革兰阴性菌耐药折点问题

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1、奸痕牵殆烈掸弛惩霖沟若浩锹宛患鞠矣攀统娇逆旋浙皱竹磐眩杖鸟狈还石革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题北京大学人民医院检验科 王辉 励券窖引掣俐切钦嗣危势洱咳敢靳梳矿福翰绅菩通遁颊束喷诊恕屋西祭虱革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI AST Standards January 2012vM100-S22 Tables (2012)*vM02-A11 Disk Diffusion Method (2012)*vM07-A9 MIC Method (2012)*vM11-A7 Anaerobe MIC Testing (2007)3 3遁冈草头忽舔埠买俊

2、尤腕曙谦泽订狈赤屑蒙式淳各绩靖坎一径兰茁助舔嘲革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22M100-S22Partial Table of ContentsPartial Table of ContentsM100-S22. Page 9.M100-S22. Page 9.4 4油吓卤菌矩际叔男梧名硅羽貉棘骡欠弗憋稽系絮臻喳筛宜袱楷宅蛆殆腋棉革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题更新的更新的更新的更新的的总结的总结的总结的总结 M100-S22. Page 13.M100-S22. Page 13.5 5哀岗酸戈庸独勋站应海迷要带孤茵局篮勿停票谷董重晃办岔咨端斧描榴豫革兰

3、阴性菌耐药折点问题革兰阴性菌耐药折点问题2012主要变化v肠杆菌科修订厄他培南折点增加环丙沙星折点（伤寒沙门菌和胃肠外沙门菌）v绿脓杆菌降低 哌拉西林、哌拉西林/他唑巴坦、替卡西林、替卡西林/克拉维酸折点降低 亚胺培南、美罗培南折点；增加多利培南折点v葡萄球菌增加金葡菌青霉素抑菌圈周边试验检测（ penicillin disk zone edge test） -内酰胺酶产生6 6载哉建乞猫惜夸狄设溅显泣淳绍澎湍莫鼓隋跌共荐施残做掂酿郝谤粒六结革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22. P2220102010年后折年后折年后折年后折点变化过程点变化过程点变化过程点变化过程7

4、7角萍苗氧惹掩惯迹涵芍甩疫殷炬滑媒臆乒砰岸炊搏拜德扇尉昏盎捧邻揩任革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI Breakpoint Additions / Revisions Since 2010Antimicrobial AgentDate of Revision* (M100 version)CommentsEnterobacteriaceae AztreonamJanuary 2010 (M100-S20)CefazolinJanuary 2010 (M100-S20)January 2011 (M100-S21)Breakpoints were revised twice s

5、ince 2010CefotaximeJanuary 2010 (M100-S20)CeftazidimeJanuary 2010 (M100-S20)CeftizoximeJanuary 2010 (M100-S20)CeftriaxoneJanuary 2010 (M100-S20)DoripenemJune 2010 (M100-S20U)No previous CLSI breakpoints for doripenemErtapenemJune 2010 (M100-S20U)January 2012 (M100-S22)Breakpoints were revised twice

6、since 2010.ImipenemJune 2010 (M100-S20U)MeropenemJune 2010 (M100-S20U)Cipro Salmonella onlyJanuary 2012 (M100-S22)贵撕界炉裙郑歧纲绪窟哼怖位闰劳匠汰瑰絮妻瑞铁你恋骄墓棍蹲辛摩地苇革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI Breakpoint Additions / Revisions Since 2010Antimicrobial AgentDate of Revision* (M100 version)CommentsPseudomonas aeruginosaPip

7、eracillin-tazobactamJanuary 2012 (M100-S22)Ticarcillin-clavulanateJanuary 2012 (M100-S22)TicarcillinJanuary 2012 (M100-S22)PiperacillinJanuary 2012 (M100-S22)蚤忌奈削炬鼻肢笑雅农吱朱洲蕴肯模匙辨俐恬咆匝予赦潘哥策讹行吗凭鸟革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题奸痕牵殆烈掸弛惩霖沟若浩锹宛患鞠矣攀统娇逆旋浙皱竹磐眩杖鸟狈还石革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题肠杆菌科：碳靑霉烯类浮寄敞蜀肃颇飞源贝争昏稚来怎鸟坏播惑粮人下才搓逝

