e'f o{rudtfl urua nr:rirrfi uu'tt dui-tuil'l

A a AA I a S l4 I q -Y- 't. froruasru nr:Trn : rv fi rfr orJ : v r:t-.u n rrs l: n "[n ttm : ndeulu {r.l ?utu tt4 ?'lur io A , a

2. raq:vuvr?at1if i l t i l i lnl: 1 l i luluu * 18 i lquluu 2553

1, a 4 A *f SA o F

3. n?lililnil?ul Rl :?l:otlu? nnil lu lufl 1:91 1 luufl 'l:

YAn?]il4n1{?ulR1:

luil o qrTufi frrJ rurilu I:n'[n':r uu6o'lndrunr nrqrduq nfl In utanrvl: sr'lsrrrm: ndoutu frrJ rud^.f l^ ^^ i^q t ) , - - - r - y, -2t^,1^^. .^^ t^^4^.^ v- - - - .Orn. . |U

rul4?'lu fr lr l lunr:vq{i l1nmq tucrru{uil:vulalf lo{:gttavlo{41J?uto{ 9t{uufl l :nut,t ln?1:Jtersvrgr l t l , '

flo{Rr?y t:n tsluyr:nclJouao tsrlu:yuvr?rurr:ntorfrrhutu'n4?rurflufildrri'q uavf,lnlrfluilcymroqi

lufloqrTu rv{:'ryo'rRr:uda{ro'rJ:n'lsrdrutnarturrur,?uu:n'hirisuoflorflt:tor1 fidrrurvfi0uet5?0ue, l , r r f dr i -4- rn: / -^.4 - i - r - ' { - - - u a u 4

rryu"ld "lrurrovriluornr:rilooll4t: nriula 01[0uu t14uou{tu ooutt:{ taousl nunlilzu?l4u{ uoet 6t o l4 | " i

.e - i -9 d^ -1,--4- | v -- .a- !^ .+^ alJ?tJ r f i ]U?i l 14]U10nluln - [ rJOUn:Vvr{6l i r r lu? lu:Jvr0vtn9tn0aoof l { lu nunl : tnn01[a0n n]: t f l9

A e, dt iu,a o 1l -14-!4-, q. qy - t4y -{ . .^ t lnyn:? n?uruuornl:yr t lJi ln?rru{rrvrrvsioJ:n ttnror0 ttJuotfl ' l : lsrl 1r4'n:?o?\i l"[6 uonotnutrt i

rdr{tu:yuequu:rdurr#r f ioro0vv{uorn1:rfruq'hi6ornr:dororiquond.rnutfinnruzuol' lsr niu

nrrrud'uJnfinqr olnr:il?rr unyrunfl1:a:?oflrrarrvfifinlrrufiEr:JnF lprufi'rli lfrrhuei'luil1n#n0eutrr6t@tJlqtqY-lrunouau lonuornr:rilnru rr?u n4€U0v rHn?rilflulosioornr:rdurJrs,frrfie'duu'tnn'j't oultuorflt:d l tn rU9/4 u. q d Aroililxer til ta0{6'efiulorurnurr?\nu frrornr:rillrhqfrrfJuotnt:'lu:vuvqqfrtuzuoll:ntrdr virl#rfiel

r t , q v q i -o- .4t- l t^ y. - . 9)- - - - y--q. .

nxlila1'r'1 [un1: :flu 1 ttav tumqn 0 1[lJuslo{: fl u 191?ufl 1: a 1{ [91

flr:er:?oirn:rv#u'r Albumin 'lufla?fr?unseiruitn:tvdanravtol'lsr dq A*rri.un

Diabetes Association (ADA) rtuviltl#gr:eoul Microalbumin in urine (MAU)

lufrrJeui,ifinr:qqrfiu Albumin hJtuilacn?rulfinv 20 - 200 'hJn:nflr rrrul:CItfiuutreez ----tu Albumin rJ?ilril z0-200 finn^niru luilaarlv t fisr:d'triumrnfrnr:dlflddlxlt9lf lUfl1:gl:?0Y'lu Albumm U:l

