CA2426282A1 - Apparatuses and methods for analyte concentration determination - Google Patents

Abstract

Apparatuses and methods for determining the concentration of an analyte in a physiological sample are provided. The subject apparatuses include at least one light source, a detector array, means for determining whether a sufficient amount of sample is present on each of the plurality of different areas, and means for determining the concentration of the analyte based on the reflected light detected from those areas determined to have sufficient sample, where areas having insufficient sample are not used in analyte concentration determination. The subject methods include illuminating each area of a test strip, obtaining reflectance from each of the different areas, determining which areas have sufficient sample based on detected light therefrom and deriving analyte concentration from the areas determined to have sufficient sample, where areas determined not to have sufficient sample are not used in the derivation. Also provided are kits for use in practicing the subject methods.

Description

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~~1PPARaTU5E5 A,:\11 :METHODS FOIZ .W.-~L1'rE: C:t)~'C'E.~'1'R.aTttl' DE'I'EFL11I~.~TIO~
FIEI D OI' .I NE 1:~~'E~TI(>:v ''he field of thi; tnventrcan is ar:alvtr_ concentration determrr:ataor;
B..~r.L:cric~t~~IJ OF °f IrE Iw~Tic~s .~nalvte concentration caet~rrn~natiort in pnv5ruforuc,:i aamples is of ever increastnE importance to today's sov;:~t~ - ;such assays find use i:t ;~
variety of appiicaoi~n settiags, including clinical lab<tratory tcsttng, hump taurr~~, etc.. 4~here the results of surf:
testing phiy a promin:nt role: i:: the d:agnoais and rnana<~ement c:t a var:etv of disease condrttons. Analyzes of interest incl~;de glucose for diabetes rnanayTement, cholesterol for monitonn:; ~:ardit>vascular :ondi~ ions, and the lii:e.
In response try this ~>rawrnt.: i.nportance of anulyte concentration determination. a vanetv of analyte ;:ancentrat.i:>n deterrnination protocols and devices for both ctintcal ;md home testing have been deve:oped ~:nd, ~~pecifrc~t,ly, a variety of analyze measurement devices and methods for enaali7~ pat.rent~, to test them own blomi for the presence anc;
concentration detennmation of a variety, of different analvte5 are well I:nuwn in the art.
C):~great interest anu use' in this are_r are optic~ul based measurement de~~ices and methods in which a sample i.s illuminated area. reflected lr~ht therei~om is detec:ted to obtain an analvte concentrauon. Uf increasi~:47 interest in such optie:a) based measurement protocols is the use of assay svster~rs trat employ test strips or cards and meters for reading these test strips. Typically. a phvsialo~;ical sample such as blood, blood ceriva;ives. interstuial fluic. uri~nc. etc is introduced to a test strip tc~
wet a particular testing or measurement area of the test strip The sample rea~as wilt certain reagents or cornpc7nents assoc;ated wttli the t~.rstmg area to produce a col,7r change m those areas a~~here the zest strip has be;:n wetted by the sample ftefleczec! irght detected from this testing area is what is used to obtain an analyte concentration. as mentioned above, by relating tie amount ofref'~ected :~~aht to an;~lyte concentratic~r~
,~ eharacterisuc o' demctvs and methods that promda for anaivre concentration determination using a measures: reflectance value is that sample size and the uniform or even dtstributton thereon ;.an haua an Impact on the final measurement, where a sz.mple LFS-!9 ~ItV Dk; N0 LI: ~-Q-size tt;at rs toa small or a sample tl-,at snot uniforrniv alspIiea can cruse e,:oneuu, u-inaccurate results Spectfrcally, :fan v,sutt.ccent 4amm ot-sa: Ipi~ ~:, applred to t.e tes:
strip and~o;~ sample is Trot unifc.srmiv al-piae~i, only- ~: pcortrun u.i tiur tisunarea is wetted by Che sample while other partiuns af;he t~stin~T area are nc~? wet°:d-In ccmventicrna!
apttcal based measurement dev-ices arid mr=t.hods, litht is de~eute~i ti'om the entire testing_ area rncludrn4~ thaw Y~oniuns that are no' w atted b~' sanuple I-lo~.-cver, the use o~' ii~=h~:
detected tram nc>n-wetted port sons of tare testing= area can cause -ire determ:natiun of anaivZe cun~entratron to be eronec~rt: or tnacct.rrate Attempts at s<alvtng ti'r~ r:bov::: described problems c~f rn.~:ufficient and,ur nan-unifarmly applied s'arnple ha~.e nut l.een wholly adequate In the simplest process, it is incumbent upon the user to visually monitor whether sufficien: sample has been applied and ~:vhethcr the testrng area has hewn uniformly wetted. However, such visual monitoring rs nut very relialvle. esp~~ciallv for' persons with dir:bcnes who typically have impaired viait>n.
In :.~rrother attempt to solve: fhe prablem~ described ab~_we, EPE30()874ti6 describes an apparatus that e,tirnates whetl;ar the arnuunt of sarnp'~e is xufficierrt an the basis c;f absut~~tieJn of water in the infrarei: re~u7n of this eleetrorna~'nuttc spectnrm. Hawever, ;uch an apparatus requires a mea is fur quantitative analysis and an infrared transde.cer and receiver and is therefore disrdvantarecsus for use a:> a pcsrtable system such as v:or home glucose testing by ciahet.ic.,; Furthermore, in usirQy tha apparatus disclosed in EPBOOai7466, instances u: here s;rmple is pan-uniformly aplsired can nest be easily identified.
L .S. Patent Nos ~,H89.:e8s and 6,05,060 also attempt to solve the problem described above by corn,~arina values obtained fram twc3 c:ifferent test strip sites to each csther, where a pertain maanitur:e ok deviation indicates that the measuring field i.s not uniformly wetted. Wherr non-tsnifortniry is indicated, tE;e ~nser is prompted to apply mare sample or, u7 crrtain in:aance:; prompted that tucmuch t~nre has elapsed and a new test must be comrrtenced. Mhat is, neither the '~~5 patent near tt,e 'Oto patent providers for anal4~t~ concentration c.eterm nation using the small samxrlL pro ~ riled and;
or the unevenly wetted measurement aver: ana. instead requires the user if} apply more sample to the test strip ar begin a new test. I~ej:her of these options is wholly satisfactory.
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Att~.: Dla \'u LIFt_t;_ In the utstan;.e w'ttere the user :s p.ornptc~d to apply more sample. the us"
ei;i:er has to acternpt to squeeze ttte it mal st.e o: the n~E<:lc; stn:k :a ,erc.~x m tr'; to "mifh" or massage more 'blood out of that site aT the user must p;erce astir si~tr~ once a'ain a, anatrler site. Because blood clots quis kty=~ by the t:rzte tt;e u:;er i_>
prompted to apply more hlac.d, it is not uncommon tha- arrothyr stte must be pierced w nt. a needle.
The pierrin::
procedure for ohta;nin~ samp'~~ can 1~4 painful, where it will he obvious that the pain tr compc~unde:I when tl;e skin nf:eds bC pierced nrulupla trmea zn order tL~
obtain the requtsrte sample volume to conduct ~:'t~e rest. hue to ttu~ pain, it ~~> not uncommon far utdtvrdu3ls who require freyuent me~nm,~nn~ ofan anaiyte to simply a~.otd monitoring the anal~,te at interest all to_~~arer w'iti-s diabetics, fur example. the failure to measure thcYir ~Iucose level on a prescribed f:ntsi°_; results in a Iack of information necessan~ to properly control tht;~ level of glucow (_:ncontroiled «Iuco:;e ie~r:~ls oan be very danoeraus and even Iite threatening_.
In the instance where ~. nev. , second test must be c,om:nenced, a new test strip is required for the second test .~s su.;h, ttm tesz strip used for th-: first.
uncompleted te:.t a discarded in pla;:e of a new test st; tp fir use with the second ;est.
resulun~T m the u,c~ of t~~o test strips, ratter titan ~>ne, lo a s;ngle analyte concentration determination. 'Thi;
increases the already hi~Th vo5t ax test strip-based analvte cor.c;entratton determination.
;~s such. there is c~,ntinue..i interest tit the developmerst of new devices and methods for analyte concenu-auoa determination that provide accurate analyte concentrations in the cases wher;~ sntali sample volumes are applied to a test strip measurement area and~ar the measurement area of the test strip is not evenly or uniforn2l~: wetted b4 sam~~le. C)~, pan.ic:ular interest would be. the development of such devices and methods which are easy to use, particularly foa visually impaired irtdi~riduals, mvalve minimal goon anct are portable_ SL'~f~LARY Ot~ THE I1VL'EIVTItW
Apparatuses and methe.v~.is fr>r determining the canc;entraoon of an analvte in a phvfsitaloetcat sample arv prc7vvded The ~;ub~ect appararus4include at least one lr«ht sourc;, for irradiating a plurali:v ar different areas of a test strip that has been inserted into the apparatus. a detector ::rrra~ for detecting reflectec. Iteht from each of the plurality LF~-lq4 3 Atn. r)kt. ~o. L;~6.~':
of different areas respectively . mean:; for secerm~n:ny whether .: sufItcient amount o sample is present on each of tire plu-;~I~t~. of difi'erent are:.~~. h-.
!~~t~~r;mnin~, retl~"e~. Ii~~:::
therefrom. and means for det-~mnimrttt tine con4entratron o: the anrivt~ based o;mi:~
reflected liu_~ht detected from :hose rrea~ determined to have sufticien:
sample. whey:
areas deterrruned not to have sufficient strmple are not used m tpe anslv.~te eonc~entrati;~r2 detertmnatron.
(n the sur;ie~~t methods for c:eternoning tier concentratn~n of an anaiyte i:r ~a plrysiolo~~~cal sample applre~ to s test steep. a plurafy~ of d:tferent area~
of the test strip i"~av,n~ phvsiolo4.actrt sample: applied thereto are illuminated, a respective retle:ctanc:
valve l; obtainer from each of' tl:e plurality c~f different areas. the obtained reflectance data from each of tote piuraiiW dtf~ererrt areas is determured to be indicative of a sufficient amount of sample or no;., and the concentration of' the anaiy-te in the ph:;siological sample i5 derived from the areas determined tc: have sufficient sample:.
where areas determined net to hs-: a Sufficient sazrtpie are nor used m the derivation. Also nrc~vicleci are kits r~r use it p~a~=t~mn'~ the subject methods.
BRIEF I)E5C 121PTION OF THE DRAWI',V(::S
Figure 1 an eremFtlary, r:~presentaove colorimetnc test steep suitable for use with the: subiect invention.
Figure ? is a schematic ~ rev4 of an exemplary embtzdrment of a subject apparatus having a test strip assocrcaed thc~rewv~n.
Figures ~:~-3H strove enlarged, plan views of various exemplary embodiments of the detector array of the subjec° inventiorr having the rndivtdual detectors en a variety of confiQUrations.
F~il;ures .~A-.~C snow e~.emplary embodiments of imaging optics of the subject invention Figure s shows en exernpfan~ embodiment of an eLemplary measurement area of a test strip wits: a detector arrt:;~~ of the subject invention.
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I)E'I'AILED ()ESCI~1PT1(~v OF TtiE Iv'~'E~TtO'~
:~,pF,aratuses and metlwds c>~ ~e:.~Lrmm;n~~ ti;~ un; errtr_rton c; sn analye in ph~.fsrulagica't sampl: are pro:iced. Che aubje~.t apparatuses ;nt_I~rdr at least one lr'~h:
source for .rradiaung, a plura'rn of ~Irfterent areas oa tes: strip that has been in:erte into the apparatus, t: detector array ~iir uetectiny reflected Ii~~Th~: from eat; of the plur~..Itt~
of clit~ferent areas respeceiveiv, means fur dete:-rnrninn wh~tizer :~
sufficient amount of sample is present an each of the pl=.rralrt~ of different area by tieterTrrinin~l retiectec: ir~~l;;
.rer~~from, and means for dete:-mrrr,n~r tlae concentration ~>f th_ analvte based on ti:e reflected tight detected from; those areas determined to have sufficient sample, where_ areas determined n.ut to have suf'frvient sample pare not used iru the analvte concentra:ion determination.
Ii: the subject methods fur determining the concentration of an analyte in a physiological sample applied to a test strip, a plurality of different areas of tl~e test step caving phvsiolug:acal samFle app; led thereto are illuminated a respective reflectance value is ohtained from each i>f th:: plurality of different area:;, the obtained ret~ecta:~ce data from each of the plurnIit~V d:fl~er~rrt areas is determined to be rridicative of a sufficient amount of samF.le or nut, and the concentration of the analyze In the pysrological sample is d~:rived i~om the areas determined ~.o have sufficient sample, where areas determined nut to have sufficient sample are nit used in the derivation. Also provided are kita for use .n practiLiri~F the subject methods.
Before the present inveruon i5 described, it is to b~ undezstood that this invention is nut limited to parttcul4~r e:mb~ ~dirnents described, as such may, of course, vary. It is also to be understood that the t~.rmrnology used herein i5 fur the purpase of describing par~.icular embodiments only. and a not intended to be limiting, since the scope; of the present invention will b~~ iimit~.d only by the appended clarrns.
Where a range ef values is provided, it is understcrcad that each intervening value, to the tenth of the unit cf the lower limit unless the context clearly dictates otherv, ise, between the upper and lower irnir of that range and any Inner stated or intervening value in that stated range is encompassed within the invention. t he upper and Iower limits of these smaller ranges may ind;.=pendentl~ be included in ttC smaller ranges is also encompassed within, the :nue rtrur:, subject to any specif,cally excluded limit in the stated LF'~- t 94 ,~,rn nkc. v.> LI~c->'~
.-an~:e. Where the stated ran_7r incim:es ~sn~ or i,utc,~tIC: itn~rt:: ran<.es etcludtr:_~ e;t:.r both of those rnLluded limits ,ire al;;imiudeci ~r tl:c ;nvenTC~n.
L nlcas defined otherw rse, al! tec:r;,ical and sc~enttt;~ terTns used herein hav,'tin same mean.ng as coa.rmonly indersvooc: lvrv one ~5furuina~v i..fi in t!:e an to wrrict; th.~
invention beion~s. .:lIthouoh anv n:ethud: and materials similar or eyurvalent to tho;~
ije~Lrrbed i;ere:n car: alyc~ be us~uc it rn4 practise c~r te;ttn_ of tic present Gnvenuon, ttre preferred rrrtahods and mate ia.s ari° now- described <~1l publr::auon~, mentioned i:er~.;:
arv incc'rporated ivereir~ by rc:ferenc.v to disclose rnd desi:nbe the methods and: c>r materials in c<>nnectron with. whr~:I, tlae publrcauuns are cited.
it rrrust be noted tha as use d herein and in tle api~endfd claims, the sineular ti~rrrrs "a' , ''ancl'~, and "the' incluce plural referents unless the ::ontext clearly- dictates athervs=isc:. Thus, for examt~le, rei~renret to "a reagent" rnciufies a plurality ofsuch re;:gents and refer:nce to ".he apfaratus" includes reference e.~ one or more apparar.rses and eduivalents thereof known to tho~;e skilled in tl~e art, nisei :to forth.
'd he publtcatiuns d >cusse:.j herein axe prow rded solel-Y 'tar then disclosure prior to the fiin~ date of the present app',c:atron. ~ot:rmV herein cs vci be construed as an admission that the present ~nvemion Gs not c:nt:tled to ar~ted~tt such publication by virtue a~ prior invention. Further, the ;iste~, of publication pre>vrded may be different from the actusl publication dates N=hrch n.av need tr> be independenttv contfnned.
In furtl'redescrib.n~; tare yu't3~ect invention. the subject dev;ces are describf.d first.
Next, a description of the subie_°t methods is provrded~ fuli~:rwed by a review° of hits which include t!:e subject devices.