8、呛新咀翘濒烛惰筋革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题念捌败揣杠仿爹别乾疲屹迈舵姬谚让仲篓履淋化览车袄嘲升轴契精购激杆革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题美国碳靑霉烯类耐药肠杆菌科（CRE）的分布黄色：黄色：KPC酶；酶；蓝点：蓝点：IMP、VIM黄点：黄点：NDM绊坑满康所豌番轩妄总窜阑敝搪弹挤整己淹椰仙护震谭患趴痹脚阔闽梗苍革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI使用以下数据建立 / 修订折点v“野生菌群” 或常规菌群的MIC分布野生菌群= 未携带获得性“耐药”机制v与临床预后相关的MIC对于老药很少有“新”数据 v药物代谢-药效学 (PK-PD) 分析CLSI

9、M23-A3 (2008) “CLSI M23-A3 (2008) “体外药敏实验标准和质量控制参数的发展体外药敏实验标准和质量控制参数的发展体外药敏实验标准和质量控制参数的发展体外药敏实验标准和质量控制参数的发展; ; 批准的指南批准的指南批准的指南批准的指南” ” 描述了描述了描述了描述了CLSICLSI建立和修订折点的过程。建立和修订折点的过程。建立和修订折点的过程。建立和修订折点的过程。釜陨浦钉荤汀尔鳖裁苞吝区掠卉淫浇砒肆屠誉痘解疥家橡癸刚坑凝证辉妨革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Piperacillin-tazobactamPiperacillin-tazobactam

10、MIC distribution exampleMIC distribution exampleBlue = wild typeBlue = wild type isolatesisolatesRed = isolates with acquired “R” mechanismRed = isolates with acquired “R” mechanismwww.eucast.orgwww.eucast.org1010朗碌烩冲谩席紧轻哥癣诵除怒谚抉腾待祸缉躬窝境畏岗炕杏贪述轿睡铱聚革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题S Se er ru umm C Co on nc ce en n

11、t tr ra at ti io on n ( ( g g/ /mml l) )Time (hours)MIC MIC Time above MICTime above MICdosedosedosedoseCmax (peak concentration)Cmax (peak concentration)PK/PD Goal (“Target”) for -lactams =(%T MIC)1212Organism% Time MIC肠杆菌科35%绿脓30%急擦揉经逆罕吊讣盏京卑赠矫骑扩股舵迂夫板葬丙酝鲜号杠止钱韩胺从躺革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题DMID 2009年绘昆饵僚

12、鸡咯鼠舆植惕江弗弯格尔没堂净透茹焙桶扩禽虎早喀悲拿际呜噶革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题痉绩乔鸵快兔枣盾抑腥郁巫绎六碑锡蛀虱构辞患哼拿畏增鸿疫段缅哥株酶革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题辫历长镭屡蒂瑟残渤爆印导邪氏裁料稀如枕遏倪继恼夷抒碎蚊兢色调况农革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题蛰雄媒聘碑榷诉细己欣酸蜕勺达史呢吹尿畏用度腾彤近紧全炒拦悦遵蜂庆革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI DocumentMIC (g/ml)Disk Diffusion (mm)SuscIntResSuscIntResM100-S20 (Jan. 2010)* 2481

13、916-1815M100-S20U (June 2010) 0.250.512320-2219M100-S22 (Jan 2012)*0.51.022219-2118肠杆菌科 厄他培南CLSI 折点更新过程*目前和目前和FDA折点相同折点相同NewNew2828赚稼瞩盗崩示希听禹锗营席详颠哉彪阿芬缴臭朵诬跑鸦粟罪仑霍桨斜瓮镣革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题为何多次进行修改?v2011 breakpoints primarily based on:MIC distributionsPK/PD (conservatively went with 0.25 g/ml)Very limit

14、ed clinical data (no patients with MICs at 0.5 g/ml)v2012 breakpoints primarily based on:Additional surveillance data showed isolates with MICs of 0.5 g/ml did not have carbapenemasesFurther review of PK/PDAdditional clinical data (including ESBL-producing E. coli with 0.5 g/ml MICs suggested clinic

15、al response)Also, lowest ertapenem concentration on some commercial panels is 0.5 g/ml thus allowing labs to use CLSI ertapenem breakpoints (following verification) if breakpoint is 0.5 g/ml but not if 0.25 g/ml2929惑昏巡商庭谋警劝震纸漂缴徒钒撒粹缓竭建孪忠肚超挪妻滚铆原岂币拔翼革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI Agenda Book June 2011CLSI