4 u a cf q ul i< ^

z{ a a u

d{r1-{aunu 1.5 dsr: frovn:ronu Albumin tuilaarrvfrrfru 24 vu. qsfil 30 - 300 nndnfru fl]?s: I d | - d1 e 4 d i . I a s. - - 4---e1-61-d y--gr'.rnrirrr5un'it Microalbuminuria tlnytilufitvtttetqlfl{n1?vtdu{9t0fl1:lfln [:niln0nlaonfi? [0onn?u

s gt t t d v S a . y^- .^- .a^^^^. .4" t a-S- - .s q 4 t A

lnurqi lrs{rJrururi l?turrnv:rnrr i lFt 'ulnrorqlorruovnnrrrurt iulsrof l t : tnq [:nm? [04{ 10 [111 []J0

rA 4r q, yt t g/- .s--^ i q. . - t a . . -9- ,1 -- . .4t J 9/- i - -= Al lUri lSuurfrelun'l{rhun?ti le'u InlrnqlvrdRl?v-[nilnpr Htnryil?uri lu?t{[ut?t?lurtnvn?1il4u [nilf l r i . - .

d a) et et d o a &^-r^q^. .^- . t4-q-y.d.^.^^^^.^.^^f i 4- - - . -3- .^ i ' r

r?atrnu?n'udruudrovilnr:yrrnruHaoqtdonyr':rr-t0rrnv-[sr tvttauuluil lntu ttJoxl] lu15dtl1?\vltJ

n?lilrfiuilrururndu fiovrfisrnr:diurfiu}J:6uluilae trvunvrfiafllrrfonuutsd'u guN rrflu creatinine9t. !2) t9r9

o a 4 q ^ i d-

"- - - - - l< | e ' l r r r r 4- 4^ a { ; t )"lurfroerrutnr-u oulufrqprfrovrnqnt:li lnuurriln{nnuileuo{9il:1{ letzuu tuov'|u'lsdRlTlrl{fluuttn?

9f s idt | 149,,o, y, d -61 -y-o-. .A 14 l9 l - - -149.. 'd I - i l^nly. .Z^gfi' jrJ:nfrriluoqjoro'[6ilnr:fnsrulU?u1lfentuu-ttJftnl tpt ttnndlutflufl?10vilqnu{ [nrtn?_rtr

flt:et:?1isrrr:y6'u Microalburnin (vrau) luilaarsldriJu6'rrilfrfrqn'ltiltfruqdonl5tfiFl

l:n'lsrgvr:ndou'16'd{rrdr?ildu (Early Detection)t''t' tutrurdn,rrr?ol41 BUN , creatinine tufifil

mionr:n:?oTtu protein tuilaarrv]qeJn:?001flttCIuet:?0flrfdl?v (uA Strip test) r{Jud'?tildti+]

2

,i,f;,nr'tudulrovdosqnrirnrulilndrnrfqdqov?ir1#:vd'r creatinine turfieprrfiuqufiuT,i'riu; rsr u?unr:ilurfr1oqI:novdlfiupiohJ oufr{:vtrvqorfrruroq'lnrrulu:vrJv 2 - 3flrvirriu tr3Jnr:

9)n; 'iilr Creatinine Clearance ovrruriluon'jrt?rutn^rrflcgrrsiols,fiurrdrfisrr:r rrsinr:n:?0?tl::.:tnine clearance ovdrrqilrvlu:tufra'rti'urvirfu oronrirrld''jr Microalbumin (MAU) rilud'rri.,rd', ';. r: arriqnlufloqriufrl#rj.rronflcymrrionr:rfiql:n'lnr?:rrr:nld'ri'uvixfi

4 q-.94_. ^.a^.__.-14-- t^^utg a4 v _ar a u J AA v Ilu0{0ln Protein tui ldf l ' l?vl tnt : t i lnuutt i ln ' : ' [pfnrt i loo'unr la: :y?ytutpt{uunt:?u0qu?l

