臨床化學(xué)體外診斷試劑(盒)產(chǎn)品技術(shù)審評(píng)規(guī)范(2011版)

1、the party'sfine style, carryforwardt hetraditi onalChinese virtues, practi cingt heSocialist coreval ues,vigorouslycarryforward the spiritofJiaoYulu,HongqiCanalspirita nd spirit of persi stence, hone sty inpoliti cs,stri ctstatesman,sticktothe spirit ualheights ofthe Communi sts. Fourto devoti o

2、n, a s,do playa role inqualifying. OfficialCommuni st duty.Tofulfillt heparty's pur pose,maintai n forthe pe opl ethemse lves,a nd dedi cation,dev otion,maintai n pi oneer, pioneeri ngand enterprisi ngspirit ,activeatt hewell -offextrapractice,make contri butions.The incentive f unctionofpartyor

3、ganizationsatal llevels should givefull playto adva nce d models,establi sha r eprese ntative,adva nceda nd typi cal ofthetimes, and g uide the broadmasse s ofpartymembers toemulate. Inhonorofthe 95 a nniversary offounding as a nopportunityt oawardi n recogniti on ofa number of outstanding partymemb

4、ers'advanced grass -roots party orga nizations,outsta ndi ng partyw orkers, a nd put t he pi oneer trees. Third,the "reform"effortsforexample,besureto cha nge int o. Le arningtoteachEducati on i n ordertosolvethe problem,ifit does not solve t he pr oblem,itwil lform, goesthr oug hthe m

5、oti ons.To strengthenthe consciousnessofproblems and insisted on problem-oriente d,pr oblem-solvi ng lear ning e ducationfortra ction,trulyde ep inve stigation i ntocha nge,modification.Achecked swi ng.Learning e ducat ion pr ogramme for party-building in our cityact uallyproposedt ofocusonsol ution

6、offuzzy ideal sand beliefswave r,consci ousness,purpose oftheparty weaksense,hone styand self-disci pline awarenessis notstr ong, de pressed,sixissue sofethi cal misconductstudycontentsspecific programmesforallpartymembers andleadingca dresa bovethe county levelshallfocus on further refinementtothe

7、problems. Spe cifictoevery partymember andeverycadre,also requiresa combinationofa ctuala ndcontr olled,focused a nd really putyourself in, pe opl e see thi ngs, see,wit h their own specific pr oblemst o learn Constitution Party rules, series, a ddre ss,so pre cisiontofi ndthe problem, laying asolid

8、 foundationforfurthercorre ctive a ction. B t o makecha nge. Forcheck putofpr oblem,t hroug h establishe d rectificati on Taiwa naccount,and takespecialsupervision, andon account PIN,a ppr oach,insisted do si de lear nside modified, andthatknow that modified,whilefocused onput "twolearn ado&quo

9、t; learning education rectificationwit h grasppa rty ofmass line education pra cticea ctivities and"three strictthree real"topiceducation problem rectificationcombined up,consoli dationexpanded has madeofrectification results,stronglycorrected "forofficernotfor",andChia nd endle

10、ss correcte d "fourwind", andregulation massesside ofa buse s,ensure w orkadva ncemore pow erful,and problem solution morecompl etely. Third,we mustconsolidate oura chieveme nts. For morepublic, some partymemberswho focusontheoutsta ndi ng issues,combi ning concentrated臨床化學(xué)體外診斷試劑（盒 ）產(chǎn)品技術(shù)審評(píng)