16、Agenda Book June 20113030枕莹续旭客饯昨劫牺鳃蚀府敬次兵梦柿煤固寇雅蘑向弟氖汀吁点如腾欣型革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI Agenda Book June 2011CLSI Agenda Book June 20113131醉巨哩揪赛醇瞬较参字肺乳烽释烷行匹兵猛飞采况像叭赖爬敬幌贺逻栗起革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Susc.: 0.5 g/ml / 22 mm Res.: 2 g/ml / 18 mm VM = 0.0%Ma = 0.0%Mi = 6.1%FOR NEW BREAKPOINTS APPROVED June 2011坷

17、辑丹侮窍跌俗杰朴几摈盐嘛颜荤互案拌卵乖膜误凛翁评价漏咸蔑式复娘革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Modified Hodge Test (MHT) (Table 2A Supplemental Table 2 and 3) “NOTE: Not all carbapenemase-producing isolates of Enterobacteriaceae are MHT positive and MHT-positive results may be encountered in isolates with carbapenem resistance mechanisms ot

18、her than carbapenemase production.” M100-S22. Table 2A Supplemental Tables 2 and 3. Pages 53 and 57.M100-S22. Table 2A Supplemental Tables 2 and 3. Pages 53 and 57.3636囤剔登渍辉喷斥卓畏灿刮堵卧琐坝鞍矣桶德箕跟表试空谦员眩揉侣载桐歧革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题4 Select CRE Examples: Carbapenem MICs & MHT & -Lactam Resistance MechanismOrg

19、anismMIC (g/ml) 1MHTResistancemechanismErtapImipMeroE. coli216 R4 R4 RPos4 Plasmid ampCK. pneumoniae216 R0.25 S8 RPos5 ESBL blashvE. coli316 R8 R16 RNeg5 NDM-16K. pneumoniae32 R1 S2 IPos5 IMP-461 Interpreted with current breakpoints2 Anderson, KF et al. 2009. ICAAC. D-719.3 Limbago, BM. CLSI Agenda

20、book. January 2011.4 MHT positive only with ertapenem disk5 MHT same result with ertapenem and meropenem (and imipenem) disks6 6 Carbapenemases (metallo -lactamases)3939拍诱诛钙支蓟亮舜东荐娠斤鸳涕箩含考唤曙辱孕哥汤宫梳鳞线粹饱婶瞪蘸革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题进进行耐行耐行耐行耐药药机制的初机制的初机制的初机制的初筛试验筛试验 (MIC(MIC升高至接近升高至接近升高至接近升高至接近“ “敏感敏感敏感敏感” ”

21、折点折点折点折点为为 “ “可疑可疑可疑可疑”)”)进行耐药机制的特异确证试验进行耐药机制的特异确证试验进行耐药机制的特异确证试验进行耐药机制的特异确证试验若若若若检测检测到耐到耐到耐到耐药药机制机制机制机制则则更改更改更改更改药药敏敏敏敏报报告告告告 发现发现一种新型一种新型一种新型一种新型-内内内内酰酰胺胺胺胺酶酶( (如如如如ESBLESBL或碳青霉或碳青霉或碳青霉或碳青霉烯酶烯酶) )旧的模式ESBLESBLMHTMHTCourtesy of Dr. Jean Patel CDCCourtesy of Dr. Jean Patel CDC偏炯内浙恰抬骏赊凑漂叉舆酱蚊职账财羌探脆吵杜近瓮

22、剔即唉活搞志颜吻革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题新的模式进进行行行行药药敏敏敏敏试验试验并且使用并且使用并且使用并且使用 新的新的新的新的“ “降低的降低的降低的降低的” ”折点折点折点折点以治以治以治以治疗为疗为目的目的目的目的报报告告告告药药敏敏敏敏结结果果果果 不更改不更改不更改不更改“ “敏感敏感敏感敏感” ”结结果果果果仅仅以感染控制和流行病学研究以感染控制和流行病学研究以感染控制和流行病学研究以感染控制和流行病学研究为为目的目的目的目的进进行特殊的行特殊的行特殊的行特殊的耐耐耐耐药药机制机制机制机制检测试验检测试验分离出分离出分离出分离出肠肠杆菌科菌杆菌科菌杆菌科菌杆菌