9t\ficroalbuminuria d.rnr:ld'funr:6uriudrunr:fl:?0rr:vd'u Albumin luilaairv 3 o;u2-4 ti'rjnr# #tsr:ronuoditrie a z \u 3 erfrovdruduf,up{nnr:ifiod'uki

nr:rfililddt?yet:?0141 Microalbumin (MAU) fi 3 aG do

:-1 l-o. collection tflunr:sr:?0141 Albumin luflaarrvfirfiusrnopr 24 d'rlrut dqfio,irriluififid=3i- larilu Gold Standard(3)

tL:red collection rflunr:sr :?0?n Albumin luilaarrv fi rfi uludru,ru-.,rdo1

S:ot Collection rfludrdn:taruto't Albumin r[o& Creatinine fr;rlufloolrru#uruoul rflunr:i r yt t j (a\; : I i l l t duFt?flgtotJ1J?uutf lytdgr' ' '

ou!rnl:FllU?61J141O91:1d?U1JO.1 Albumin siO Creatinine 01fl Spot Collection l#Asr:ri11?6g

q,

Microalbumin in urine (mg) x 1000

Urine Creatinine (gm)

rirrJn6lu#1*qj

rirrJnfilurdn (orq 3-s fl)

r :'' ; n : : o'trn : tv?it4 I Microalbumin tufl aarlyfi u^u:J l#fi 3 r d'nn r:fr o

3-:droimmunoassay tu il o E riu tn^n 1 #rfr o r o r n fi fi u si o d r q n r u frn :'l o irn s wv{* \:phelometer assay tff unt:iprnrrrurjulafla:{01fld'ruruurlornzuoq}J:6u uicroalbumin

20 mg albumin I gm createnine

37 mg albumin I gm creatinine

fll:91:?0?{l Microalbumin lugrJto'rdgr:taruqlot Albumin gio Creatinine ovyrunnn?1ru[oiti.]nnrnil0{'umr{45:v?melt 6'urrio.rotnnt:njduurrilnrI:J:6uluil?rdr?yrrnvt#srrrrr-irrfiefiov{.:'; i""; Sensitivity ltoy Specificity rffonjGuilrfruurYunrrrurfl:r{u,uo{ albumin tuflnarry d'lsri:rqfi tttlliti t rrJ6ultfiul Sensitivity [tOe Specificity'uo.l Urinary Albumin to Creatinine Ratio (UACR)

:: I- nnary Albumin Concentration (UAC)(')

Method Specificity

UACR

UAC

Sensitivity

92-93%

3

3. Immunoturbidimetric assay rffunr:iorn?t:J{u ld entiuoay fifinrtilrilv{tyr1ty0{fiurYu Albumini 61 9, taa^ 4f q ai

lau lsilaf]:ulytli lrnil n{il

Albumin Antigen + Anti - Albumin Antibody

(Ilrine) (Reagent)' f

uua6sr iillfrlunr :ri r rfi unr :

Antigen - Antibodv Complex

(Turbidity)

tfrolorn?f;ilfrffrluo6sr n{ru{rJruI:nrrrmrrufiunvrdard'u'irrvfinrrvl:n'lsrgvr:ndouoyq-y-el- t l - - d g-r A I , .^1,^ l - - . r^. t^^.61 2. .^^ yt_._.- i drlfi{tJrurfiuilaarrvtfrodqnT?arl}J:fiulsrutduausr:rnilaarlv (uA strip test) cr{rilunt:st:?0r.1

m'l{qilnlil (Qualitative) ttnvfll:14l BUN, Creatinine tufiiru (Serum) 6..rfi{orfiuvirt#hidrilt;rl

st:?0t4rRrrv'lsrfiorJn6 tu:vuvt?ilrr:n'ld' rirt#rflr.hurutr4?1ufifinrryl:nnlnum:ndouusir?rugm3 i V9v e ' I e/ r a! q .c hqr^ 'uq lonle frov'[6fu nr: inu totjtwi'uvir'rfr {rau o nra r rudr ld'rfirfl1:il fl n orrffori'ern: or frrJrur].J114'nu

fifrnrrsI:nnlnum:ndouusiFruu:nfil#nrarffunrlsruifrnl:a:?odruunun:?oflddr.:v (uA strip test)tq y dr l - - .?4 i^^ r , . r r . a_o__ . 9t - r Gl j a q yyt l , J s j