As mentioned above. tire subject devices includes apparatuses for detennuring the concentration of at leas? one arralyte in a phvsrulogical sa,nple applrCd to a test stnp that is insered rntc a subject apparatu< More specifically, the: apparatuses of the suEject invention enable the determrn.ztrur, ~ji th;: cuncentratron c>f at least one analvte in a phys;ological sample, even in tho~;e instances where the ;n;:asurement area of the test strip is not uniformly wetted. or example because an in:,uficient amount of sample is apparel theret« arrd;or beeau~,e sample applied thereto is not evenly distributed over the LFS-194 t;

arcv Dki. Vr LiFi:-~::' entire measurers ent area Gen_rrll~~. ,.r:e subbed: apparatuses gar; he chara;.terizec' ay opUCally-based meters and art: conteaure~: for ;eeem..yv a t~~:;t srp. such as the rs~pe o:
test strip described below. The optic :i1 al3parattisea read t'ric- test ~:5tp c>r determine ana!vte concentration of a sample applied ti- the test strip by tllummctn.74~ a plttral:ty of differen:
areas afthe test suip and measurirt~e detectin'T re'tie~ted linht from each area separately usm~, at least one d;:tector far each ..~;f°'t~lrent area. Onl~~ trt~
,nea~urements front thane areas which are det:rmined 'u 7avr ~: sufficient amount ax sample bayed on the amount cli retlected Iitht detected thc:rcrfror:t. i.~.. are sufficiently wett;:ci by sample, are used in tyre determmatian c>f analyte conceri.ration, where the areas dr°.termined not to have sufficient sanople, r.e.. not t } he sufictently Lvetted by sample, are not used or rattier are excluded from the determination i;t analyte concentration.
'F tie subiecinventi~:>n is s:itablc far use with a vartet~ ui calorimetric, phatometric or optical (herein used incerehan~~eably-J type te:;t stnps as are lcnomn ut the art where representative calorirn::t.rcc test stnps will be descjbed irt greater detail below.
~,uch teat step: find use in th,C vie,ermtnation of a wide variety of different analwe concentrations, where rep:e,~;ettt~:tive analvtes include, but are not limned to, glucose.
cholesterol, lactate, alcohol, bili;ubLn° hematocnt, anti the l:ke. In many embodiments, the test strips used with C2e sub,j:~ct ;nventrun are used to determine the glucose concentration in a phvsic.lo~~i~a sample, E°.g., interstitial fliitd.
blood, blond fractions, constituents thereof, and the lik:
En further descrit~in~.~ thc° subject invention, a rLvre~.v of representaUve calorimetric test strips that may find use wt:..7 the subject apparatuses i:a provided first to provide a proper foundation far tie subjf~ct invention, where such a review is by way of example and is not intended to Itm~t thscope of the invention. The review of representative test strtps is followed by a ~ieacripion of the subject apparatuses and the subject me:hods.
Finally, a descnpuon of kits tEar a>e in practtcuy the sub;wt methods is provided Representative (:alor:metri~ Test Stri The colorimeC-is rea~:ent test strips empioyc:d rn these embodiments of the sub~eet uiventican are generailv rnad~.= up so; at least the 2allowinz ~:amponents: a matrr~_ I I for receiving a sample, a rea;ert composition (not shown :~:a structural component] that LFS-l~a~ , Attv Dkt. Lo LIr't-i',~~:
typically includes one or more member:~ of an a:7a!yte oxtdatio-. si~~nal produmn~ syste,~.n and a support element I ~. Tr.e colonme:r~c test :;trip_~ .ire punt ~urc:d and adapt:d to he received in an automated mete:-, .a described 6t:ICw. for a.ui~n:nticali~, dete:zn:ninU to concentration of an analyte. An exemplary emI>odtment of a : epresentat;ve coiorimetr;c test step is shown i.n Figure 1. Figtre I shows ~olorrmetrir te:~t strip ~0 in which ma~:nx 1 1 is positioned at one end of ~upl-e>rt v?4mertt I? with ac!hesi:-a 1 3. .~
hole 1-t is pre~,ent iri supporelement I~ in the area of matrix I T ire which a sample can be applied to one stilt of rrat:i:~ I l a nil a tea. Lion c;:n. br detected therefrom.
L.':;ually. sample a appii~°d tt~
one stile of matrix 11 and a reactirin is detected at another or opposite side of matrix. 1.
however, other corzftgurations are possible as well. The cc.>ml~unents of a representattve,~
exemplary colarimetric test strip 4~ill now be described in me>re detail.
Matrix Matrix 1 I is made of an inert material which provides a support for the various rnenubers of ttte srgnal produe;n:.: system, cles: rSbed below, a~ we'll as the light absorbing or cltromogenic product, i.e., eh-:: indicator, produced by ths1 signal productn~~ svst~~m.
Mtatrix I I is configured to prc.w:de a location for the physt<ilogica!
sample. e.g., blood.
application and a location for t!.e detection of the light-absc>rbin~; product produced by the indicator of the sign:;l Iorod:acine:~T system .4s such. tire :utter location may be characterized as the test.n~~, de°:ectton or measurement area of the test strip. As surf.
matrix 1 1 is one that is ;~ermts >ive of aqueau~: fluid flow through it and provides sufficient void space fo,- the chemical reactions ofthe signal producing system w take plrtce- A num'oer of different .natr ices have been developed for use in various a.~talyte detection assays, whirl; rnatri:es rnav differ in terms of materials, dimensions avod the like, where representative ma::r:ces include, but are not l~rnited to, those descrbed in U.S.
Patent Nos : 4,734,36( y :~,y~t;,~b6: 4,935,346; 5,03,39~:: 3.30,46$;
.306,6:_'?;
5,41$.I4?; 5.42f,~32: 5.'1~.! ,'(.); :,52h,1:~(li::.>63,04?: ~.620.Ifb3:
5,.'53,429;
S,5"3.452: 3..?$(),304: 5,7$9 _'S5: ~,$=I~3,6NI; i,'i4b.4~6 .',968.$3ti arid 5.9;'_',=.9:1; the disclosures of which :ue her~;ur trtcorporated by referen~.~e. In principle, the nature of matrix 11 is not critical to t'r.e subsect test strips and therefore is chosen with respect tp other factors, includi:y~ the i:tture of the instrument which is used to read the test strip, LFS. I94 ~s Atty. L)kt. ;yo LI~~- r'~
convenienc:: and the like As such. ;~~ citmensianand poroart. of the matrix :r:av s",ry, greatly, where matrix I 1 may o: nta-. nee have padres ;trod-t,r '~ pu;osm ~radien:. r.~.<> ,vt'.°:
large: pores near or at the sartlple appiiCatran re<~~an and srnall~vr pores at the detectior region. The materials from v~h>ch rrratr~x 1 1 rear be fabn~:atec:, van, and include polymers, ~.b. paiysulfane, Falyam;des, cellulose or absorbent paper_ and the like, where the maten~i may or may not he ftm.:t,o~'rali2e~.1 to prcw;de fc~; c~~valent or non-covalent attachment of the various m:~mber~ of the signal praducm; sv-item.
~I~nal I'roduein~ System In addit~c)n to matrr~. 1 1, th.= test strips further include c)ne or mare members of a signal producing system which pr )due.es a detectable praduc? m response to the prercence of analvte, which eietectabf~ prodt:ct can be used to derive the amount of analyte preaent an the assayed sar;.~ple. In vhe test strips, the one or more members of the signal producing system are assa~iated, ~.~~ covalently or non-covalently attached to, at I~~asi a portion of (r e.. flue detects gin. tes in~~ or measurement areas r~~atrrx s 1. and m cerian~
embodiments to substantially all of matrix l 1.
tn certain embodiments, ~.'z.. where glucose is the a~alWe of interest, the signal producing system is an analyte c~xtdatton signal producing :,vstem. By analyte oxidation srgnal producrnt; system s meaaa that in generating the detectable stSnal from wh:.ch the analyte concenL:ation tn 'he sample is derived. the analyte a oxidized by one or rr:ore suitable enzymes to produce an oxidized t~)nn of the analyze and a corresponding or proportional amount aFlydrag~n peroxide. 'The hydrogen peroxide is then employed, in turn, to generate the det~:ctable product from one c:)r more ndicatar compounds, where the amount of detectable: prodccct generated by the signal measuring system, i.e. the signal, is then related to the amount of analvte in the imttal sample. As such, the analyze oxidatron signal producrn_, sy~,trms present in the subject test strips are also correctly characterized as hydrok;en peraxicle based signal produciry~ systems As indicated above, th.c~ hydrogen peroxide based srgnal producin~z systems include a first enzyme that oxtdize~ the analyte and produces a corresponding amount of hydrogen peroxide, i-e., the an-taunt of :hydrogen peroxice that is produced is proportional to the amount of analwe present in the sample The specific nature of this LFS- I 9~.