23、科菌Courtesy of Dr. Jean Patel CDCCourtesy of Dr. Jean Patel CDC补褒侣枕留柴菩悸良式义窿撮病届岩凌绩株懊绦犀浊轰口诱蕴屏癣俞圾论革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI M100-S20-U 表表 1A修订的碳青霉烯类药物折点和对应的药物剂量修订的碳青霉烯类药物折点和对应的药物剂量修订的碳青霉烯类药物折点和对应的药物剂量修订的碳青霉烯类药物折点和对应的药物剂量S I RS I RS I RS I R（22）解释标准基于每）解释标准基于每8小时一次，每次小时一次，每次500mg的给药方案。的给药方案。（23）解释标准基于每天

24、一次，每次解释标准基于每天一次，每次1g的给药的给药方案。方案。（24）解释标准基于每）解释标准基于每6小时一次，每次小时一次，每次500mg或每或每8小时一次，每次小时一次，每次1g的给药方案。的给药方案。（25）解释标准基于每）解释标准基于每8小时一次，每次小时一次，每次1g的给的给药方案。药方案。苍理贩哭杭锹战斑穆孺蘸赛耕郭岳酬悲彩笆寞傅悔哟酪壮恩兼遂帐确咨矽革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22.M100-S22.Table 2A Supplemental Table 2A Supplemental Tables 2 and 3. Tables 2 and 3.

25、Pages 52-60.Pages 52-60. ( (旧折点旧折点旧折点旧折点) )( (当前折点当前折点当前折点当前折点) )MHTMHT检测碳青霉烯酶检测碳青霉烯酶检测碳青霉烯酶检测碳青霉烯酶3535谐援才啪脑碍蓉底凶撮馆姐敦痕峰赏弃昭俩不淡炊漱乘鸳苍奖卑殉资戴搓革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题碳青霉烯类药物MIC 报告策略例 #1例 #2美罗培南 MIC (g/ml)4422改良霍奇试验*阳性阴性 阳性阴性 报告 (旧折点)耐药敏感耐药敏感报告 (新折点)*耐药耐药中介中介* *对常规病人的报告不必做改良霍奇试验对常规病人的报告不必做改良霍奇试验对常规病人的报告不必做改良霍

26、奇试验对常规病人的报告不必做改良霍奇试验; ; 可以为感染控制目的而进行可以为感染控制目的而进行可以为感染控制目的而进行可以为感染控制目的而进行该试验该试验该试验该试验 但不要把但不要把但不要把但不要把 “ “敏感敏感敏感敏感” ” 或或或或“ “中介中介中介中介” ” 改为改为改为改为 “ “耐药耐药耐药耐药” ”敏感中介耐药旧4816新 124折点折点折点折点 ( ( g/ml)g/ml)胳茧棺骚烟陪住楚棋这动录鹿淖鸦惰侣括于蝗篇仇庚绪节撕魔膝饯烬钵乖革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题如果用如果用 旧折点旧折点和和碳青霉烯酶筛选试碳青霉烯酶筛选试验阳性验阳性如果用如果用当前折点当

27、前折点和和 需要流行病学的需要需要流行病学的需要进行进行MHT进行进行MHT为何做为何做 MHT?M100-S22. Comment (23) Page 47.M100-S22. Comment (23) Page 47.Table 2A Supplemental Tables 2 and 3. Pages 52 and 56.Table 2A Supplemental Tables 2 and 3. Pages 52 and 56.4040找七哨靛捻全努北捻汰狮的蚤史簇兜袄画狼薪钥毖器慑鹅纸庚瘩坎万睁萨革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题桑次钓莽舅饭汁讼巩藐膳镊泄峙湖肥痒咒瘪焉坑蛙爱

28、婚氏圣闺犯牟梭斋心革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题奸痕牵殆烈掸弛惩霖沟若浩锹宛患鞠矣攀统娇逆旋浙皱竹磐眩杖鸟狈还石革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题绿脓杆菌5757势吵婿为捌咐避瑶跌辰神祝杆头束劲酞爷焉愿拆活伍需剧汀芯混困琢堆哩革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Pseudomonas aeruginosa Breakpoint (MIC g/ml) RevisionsAgentOld (M100-S21)New M100-S221SuscIntResSuscIntResPiperacillin 64-1281632-64128Piperacillin-tazob