ltel tl4t{ntiluU?n taU?fin1:sl:?0141 Microalbumin il-ilturuSoUaylvitlsrfisvttlt{{ilrunq'rufrqJrelonrAfr

ov16'iunr:inurodrqfruyi'ltfiuavfiIon1?f0vrfluJ:n'lsrrruilfo'lfldrurunerfludun:ruriofi?nfrrJru drdl o u ' , 6r . . I t

tflunt:v q{ilrnlunr:ins tnu1u1nfr{lud'ruruil:silrarqJorigrrnvror frrJruror : rrufr'sq nrnrilfi?slYtt I I a a

fl o.: 41J ?Ugt O ULJ : U dyt I R ]iln {

R1:sl5?0irn:rvt{r1 Microalbumin tugrJd'n:tciruzuot Microalbumin sio Creatinin. do.:tdi a lvtnsosTtn:rvfidsrluffrrfrurrarlunr:al6'rodx tdnnrlunr:rnEurud'rodr{unyflr:?rn:ry# lufloqriu

frttnln:eodnn:olrr Microalbumin tuilanllv (Micral - Test) rflunr:ipruuuEarnrilfrqil?ilr6u

(Simiquantitative) firir cut off d 20 mgll iemrdril?rurarldrfJu 3 Eirs 20 mgl ,50 mg/t rra&100

mg/r l#lad'nnl: Immunoassay fltilt5CIa:?0ttnvm:rue{nule1nrutu r - 2 u'tfi rrillyril4irlt#rilu

Pocr trl:,rvfin?1udsn?n :rsrt$r {rauo rlorruduirnr:rilGuurfisuifinr:Hl Microatbu*i,rlnuld

ttfluel:?0dnn:ol Micral - Test ri'uiGitn:rv#d'rutniotirn:rrrid'srlu:isr^ cobas Integra +oo d.rt#rilu

Reference Method ,durlurrrurirrfiofrotunr:tdrrnun:rori'srn:ol Micrat - Testt d

" J:

E 9r lJ: s d{ln { o{ R 15yt 1fl 1 : m q a 0 { n :{ u

t. tffovrnnoqdrnr:n:?0 Microatbumin dlrur:fltdlunr:rirdnrlyJ:n'[srtu:yrJsr?ild'ulu#rJru

rllr?{?1u"lddn'jrnr:td ua strip test-.. I d a, J

I t '

I e ro o,

,

2. EnrJ:vatrimn'nnr:mnno{nirfirffor,rljr{rJrurutt4?rufrfinrrvI:nulsruyr:ndoulu:vuv6ruu:n'hj3f1u1:nfl:?ov'tu'[d'IpruiGn:roriqn:o-t (uA strip test) rruurdru rrsiarilr:CIet:?0?\uldlnuiGnr:

st:?o Microalbumin fidrururvirlo rfton^t#{rhun{rufirrsrJonra'ldiunr:insrueir?ilduJqnrfr' jufl ouyr [a?tut4io'lsrdruru nr

l. nj:^olrfiuuT6nt:irn:tvdut Microalbumin druufluet:?0 Micral - Test riurntoqirn:rsr{o, S a/A

091 tilusl (Cobas Integra - 400)

r-tF_IrIr^Ir-lr-tnr-lnnnn1-lnnnnnnn

4

+. a:il ar : v cir 6'ru " u u,*u u,,u r.?r,

" u u n r : ci r rfi u n r :

qs

9)a)oa

4.1 f luaounl:qlruunl :

4.r.r finulravruvr?u?::a"rn::rrfirfiur{oqornr,rfiqfio fisfi:Jdrrnvrru?d'urfforirrur

riruu n n: ourru ?n^q rrav : ilrruil nr: ?r qn o.lqJ

v A 4 o j ia A a t<4.r.2 fipauttn?o{fromono.rlufrfrfrotn5olTtn:rvild'srJufisr^ Cobas Integra +oo Iqut#

I aq o A r dt n | -o io

h/ryxro.rr5fvrrurfirflr:lr Ftdou dflrv'lrn?ovirr[lu "liln r:rn ard:Jilstlr n1Hua'[irrnvq

t4 YA . ae o , 9) ArJinutnttrurrt iy (Specialis| zuo.tu:snvtrnr:f l : ' l0doua?r:J?\5oxJlJ0{tnto{(uu'rg)