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ftr~;t enzvn:e necessarily drpt~nt!s ot, t:ri~~ nature of the unal~~~t~
l:~ein~ assayed but is generally an oxidas~'~. As sac h_ the :'first enzyn.e ;rcav t?e: 4~Iu;.~;s~
oxidase (where tier analye is gfucose;?: ~hofeste:ol oxutase (where t;te analvte :~ chcolesterol)_ alcohol oxidise (w-here the analvte is alcoli:oll; lactate oxidise (w-here tire anaivte rs la~urte) an;j the Itke. Other oxiuizing e.~.zymes fc~r use with thesi and ottmr anal ;es of interest are i:nown to those o-~~ill m Ire ;rrt a~-td may also be ernploved_ in those preferred embodiments where the reauent to >t strip is desy~ned for the detection ot~
glucose con~:eritr;ttzun. the first enzyme cs ._lui;ose oxtdase. The ~~,Tluc<~sc oxiCase may be obt,atned from any convenif:nt source. e.g ;naturally oc::urrcng source such as Aspergillus nt'=e:
rar henicillunr, or rccombinantiy l:rodtic-~d.
~~, second enzyme c-f the signal productn i system rna~r be an enzyme that ::atalyzes the conversion o'~one a mare indicator compounds into a detectable product in the presence of h~°d.rogen lyeroxioe, where the amount of detectable product that is produced by this reaction ~s prol>orttunal to the amount of h~rdrogen peroxide that is present This second enz~: me m :.;eneralIy ~ peroxidase, wh~:r-~ suitable peroxidase:;
include horseradish perociuase :.llRi't, soy peroxidase, rec~~mbinantly produced peroxidase and synthetic analota hay°ing peroxidative actiwrv and the like. See e_o., Y
Cf, F~. t~Vang; Analyoca Chimcc.. ,~cta, 23:5 (I99U). 294-30~' The indicator conrpounc or compounds, c~.g., substrates, are ones that are father formed tar decomposed by he t~ydro~:en peroxide u1 the presence of the peroxid;3se to produce an indicator dye that at}sorbs light in a predeterm;:zc:d wavelength range.
1'referabiy tine indicator tiye absorbs strongly at a w~avelen~=ttr different from that at which the sample or the testrn~: rra4_=eat at~sorbs strongly. The omdized form of the indicator may be a colored, faintly-color-ed, or colorless final product that evidences a charge in color of the testing side of the membrane. That is to say, the testing reagent can indicate the, presence oI glucose fir} a saa°npie by a colored area bein4, bleai:hed or, alternatively, by a r;olorless area developing cc. (o r.
Indicator compounds ;hat are useful tn the present ;nventiun include both one-and two-component chromogemc substrates. One-component systems include aromatic amines, aromatic alcol~ols, a<°;nes, and benzidines, such a.
tetramet"rtyl benzidir.e-HC1.
Suitable two-componewnt systems Include those tn which one component is MBTH, an LFS-194 ly A;n~. L.~kc. ~o L(Fi=-i)'_ MI$TH dertvauve is~=e for exsimple tnasr. ~i~sclG.tse~ in C:.S Patc.Tnt .~pplicatton her. \o G~i3G'_',~7~. incorporated her-rin by -eier"ice). ur »-arr;inalan:i~=~~~:ne ;snd the otae:
component r<, an arGinatic arr~rne, aromatsc alcuhul, conju«atec:a :rmme. ion-ju~ated alcohol or aromatic or aliphatic ald~hvue Ex.empiarv twc~-cornhonent systems are ~,-methyl-2-henzothra.zolrnone i-tvdra: ~lne hvdrocl:ioride ('~1$ ~ f-) comi~ined with 3-dimethvlam:nubenroic acid iDVI:IB;. '1$Tl-I combined wtth Y..~-dichloro-?-nvdroxyb~nzene-sulfonic ac id (I.7(-'H$S;; anc~-methyl-~'-her~zuthiazoltnonehydra~:un~
-sulaiw.l benzenesulfonate mc~n~~sociium i.;~IEtZHjI3) combined with ~;-aniline-1 naphthalene sultonic acid arnmon;urn ( aNS;. In certain ernbudiments, the dvc eot.y~le M~THS$-A.'v'S is-preferreJ.
In vet othevr embod:,ytients synal prc.~ducrny~ syst~ams that produce a tluoresc~_nt detectable produc:; (or detectable nun fluorescent substance. ~.g. in a tluorescent background) may be empioved, =:cich as thane described in: hiyoshi Zaitsu.
~'osuke Ohtci:rw '.clew fluaragent,- sut~strates for Horseradish Peruxidase: rapid and sensitive assay for h~~drogen pera~cd~r an:_' the F'eroxidase. Analytical Btochemrstn~ ( I93G) 1G9, 1 G9- I l _i Support I:,iemen ~latr ix 1 I is usu;:ll~~ att.ch~d to a support element I _'. Support element I? may be of a material that is sufiicreatly rt~~id to be inserted into an automated device such as a meter without undue bendin~y~ ~>r kinkinb. I~1atrix I I rnay be: attached to support ~~Iement I? by arty convenient n;ec:han.sms, e.g., clamps, adhesive:, etc., herein shown attached using an adhesive 13. In many erttbudirrients, support member 1? is made of material such as polyoiefins, e.~;., poll. ahvlene car polypropyene, polystyrene or polyesters.
Consequently, the length of t-c: support element 12 typic:allv divtates or corresponds to the length ~.~f the test s<rip. In t!~e example chown in Figure l, one support elern~:nt I~ f;
employed on one side of ma:rtx f ! However, in certain embodiments, another support element is attached to th.e utae;r ;aide of matrix f 1 sc> as o~ 'vandwich"
the matrvx between iwc; support elements.
Regardless of whettttr c7r not the length of support element 1 ~ dictates or Corresponds to the length o- test strip 5G, the total length of the test step 80 generally ~tt~: j7kt-~c'~ i.l~r=-l.;'' ranires from about ~'0 mm to ai,o~.rt 8~: nun. usually. irotrt abou: ~~' mrn to about c>~ m~:, and mare usually from about .-~~ rnm to about v~' tram. tl;u w Idth ce tree test strip y() typically ranges from about 5 rn.nr to about : 5 mrr7. more uauall. t~rom about ti mm to about 19 mm and the: thickne:a of th~~ teat strip 8G tvpr.~ail~r ranges from ahout {~.1 ~ n~rn to about 0.40 mm~ more usualv from about (n. 9 '~~ :nm t~.~ about « 3~' mm As described abc'>ve, ~ul:~por, eler"ent 1 ~ t°> usually ccsnt:yTured to enable test strip 8G to be used with or inserted! into a: meter. .a.6 srtch, suppon element l~, and thus; lust sir ip 80, is n~prcaily tn 'the fi-rnt of c substantrafiv rectan~tular ~>r square-like strip, wit:rr the drmensu~ns of support element I ~ vary according to a variety of t'actors, as wail be apparent to those df skill in they art In using such a colorimetriv test strip, sample is allowed to react with the members of the sinal procucing :.vstern to prcaduce a detectable product that is present in an amount propornonal ~o the retrial amount present in the sample. The amount of ;ample taat c6 introduced t rnatr ,~ 1 1 of the test strip rnay vary. but generally has a volume ranging from abola U.~ u! to about I() ul Tne samp;c; my be introduced'te matrix 1 I using any convt:ntent I-~rotoeol, v~°here the sample may be injected, allowed to mck, or be otherwise introduce:. The amctur;t of detectable product, :.e., signal pr~aduced b,~ the signal producing= s~~stem. s than determined anti rel:aed to the amount of analyze in the Initial sample. As mt_nticned above_ in many emboaununts sample is applr,:d to one side or a first side of matrix 1 1 and the amount of detestable product is then determined at another or se~ccjnt;l sloe of matrix 1 1. where n many embodiments the amnunt of detectable pre-duct l; determined on a side opposite the first side.
In certain embodiments, automated metes that perform the above mentioned detection ana relation steps are employed, as uo~,ed bc>ve: The above describes reaction, detection and relating steps, as well as instruments t-.~r purfor~rring the same, arf:~ turthc.r described in U.S.
Patent Nos. 4.'"34,3e~0, 4.400 ~b~~. -~,93~.=fib; 6,()39.394 ~,30~,:~68;
5,306,6_':3;
5,418, I42: 5,426,Q32; S.r 13."(): 3.5?6,1?Oa 3.~63,U42; >,6''0,863:
5,7~3,4?9;
5.5';3.452: 5,~'8G,3U4: ~.i89..';~_ ~.84:.b~~l; 5.;46.486: ~.9h3,83fi and 3,q?.?94: the disclosures of which t.re her;-I.I Ir.corp<>rated by refuren~ a Examples of colonmetnc reagent test strip<; tha: may be used with the subject Invention Include, bus are nca itnrtted tc,, those descnbed In U.S Patent Ivos.: _>,U49,487;
LI~S-19:~ 1?

