CA2184313C - Diffused light reflectance readhead - Google Patents

Diffused light reflectance readhead

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Publication number
CA2184313C
CA2184313C CA002184313A CA2184313A CA2184313C CA 2184313 C CA2184313 C CA 2184313C CA 002184313 A CA002184313 A CA 002184313A CA 2184313 A CA2184313 A CA 2184313A CA 2184313 C CA2184313 C CA 2184313C
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CA
Canada
Prior art keywords
light
sensor
reagent test
test pad
readhead
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002184313A
Other languages
French (fr)
Other versions
CA2184313A1 (en
Inventor
Andrew Dosmann
Mohammad A. Kheiri
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Corp
Original Assignee
Bayer Corp
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Filing date
Publication date
Application filed by Bayer Corp filed Critical Bayer Corp
Publication of CA2184313A1 publication Critical patent/CA2184313A1/en
Application granted granted Critical
Publication of CA2184313C publication Critical patent/CA2184313C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/4738Diffuse reflection, e.g. also for testing fluids, fibrous materials
    • G01N21/474Details of optical heads therefor, e.g. using optical fibres

Abstract

A diffused light reflectance readhead is disclosed. The readhead employs an improved light emitting diode (LED) providing a more strongly collimated beam of light around a beam axis onto a reagent test pad. The reagent test pad is supported on a strip guide at an angle .alpha. of 5 degrees with respect to the perpendicular of the beam axis. It has been discovered that when .alpha. is between 3 and 8 degrees that specular reflection is dramatically reduced in relation to the small reduction in reflected light received by a sensor. The diffuse reflected light travels to the sensor by passing through a staircase optical baffle at an angle of 45 degrees to the perpendicular of the beam axis. The sensor converts the optical signal into an electrical one for processing and analysis. One embodiment of the present invention can detect the presence of glucose in a blood sample.

Description

Dlt ~ U~ LIGHT REFLECTANCE READHEAD

Field Of The Invention The present invention generally relates to the field of mPAi~ 1i~nl~sti-~.
equipment used in clinical rhPmi~try. More particularly, the present invention relates to a hll~r~ved dirîu~ light reflect~n~ re~hP^~ uscd as part of a visual im~jnp S system for dete~ti~ analytes present in other s.,l,st~nr~s such as gll)c~se in blood, on a reagent test strip.