(System Check) titnr: Calibrate rjrurfrl# vit Precision study ttnu Linearity study

et ttJ Protorot d t?d'vr riir u pr 1{

4.(.3 trit Qua1ty Contro('UOn Microaf6umrn rn urrne tffiy Gine Creatinine919t

4.r.4 6'q6o i'qrt iaqqrJn:af lunr:n:?0ern: Ey{ fiT4unqarn'nuflryzuo{frur rrnr,rrfluq

t)

fii : ? 0 ri'n n : o { t4 I Microalbumin T ?il vY{ [ to u st : I 0 tl I Albumin lu fl aat rv

4.1.5 riruuprzuutetl;o{ndrud'rodx 1#dsr^sr^nr:rrdrr5o:il.uor Taro yamane fi:yd'uq ' - - -o- - - -

dvFt?'liltryoilu 95 %

4.r.6 virnt:sr:roitn:rv#6'rodrsilcRrrvrffosr:rori'prn:o{erR'rrvJ:n'lpruil:ndou0rn

frr.hurtrrrrufiriq:J'r0rnfluetu?nr:etrnr:€udll n:{rvrvrxJr4run: 68 urir Ieat,irnr:q qJ - ' - ' - - - - -q E - ' ' '

a / 5 ctygl:?oitn:]vfi leulfttnun:?0 UA - strip test ttni lf l :?o Micral - Test ttnyvitnt:

- -^^ l^^. .^4^^=.--- - {v s- -q^ j o a J rnvl ragl:?0 [9lUtFl:O{?tf,i: 'IY14Ofl tUiln Integra - 400 cr{0y?llfi l:?[Ft:lyfi14'l-tgtyt,ltj::lrAt

Microalbumin trnvlutildfl : rdru Microalbumin gio Creatinineql

4.r.7 tiu vr*n pqn nt : T Ft dou rrn y il : e il ?n run

+.18 il:vttJ^up{nflr:irn:rv#nJEerurfiuurv,ldomrnrrrrfiofiuroriG?rn:ry#1#nr:o |1|- . . - o s q 9, l A a du s oanli l ' l€l t l4]n?]i l t?ttnvn?]i l0]t?t| ' ]Y tau tstn:0{?tn: ' ly140n l i l i lFt Cobas Intesra - 400

dt ada dy a s q9)

tuu?fi l tn:1y1{01{0{ [9tu tsqa:

% fr?r:J.h (Sensitivity): r{nu?no?{ (Tp) x 100

r'{nu?no?{ (TP) + p{nnunx{(FN)

% n?lildttv{ly (Specificity): r{nnuo?{ (TN\ ' t oo

r{nnu0;{ (TN) + p{nu?fln?{(FP)

Predictive Value of Positive Result (%): t{nUlo0;{ (TP)x 100

p{au?no?{ (TP) + p{nu?fla?{(FP)

Predictive Value of Negative Result (%): p{nnuo?{ (TN) x 100

p{aaun?{(FN) + r{nau o?.:(TN)

nnnhlhnnr lr-Inr-lr-tr-Innnn]-tnn

4.2

s 6l o i+

Prevalence (nrtruEfl 10{ t:n) lun:ilufioout- :: dtulud'totittfr gt: lovttu Microalbomin

,l

druru6'rodxfr'luruPr

Sensitivity : True Positive in disease

Specificity : True Negative in normal

Positive predictive value : True Positive in Test positive

Negative predictive value : True Negative in Test negative

4.r.g a:"rJ zuanr: rJ:v rfi uttn vfl t: vlqno{

nltm9|noi l

4.2.r vi r n r : n : r or^rn : r v #u r atuumin Jq uldr rfl u vr er dou UA-strip test €#o

TEco D\AGN osr\cs 6 s{fi{oqfi drrinsru$uqer: st5t5 t[q\\\sxqu{rB nr:

e{l r 1 : il qt dr rin ou tfiun q s tvr u }J 14 r u n : vi r n r : q : r r irn : r v #vr r MicroalbuminId'luttfluvletdou Micral - Test ttnvrn?osirn:rvvidsrlu:isl^ (Cobas Integra 400) 0tn

dro dr { fl act r v d t u ?u 400 d'r o dr.r fr riu u'.rr t r oirn : r v #o r n gu ril?n r : ar r r : ni qU

4.2.2 p{af l r :Tacf ouf i rodt l f i rurrrruvrerf lou:ru' [qe.ra\r idoanfrol f iurn?os?rn:ryv{g--s . qa I u

" !