A;r~ Dkt. vc> LIFc-i c,j63.ti:~~'; ~.~~?,~~2. ~,~'S9,'_'~~, t:.e dtsl:l~:~surea ivwniW t;re h-:r~.n incorporateu by reference The Optical Apparatz~ses As ~urnrnariz::d above, the st:b~ect invention prc.7vices a;7pararuses. t.e., optm:3l meter ~, for use w ith test strip ;. swh as tae type e:escribed ahv.yv=. and which ar a contyured tc~ deternttne the concen~rativn of at least one analyse in a pi,vsiolo4Tma1 5smpie applied to the test strip. The optical meters c:~attte ~urje;a u-tvention include ~t ie:;t one Iraht source for illumina:.ing a testrnp area or a test strip that is inserted into the miter, r~ detector array madE-uo of a plurality of detectors for detecting reflected li~~ht ft~.~rra each different area of' the test:n~ area othe test step respCCtrvely, means for c:f~~ter-m~niry~ whether each d:f~f~~ren~ area of the testuyr area hay a sufficient amount a sample based on th,e arnou~~; oret:ected light detected therefrom. arnd means for determining, from only tho-;e area; determined to have a suffewent amount ofsarnple.
l a . those areas cietermineu to be ~:uffcctentlv wetted by sarnpie, the concentration o1~ at Least one analy2e in the ph~,siulu~x ::al :;ample applied to the n:~t strip.
'l he size of the suh ect miters wall vary dependrno ort a variety of factors such as he sine of the test strips u~,eoi wit;i the meters. the shape ot~ac: test strips, etc. However Uenerall v. the meters of tn~~ subjt~ct invention are small enough to be portable or easily moveable By wav of example, t::e length of an apparatus t~. picallv ranges from about 4 l mm to about 16C min and more .isually from about SO mm tcv about Is() mm, the ~~ridih t~~pieally ranges from about 3~ rnm to about 8U min and mere usually from about ~~0 mm to about ?~ rnm and the t ~ic:l:.ne~s yptcally ranges from abut~t 10 mm to about 3~J mm and more usually from about 1 ( mm to atrout '~s mm, Likewise, the shapes of the ;object meters wiI! var;. where the shapes may range from simple to t:omplex in marr. embodiments, the sub~e,a meters will assume a ctrrular, oblonr~:, oval, square c;:- recrrngular shape, al:hour;l: other shapes are possible as well, such as irregular o; comF::ex st;ape The subject met~~r~ winc»4 be further clescnbed =~wih re:erence to the k=i~ures, where like numerals relrresent like components or feature°s .-~n exemplsrv embodiment of a subject apparatus tJ ~s sl~~awr: schematrcallv m 1~i~uf-e 2 where a portion of LFS-194 I ;

Atrv Dkt ~c~ LIFE.-U'>
representarive test strap BCC, i.e , rnatr.~ or testing arer ( ; af~mee to a portion of ;uppo-_ I?, is shown operatively associated ~~nth apparani:> ~t.
As mentianet~ above. appara:us :'tJ tnclud~s at mast one i:~~ht sour~u 1~.
Li;ht source I9 projects light onto :h~, area of tile test strip. e.'__ matrt.r ( 1, having sample applied theceto and 'which hay regents for rea~.t3r;~; with certarrr analy-tes in the samplt~, as described ahoie. vlore spe~c:f-tca iv, z~~ht sr~ur~:v l y prc~;e:;ts lyht onto the tes:in;~ a-ea vmatrix l 1. l e.. al; of the t~sttn,~ ;areas I la-E 1 ~: of matrix . 1 I_r~ht -source 1~1 yp~c,rliy In::Iudes a light emtin<~ dio=ae (LE:~7) car anw~ther t;onvenient fztttrt source such as tt -aser diode, a f:itered larnp, a photo!:ran.~stor, and the Itke. Usually it~ht sour;:e I ~ contains nva cu more L,ED sources, t .~., three LED sources, or a sin;lv diode capable of emitttn!~
twcy or more distinct wavelc-ngths :~f light. Light source 19 is usually capable of emuaing light at wavelengths rangin4; from about 40U nrn to about l~J(~U am, usually from about ~Ut.~ nrn to about S-~0 am. Eor eva:nple, where two distinct wavelengths are employed, ,fight source l~ is capable crf emit:inir Ii<,ht <tt about 63~ am and about 700 am and in many embodiments the Ill ht sc>u~ce i~; capable of emitun~~ light at about 660 am and 940 art., and in certain embodiments .he it~~ht source is capable of ernitttng light at about ~~S
am, b3U am and 940 am. It will ~~e apparent that the wtrvolengths described herein are for exernpl;tr~ purposes only and ar:~ in au way intended to Itmit the scope of the invention as many other combination; of ~aav~lenQths are possible as well.
C°ommercta(ly available light sources tha:r produc:~ waveen<~ths of light described abc:>ve are known in the an and include, but is not limite~,i to, are LA'S A6?6 light source capable of emitting light of 635 am and X00 nrn available: from .~,SR aM (7pto Semiconductor, Inc.
~ppararas ZU also ,ncludes a plurality of light detectors or rather an array of detectors ? I . Bv plurali~.y is meant greater than about two detectors.
Typically, about three detectors or mare are pr;~sent, e.g., tn a linear or ti iangular arrangement, usually about Four detectors or more ;re present (e.g., configured m a ?1~' arrangernenty, where the number of detector? may Tane:.w from: about 6 detectors to about 100 or more detectors, where the rn.mber .,: detectors employed will vary depending on the size and shape of the testing arx~a of n~~atrr~ 1 1, etc. Irr other words., the number ol~ individual detectors that. make-uh deter-.or array ? 1 is related to the number or' discrete se~_tions or areas of a testing area that ar-~ measured. (~f rrtterest are cleteetor arrays that include about LFS-19~t I ~

