Company Change Mean 2A060-7686-0Analytic54 corpusclar Whole blood Caculation 19-301-01 al volume Instrume nt Model Change No. CNAS MT0054 第54页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Analytic al Instrume nt Company Change Mean 2A070-1352-0Analytic55 corpuscular Whole blood Caculation 19-301-01 al hemoglobin Instrume nt Model Change Analytic al Mean 2A070-1352-0Instrume55 corpuscular Whole blood Caculation 19-301-01 nt hemoglobin Company Change Analytic al Mean Instrumecorpuscular 2A080-1352-056 Whole blood Caculation nt Model hemoglobin 19-301-01 Change concentration Analytic al Instrume nt Company Change RBC Cumulative 2A040-7686-057 Haematocrit Whole blood Pulse Height 19-301-01 AnalyticDetection al Method Instrume nt Model Change No. CNAS MT0054 第55页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Analytic al Instrume nt Company Change Manual Micro 2A160-1351-058 Blood picture Whole blood Examination 34-605-64 Method Urine specific 1A030-1351-0Dry chemistry 59 Urine gravity 03-291-12 analysis 1A010-1351-0Dry chemistry 60 Urine protein Urine 03-291-12 analysis 1A020-1351-0Dry chemistry 61 Urine glucose Urine 03-291-12 analysis 1A080-1351-0Dry chemistry 62 Urine nitrite Urine 03-291-12 analysis Urine 1A050-1351-0Dry chemistry 63 Urine bilirubin 03-291-12 analysis 1A040-1351-0Dry chemistry 64 Urobilinogen Urine 03-291-12 analysis 1A035-1351-0Dry chemistry 65 Urine PH Urine 03-291-12 analysis 1A060-1351-0Dry chemistry 66 Urine ketones Urine 03-291-12 analysis Urine 1A075-1351-0Dry chemistry 67 leucocyte Urine 03-291-12 analysis count Urine occult 1A100-1351-0Dry chemistry 68 Urine blood test 03-291-12 analysis 1A105-1351-0Urine Manual test 03-XXX-02 Urine formed 69 element Analyticanalysis al 1A105-1351-0Flow Urine Instrume03-XXX-01 Cytometry n changes No. CNAS MT0054 第56页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 Examination Analytical ? Sample Type Code Notes Item Method Centrifugal microscopic examination No. CNAS MT0054 第57页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO 15189 认可证书 CNAS-PD20/10-B/2 No. CNAS MT0054 第58页 共58页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.