0 9t tu :J Ft t tn y t tn n n I { fl u tJ I fi m I n 1 : yt 9t Ro I ryi

4.2.3 rirnr:q:rsr:rodufrunr:trilnrunnr:ejrurrnlrer:?0flaarrvlerudilr#rilriifirinrvrnfin

nr:ttumdttavtdturintruim€Jrntasrfnr:uyrmrfuolrtrrinqru*'uqn:dtrr:ilqql €jru

ruiln zua nJG uurfr uu ri'r firau o zun{ruqJ

2nfl1:mnn0'1

01flf l1:?ttuuo,durird'roditf lantrvdruru 400 :turJrn:loirn swv{vnAlbumin nu'irar9lri'iln Negative Iqu?fr UA-strip test 310:tu trsil#e.rn Positive 70:tu (Cut off 20 mg/l) Inu

?G vti.rul-test trnvl#p.ra Positive 61 :ru (Cut off 20 mgtt) JquiGirn:rv#druruiuu Cobas

Integra +oo luralvfil#eln Positive Jsru?G UA - strip test 90 :tu ryl#nrn positive 90 :tut t ,

ri'{iG Micral-test tlou Cobas Intesra +OO d'lnt:xfi Z

4.3

f-tI

FIInLL

t

FTt

F]t1:

I-I:

FInI-Ifrr-ItrlI-Ir-Ir-It-IniI

:

rIItt

t-rt6

I

rII

fr

"lt',udz njiuurfiuilrlnfll:st:lo Albumin tuilaarrsJsruiG uA - srtip test, Micral - test ttdu cobas

0rflen:1{fi z uu'ilfl'r:er:?orTprn:orflr.hururratufianrrvJ:n'lflttm:ndouJnuif;

uA - strip test uuurfirufirnurlfrrior^fi'urur fifrrhu 6r -70:lu 01fl 310 :1u ttrlnrun'jrrlnfiAArilo?rn:l svlilaanv rto r''ufrl#nra Negative leu?f; uA - strip test rirnr:nl6uutfisuur

d'n:r6iru Albumin sio Creatinine Jerul#tnio{ Cobas Integra +oo (t# Cut off fr zomg albumin/gm

creatinine)

olflnr:finutul Ratio :yu'jtl Microalbumin in urine ttfiu Urine Creatinine lun{ruffrJro

rrrrrru,il'ru?u 310 :ru 6rnrJrun4udt#^nflr:er:?o Albumin'luilaarrvlnu'ldrtousr:?0 uA - stripa

test 6r?o TEC9) rflu Negative finil:1nfln:?0uufi Ratio 20 - 2gg mg albumin/gm creatinine {ruru ol

:tu (20.3 zW frRatio <20mg albumin/gm creatinine dturu 2;45 11t) (79.03%) ttutfi Ratio > 300 mg

albumin/gm creatinine {ruru 2 flu(0.65%) dquensrtlur,,r,ud 3 ttnvtthlu4ru^;rJnrufi t doo1n^un,'tI

,ruuodrraoql#r#u'ld'irnr:fl5?0 Microalbumin in urine tffomr Ratio :vil'irs Microalbumin tlou

creatinine lunr:rirfiolrrl:nnlnuil:ndouluffrJrururu'rrudruru 310 :ru uufrrJeufifinrrvJ:n'lsl

rrvr:ndoulu:yusGru6'ufis 63:ru fi..r{rJrun{rudorLfliunr:fnutodtqfr'uvirsfirtfiofil#I:nqnulu du

ru]iuurfiuufi'u?f;r6ruflr-hun{rudoshildirnr:fnsrnrrvl:nulnrtm:ndoulu:vov6rudu

rt',r',ud S aqrlnrnflt?u Albuminutia tuffrhUrLlll4?ludruru 310 :lU

Integra - 400

(UA-Srtip test)