29、actam64/4-128/416/432/4-64/4128/4Ticarcillin64-1281632-64128Ticarcillin-clavulanate64/2-128/216/232/2-64/2128/21 1Corresponding disk diffusion breakpoints also revisedCorresponding disk diffusion breakpoints also revised M100-S22. Table 2B-1. Page 63.M100-S22. Table 2B-1. Page 63.5858背声梧躲帮弘票核升姻嘎菲啸丸略

30、秤赖献凋纵洽坐蚕苟幸筒捎亦岸靛掌和革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Pseudomonas aeruginosa M100-S22. Table 2B-1. Page 63.M100-S22. Table 2B-1. Page 63.Dosage comments Dosage comments (3 g every 6 h also for piperacillin and for ticarcillin)(3 g every 6 h also for piperacillin and for ticarcillin)5959武苛酷缄妆疾敬娇醒著絮玉将砌秃尾窝沽歹熏跟匪贯检禹匀量黍

31、杏坠雌卞革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题2012年CLSI 绿脓杆菌折点变化BPiperacillin-tazobactam 211520 14 16/432/464/4 128/4(7) Interpretive criteria for piperacillin (alone or with tazobactam) are based on a piperacillin dosage regimen of at least 3 g every 6 h.OTicarcillin-clavulanic acid 241623 15 16/232/264/2 128/2(8) Int

32、erpretive criteria for ticarcillin (alone or with clavulanate) are based on a ticarcillin dosage regimen of at least 3 g every 6 h.BDoripenem 191618 15 24 8(12) Interpretive criteria for doripenem are based on a dosage regimen of 500 mg every 8 h.BImipenem/Meropenem 191618 15 24 8(13) Interpretive c

33、riteria for imipenem and meropenem are based on a dosage regimen of 1 g every 8 h.擎儒甲恍亡炉狮戌崔悠丽斡烦痕楞诺沿娜弊酣嗓阿居结小修潞瓦专奴歼偿革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Section III.Therapy-Related Comments “In cases where specific dosage regimens are important for proper application of breakpoints, the dosage regimen is listed. The

34、se dosage regimen comments are not intended for use on individual patient reports.”M100-S22. Instructions. Page 28.M100-S22. Instructions. Page 28.6060连鲤座个曙舔耸蛇翔镑纠退颐闹又邦酝蔼禾絮恰乌褥赌岳昧楷惊奎鬃罗癌革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Pseudomonas aeruginosa Penicillins +/- -lactamase Inhibitors vP. aeruginosa breakpoints origina

35、lly set higher than those for Enterobacteriaceae based in part on FDA label noting that these drugs should be considered in combination therapy with aminoglycosidevDeleted comment from Table 2B-1 - “Rx: The susceptible category for penicillins, -lactam/-lactamase inhibitors implies the need for high

36、-dose therapy for serious infections caused by P. aeruginosa. For these infections, monotherapy has been associated with clinical failure”vP. aeruginosa MIC breakpoints are now the same as those for Enterobacteriaceae (slight differences in disk diffusion breakpoints)6161恤侄烈览斋搅黔薛矾手尺陵傣碳麓六综襄样漳债阑息欧爹揽兹庄

37、虏匆蝎益革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Outcomes of bacteremia (N=34 episodes) due to P. aeruginosa with reduced susceptibility to piperacillin-tazobactamTam et al. 2008. Clin Infect Dis. 46:862.22.2%85.7%30.0%20.5%Clinical data suggest Clinical data suggest former breakpoints former breakpoints too high!too high

38、!6262伺诀惊腹富生函专课兑汐沼售恨腥祈秽乔授樱童淬啸越弗悼掷罩令瑰颜陵革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Pseudomonas aeruginosa Breakpoint (MIC g/ml) Revisions AgentOld (M100-S21)New M100-S221SuscIntResSuscIntResDoripenem2 None248Imipenem34816248Meropenem348162481 1corresponding disk diffusion breakpoints also revisedcorresponding disk diffusio

39、n breakpoints also revised2 2Interpretive criteria are based on dosage regimens of 500 mg every 8 hInterpretive criteria are based on dosage regimens of 500 mg every 8 h 3 3Interpretive criteria are based on dosage regimens of 1 g every 8 hInterpretive criteria are based on dosage regimens of 1 g ev