BacL~und Of The l~l~e.ltion Reagent test strips are widely used in clinical l hPmi~try. A reagent test strip usually has one or more test areas (pads), and each pad is capable of undelgo~ g a 10 color change in re~l~n~ to contact with an analyte in a liquid ,~;...Pn The liquid ~imen is reacted ~,vith a pad on the reagent strip in order to ascel~in the plese of one or more analytes, i.e., cQfi~ u~Pnt~ or p~pe~lies of interest, in the liquid sl~~ M The p~sence and cQncenl~ n~ of these analytes in the ~ n are in~lic~ted by a color change in the pads of the test strip when reacted with the 15 analyte. Diffuse light refl~P~te~A. off of the reacte~ reagent test strip is analyæd to Ae~- ~--in~ the ~mount of color ch~n~e~ Usually, this analysis involves a color co...r~ ;.~n b~lwæn the reacted test pad and a color standard or scale. In this way, r~agelll test strips assist n eA~ p~nncl in ~ o~ing the eYiQtenc~ of ~ eqces and other health probl.omc An eY~mple of a reagent test strip suitable for use with the present invention is the Gluco-l-eler Lncol~ - Blood ~lUC4Se Test Strips sold by Bayer Col~.i~;on, Di~gnostirs Division, of Elkhart, ~nf~i~n~ 46515.
RPflç~t~Pd light co...~ on~ made with the naked eye can lead to imprecise S mea~urelll~nl. Today, reagent strip reading instruments exist that employ reflP~t~nrR
photoll*ll~ for reading test strip rh~Ps. Some reagent strip reading insLIulllents have re~f1hP~ls that contain light emitting diodes (LEDs) for ;11.. ;nA~ g reagent pads. Some of the light from the LED is reflP~te~ off of each pad while some is absorbed in such a way to indic~te the color change of the pad due to its reaction 10 with the substance of interest, such as plllcose~ The diffuse reflP~t~ light, i.e., the color-changed light, is detP~tPd by a sensor which C~IlVt;l~ the light into electronic signals for pr~ ;ng.
It has been found that present light ~-..;II;ng diodes (LEDs) are not ideal for use in rP.~f1hp~s bec~u~ the beam of light they produce is not very well collim~tf-~d 15 A ~ignifir~nt pclcenlage of the diffused light produced by present LEDs tends to become stray light that must be filtered out.
Some prior art inventions have tried to address the problem of stray light being emitted from the LED. One approach has been to enf~rsll1~te the sides of the ~ Fn with a light absoll,ing m~tPri~l. An eY~mpl^ of a device with such en-~r.s.. l~tion is U.S. Patent No. 5,122,943 by Pugh. This approach results in an LED that absorbs a portion of the light it g~U,.il1~.5 in the en~ar.~ tiQn m7~tPri~h It would be de~ hl~p to have an LED adapted for use in a re~flhP~d such that less stray light is ~ioduced that l~U~,S filtP,ring. Mol~ r, it would be even more ~ir.qhl^ to cQl1imqtP~ more of the light that would other~-vise be~^-4mP, stray light in order to increase the signal and effi-^ienry of the re~q-Ahe~
However, even when light is fairly well col1imqt~ the problem of spe~ul-q-~reflection erre ;tively raises the level of "noise" in the light signal .cceived by the S sensor. Specular re,flP~;tion of light is analogous to light bolm^in~ off of a mirror wl~crcill the overall color of the r~fl~^-ted light is not ~i~ifi-^qntly changed. Thus, s~Ul-qr refl~til^n works against sensing a color change of a pad on the reagent strip.
It would be desi-q-b1e to decrease the spe~ qr reflPc~nn of light r~eived by the light sensor in order to provide a better signal-to-noise ratio.
Rer,,qu~ stray light makes sensing the color change of a pad more ~liffi~^~ult and less ~^,cllr.qte, various optical baffles have been employed to filter some of the stray light. For e~qmp'.^-7 a spiral llueaded ap~llu~e has been used to reduce stray light.
Only light coming from a narrow field of view can travel through the threaded ap~lluuG to the sensor, thus stray light is c~lu~d However, threaded ap~llu,es can 15 be costly to form bec~us~ they require extra mqnllf~ lri~ steps. One way the threaded a~lul~ is formed is by emhed~ling a screw-like el~mPnt into the plastic as it is being mnl~e~l When the plastic has cooled the screw-like e1P-mPnt is unsclewcd in order to leave a collw7~n~;n~ threaded ap~lluu~. Another threaded a~cllu~
drawback is that threaded ~luuCS tend to have smaller ~;~n~ which reduce the 20 total qmount of light .ccGived by the sensor, which in turn imptqct~ the sensor's llr^^y. Thus, it would be desirable to have an optical baffle that reduces stray light, but is less t:~l~n~;ve and easier to fqhrirq~ FurthPrmore, it is de-~ ble to have an optical baffle that increases the amount of d~P-~ir~le light received by the sensor.

Su-l----~y of the Invention The present invention is an app~udlus and method for providing il"pr~ved S det~ctinn of analytes reacted with reagent test pads. One embo~ t of the present invention provides an improved diffused light reflPct~nre re~h~P~I used in a nP4n~t~1 station as part of a visual im~ing system used to detect glucose in blood ~mples The visual im~gjng system analyzes a color change ~cSori~t~ with one or more test pad areas on a reagent test strip following contact thereof with liquid specimpn~ for 10 eY~mpl~, blood or urine, in order to detect analytes such as glucose, protein, blood, , bilirubin, urobilinogen, nihite, chole-t~rol~ etc. Light reflPcted off of the reagent ship is conv~l~d into elechic~l signals that can be analyzed with ii~noshr, e~luip",~l l. More ~ifir~lly~ one embotlimpnt of the present invention employs a new light emitting diode (LED) op!;...;,~d for use with a r-p~lhp~- The LED's 15 geometry has been redesignP~ to il~c~ the productir,ln of collim~tPd light. The length bc;l~ a light emithng semicQn~luctor and a curved outer surface of the LED
has been increased to more nearly bring the light emitting spmirontluctor to a foG~l point of the cuNed outer LED sllrf^^~e. l?Ppo~ nni~ the light emitting sP-mir4nductor in this way has the effect of much more sL,ùngly collim~hing the 20 emi~d light, th~eb~ reduring u"w~nted stray light while increasing the d~P~ir~ble illl....;-u~;rn of a given reagent test pad. The present design of the T Fn has the effect of h,l~u~ing the signal-to-noiæ ratio of the light ,~ived by the ænsor.