~m Dkt. ~o LIF'~-a?-a dete;.tc~rs. e-~ , in a ~ x 3 ar-nn~_=em~tnt. about Ity cletec-torn. ~.g..
in a ~ x ~ aran~~rm°;;t.
anti aoout ~'~ detectors or more, e.~>_- rn :.~- x ~. arran'~e:neW c:rr ~;~ an ~ x ~ arran4?emo:7~
fog etnboci;ments havin:.~ 6~ cieteeto,-s. etc.. for example for use watt;
rectangular or square-lil:~ shaped testing areas I~ certain embodiments oftr<s~ subject tnyent:on employing.; a charge coupled devicr ("C.'C'D"1 camera array. the array may have abom O()J or mare detector ~. e.g . arranY~ed lri a ~ 1'_' x =t~a-I ~ar.~an~rene;;t or 10?~. t _'0-iS
a:-rangerrtent. Accordingly, th° nmnber z~f detectors of the iiet~etar array may rancor: lron~
about ? t,~ thousanca. 13y w av of e~;ample only ~.md not in any way intended to limit the acope of the invention, for a testtr~~ area that has a length ranyn~: from about ~ mm t~~
Vrbout 6 mm and a width rankings 'r'om about ? mm to about c, mm, the number of detectors will usually range fiam about 9 to about 1 U0, and more usually from about ''~
to ab~u_ 64.
The configuration othe ~i4tectors that make up the detector array may yar;
aceordsnY~ to a variety of 'actors such as the mze snd shape of the lusting area and ';he like- how°ever, t':e detector ar~a~. ~s .:onft~ured as a single urvt.
That is, the detectors are associarted together to fo rn one piece or one component. a ~;., tn a matrix or grid type arr~:ngernent or pattern c~r the I:le.
Figures ~A-3H show e,empiary r>mbodiments of the subaect detector array having a number of different C;;tectc~rs ~ 1 a-? I Iv in a variety of configurations, where such numbers of detectors anct:onti;uratiuns thereof are exemplary only and :u~~ in no way intended to lrrnit t!~e scope otl3e invention. Accordsngly, Figure 3 A
shows an exemplary embodiment of detectcar array ~I havtnE 6 detectors, first detector '' I a, second detector 21 b, third decretor ~ j c. :ourth detector ? I d, fifth detector ?
1e and sixth detector elf, confrgured m a 3 x ~' ardnn~~urrtent. Figure 3$ show; an exemplary embodiment of detector array' 1 having. 9 detectors, first detector '' I a, second detector ~' 1 b, third detector 21c, fourth c'.etector ~' L ci, fifrh detector 21 e, sixth detector 21 f, seventh detector 1 g, eighth detector '_' l h an~i ninth detector ? I j, configured in a 3 x 3 arrangement, Figure 3C.' shows an exerrtp~ar~ embodiment of deteetcr array ? 1 havin'z 8 detectors, ~ 1a-21'tr, configured in a d x Y ~:.aanuc:ment. Figure 3D shows an exemplary embodiment of detector ar.-3y ? I having 1 .: detector:a, ? j a-? I 1, configured in a 4 x 3 arrangement. Figure 3~shows an exemF.larr~ erabodtment of detector array. ':'_ I having 16 detectors, ? la-?Ip, LFS-l9$ 15 .4ttv Dkt h'i: LI~~'-t?'<
confmured en a-1 r ~ arTanl_~erne~rt. F:tTur:: ~F s;irw:; a~ ~~~cemplt~
embodiment oa detector array-. ''1 ha~~rng I(.t d.~t~.ctor_. ~a-? 1y. cont:~Vurec: in 'a = x _ arrangement. F:~ ur4 3t;r ahoy s an exemplary emb~~drmer t of c~etect~7r array '' I ira,~irr;~ ~ ?
detectors. ~' I a-'~ 1 ~ .
configures: in a ~ x :S arrangement. I inure 3F1 shiwvs art eken;p;;.-v err:bodrment o detector array ? I having 6+ eietecu:~rs '? s ~!-'_ I~ conf;'_~ured en win 8 x !~ arrange:nant. a,s apparer;t, thc~ number of indr~, iuual dote: toes :racy ti-te ::onf~ur< troy;
thereof emplove~j to make-up a su(rjeca etei:tc:rr :~rrav ~ ay ~~ar~, as approprrate, a g . may be made or lea:., ~rr marl. detectors ti~a-slu~~~n ;erein A~ descrued above each detector of detector array ? . is capable of detecttn~~
ur stilt:-rceptmg reelected light. e.g.. cf.ffu:~eiy reflected light, fratrr a respective area or ~,ection c?f~ a testin= area of matrix: 1 s . That is, with respect tc: higure ~ for example:, each detector ? 1 a to ? I r ot~ detector art ay ? 1 detects reflected li<_he ti-om a corresponding, discrete single respective area o' matrrx l ;,. A5 shown cn FiV_=ore ~?, t':rst detector ~ la colle:as reflected ligat tro;n first area '1 la. second detector ~ I b detects light from second area I 1b, third d:tector ~ c detC:_ts irC~ht from thud area 1 IL_ fourth detector ? 1d detects light from fourth area 1 ) d, !:fth detector ? s a detect li~'?o iir.~rn ttftla area I 1 t, sixth detector ? 1 f det~_ct light t rom f s ~t'n area I s f, seventh detector ~ I g detects light from seventh area I 1 g, eight c:etecto: ;~ I h cieteets iis~ht from eigat area 1 1 h and ninth detector 1i detects ligh_ from niratt: ar e.r 1 s i_ The size of the discrete, corresponding area detected by each detector will va;y dept_ndirr~; on a variety of :actors including, but not lir.~ited to, the number of detectors employed. the size of t1e matrix, etc. Signals from each detector are tr;msrnitteci to one re rnc~re analysis means for analysis, as will be described in greater detail below, for deternvin:n'~ ;whether each area has a sufficient amount of sample appl;ed thereto, Apparatus 20 also includes imaging optics ~I for imaging reflected light from specifre areas of matrt:~ ; I onto specific, respective detectors. As shown in Figure ~, imaging optics 31 is conf iUurc:d to rma'~e Itght from first area I La onto first detector 21a, light from second area I s b into secon~:f dt.~tector ? I b, li-,ta from third area I 1 c onto third detector'_lc and ltgh: from ;~urti-r arE;~ 1 id onto fourth detectar ~ Id. and so forth for each area and respec.me de:ectc>r of the detector a=-t-ay ..s::: appropriate Imagin;: optics 31 may take the form o one o, mare: lenses or rntrrors ear combination thereof.
For example, L.FS-1'~4 1 ft ,4rv Dkt. \o LI:'l:-(~,~
n certain embodiments, imaging op:~os :,1 ma~, tai'e tae f~rrrro o; :: stn~se e?ement lens suca as a double: convex lens, as sha°,vn m Ft~,ure ~: and F r~~trr--~ -f. ,In ~ertarn otl;er ernboc'iiments. imagiry r.>pncs may t"ke thc° form u: a double °l~rrrent lens such as tw~~
piano-convex lenses shown u; Fgur-~ ~E~. In other embodtrnent . an actitomat lens system whereby t~vo aeluorriatic: lenses, each hawn;~ ~.c7nvei cr<_7wn su~f;~c~s. face coca;
other. a;, sl.own iii F:aure ~Cmay Ije uaed. 7rhe lens cr.mli~,t:ra~o>na described :rbu>ve ~~.re known n the art_ .Apparariis ~(J also in.~ludes :~nearo, 24 for determinini,r u-Nether a sufficient am~:~unt or volume of sample is presr;nt in each area that makes--up the tesun~: area oi~rnatrix 1 I, where such detertninatian i:~. based Lipon the amc5unt of retlect~:~i light detected from each area, i.e., from the area whi._h eac't; detector detects reflected :i~~ht. ":
his means is eenerallv a digital integrated circuit ~=:, w~her-e such a digital :nte~Trated ctreuit ?:~ is under the control of a software program and thus is suitably prcaararnmed to execute all of the ,reps or functions required of it tc cletertnine whether ref7ectec~ light detected from each area ind:,:ates a sufficient ;:motrn' of sample, or- anv hare.lwar-or so;mvare combination that will perform such required frr.wtmns. That is, sample anic>unt determination mt:ans 24 is capable of executrn~, or foll,rw~rn~ an al4;arithm stored tit the meter to determine, based an reflected light dete;:ted from each area of matrix I I . whether sufficient sample is prcaent in each area. S;rmple amount determination meana ~-I usually reads thc: ~autput of a signal conversion element s:xch as analoedigital converter ?'' which converts au analog signal frt'~rn each eietecto: to a digital signal Accorainely, Sample amount determination means 24 5 capafoe ~>f cam~inc out all the steps necessary to determine whether reflected light d=te;ctec.' from a particular area of tt:e test strip Indicates a sufficient amount of sample in :hat area, i.e.. indicates that a particular area is sufficiently wetted with sample or n~nt.
In addi:ion to th~~ abav~r means far determining whether sufficient sample i:s present in each of the ae least a,~a ;.areas on a test serif, the subject meters also include means 2b for determining the ;,oncentratiart of an analv~t~ in the sample based orthe areas determined to ha~:e a au~~fici~nt amount of sample based an the reflected li=The detected from those ar,;as of tire test strip, where areas drtenniried not to have a sufficient amount of sample or are net ~atisfactonly wetted wuth s;:rnple are not used to determine LFS-194 I"