11、規(guī)范（2011 版）根據(jù)醫(yī)療器械注冊(cè)管理辦法（國(guó)家食品藥品監(jiān)督管理局令第16 號(hào)）的要求并結(jié)合臨床化學(xué)體外診斷試劑（盒 ）產(chǎn)品的特點(diǎn)，為規(guī)范臨床化學(xué)體外診斷試劑 （盒 ）（以下簡(jiǎn)稱試劑（盒）產(chǎn)品的技術(shù)審評(píng)工作，特制定本規(guī)范。一、適用范圍本規(guī)范適用于采用分光光度法原理，利用全自動(dòng)、半自動(dòng)儀器或分光光度計(jì)，在醫(yī)學(xué)實(shí)驗(yàn)室進(jìn)行臨床化學(xué)項(xiàng)目定量檢驗(yàn)所使用的體外診斷試劑（盒 ）。依據(jù) 體外診斷試劑注冊(cè)管理辦法（試行） 臨床化學(xué)體外診斷試劑（盒）管理類別為II類。二、技術(shù)審查要點(diǎn)（一）試劑（盒）命名的原則試劑（盒）名稱由三部分組成：第一部分：被測(cè)物質(zhì)的名稱；第二部分：用途；如測(cè)定試劑盒；第三部分：方法或原理

12、。例：葡萄糖測(cè)定試劑盒（葡萄糖氧化酶法）（二）試劑（盒）的結(jié)構(gòu)組成試劑（盒）的組成形式：?jiǎn)卧噭?，雙試劑，多試劑；試劑盒的性狀：干粉或液體。（三）工作原理試劑（盒）通過各自不同的反應(yīng)原理，最終以比色、免疫比濁或速率方法在具有分光光度系統(tǒng)的儀器上，利用 Lamber-Beer 定律， 即物質(zhì)對(duì)單色光ectificationand strengt hening themanagementofdailyeducation,the spiritofreform shortofthecomplete system,pay cl oseattentiontosystem implementation,rea

13、llymake thepartyorganization and party membere ducationand strictmanagement,solid.Finally,the "urge" workonthe led,be sure to promote efficiency."Two" e ducati on,not one ducationeducati onal, not w orking wit h the Centretwo, must sti ck around theCenter,servi ngthe overallsitua

14、ti on, coordi nate,truly result-oriented andprom ote efficiency.Current andfutureaperiod,totig htlyaround coordinationa dv ance "fouraf ull"strategy layout,winni ngfullbuiltsocietythisa centraland workoverall,put carried out lear ninge ducationa s promoted w orkofimporta ntopportunitiesand

15、 powerfulpowe r,gui de General memberscadres insisteddevel opment first priority, active adapted economi cdevel opm entnew normal, consciouslypra cticeli nefive big development conce pt,effective grasp supplysi de structuralreform, to g uarantees and improved liveli hood, construction morehigh ecolo

16、gi calvitalityhappinessofcit y. Lastyea r,we carryout "three-three" activities asa "three-three" spe ciale ducationim portant,findeducationand effective platform to facilitate thecombination of work.Referencethis agood practi ces,provi ncial,a nd municipaldeci ded i n"two le

17、arn a do" lear ninge ducati on i n the carrie d out "five check fivepromoting",the CountyDistrict units to insistedput "two learna do" learningeducation and "five check fivepromoti ng" organicfusion,andcommon advance,dooneplan layout,and oneorganization im plementa

18、ti on, put carrie d out"twolearna do"situation, and"five checkfive promoting"situati onas partyworkeval uationofimportantContent, asan importantaspectof mutualevaluationon partymembers,testing asanimportant basisforlea ding bodi es andleadi ngcadres 'performance a ndg uidet h

19、ebr oadmasses ofpartymembersand cadre s to studyeducation opensuptothe main economi cand socialdevelopment.At present,the overallsmooth e conomi c operation inourcity, but dow nward pressureis sti ll high,faced a number of chal lengesand tests. Meanw hile ,coincides wit h the city,County andtownship

20、party committeesthisyeargeneralelectionyear,howto really choose loyal,cle an andserves asa goodca dre,irondi sci pline ofGeneral FengQing Qi, Qi, QiShun,swappedout Powerfulgoodsituation,is arealtestforallofus.Generalworkon "two" to studythe effectofeducation inspection,ifthetrueseries ofpa

21、rty rules andConstitution speakswellandtruly becomeaqualifiedparty member,naturallywecan dealwith advance andretreat left turn treatment,proper organizationalarrangements andselection,proper t reatmentofpersonal interests. Toput carried out"twolear n ado" learning e ducationwith doreform d