(TECO)

Micral - test Cobas Integra - 400

<20 mell > 20 mgn < 20 mg/l > 20 mgll

- ve test

* ve test

310

90

240

0

70

90

249

0

6I

90

N 400240 160 249 151

400 400

Albuminuria Spot Collection Sample mg. Albumin/gm. creatinine

Normal 24s (72.03%) <20

Microalbuminuria 63 (20.32%) 20 -299

Clinical Albuminuria 2 (0.6s%) >300

Total 310

rrrlnrlnF-|l-rhhf-lhhhlt,

FIr-ltrn,nI-IFT

ur.ruqru^gilnrnfi t aqrJl.rnflr?y Albuminu.iu tu{ll?uruli?ru 310 :ru rflu#ounv

Clinicalalbuminur ia

0.65%

Early nephropathy20.32%

Normal funct ion79.03%

rrnnr:irn : rvfsrr: xfr 2 rrnvnr: xfr : rff orirfl aarrv frlhuru'n4 ?ru d t u ru 400 : ru

sr:rolsruiGl#unlsr:roilcar?vuA - strip test en?01{1 Albumin l#run Negative 310 :lu itn:rv#lnu

ruiul Cobas Integra +OO l#nro Negativ e 249:tu InuinrflurJ?ruril Albumin Concentration (ilriruieldt rA dr v 1 r 619 d1 A

tilu mg/l ) rtgrtilorrtiluogt:ld?urrO Creatinine tHr.ln Negative 245 llu nan{ 4 :lU [lJut{nlu0{01n

flo{'ua3:vro..:frrhu niu n',rdurilrurnrfiuriont:osrrirfie.rnsiorJ?ilrarqrorflaarrv rdosr:roiqtfJu

dsr:rriru Albumin sio Creatinine rrfionqfloi'unrrirfi rflunrnt# Negative 4 :tu (false negative) tfioio

rffurrJdsr:rciru sio creatinine ovh?r^rnrflu positive d'ltqiun:roflaerrrvnu'lq1'ld'etuurnin : 15.2 m/l

tl#^u Negative) Urine creatinine :47.Smgldl rfiorirrurnrlugrJdn:triru mg. albumin sio gm. creatinineoSA4dnlu?6n [nurn:o{?tn:1v14 0lnqn:

Microalbumin in urine (mg) x 1000 :15.2 x 1000 :32mg. Albumin/gm. Creatinine

Urine Creatinine (gm) 47.5xI0

drt#nrnrflu positive oqjluqirl zo -299 mg. Albumin/gm. Creatinine fro'jrrilu Microalbuminuria ttnvluia,

ilaorrv lto :rufitvi'e.rnrilu Negative Jsrunt:sr:rodauttflua:?0 uA - strip test uv 2:tufrt[Ju c[nical

albuminuria (Albumin ) 300 mg/gm Creatinine) dtttagxlugrt:tlfr : rqiu nu'lq?nurui'tgt:'to?\u Urine

Microalbumin: 66.6 mg4 td{l#p{ff Negative ffioigrd?U UA * strip test) Urine Creatinine: 21.5 mgldl

rdoriru'rnrlourndor?rn:rv#rrrurrflugrJdn:rriruorld G6.6 t 2r.s x 10) x 1000 :30e.6

mg. albumin/gm. Creatinin. i'noqjlun{ru Ctinical albuminuria (2 :OO mg albumin /gm Creatinine)

0tnp{nntsmqno{nj6utrfruunl:er:?odruttnu Micral test ti ' lnt: et:?0atn:rr#drurniol

cobas Integra - 400 d'luasrt'lurlr'lud z otnfrrodr'rilnarrv{rJru 400 :tu t#e.rn Negative 24011u

Positive 160 :tU d'ruif; Micral - test trnv'[#p'rn Negative 24g z^tu Positive 151 :lU 0lnnl:etn:rv#d'rg