Am.. Dkt. No LIFE-J
ana;yt~ concentration Thts means is Tenerallv ;t i'yutal mte~ratei: circuit ?b, whc:e sue;;
a diei:al rntearated circwt ?6 :~ uncle the c onu~t~l ~>: a ,otrwar a 1~;
a>~wram and thus is suitably praerarnrned to execute all t~f the ;tepa or ;unction; required uit.
or any hardware: or softwar~° combination ti.~~a t.r?1 perform su,:h rruur~eu tiinruans. T itat rs, arralvte concentration deterTrr;narion means ?b is cap,.ibie t~f ~Yec.ttin'~
or f;~llowin4. an algorithm stored in tt;e mete: tc> dct=~rrn:ne arralvte rc~neen;ratic-a from those areas determined to have sufficient sump ~. w°here the areas deterrniued not to have sufiic:en:
sample arL ~~xclu~ec~ from tl~~ determination of anaivte i;onrentratiorl.
tAnalvt~
concentrate>n detei-rninanor me,rn: 6 rs shown in fcf_>ure '? ;rs z separate component _:trn:
santple~ amount evaluation means :'4, but in certain ernbodimerits means far determinin~7 whether iz suffcient amount of sample is present acrd means farr dete;mrning the E:oricentration of a.n a;~alvte based on the thane areas determured to have sufficient sample may be the same integrated circuit.) .F~ccordrn~:ly~, digital mte=rated circuiL?Cj is caFabfe of ca.-n°rng out all the stet's nece~;:;ar~~ to e.~cchr< e, from its detrrr-mination of analy~te ec~ncunt:atu.m, an~~ areas c~ete.~.n; ;eci tc~ have an msufficrent sample.
based on the rel7ecti~~e light values det~ctud taereE'ram and u7clude only those areas of the test svrip v here suffctent sample is preseat, i a , thc° sufticrentlv wet ed areas-The subject meth ids m~:~: also include rneans'3 for ralibratin~Y the apparatus and specif,cally eac:: detecto: of th<~ array detector indepenctentl~:. 'This means is generally a ciigttal inteeratc:d circuit ?~~, w1 ere such a caiibrat;on :nears '_' > is unaer the contrail of a -software program and thus is surtably programmed to execute all of the steps or functions rewired of it. or any- hardware or software combination that will perform such required functions That rs, ca:ibration means ?3 is capable of eYecutin~T or following> an algorithm stored in the meter for calibratrnc the meter, e.e , each detector of the detector array Z 1- (t:a;:bration =aeons w:~ rs shown in Figure '? as a aeparate component f,-om siimple amount deterrriinatior: means ''~l and analvte° concentration determmaticn means ?6, but tn certain embc>dimerrts may be the sam4 integrated circuit as one or both of means '--_'~t and means ?6. ) .~:-ecir:lirrgly. calibration mCa~s '_'3 ii;
capable of carr~~in~~ out all the steps necessary t~ ea,tbrate eaci~ detector of the ,ipparar=,r~;
independently The subject meters :aav also triclude m~an~ for d~~term~nin~~ the total volume of sample applied to a Pest strtn ~~, where such a total sample vah.rrrre determination is LFS-1'~4 ;

.urn'. Dkr. .'~0. I_ICC.-u":
based upon: tile amount afreviected light detected :~;,n-i each ar:r dete~n:ned to haws a sutfi4~ent amount of sample;. Tizi~ rte~.:r:~ is «~n~::rlia zc ::~.~i::~l ;;t~~~r~ued cir::u::'_'~.
w7ere such :~ di;aal integrated circuit ~~ is under the concr«I u~; a aot:ware program anti thus is suitaoly pravrarnmec to ere-utc all of the steps ar funct;ons required o.~ it to dete~~rrtinr the total sample volume applied tc> tl:e test strt!~. or ;.~ny hardware ar sottvc-..ir combtnat an that wil! perfo-rrr snc : re:~lt iced tur;cuun~ 'ihat ts. total sample 4olume means 2; t:3 capable af~exe~sutin~_= ,tr foliowtn~ art aigaritam stored ir:
the meter to ~iet~~rniir~~, base;! on refleceed li:vlrt detected li-um each area of the test strip determined to Have a sufficient amount ~~l~sample, the Iota! sample ualume applied to the test strrp The subject meters also ir_cluc?e program and data mt~mory ~ r, which mau be a digital integrated circuit, t.;at sto:-es data and the operatrnt_ program of one or more of the digital integrated circuits :~f the i;ieter. The subject meters ais~~ include reporting device 2ri for communicating total sam,~le volume, results of anal~'te concentration.
error messages, etc., to the use, . .~ccc~rdin~'ty, reporting deuice ? l may take various hard copy and so=t copy forms- L~st:al:v n ;; a ~ i.~ual display such as a liquid crystal drsplay (LCD) or lijht emittinft diode (1_EDt d;splav, but it may also be a tape printer, audible sit-rnai, or me like.
yIETHODS
Tlte suhject invt;ntion also provides methods for determining the concentration of an analyte in ~. physiolcagtcal sample applied to a test striln. Specifically.
the subject invention provides methods fair determining the i:onc;entration aan analyte in a physiologrcal sample applied to a test strip euen in those instances where the entire area of the test strip where measurements are taken, l.c., the testing area, detection area or rrreasurement area, is not entirely wetted by the sample either because too small of an am«unt of sa.tnple is applied :hereto to wet the entire area andi'or sample is applied unevenly or nanunifarmlv~.
As such, rt wUl he al>par<;nt that the subject methods provide the accurate determination of one or mo-e analyte concentrations u:;ing small sample amounts, l.c., sample amauncs less than c~~nv:ntionallv required. In current practice, sample amounts of about 5 fit! or mare are needed to wet a testing area :of a test step for accurate analyte :sir; Dkt. W~ LIFc-~:)-;
cuncentranun detern.~inauon. Hc~we~., en. Ytecau:,e ;'t~~: entire te~trr:_ arena need not be wetxe in <>raer to obtain accurate ar~ai~:t~~ e;:~n~.entration ueterzntn;~tmr.~
ustn4_> the subiect meth~>da, sample amounts le~;s .han about ~ u1. uttentmes less tnan about , ul ;nay i~c used. where sample amounts o' ab<:ut ~' u1 or lea; m~us. be uses: :rz the aub~ect methods ti;
certain embodiments. For example in ;;ertain ewthodun:ents s~an~ple wlumes of abo~.tt U f ~i ntay be used to obtain an accurae araaIvte :onc:eraratcon de:~:v-minatiar,.
Sample rn.m he introduced into the apprc pria:e :rea c~f the, test strip utan~~ rnv convenient protoco..
where sample may be inier:~ec:, wi:.het:, ~:,tc., as rnav be convenient.
sample may be appitecl to a test stitp before or afi-:r ttte test step is insertet< rrmr.t or otherwise operat;v~l~
associated with a :;nyect apparanu. suc:l: that the testtn« area. r e., each area of the testin<~
~uea, of the test st; rp may register w atlx the optical componan~:s of the apparatus.
CJenerally. the subj~et memos include applyns> sample to a testing area of;i test strip, illuminaant; the testing area with light, obtaining a reflectance value from dif:erent areas of the testin!~ area separateiv or independently, determining whether the obtained re:'e,:tance value from ea~:rl area indicates that a sufficient amount of sample is present in each of the areas, i.e_, det~~rrninrt~; whether each area is suf:i~:ientl~
wetted by sample, and deriving the ;:oncentr:~tton c;at !east cme analyne from :he areas determined to have a sufficient amount of sample, w4.ere the areas deterTnined nco to have a sufficient amount ef sample are nt~t used in analv:e rvncentration deterzninat:on, i.e., non-wetted or insuffictentlv wetted areas are excluded from the anaivte concentration determination computations. Ivlethods for generally deriviry araalyte eoncentrauon from refleeta.nee values are known u7 the an:. ko~ example see L~.S. Patent I~c> a,0'~9,?94, the disClusure of whtctis herein incorporat4d b.: reference .~ feari,re ofthe subjec: methods is that Instead of deriving a single reflectance value fur the entire testing area as a cumtnonly done, multiple reflectance value:, are derived from multiple, discrete areas of the testing area. in this way, those areas of the testing area having insuffictet~t sample may be identified and omitted from anal,~rte concentration determinatton_ Accordingly, eac~t de:ectur of an array of detectors, i.e.. of a plurality ol~
detectors, detects reflected Ir-iht f-rum a discrete, respective section or area of a test strip, i.e.. from a specific number {rr areas of the test strip, respectively, where imaging optics LFS-19~ 2tJ