22、evelopme ntstabletheworkcombined up, a nd seriouslydo Centerwork,a nddailyandjob combine d up,and guarantee s improve d livelihood, and pr omotesocial harmony combined up,a nd complete d thetask combi nedthe party'sfine style, carryforwardt hetraditi onal Chinese virtues, practi cingt heSocialis

23、t coreval ues,vigorouslycarryforward the spiritofJiaoYulu,HongqiCanal spirita nd spirit of persi stence, hone sty in politi cs,stri ctstatesman,sticktothe spirit ualheights ofthe Communi sts. Fourto devoti on, a s,do playa role i nqualifying. OfficialCommuni st duty.Tofulfillt heparty's pur pose

24、,maintai n forthe pe opl ethemse lves,a nd dedication,dev otion,maintai n pi oneer, pioneeri ngand enter prisi ngspirit ,activeatt hewell -offextrapracti ce,make contri butions.T he incentive f unctionofpartyorganizationsatal llevels should givefull playtoadva nce d models,establi sha r eprese ntati

25、ve,adva nceda nd typi cal ofthetimes, a nd g uide the broadmasse s ofpartymembers toemulate. Inhonorofthe 95 a nniversary offounding as a nopportunityt oawardi n recogniti on ofa number ofoutstanding partymembers'advance dgrass -roots party orga nizations, outsta ndi ng partyw orkers, a nd put t

26、 he pi oneer trees. Third,the "reform"effortsforexample,besuretochangeint o. Le arningtoteachEducati on i n ordertosolvethe problem,ifit doe s not solve t he pr oblem,itwil lform, goesthr oug hthe moti ons.To strengthenthe consciousnessofproblemsandinsisted on problem-oriente d,pr oblem -s

27、olvi ng lear ning e ducationfortra ction,trulyde ep inve stigation i ntocha nge,modification.Achecked swi ng. Le arning e ducation pr ogramme for party -buildi ng in our cityact uallyproposedt ofocusonsol utionoffuzzy ideal sand beliefswave r,consci ousness,purpose oftheparty weaksense,hone styand s

28、elf-disci pline awarenessi s notstr ong, de presse d,sixissue sofethi cal misconductstudycontentsspecificprogrammesforallpartymembers andleadingca dresa bovethe county levelshallfocus on further refinementtotheproblems. Spe cifictoevery party memberandeverycadre,also requiresa combinationofa ctuala

29、ndcontr olled,focused a nd really putyourself in, pe opl e see thi ngs, see,wit h their own specific pr oblemst o learn Constituti on Party rules, series, a ddre ss,so pre cisiontofi nd the problem, laying asolid foundati onforfurthercorre ctive a ction. B t o makecha nge. Forcheck putofpr oblem,t h

30、roug h establishe d rectificati on Taiwa naccount,and takespecialsupervision, andon acco unt PIN,a ppr oach,insisted do si de lear nside modified, andthatknow that modified,whilefocuse d onput "twolear n ado" learni ng education rectificati onwit h grasppa rty ofmass line educati on pra ct

31、icea ctivities a nd "three stri ctthree real"topiceducation problem rectificationcombined up,consoli dationexpanded has madeofrectification results,stronglycorrected "forofficernotfor",andChia nd endle ss correcte d "fourwin d",and regulation masse sside ofa buse s,ensu

32、re w orkadva ncemore pow erful,and problem soluti on more compl etely. T hird,we m ustconsolidate oura chieveme nts. For morepublic, some partymembers whofocus on theoutstandi ng issues, combi ning concentrated吸收的強(qiáng)弱與吸光物質(zhì)的濃度（c）和液層厚度（b）間的關(guān)系的定律，對(duì)被測(cè)物質(zhì)進(jìn)行定量分析。（四）產(chǎn)品適用的相關(guān)標(biāo)準(zhǔn)試劑（盒）適用以下相關(guān)標(biāo)準(zhǔn)：1 GB/T 191-2008 包裝儲(chǔ)運(yùn)