,oduu Cobas Integra +oo rfiorirrurirn:rvflu:run&tduntttnuot'ldarilen:r{d + ,'lr'tuds ,,urr'.tt',.tfi o

Micral - test NCobas Integra 400

(7o) wrong result< 20 mg/l > 20 mg/l

- ve test 0 240 231 9 3.7

+ ve test 20

50

100

67

62

31

18

0

0

49

62

31

26.9

0

0

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Micral - test ttaviln:'lv?49l?Utniol Cobas Integra 400

ntrt{d 5 ltdct{l Diagnostic accuracy of Micral - test for detection of microalbuminuria rfiuufiilif;

Immunoturbidimetric assay (Cobas Integra 400)

01nfl1:1aao{ril6uurfiuu Micral - test riu Cobus Integra 400 t#r.raaoorndolfiufr{ 92%

tldu Micral - Test 6fuJ1:n:uqna'jr Normal (Albumin < 20 mg/l) uio emormal (Albumin > 20 mg/l)

l#nraaoondosfiu Cobas Integra +oo frq 98% rffofirnr:ur Diagnostic Accuracy floil Micral - Test

rfiuutiu Cobas Integra +oo 'ldrir Sensitivity g4yo LLay Specificity :92.8 gzo rirtrcalllunr:xfi s ttav

eflrt{fi 6 1tRst1:1{fi 4 ldrir Positive predictive value 88.s% false + ve 18 :lu (7%) false - ve 9 t'lu

(6%)

Positive Predictive value : TP x 100 : 142 x 100 : 88.8 %

TP+FP T42+T8

:' 18 x 100:l Yo

18 + 231

: 9 x l00:6o/o

9+142

palss * ve

False - ve

Micral - testCobas - Integra 400 (Immunoturbidimetric)

> 20 mg/l <20 mgll

> 20 mgll 142 l8

<20 mgll 9 23r

nr:t{d 6 llda{efirirurum'l Zo Sensitivity % Specificity florl Micral - test rfiuufi'u Cobas - Integra - 400

% Sensitivity : TP x 100 : 142 x 100 : 94 %

TP+FN 142+9

% Specificity: TN x 100: 231 x i00: 92.8%

TN+FP 231 + 18

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f,.

6.

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5. onrTuvr*np{nfl r:a: a o?rn : rv#

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2r l o A tn t4t

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9

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Sensitivity tlfl& Specificity tfru goolonr:fr Micral - Test tfin false + ve (7oh) rflufiuorufuld'lunr:ldrflu4 oqgrd :

Screening test 6l ADA uuvrir'h4ilnr:n:roryt t ni{ luqi?{r?nr z- + &ilarri lprunr:5pr Albumin to

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+.+ apJar:vrirri'rg

otnnt:dflsrmanoqnr:?tn:rv#rfforJ:vrfrunrrvJ:n'lsrum:ndoulu{rJrutu114?ru 1#

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Test Micral - Test ttdurnioqitn:rv#dsr]u:ifr Cobas Integra +oO vw'jt Micral - Test tri'e.rn

fl1:91:?0 Microalbumin dorfiuufi'u Cobas Integra +OO Inufi Sensitivity tlau Specificity

rurnn'ir g0% it false*ve |oh tLaY false-ve 6% tvtutvdrrfuldrilu Screening test ttnyd{

Micral - Test ttfie Cobas Integra 400 et:?ori'srn:ot'lddn'irnr:1# Un - strip test dw:ro

frrlaul#nrnrJnfifrq 310 :tu luqrarvfi Micral - Test ttou Cobas Integra 400 et:?o?\u Micro

albumin fir zo ttnv 61 :lu srtrudtd'u rrnvrdoririlaarrs ,ro rlodilrilr4l Albumin to

creatinine Ratio lqutnio.l?rn:rvddsrlu:ifi Cobas Integra 400 sr:?ov'tu Microlbumin

(Ratio 20 -2gg mg albumin/gm Creatinin.) dt 63 :tu fiqrilu 20.32%[[nyn:?0ltu

Macroalbumin (Ratio > 300 mg. albumin/gm Creatinine) 2 :f U (0.65%)

nrrnl--|nr-lnnnnnnnnnnnnnnf-l

10

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