.4tt,. Dig. Vo LIF~..(~-;
m31' f);.' employed :CJ f(?Ctls Lr C.'rrf:Ct La Ilvtlt tr(>rrt il?CC:'.tlC
:lre3S i)rtt0 SpeCr;iC dCLtCtOI' ~y' plural?CV l:i me:llli ~.'.re3l~:' LltaIl abw~t;: t'',,-a fle;;;CIC?rt ~
~'p;C;:tl~.. 3bOtll Lllree d~'L:'Wi?r~ ;?
mare detect li«ht fronx ttse test step, ~~tsuaiiv about foe: ~.ietectur- ~~r m<'Sre detect lyht from tine tesstrip, where as many a:~ about b ile~:e~,:tor°, to about 1~?i~ or ;nor: detect li~,i-.;
from the teat step in remain e~nbodirnents, where m Borne embcuLmenLs I(i00 detectors or rni~re detect ii~ht ;om the =est str_p. where he nunnt>er r f devei:tors employed will Lrry ciependm« ors tfta size ar_d shape c>: the testtr~~; area of u-.e =.eyt strrp. etc. The deter*ora of thc3 detector at;y.' ma~~ :etCi t the i:~~:rt at sr.tbnanur.liy the same or difIeren times, but t~'piLallv the light rom each sr~a t; detected at subs;antiallv the same time.
.~s mentic>ned above, refyec~an~e ~;'alu~a from discrete, mdependertt areas of the test strap are detected by eaca correapart<:iing detector. By reflectance value is meant any value or series of v;tlues. si~~nals, o~ gray data set, etr ., relatin~~ to an observed amoune of reflected lyht from a correspondtrrT, reshect~ve area of the test strrp. :4 reflectance value rnav be in arty fornr, i.e.. tftr= retlec,:~.nc.e value may be in raw i~r processed form. A
re:~ect:mce value may be of~tainec perodicafiy or substanttalty continuously over a period of time.
Acc.ordiny to the subject rTtethsads, the observed. reflected li'.:ht from each detector is determined to b~ indrc,zirve of a ;efficient amount c~f sample or indicate that the area a sufficiently wet:eri by ~;art~pie and. if tndtcatave of such a sufficient amat:.nt of sample, is used to determuie the :c>ncerrtratton of analvte in ;ine sample. In other words, a reflectance value from eai:h dete:.:tor is evaluated to determine if the corresponding area has sufficient sample volt:me or a sufficiently wetted by satrtple or wetted by enough sample to provide an acc.tirate analvte concentration measurement, where the sample amount or volume in eac;lt area ~:orresponds or is related to the light reflected therefrom, i.e., a reffectancN value. ~.ecord:ngl, the amount crf sample required to be deterrntned sufficient will vary depertdiny~ ~,n the analyte of interest, the site of each discrete car different area, et;:. In many emi:~oatrnents, an area will be cTetermined to have sufficient sample if the stsrfai:e area there<3f i:: at least about ~~i r.o about l0u°°o covered u,'ith sample, usually at least sbout ~~-lU('~ coverea with samlrie. It will be apparent to those of skill in the art that they reflectance value totiicattng or relatin; to such sufficient amount of sample will ~ arv depending on a variety of factors including, but no't Limited LFS-~ 1!~:~ ? 1 Ar(~Dkt. W :LIrc:-()'"~
to, the tyF>e iif sample. the ana:vte at ;rnere;t, e;<:. W f'ticten: sani,lfe arrtaunts of'an an;:r may be deternnned in tiny conventeri: rnur:ner. wricr-e ~r:e tuliow in_~
embadtment~ are provuied by way of example .md are in r>a waa i(~tencle" to firn.t she scope of the invention. In till embodiment:,, a reflcctante value is ricter:n~(teti :~or eac:h cietec.ur c~: tile detectar array, as described a:~ove. ~~. her:: the det;:rmrned retlec't:xn~e value a :elated t~.~
the amount, if ay-, irf sampfcv or wet;in« of a cor, espc~rzdin~r sre a In i.ne embodiment, aftevr a r::tlectance value is cletenninecj for each detector. ti:r minlmllrn reflectanC': Vall3P 1'~)1Tl ~rilon!'~t all tilt retifa:ta(iCt' V~ilslCJ 15 CleteITIlIned. Iv::v;i ret-lecta(re~ value i5 then corrrpured tc~ tt:i;s minimum value, whereby a reflectance value and cor~espondtnLwarea is dete;-min::d to have a sufficient a(llot~nt of sample if the reflewtanc~ value produced tlteretrc.~rrt lies within a certain ran~~e~ of , :.~:., is substantia.llv the san-re as, the minimum r~~f7~ctatnc;e v aloe r.>r c~f' the area i5 tJne area that produces tf;e minimum reflectance value F~~r ey:ample, if an area provides a ret7eetance value that is widlin about ~-lU°,~ of'the rniritnit.(n ref~,ectan~e value, it is d~:t~rrnined to have a s=.ifticiLn: amaunt ~f samplta, ;.e , ;: is substantially the Same as to the minimum value, where the. areas having reti~a:anc:' vaJUr_s greater than about ~-1 (?°,v of dne minimurn reflectance value are d~,tertninerl ro have an tnsuffi~ient amount of sarnpIe, i.e.. arr nit zubstantzally the same as uie min:(nu;,malu~. For example, ;~yure S shows matrix 1 1 ~:~perativ~lv associated with detector ~ 1 havuy:.~ detector: ? 1 a-.1 l.
Employing the method described above, the reflectance ~, aloes from areas 1 1e arid 1 f wauld provide the minimum reflect:3nce values as lacy ~.:rC campleteiv wetted 9is sample and are deternuned to have a sufficient amount of sa:npla. Accordingly, the reflectance values from arias 1 1 a. ! 1 b, 1 I c, 1 1 d. ( l g. . 1 h tine. l 1; are compared to tle min.imam reflectance value and any of the areas tound to he witf: a ce.~.ain range of the minimum reflectance value, e.g., within about ~-lt)°i~ of the mini(num reflectance value, are dLterniineci have sufficient sample, i.e., determrned ~ o ire s:. ff is aenttv wetted In another embocimerit. a p,ir.;cular area is determined to have a sufficient amount of sample if'it d~;monst:.ae~ a certain drop in retIe~txnce. i.e., a predetermined drop in reflectance ar greater. t; or., a time prior to sample applicacrori to a Ume alter yantple applioa~ian and aac;h a,;. ;;rct;ir tires praduces at fc:a:>t some drop in reflectance beyond a certain rninim~m drop ii: reflectance. har example, referring again to Fyure f, LFS-19~

~ttri Dk;. .'~a~. i.Ir:-~;
ar~:a 1 It would produce a lar«e ch:::l.~e n refivctancd ror L t:;;: pnier t:?
sampl aEvpirca=.ion to a r.m~ after sample ::onl:~ation b~ mug:: i ;.: ~;~ -t,iC:el~- ~c~~ ereri m;ti~
sample Furthermore. adjacr°nt are;::; 1 t n. 1 1 ~. I :, i ! h a:n! : :
aii m ouiil proifuce a:
;east same ~han~~e in ref7ectan;:e cater ;a:npic~ ;.1p pl;cauor~ t~ui::.i;a;:
a(i .ave at least seine amount of ~~ampie .4c~ordi~~t~ay~ a-ea I I (-waul~i i» dcaer:mn~c to h:r~, a ;: sufi_;cient aitt~~un~ of =,ampf~ because ~; Inrod:ced a droll rr: r-etl~ct:.yrace ~afue that m ~qu:ri ti> or ~~~reste- t:an a prec~termrnecf ~arof; in refiectanc;: anceach ad:a;~ent area pro~iutes ~ : i~at ~.c,rr-to drr;p ire retlr;vtance. I-Io~.vevt~r, area I l c w-ouid oe ::et~r trr;ned not to hay a a sut,ic;ert.~mount ofaampe tacea:rse :t would not l7roduce a a tticient drop m -efiectance.
in certain ernbodmrents. ;in arLa is determined to t<a:e a sufficient amount of sarnp(e of a produces a cecta:n reflectance value, e.~~.. t.~ substanttaliv the same as a pr~~dc~terrnined reflectance value such as wnhrn about ' to a7out Ik"',o of a predetermined re7e.~tan~e value. and mesas an;, onC. usu oily all, of the above-described criteria, i.e_, ( I ) i~ an arcs that provides tl-a mmi:num reflectance value front amon';st all the areas, l-''?
produces a retlectarri;e v. iu~ t;~~; i_; ;e~thin a ;-ertain rarye a t:i;:
n;inimum relZectance value, or (') prc>duces a :rop rr: retie;.:tance tl;at r; as ~_reat i3r t~reatcr than a uettai~t drop in reflrctance arid ill adtacent :.real also produce a certain rrunrrrium drop in reflectance.
'lush t: method is partrct:Iarlc v ell suited for those area;; that define d1e edues of'.he testin~~ area.
As described ab;we, or,c-:. all the areas of the testir~~t area are deterrninecl ,u have a sufficient amount of sample or riot, a.e., the ar~nai or reflectance from the detectors are deterrntned to be suffic,ent crr ;nsufficient, the c:oncentrat,on of at least orte ancil~,ne in the sample is determined, nsin~T ti_e s:~nalS from orrlv thoso areas havinC~ a sufficient arriount of sample. where the c~~ncentaatron is related tca the ,rrnotcnt of light reflected frc'~m those area.5 i~aviniy a sufficie:2t anu>,;nt of sample, as is known ii; the art.
1°or example:.
reflectance values fror.~ the ~,:.~as havury ;: ,ufficren; amamnt of sample may be compared tr~ a standard curve or graph ,t a,iaivte ~c>ri~entratir>n ve=sus reflectance and the: analvte concentratcan in the s:rmpie ,:f interest obeamrd theretrc_rr: isee for example L~.~ Patent ~ios.-l,~s:~.360;-1,9(il~,f,6f.;. ~a.">.'.I~6: 5,~.i'~i,?4~; ~,.;Cr+ '6'~;
,.3(.J6.6_'i; ~,.~1~: l'?
:, , ~,~Zb,03~ S.~l',I?G. '.~'_t- l~(!. ~,5bp,ci~;.~: ~.b'_'G,~n_~. s ~~~~.4?~~;;.~~3,-t~'_';
LI~S-19:1 '' ~rv Dkt. ;~e LI: ~-i~-.~
~.~t~L'.3~)'~; ~.~'i~9.~5~: ~.c~.~~,'791; ~ r-~h.-~i5b: ~.~~f7~.~=r~ alit:
~,A;._-.~Q-;; ttlc illl'lOsUr; h' which are herein incorporated by re :ere rice: ) 1"rie above described retlecttr~.at:~ values relay be obta;ne~usi~~= any oonvunr,w:
protocol, where the followir~J prot«cal ra off~esrer..t by way o~ e~-.::np(e any; is in nu ws~, ;r;tended t lrmn the scope of the :n,'ewtec:an.
In nianv en:bo~iimerts o; ti:e srib;ect mettaoris. each dcvtci;tor G~t~the detector a:-rav ._, indeperidentiy calibrated Each ~aete-wtur may be ~~alibrated ,ism~ any 4onvoruent ~ro;ocol Ira cane such ?roto::ol fnr caliamatin~ e;ich ~Jrector ir:rcpenr;ently, eactl detr~;o c.fetects a "background ' si_ual ( R:,), winch a pcr formed befctrt~ a test strip is :nser-~c: :n:c~
°,.he m~te:~ e.g., be:or~ mse:2ing a lest strip at the tune of test!nty or at the: point of manufacture of the meter; re~~tard:cas. it is perlurnied befc>re a test strip is associated with the meter Qnce Rh is measurer' for each detectc)r. each dete~.:tor detects a "dry" signal (Pu~;~. l.~~sz.tallv, this is done: ~hith an unreacted test strip inaer;ed into the meter, but before an application of sample thereto Once each detector hay; been calibrated. sample i5 applied to the test strip and the area is illuminated with l.ght, u-~ua(l.Y' with li~~nt of one or mare wavelunyths. In many-embodiments, sample is spplie~: to une srdc: of the matrix and light illuminates and is detected from another side of tfe ma;ri~ referred w as the measurement or testing area of trio test strip, e.~., the sire oppvsjte the sample: application srde. As described above, the presence or amount. of r~_flectance is a result of formati<:~n ~>f a reaction product when sample is applied to an area on the test strip having one or more si'nal pruducin.~
components- In other words, to components of ;tie signal produ~in~~ system react to give a Irght absorbing reaction proeiuct The raw data de~scr-ibe=.i above are used to calculate parameters proportional to glucose concentration =see i~w example IJ.S. Patent ~lejs. 5,059.->94 and 5,304,48). A
logarithmic trans'formr;tian o; retiectance arialogouv. tc tt~e relationship between absorbance and analyt. conc~:Fntratron observed ;n transrn;asion spectroscopy ;;tin be used if desired. ,4 simplification o_ the 1';.ubr°Ika-l:lonk rr;flec!ance equations. as lsriown m the art, is aparticular int~r;at c: ii:nerally. the paratnett:r k~: :> is used, where H is related to absorbance and S is r~;lated en scattering- In this derivatr~an. K. '~ is related to analyze c:or~centration, where K, S de=tined by Equation 1 a:: foll:.>ws Lh'S- I 94 ?rt -~trv Dkt. ~a :.IFc-u°~
h%S.t:- (l..Rt)- =.R: (lr;luatic>tz I
~~ecordm~ty~, Rt rs thrl retlectmitvY tak~ma a partuul :r ~:tne t i:~setibed by )=uuatic>n"vvhere ;~;t is the r°fieeta ;ee, a ~ h;,. ur 1<~:,;, ~t...
c;a,respo.~,;:;n~~ to _'O
se.:onds, 3i.~ seconds, etc Thwt is. ea.c'tt ~teteccc~r provides a r~f'l;,vtmir~= i>r an Rt value ~_i~ai carresponds to the signal measured from a cu:respondin<~~ area ufthe test strip matrix wriere In varies ifom (~ for rvu ~etl~:~:ted Ity_>i1t vRhl to 1 fur to=tal :elected IyTht (Rnr,l.
Rt = (RW - R,,)' (R~r, - Rh) ( lrquation _' r R". is the reflectance devtect~d fiom araresr by a d~tict~.~: _ Accordrngly, K..~S is derived for each detector ano ~or~c:spondin~: area of the-testing area detected by a riapectt.-a detector As K:'S is related to analvte conrentra~.iun, n final or overall I~..~S value is detCrmrned using only those si finals from detectors exhibiting a certain K;'S value indtcattnU an area having sufficient sample amount o:
sample wetring, where the overai lt,~'S value is related to Lhe concentration of analyze in the sample applied to the test stro,:~
i-he suhiect metho:ls alc~ tnciucie, tn certain embodiments, the determinatron of the size of the sa~ynple appUed to the matrix of a test strip, i.~ . tae total sample volume applied to the test strip. la this way, a user may be notified .~r alerted that sufficient sample has been applied or tnsu;ficrent sample has been applied and more sample is required. Samp(w size is cietermwed by w'mrputrng the numc~er of detectors that detect reflected light from areas detern~znad to have a sufficient amount of sample, w~hc:r~ the v=olume of sample accorr,modat~d by each area i;~ known such that the total volume of sample applied to the te.=t strip s tittG~rmined by- computmt~ ire number of' areas having a sufficient amount of sample and the volume of sample retained in each area .
Sufficiency of sample size may vary accor~.iing to the partrcular analyte concentrations) to be determined' etc:., however usu~rlly sample amounts Less than about ~ p( and oftentimes less than about 3 ui are sufItenwrat, where sample amaunts crfabout ? p1 or less, in many errrbodrments about 0.5 y ma: be suffcrent in certain embodiments.
The sub~e::t methods alley ;nclude c;.Iibratinf: other components, features or aspects of the meter. such as ,~alrbratrn_a the at ;east one iy~ht source, the detectcr array, the rrna~ing option, etc. (see l~~r e~;3mpl~ copen ding C. S application entitled "I>evices and 'vlethods for .final ite Concentration Determination" to hyster and Wallace. filed on LF~-194 ?.