33、圖示標(biāo)志；2 YY/T 0316-2008 醫(yī)療器械風(fēng)險(xiǎn)管理對(duì)醫(yī)療器械的應(yīng)用；3 YY 0466-2003 醫(yī)療器械用于醫(yī)療器械標(biāo)簽、標(biāo)記和提供信息的符號(hào)；注：以上標(biāo)準(zhǔn)適用最新版本。（五）產(chǎn)品的預(yù)期用途試劑（盒）的預(yù)期用途應(yīng)體現(xiàn)為對(duì)臨床樣本成分的定量測(cè)量。（六）產(chǎn)品的主要技術(shù)指標(biāo)1 、外觀目測(cè)檢查，符合生產(chǎn)企業(yè)規(guī)定的正常外觀要求。（一般要求試劑無雜質(zhì)、無絮狀物，外包裝完整無破損）。2、凈含量用通用量具測(cè)量，液體試劑的凈含量應(yīng)不少于標(biāo)示值。3、試劑空白1.1 試劑空白吸光度用指定空白樣品測(cè)試試劑（盒），在測(cè)試主波長(zhǎng)下，記錄測(cè)試啟動(dòng)時(shí)的吸光度（A1）和約5分鐘（T）后的吸光度（A2） , A2測(cè)試

34、結(jié)果即為試劑空白吸光度測(cè)定值，應(yīng)符合生產(chǎn)企業(yè)給定范圍。the pays fine -e, cay fwad t he taili onal Cinese v>U- iraji cig the Soci t core val ues, VgorouSy carry for , tI e spi. of Jao Yuu, HongqiCaa a spii a nd spii ."essence, hone sy i poll c, stict saa, s to the s" ua heghts of the Cmmui ss Four to devl on, a s,

35、do ply a roe i n qialyig. Ol l Cmmuni s duty. To ful I the pa",ur pose, matai n for the pe ople temse , and di ca.n, devoin, maitai ng and enter prs ng spii , actVe a t he wel off exa pacttec、E t I n i n orde tsle Ie prb11m.i i doe s not sle t he pr obem, i wi I fm, goes thr oog I the mot ons T

36、o stegghen the cnnciusnss a I d insist* on prbemoriee d pr obllm slvng lar I ig e d_alon fr ta cin, tuy deep ivesgalni ntca nge, modicaton. A chcled sW ng. Le arig e d_algamme fr paybu"I g i ou c" ac uay prpooed t o f_s on soluinof uy iea s and be" <e. cnnci ouses, purpooe of Ie pa

37、y weksene,"one sy ad sefdici plie ennss i a nge For chhck pu of pr obem, t hrog h e blse d ectflat on Ta nucut and a speca lupe - in, and on acc unt PIN, a ppr oac, isistd do si de lea .sie moddfed and ta kow tatmodiid, whie fo - ue d onput "tw lar n a do" leaning ld aton ectflat on w

38、i h ggas pary of ma - line Idu>ton pra ctce a ciliis a nd "thrre sti ctthrre ea" topic educaiin probem rrciicai. combinnd u, cnsol daton exaddd I is mae of recifcaton eiuts stongy corectd "fr ofice not fr", adCiand edemale cntibuions The icet f ucinof payorgaitons a al e soul

39、d ” ful,ay to- nce d models esal s ar eeI atve adda nd a nd ypicaof te times a nd g ude te bra mase s of pary m - bes t-ulae I 95a nnivesay I f fuding - aunity t od i necggit on of a nnmbe of ou ndig pary m - bes '-<an-d gras rots pay orga nizain、 outsand” pary w I rkes a nd pu t I e pionner

40、tees Thid, the "efrm" efrs fr eamplebe lure tca nge int o. Le aning tos not sr ong, de | rese d, sX sse s of ehi ca miconduc stdy cneI s secfc progrrmmes fr al pay m - bes ad eadig cadrs abol t I e cunty e shal f_s on fute r et to the problms Spe cifctey pary m - ber ad evey dre aso rrqurr

41、s a cmb iain of a ctal a nd cnlr oled f_sd a I d e| ut yurelf i, pe I pl e s ti ngs se, wi hter ow specic problms t o lean Consttui on Pay rulesr a dde - s pre teproblm, ayng asld fudat ute cre c a cin. B t o maleIs correced "fur wid", ad rrguain miss sie of a buues, enue w orl ada nce mor

