ISOIEC17025认可证书CNAS-PD1906-.doc

中国合格评定国家认可委员会实 验 室 认 可 证 书 附 件 (No. CNAS L4011)名称：中国医学科学院皮肤病研究所检测实验室地址：江苏省南京市蒋王庙街12号签发日期：2009年04月17日 有效期至：2012年04月16日附件1-1 认可的检测能力范围序号产品/产品类别项目/参数领域代码检测标准（方法）名称及编号（含年号）限制范围说明序号名称1尿液及分泌物1淋球菌的分离鉴定0703.04淋病诊断标准WS268-2007 附录AA.2.2，A.2.32淋球菌药物敏感性试验0703.06全国性病监测方案（试行），附件5，5.4（2007年）3淋球菌核酸检测0703.05性传播疾病的实验室诊断（2001年）第八章，十三4生殖道沙眼衣原体培养鉴定0703.04性传播疾病的实验室诊断（2001年）第十二章，四5生殖道沙眼衣原体抗原检测0703.05性传播疾病的实验室诊断（2001年）第十二章，六6生殖道沙眼衣原体核酸检测0703.05性传播疾病的实验室诊断（2001年）第十二章，九7支原体培养鉴定0703.04性传播疾病的实验室诊断（2001年）第十三章，四、五8阴道毛滴虫培养鉴定0704.01性传播疾病的实验室诊断（2001年）第十八章，三、四2血液1非梅毒螺旋体抗原血清试验0703.05梅毒诊断标准WS2732007 附录A A2.12梅毒螺旋体抗原血清试验0703.05梅毒诊断标准WS2732007 附录AA2.23生殖器疱疹病毒抗体检测0705.01性传播疾病的实验室诊断（2001年）第十四章，八只用ELISA法4HIV筛查试验0705.01全国艾滋病检测技术规范（2004年版），第二章5.1艾滋病和艾滋病病毒感染诊断标准WS293-2008附录A（A1.1）5HIV确证试验0705.03全国艾滋病检测技术规范（2004年版）第二章5.2只用免疫印迹法艾滋病和艾滋病病毒感染诊断标准WS293-2008附录A,A1.23消杀产品1梅毒螺旋体制动试验0107.07新药(西药)临床前研究指导原则汇编,梅毒螺旋体体外法，制动试验 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENTAPPENDIX OF LABORATORY ACCREDITATION CERTIFICATE(No. CNAS L4011)NAME: Chinese Academy of Medical Sciences & Peking Union Medical College Institute of Dermatology Testing LaboratoryADDRESS：No.12, Jiangwangmiao Street, Nanjing, Jiangsu, ChinaDate of issue: 2009-04-17 Date of expiry: 2012-04-16APPENDIX1-1 LIST OF ACCREDITED TESTING SCOPEName of Products，Type of materialsItems, Parameter,Types of testsCode of fieldName， Code of Specification, Standard or method usedRestriction orlimitationNoteName1Urine and secretions1Isolation and Identification of gonococcus0703.04Diagnostic criteria of gonococcus WS268-2007 Appendix A A.2.2, A.2.32Antimicrobial susceptibility test of gonococcus0703.06National surveillance schema of Sexually Transmitted Diseases （Preoperation）Appendix 5 ,5.4（2007）3Nucleic acid test ofgonococcus0703.05Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 8,4Cultivation and identification of Chlamydia trachomatis0703.04Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter12,1Urine and secretions5Antigens test of Chlamydia trachomatis0703.05Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 12,VI6Nucleic acid test of Chlamydia trachomatis0703.05Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 12,IX7Cultivation and identification of mycoplasma0703.04Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 13,8Cultivation and identification oftrichomonas vaginalis0704.01Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 18,2Blood1Non-treponemal tests0703.05Diagnostic criteria of treponema pallidum WS273-2007,Appendix A ,A2.12Treponemal tests0703.05Diagnostic criteria of treponema pallidum WS273-2007,Appendix A,A2.23Antibody test of herpes genitalis0705.01Laboratory Diagnosis of Sexually Transmitted Diseases (2001) Chapter 14,Accredited only for ELISA4Screening test of HIV0705.01National Guideline for Detection of HIV/AIDS (2004) Chapter 2，5.1Diagnostic criteria for HIV/AIDS WS293-2008Appendix A1.15Confirmation test of HIV0705.03National Guideline for Detection of HIV/AIDS (2004) Chapter 2，5.2Accredited only for western blottingDiagnostic criteria for HIV/AIDS WS293-2008Appendix A1.23Disinfection Product1Treponemal immobilization test0107.07Guideline principlae assemble for preclinical study of new drug (western drug) ,In vitro test killing effect against treponema pallidum, immobilization test 中国合格评定国家认可委员会实 验 室 认 可 证 书 附 件 (No. CNAS L4011)名称：中国医学科学院皮肤病研究所检测实验室地址：江苏省南京市蒋王庙街12号签发日期：2009年04月17日 有效期至：2012年04月16日附件2 认可的授权签字人及其授权签字领域序号姓 名授权签字领域备 注1尹跃平全部检测项目2施美琴除HIV确证试验外的全部检测项目 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENTAPPENDIX OF LABORATORY ACCREDITATION CERTIFICATE(No. CNAS L4011)NAME: Chinese Academy of Medical Sciences & Peking Union Medical College Institute of Dermatology Testing LaboratoryADDRESS：No.12, Jiangwangmiao Street, Nanjing, Jiangsu, ChinaDate of issue: 2009-0