21~4313 The reagent test strip itself is placed against a s~l~pu~ g surfql~e~ The surface has been tilted 5 degrees away from a plane perpçn~ir~ q-r to the axis of the c~11im-q~te~d beam and away from the sensor. The small S degree tilt has the lln~l ec~lly large effect of reclucing spPc~~lqr r~PflPctinn to the sensor by 5 a~pr~im-q-tely a factor of 3, ~1r~qmqtirqlly incleasii~g the signal-to-noise ratio to the sensor.
To further enhq-nce the sensor's reC~pti-n of diffuse refl~ctP~ (color changed) light a series of steps in an apellu~e creating a i.t~case optical baffle is employed on only one side of an a~llu~t pc~l--;u;r~ reflPct~l light to enr4unt~-r the sensor. It has 10 been discovered that most of the lm~le~ir~ P light entered the baffle ap~ le from the side nearest the LED, where steps are now positi-~n~ thus ~ l;.,g most of the un~1~P-sirqhle light. The st~se baffle reduces stray light while allowing the rest of the a~.lule to be larger, thus allowing more diffuse reflPct~ light to reach the sensor. The other sides of the s~i.~ optical baffle are accordingly less m~lifi 15 so the baffle is easier to mqmlf~ rcr in this way as well. The,tfore, the ~t~ase baffle is both easier and less costly to mqn~lf~ lre.
flPct~ light .~ived by a sensor is col.v~l~d into elPctric-q-l signals for ~c~-c~ g Analysis of the electronic signals is p~ v- .~ to de~- . ~ e the pl.,sence of ~lllcose in blood. The present invention provides improved cost, mqnufq~lring 20 and ~ ru- .~qnce a~lv~tages over current ~;,t~,.s.
Brief Descli~)tion Of The Drawin~
Otner aspects and advantages of the invention will bec~me appa~ent upon reading the following det~iled description and upon lef~lGnce to the ~ ying dswings, in which:
S FIG. 1 is a block ~lia~rs m overview of a dirr,ls~ light refl~t~n~ re~h~
according to one embo~imPnt of the present invention.
FIG. 2 is a top view of a diffused light reflPc~nr~ re~lhP~l according to one embodimPnt of the present invention.
FIG. 3 is a bottom plan view of a dirru~d light reflP~anr~ re~lh according to one embo~ of the present invention.
FIG. 4 is a ico-mp-tric plan view of a dirr~d light refl~t~nce re^~hP^~
according to one e-nbo l;...P-nt of the present invention.