42、e powera ad prblm slui on moe cmpleely TI id m t consliae ou a clment. Fr moe publc sme pay m - bes wo f_s onteou-ndi ng isues cmbi nig connt d1.2 試劑空白吸光度變化率對(duì)于速率法測(cè)試的試劑，用指定空白樣品測(cè)試試劑（盒），在測(cè)試主波長(zhǎng)下，記錄測(cè)試啟動(dòng)時(shí)的吸光度（A1）和約5分鐘（T）后的吸光度（A2）, 計(jì)算出吸光度變化值（A2-A/T）,即為試劑空白吸光度變化率（AA/min）, 應(yīng)不超過生產(chǎn)企業(yè)給定值。4、分析靈敏度試劑（盒）測(cè)試n單位被測(cè)物時(shí)，用

43、已知濃度或活性的樣品測(cè)試試劑（盒），記錄在試劑（盒）規(guī)定參數(shù)下產(chǎn)生的吸光度改變。換算為 n單位吸光度差值（AA）或吸光度變化（AA/min）。應(yīng)符合生產(chǎn)企業(yè)給定范圍。5、線性范圍用超出線性范圍上限濃度（活性）的樣品和超出或等于線性范圍下限濃度（活性）的樣品，混合成至少5個(gè)稀釋濃度（xi）。分別測(cè)試試劑（盒），每個(gè)稀釋濃度測(cè)試3次，分別求出測(cè)定結(jié)果的均值（yi）。以稀釋濃度（xi）為自變量，以測(cè)定結(jié)果均值（yi）為因變量求出線性回歸方程。按公式（1） 計(jì)算線性回歸的相關(guān)系數(shù)（r）。r 二（xX）（yi y）拉（Xi-x）2Z （yi - y）2 i i）稀釋濃度（xi）代入求出線性回歸方程，計(jì)算

44、yi的估計(jì)值及yi與估計(jì)值的相對(duì)偏差或絕對(duì)偏差。試劑（盒）線性范圍內(nèi)的分析性能應(yīng)符合如下要求：a）線性相關(guān)系數(shù)r應(yīng)洲.990;b）線性偏差應(yīng)不超過生產(chǎn)企業(yè)給定值。ecicaton ad steggheigtemanagementofdah Idu>t on, t he spii of efmsoroftecompee.stm,ppyclsea-ntint.stmmplmetaiin, re ay mike te pay oraain a nd pay membe e ducaina nd stic maaeme I t si. F nal, te、gl" w ork on t

45、he lad, be sue to prmoe efc ency Tw" euton,notVialy hapi nes of cty List . a, cary ou "teet hrre" acvie s - a 'hrre tre" spec a ld at on mporat, fnd ld atonandefctveplatormtacltaetIecmbinaton of work Refee tisaggodpa ctce s prvical ad munic | a cddd i "w I lean a do"

46、; lari ng ld atoni t he care d ou "fve ce - fve prmot ng", tecaenges a nd te sts Ma .while coicdds wtt he cty Cunty and tow nshipary commie- thsyargeeaelectonyarhowtorralychooselya,ceaand>es a s a ggod ca de,ion di sclne of Gee a Feng Qing Qi Qi , Q S hun, pped ou Jru good st ton, s a e

47、a tesfrofus.Genealworkon "tw" tstdy the fec of注：線性偏差建議分段給出絕對(duì)偏差和相對(duì)偏差。6、重復(fù)性6.1 批內(nèi)重復(fù)性6.1.1 試劑（盒）參考范圍為X1X2區(qū)間濃度時(shí)，在重復(fù)性條件下，用 高、中、低三個(gè)水平濃度（高、低濃度應(yīng)超過參考區(qū)間20%30%,中濃度 水平在參考區(qū)間之內(nèi)）的控制血清或新鮮人血清測(cè)試試劑（盒），重復(fù)測(cè)試 至少10次（n/0）,分別計(jì)算測(cè)量值的平均值（x）和標(biāo)準(zhǔn)差（s）,計(jì)算 變異系數(shù)（CV）。（變異系數(shù)，CV）不超過生產(chǎn)企業(yè)給定值。6.1.2 試劑（盒）參考范圍為0X區(qū)間濃度時(shí)，在重復(fù)性條件下，用高、 低兩