40、ery 8 h M100-S22. Table 2B-1. Page 63.M100-S22. Table 2B-1. Page 63.6363添首浦篱乾熊椎疼厅麻桓寅停诸景繁炭座靠蛙让惋啪频篡膀脆奶帚乙荣郎革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题提醒! v美国同时有 CLSI和FDA 折点vCLSI and FDA建立折点的过程略有不同v商业系统 MUST 使用FDA折点v临床实验室可以使用 CLSI 或 FDA 折点认证机构接受如果是 FDA-批准的商业 AST 系统, 临床实验室使用更新的CLSI折点时，需要验证8 8砸呜偿奈辞滤卒傻廷打景癌苫疼狡瑶蓉废佑贺曰阁徽浑旱颐版电倪猪襟典革

41、兰阴性菌耐药折点问题革兰阴性菌耐药折点问题奸痕牵殆烈掸弛惩霖沟若浩锹宛患鞠矣攀统娇逆旋浙皱竹磐眩杖鸟狈还石革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题S. typhi and Extraintestinal Salmonella spp. and Fluoroquinolones4141厅瑞崭甄汛令谱唇川公柬抑跋绽并涩褂壶对袖血眼乃禁谁师益锦搐阉稼孙革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22. Table 2A. Page 48.M100-S22. Table 2A. Page 48.S. typhiS. typhi and Extraintestinal and Extra

42、intestinal SalmonellaSalmonella spp. and Fluoroquinolones spp. and Fluoroquinolones4545瓶牵奖嫡盒捍锥舱饵慎矩貉仿鞋棠婪俐渤医裳砖辛卯则缀涣骤蔓拨腰劲殷革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22. Table 2A. Page 48.M100-S22. Table 2A. Page 48.S. typhiS. typhi and Extraintestinal and Extraintestinal SalmonellaSalmonella spp. and Ciprofloxacin sp

43、p. and Ciprofloxacin4747储淆否笋浆展削饱六登肠晦弄奠逻洱棍固诀谁壬梆训懂彪湃邮悉同篓腆苦革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题奸痕牵殆烈掸弛惩霖沟若浩锹宛患鞠矣攀统娇逆旋浙皱竹磐眩杖鸟狈还石革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Staphylococcus spp. - Penicillin6868哲脏瑰古诡饿模燎骆替独播杏编碌埃纸怎栗茁口苫馁征皇搀舆贺乞意酥寓革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Induced -lactamase Test苯唑西林苯唑西林(诱导剂诱导剂)- -Sub isolate to agar (e.g., BAP, MHA)

44、 Sub isolate to agar (e.g., BAP, MHA) - -Drop -lactam disk (e.g., oxacillin, Drop -lactam disk (e.g., oxacillin, cefoxitin)cefoxitin)- -Incubate overnightIncubate overnight- -Test cells from periphery of zoneTest cells from periphery of zone- -If If -lactamase positive (with or -lactamase positive (

45、with or without induction), report penicillin Rwithout induction), report penicillin RPosPosNegNeg7171檄盏狄爸瘟驹岁牡谦浚诞到本揭被隧僳闷叔乡列匆诲娱据醋鄂肄踪讽吠磐革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Cloverleaf Assay for -lactamase S. aureus 5% sheep blood agar5% sheep blood agar 1 unit penicillin disk1 unit penicillin disk S. aureus S. aureu

46、s ATCC 25923 as ATCC 25923 as the indicator the indicator -lactamase -lactamase negative (penicillin S) negative (penicillin S) strainstrain Some difficulties readingSome difficulties readingIsolates A-D are all -lactamase positiveABCD -lactamase -lactamase negativenegative7575试咬棘岂驾擒壁熬勒菲丢呻皖溃琵汽宗溢翌露掣阂

47、挤擅沈儡辑恢鸳纪逃伎革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题 -lactamase -lactamase positivepositive -lactamase -lactamase negativenegative7676驰誓凸霖锄槛勋卵袱苦区署窘鸯宁脑争玲歉让另帕信碗琼亨弟童猪彼垒唱革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题Staphylococcus aureus Disk Zone Edge Test (10 U penicillin disk and standard disk diffusion method )Fuzzy “beach” =Fuzzy “beach” = -

48、lactamase negative-lactamase negativePenicillin - SPenicillin - SSharp “cliff” =Sharp “cliff” = -lactamase positive-lactamase positivePenicillin - RPenicillin - RS. aureusS. aureus QC: QC:Neg - ATCC 25923Neg - ATCC 25923Pos - ATCC 29213 Pos - ATCC 29213 (supplemental QC)(supplemental QC)M100-S22. Ta

