ISOIEC17025認(rèn)可證書CNAS-PD1906-

1、ISO/IEC 17025 認(rèn)可證書 CNAS-PD19/06-A/1 中國(guó)合格評(píng)定國(guó)家認(rèn)可委員會(huì)實(shí) 驗(yàn) 室 認(rèn) 可 證 書 附 件 (No. CNAS L4011)名稱：中國(guó)醫(yī)學(xué)科學(xué)院皮膚病研究所檢測(cè)實(shí)驗(yàn)室地址：江蘇省南京市蔣王廟街12號(hào)簽發(fā)日期：2009年04月17日 有效期至：2012年04月16日附件1-1 認(rèn)可的檢測(cè)能力范圍序號(hào)產(chǎn)品/產(chǎn)品類別項(xiàng)目/參數(shù)領(lǐng)域代碼檢測(cè)標(biāo)準(zhǔn)（方法）名稱及編號(hào)（含年號(hào)）限制范圍說明序號(hào)名稱1尿液及分泌物1淋球菌的分離鑒定0703.04淋病診斷標(biāo)準(zhǔn)WS268-2007 附錄AA.2.2，A.2.32淋球菌藥物敏感性試驗(yàn)0703.06全國(guó)性病監(jiān)測(cè)方案（試行），附

2、件5，5.4（2007年）3淋球菌核酸檢測(cè)0703.05性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第八章，十三4生殖道沙眼衣原體培養(yǎng)鑒定0703.04性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十二章，四5生殖道沙眼衣原體抗原檢測(cè)0703.05性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十二章，六6生殖道沙眼衣原體核酸檢測(cè)0703.05性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十二章，九7支原體培養(yǎng)鑒定0703.04性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十三章，四、五8陰道毛滴蟲培養(yǎng)鑒定0704.01性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十八章，三、四2血液1非梅毒螺旋體抗原血清試驗(yàn)0703.05梅毒診斷標(biāo)準(zhǔn)WS2

3、732007 附錄A A2.12梅毒螺旋體抗原血清試驗(yàn)0703.05梅毒診斷標(biāo)準(zhǔn)WS2732007 附錄AA2.23生殖器皰疹病毒抗體檢測(cè)0705.01性傳播疾病的實(shí)驗(yàn)室診斷（2001年）第十四章，八只用ELISA法4HIV篩查試驗(yàn)0705.01全國(guó)艾滋病檢測(cè)技術(shù)規(guī)范（2004年版），第二章5.1艾滋病和艾滋病病毒感染診斷標(biāo)準(zhǔn)WS293-2008附錄A（A1.1）5HIV確證試驗(yàn)0705.03全國(guó)艾滋病檢測(cè)技術(shù)規(guī)范（2004年版）第二章5.2只用免疫印跡法艾滋病和艾滋病病毒感染診斷標(biāo)準(zhǔn)WS293-2008附錄A,A1.23消殺產(chǎn)品1梅毒螺旋體制動(dòng)試驗(yàn)0107.07新藥(西藥)臨床前研究指導(dǎo)原則

4、匯編,梅毒螺旋體體外法，制動(dòng)試驗(yàn) 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,

5、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 secretio

6、ns1Isolation 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 ofgonococ

7、cus0703.05Laboratory 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 Diagnos

8、is 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

9、 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 pa

10、llidum 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 WS

11、293-2008Appendix 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 f

12、or preclinical study of new drug (western drug) ,In vitro test killing effect against treponema pallidum, immobilization test 中國(guó)合格評(píng)定國(guó)家認(rèn)可委員會(huì)實(shí) 驗(yàn) 室 認(rèn) 可 證 書 附 件 (No. CNAS L4011)名稱：中國(guó)醫(yī)學(xué)科學(xué)院皮膚病研究所檢測(cè)實(shí)驗(yàn)室地址：江蘇省南京市蔣王廟街12號(hào)簽發(fā)日期：2009年04月17日 有效期至：2012年04月16日附件2 認(rèn)可的授權(quán)簽字人及其授權(quán)簽字領(lǐng)域序號(hào)姓 名授權(quán)簽字領(lǐng)域備 注1尹躍平全部檢測(cè)項(xiàng)目2施美琴除HIV確證試驗(yàn)外

13、的全部檢測(cè)項(xiàng)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: 2009-04-17 Date of expiry: 2