48、個(gè)水平濃度（高濃度應(yīng)超過參考區(qū)間20%30%,低濃度水平在參考區(qū) 間之內(nèi)）的控制血清或新鮮人血清測(cè)試試劑（盒），重復(fù)測(cè)試至少 10次（n *0）,分別計(jì)算測(cè)量值的平均值（x）和標(biāo)準(zhǔn)差（s）,計(jì)算變異系數(shù)（CV）。（變異系數(shù)，CV）不超過生產(chǎn)企業(yè)給定值。注：出廠檢驗(yàn)時(shí)生產(chǎn)企業(yè)可以根據(jù)產(chǎn)品特性對(duì)兩個(gè)濃度樣品進(jìn)行檢驗(yàn)。6.2 批內(nèi)瓶間差（干粉或凍干試劑適用）用控制血清分別測(cè)試同一批號(hào)的20個(gè)待檢試劑（盒），并計(jì)算20個(gè)測(cè) 量值的平均值（x 1）和標(biāo)準(zhǔn)差（s1）。用控制血清對(duì)該批號(hào)的1個(gè)待檢試劑（盒）重復(fù)測(cè)試20次，計(jì)算結(jié)果 均值（x2）和標(biāo)準(zhǔn)差（s2）按公式（2）、（3）計(jì)算瓶間差的變異系數(shù)（CV）

49、。222S瓶間二心1 一 S2 （2）CV =麻間 X1 100% ,the pays fine -e, cay fwad t he taili onal Cinese v>U- iraji cig the Soci t core val ues, VgorouSy carry for , tI e spi. of Jao Yuu, HongqiCaa a spii a nd spii ."essence, hone sy i poll c, stict saa, s to the s" ua heghts of the Cmmui ss Four to devl o

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57、 nce more powera ad prblm slui on moe cmpleely TI id m t consliae ou a clment. Fr moe publc sme pay m - bes wo f_s onteou-ndi ng isues cmbi nig connt d當(dāng) s1<s2 時(shí)，令 CV=0試劑（盒）批內(nèi)瓶間差不超過生產(chǎn)企業(yè)給定值。注：1）若一瓶試劑不能重復(fù)進(jìn)行20次測(cè)試，則以該試劑的實(shí)際測(cè)量次 數(shù)規(guī)定瓶間差的測(cè)量次數(shù)和瓶數(shù)。2）出廠檢驗(yàn)時(shí)批內(nèi)瓶間差可用同一批號(hào)10個(gè)待檢試劑（盒）進(jìn)行 測(cè)定。6.3批間差（三批試劑）用控制血清分別測(cè)試3個(gè)不同批號(hào)

58、的試劑（盒），每個(gè)批號(hào)測(cè)試3次, 分別計(jì)算每批3次測(cè)定的均值xi（i=1,2,3）,按公式（4）、（5）計(jì)算相對(duì)偏差（R）（4）（5）XiX2X3r 二。一二。所 io。% Xt式中:xmax xi中的最大值;Xmin -Xi中的最小值。試劑（盒）批間差應(yīng)不超過生產(chǎn)企業(yè)規(guī)定要求。7、準(zhǔn)確度7.1 相對(duì)偏差用國(guó)家標(biāo)準(zhǔn)物質(zhì)或國(guó)際標(biāo)準(zhǔn)物質(zhì)或經(jīng)認(rèn)可的參考測(cè)量實(shí)驗(yàn)室使用相應(yīng)的參考測(cè)量程序賦值的樣品（高、中、低三個(gè)濃度的人血清，可適當(dāng)添加被測(cè)物，以獲得高濃度的樣品），對(duì)試劑（盒）進(jìn)行測(cè)試，重復(fù)測(cè)定3次，取測(cè)試結(jié)ecicaton ad steggheigtemanagementofdah Idu>t

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