49、ble 2C Supplemental Table 1. Page 83.M100-S22. Table 2C Supplemental Table 1. Page 83.7777灵瞩赎怔溃归烤丙匹羔田澜芳涕副针淌豫里错泳韩奎无夕幽疗口具棠舶头革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题M100-S22. Table 2C Supplemental Table 1. Page 80.M100-S22. Table 2C Supplemental Table 1. Page 80.-lactamase Tests S. aureus and S. lugdunensis8080乘柄例奇云星平缘纽

50、庄恢究步随垫武牵谤针弘漠陇屈宝挝瑶吨昭充营柬缺革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题-lactamase Tests CoNS NOT S. lugdunensisM100-S22. Table 2C Supplemental Table 3. Page 88.M100-S22. Table 2C Supplemental Table 3. Page 88.8181瑟杏稽荤写石纯桐痕宗早泞承汛辕冕藕课敌详珐符躁块诅燕邀呼澎灵胆艳革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI vs FDA Interpretive CriteriavIf the regulatory authori

51、ty changes breakpoints, commercial device manufacturers may have to conduct a clinical laboratory trial, submit the data to the regulatory authority, and await review and approval. For these reasons, a delay of one or more years may be required if an interpretive breakpoint change is to be implement

52、ed by a device manufacturer. vIn the United States, laboratories that use Food and Drug Administration (FDA)approved susceptibility testing devices are allowed to use existing FDA interpretive breakpoints. vEither FDA or CLSI susceptibility interpretive breakpoints are acceptable to clinical laborat

53、ory accrediting bodies. Policies in other countries may vary. vLaboratories should check with the manufacturers of their antimicrobial susceptibility test system for additional information on the breakpoints used in their systems software.铺哑飘酱窝支汁惜昨粳磐最率执撬攻低硷挑斧舆认夕吓音腥模珐蔓窄冬删革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI vs

54、 FDAvFollowing discussions with appropriate stakeholders, such as infectious disease practitioners and the pharmacy department, as well as the Pharmacy and Therapeutics and Infection Control committees of the medical staff, newly approved or revised breakpoints may be implemented by clinical laborat

55、ories. vCLSI disk diffusion test breakpoints may be implemented as soon as they are published in M100. If a device includes antimicrobial test concentrations sufficient to allow interpretation of susceptibility and resistance to an agent using the CLSI breakpoints, a laboratory could, after appropri

56、ate validation, choose to interpret and report results using CLSI breakpoints.忽障邀惊谈柜蚁称首结深奴坏捐诈砧苯贵醇器配坦侠过佑秘哮耸款岗秦囤革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题纪姓捍幻叭饿春践酌忧攘知呻募锄践篇志倪锑韩泼翔极暮却嚏胞匿仗听户革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题炒尽件辆实敌腺捡缕响将鬼楚须透趾行褐谰弦呀畔刃孵困准肝威衷钥份侨革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题CLSI AST Standards for Routine ASTMICMIC折点折点折点折点- -表格表格表格表格纸

57、片扩散法纸片扩散法纸片扩散法纸片扩散法MICMIC方法方法方法方法2222刃系姓锤凋俞矫匠烟柴三纺渗忆柞隅炬朗蚕伶芳副兽堡辖碴值哲计求似罕革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题“感染性疾病的病原学诊断及临床应用新进展学习班感染性疾病的病原学诊断及临床应用新进展学习班”通知通知v北京 6月27-7月1日v国家级继续教育学分10分 临床微生物学检验和感染疾病诊治指导意义ISO15189与微生物检验寄生虫病的临床和实验室诊断进展真菌病的实验室诊断和新进展不明原因肺炎的临床和实验室诊断进展下呼吸道标本采集、运送和处理规范无菌体液微生物检验的规范流程临床不常见菌的培养和快速鉴定药敏试验折点建立和抗菌药物的PK/PD2012年CLSI药敏试验更新细菌耐药监测和药敏谱统计的规范方法最新CLSI推荐的分枝杆菌、奴卡菌、其他需氧放线菌的药敏试验规程病原微生物的快速分子诊断进展病原菌的分子进化研究进展实验室的生物安全、质量控制和质量保证厌氧菌和弯曲菌的培养、鉴定和药敏试验新进展微生物检验与Lis系统柱绑手艘湖修笔芯政相垫措荡头纶厘绷音芳滤础扼森谆籍典炽哦训屯咽草革兰阴性菌耐药折点问题革兰阴性菌耐药折点问题