~CtV Dkl. '.0 LINE-t''' i~1riv C, '0t ~?, and ccapendin« L' S. aaplr~,aion entitle;.' ....~t,~,~yy >
and a'~letiLods for ~-:;vte Concentration Determinatuo,~' to )Y,-ster :xnd '4~-aiCSC;~. t:le.i t,rr ~1::~.
i . ~"i~~-').. tim disciusur;:-:; of~whici, are her~:u~ inc_>rpor;zted by c-:~ference h.ITS
F;;ra111~, krt~ fo: practicin;~ !;~G rrl~-ect methifd; are pru~;ded The subject kris raclude an apparatus accorc;in' to :he aubject invent,un. .e., :. subte, t optical mete: T i:~
:subject k:ta nw also include crne =~r nvo;e test ;trips. usually ~i oCuralrty of test strap;.
;uch as the t~r~pe of test strr;~ Gescr:bed above. -i he subject ki:s may curtner mcludc'e ar:
~Ie:nent For ~rbtainm~ a ph:sroiu~-rc~a! sample. l~or example, ~~ here the physiolor;icsl samp;e a blood, the subject kits roav Iurther ir7c1tr;3r_ an element for c'~btainin,~ a blo;~d sample such as a lance f-o- stickr:y~ a finer, a lance actuation means, and the like. In adclitiorr, the sub;ect kits r:vay in~:audc a control solution or standard, e.~., a control solution that has a known aralw~ conc;:entration such as a k:o~4vn glucose coneentrWron.
T:~e kit5 m:iy ;irt~ther ircl:rdte insructir~ns fr}r usin~~ the ~apparWrtus ft7r determining the presen::e andlor cuncentr:jtion c; at aeast orrc anaCvte rrr a pnvsruluitcal sample applied to a test step The instructions may b~ pnntcd urr a substrate such as paper or plastic. etc.
:~ls such. the instructions mas t;~ present in the ktcs as a paw-kage insert.
in the labf.lin~ of the container o~ the kit c.r cornt'~:-vents thereof (r.e_, assc~ciatrd witJ-~
the packa~;int~. or sub-packaging) etc. In other embo,iimertts, tJ~e inst<-uctions are; present as an electronic ,forage data file present on a s~ritabie computer readable sturage medium, e.g., CD-RC)M, diskette, etc.
It is ev-rdent fram the <rbove description and discussion that the above described invention provides devices arid methods f(:~r accuram anal°te concentration determination irA the cases H here smt:Jl sample 4olum~;a are applied to :t test strip testin~~ area and: or the testing area of the test strip t:. not evenly or uniformly wetted by sample The a'aove described invention p;ovide~ ti number of advantages, irrcludinv~, but not limited to, ease of use, porta'oility, an~~ accurate :rnalytc: concentration deterTnir,ations usrnQ small amounts of sample, ttrereby reduc.ng the Cike;ihuod a~f multiple tin;er sticks. .-~s such, the.
;~ut7ject invention rep-eaen.t:: a sr~;niticant contributrort to the art.
LFS-194 ?6 ~a~;t7la. W~ LIFc-(''~
The subject invention to stto.tn any d~_scr~'c~eri ner~:n :n w hat is considered to f?
the mos.: practical. and prelerTe ~ en.LOu,r,r~~nt~, ~; ~rmc>;n:.e',...
,~.owwer. that departures rray 6e made thenef~om v'a:~iare: u;t;rirr tae ~;:c~p~. i~i the inventtor;. anr; taut obmuus mociifioations will c:ccur tc un~ .wkill~d m the art .Ipo~ readrnt.~
the da,:io;ur.
The spec~tic devices and m,°thod, dis.:lo:,ed are ~c~n~ri;~red to be ~Ilustratrve ant:
not res.rr~:tme. t~lv>dif;uatio is that ~wm~ within thc~ m~~,~n:n~ :.:3~1 ;an«e of epumalern:, c~f tine disLlosed concepts. suci~ as the :;e that would read~iv ljccur t,> onc:
::killed t:n the relcwant art, ure intended tc: be i:ic:ude~~ wuthin the Scope o~ t;m appended ela;ms.
LFS-1 ~4 ? -'

Claims (10)

WHAT IS CLAIMED IS:

1. An apparatus configured for receiving a test strip and for determining the concentration of at least one analyte in a physiological sample applied to the test strip, said apparatus comprising:
(a) at least one light source for irradiating a plurality of different areas of said test strip that has been operatively associated with said apparatus;
(b) a detector array for detecting reflected light from each of said plurality of different areas, respectively;
(c) means for determining whether each of said plurality of different areas has a sufficient amount of sample based on said detected reflected light; and (d) means for determining the concentration of at least one analyte based on said reflected light detected from those areas determined to have a sufficient amount of sample, wherein areas determined not to have a sufficient amount of sample are not used in said analyte concentration determination.

2. The apparatus according to claim 1, wherein said light source is capable of emitting light of at least two different wavelengths.

3. The apparatus according to claims 1 or 2, wherein from about 4 to about 1,000 detectors comprise said detector array.

4. The apparatus according to claims 1 or 2, wherein about 1,000 detectors or more comprise said detector array.

5. The apparatus according to claims 1 to 4, further comprising imaging optics for imaging reflected light from said plurality of areas onto respective detectors of said detector array

6. The apparatus according to any of claims 1 to 5, further comprising at least one test strip.

7. A method for determining the concentration of at least one analyte in a physiological sample applied to a test strip, said method comprising:
(a) illuminating a plurality of different areas of said test strip having physiological sample applied thereto:
(b) obtaining a respective reflectance value from each area of said plurality of different areas:
(c) determining whether each of said plurality of different areas has a sufficient amount of sample based on said obtained reflectance value:
(d) deriving the concentration of said at least one analyte in said physiological sample from each of said plurality of different areas determined to have a sufficient amount of sample, wherein areas determined not to have a sufficient amount of sample are not used in said derivation.

8. The method according to claim 7, wherein said method comprises employing an apparatus according to any of Claims 1 to 7.

9. A kit for determining the concentration of an analyte in a physiological sample, said kit comprising:
(a) an apparatus according to any of claims 1 to 7; and (b) at least one test strip.

10. A kit for determining the concentration of an analyte in a physiological sample, said kit comprising:
(a) an apparatus according to any of claims 1 to 7; and (b) at least one of an element for obtaining sample and control solution