Detailed Des~ j)tion Of The P~GfGllGd Embodh,~ L~
While the invention is suscG~lible to various m~ylifi~tions and ~lt~rn~tive 15 forrns, a llUlll't)~' of srecific P- -bo~;---ent~ thereof have been shown by way of eY~mple in the dlawil~gs and will be des~ribed in detail herein. It should be undG~tood, however, that this is not intPn-lPd to limit the invention to the particular forms ~ o~ On the co~ ~y, the intPnti-~n is to cover all mo lifi~tion~, equivalents and ~ 5~;~eS falling within the spirit and scope of the invention as 20 defined by the arpend~P~ claims.
One embo~ P-~-t of the present invention is used in an nP~n~ l mP~dic~l ~li~i^ost~ in;,l,u.ncl~t to Ill~Lc~e dirrus~d light reflP~^-ted from reagent paper that has been reacted with specim.^n ~l.t;.;ning an analyte, such as blood c~l.l;.;.~il-g gll)c~se.
In Figures 1 - 4, a diLru3~d light refl-c~n^e re^ 111~^~ 10 is ~ecignPd with one 5 or more i..lproved light emitting diodes a,EDs) 12 to reflect light 13 off of a reagent test pad reacted with an analyte 14. The ~ Fns 12 are pulsed on and off using a conct~nt-current pulsed direct current (DC) power supply (not shown). Pulsing the LEDs 12 .ni~ f s heating âS well as ^~ çd light 13 intens,l~ and wavelength v~ri^tic.n It has been discovered that c~llim~tP~d light is ~lc-cir. bl~^- for analysis ~ul~oses, while unc~llimqtçd light is not ~ccir~ ^ because it tends to produce stray light.
F~ e~ it was also discovered that the LED's 12 curved outer surface in its epoxy casing acts as a lens to some degree. The present invention takes advantage of the lensing effect by reloc~tin~ a light emittin~ srmiG~ndl~ctor die 15 (also commonly 15 known as a "chip") inside the LED 12 to a positinn a~ q~Ply at the focal point of the curved outer sllrf~^-fP Co,--~u~. mo~P1ing and Pyrerimpnt~1 results were used to obtain an oplilllulll tip-to-die ~lict~^~nGe (~) of 0.170 iO.Ol inch for this configllr~t on Note that other ~lict~nc~ps for A can be used but are not cc.nc;~ered optim~l The present invention reduces the light's 13 reslllt~nt ill.. in~lion spot size on the reagent strip 14. A ci~nific~nt portion of the spot size is less than 0.100 inch in -r at a tlict~nc~ of O.lSO inch beyond the rP~hP- l sllrf~cP. Recau~e the spot size is ~luced the need for a focu~,ng lens is e~ h~ d~ thus saving its cost.
Another advantage of the present T Fn 12 design is that it decreases the rP~lhP~d~s s~ns;livily to mP~h~ni~l vibrations and die 15 c~nl~. ;.-g errors. A
standard T1 LED, for e~mple, has a die-to-tip ~liQ~llr~ (~) of about 0.100 inch. As ~ is increased to approach the focal point of the standard Tl LED the light 13 out 5 from the standard ~ Fn be~.l.cs more cctllim~t~p~d This tends to produce a smaller spot for an equivalent apel~ule size. The smaller spot size and increased collim~hnn has the advantage of making the re~lhP~1 less sensitive to pocitiltning of the die 15 within the LEDs 12. Thus, if the LEDs' 12 die 15 is not placed at the center of the LEDs 12, the output spot posiff~tn will be shifted a smaller amount in plu~Lon to 10 the die 15 cenlf ~ g error.
Other factors were c~ nQ;~P-red in the design of the ~ Fns 12. Each LED 12 and each illlu~;n~ n apt;llule lC ~cs~ ed with that LED 12 must ill~ e a spot - of the proper size and intensity. The ~ignifit~nt portion of the spot size should be less than the pad size to reduce genF al; tn of stray light. ~enp~lly~ greater intensity 15 is desirable b~ ~ signal sllellglll is incleas~. Fu~ t- ...ore, the LEDs 12 have their sides coated with a light absoll,~g m~tPri~l to further reduce stray light as is known in the arts. The total effect is appio~ p-ly a 200-300 percent signal ru~ c~t over prior I Fns used in re~lhP~lc Light 13 from the LEDs 12 travel through the illu...in~l;t n a~cllulcs 16 to ~e 20 reagent pad 14 on a reagent test strip guide 18. It is known to have ~e strip guide 18 hold the reagent s~ip 14 ~Ip n~ r to the axis of the collim~tçd light 13 emitted from the T Fn 12. Note that in Figure 1 a defines the angle belween a perp~n~iC ll~r plane 20 that is perp~Pntli~ r to the axis of the collim~tPd beam and a 2l843l3 guide plane 22 that is parallel to the Qrient~tion of the strip guide 18, which is æro degl~s in the prior art. It has been found that tilting the strip guide 18 with the ~C~oci~tpd reagent pad 14 in a direction away from a light sensor 24 by only 5 degrees, i.e., a is equal to S degrees, produced the ~np~l~c~ benefit of re~lucing 5 specul~r reflPchQn l~ceived by the sensor 24 by app~ çly a factor of three. It was un~ ~ted that such a small change in angle a would produce such a large decrease in spP~ r reflPctic-n FurthPrmore, the large rP~uction of ~ec~ r reflPctic-n enabled the LEDs 12 and the light sensor 24 to be located in closer proximity to one another than ~ ~n~ly possible, thereby rPA-l~ing the size of the 10 rPflP~t~n~e photQmPtpr. In one embo~ -n~ the sample to det~t~r tli~t~nl~ iS
applu~ p~y 0.4 inch, which is one half of some current rP~hP~s, thus providing an increase in signal by about a factor of 4. Mo~cl)v~r, the reduction in sp-pctr rçflPctinn enabled the viewing area of the light sensor 24 to be opened up, engen~le~ g sig~ifi-~nt improve.,lents in the rr lhP~d's 10 sensitivity to variations in 15 reagent strip 14 height variations.
The optimal range of angle a has been found to appr~,~;...A~ly range between 3 degrees and 8 degrees for reagent test strips 14 reacted with blood con~ining gll)cose~ howt;v~, the range should be similar for other analytes as well. When angle a becol..çs less than 3 degl~s the reductinn in sreclll~r rPflPctinn be~llles 20 l~lalively small. Con~l~ly, when angle a becolll~s greater than 8 degrees then desirable diffuse color rçflpctinn is recl-~c~l, along with ~ le ~eCul~r rPflPctinn, to the point that signifir~nt signal loss begins to occur. Note that if a is less than 3 degrees or greater than 8 degrees the r~ lhP~l 10 will still p~.rolm, however, not optim~lly.
In Figure 1, after light 13 from the L_Ds 12 is refle~d off of the reagent pad 14 it passes through a ;,t~ case baffle 26 at an angle ,~ of ap~lc~ tPl~ 45 5 degrees to the perpen~lirnl~- plane 20 before rP~^hir~ the sensor 24. As shown in FIGS.l, 2 and 4, the staircase baffle 26 has a series of steps 28 prim~rily on one side. In one embo limPnt each step's top side 30 and vertical side 32 (both steps 28 and sides 30,32 are l~lcse ~ ely marked), are appl~ e1y of equal length and positinnPA at a 90 degree angle to each other. It has been found that the length of 10 each step side 30,32 works best to e~ n~le stray light and pass desirable diffuse rPflP~teA light 13 when sized b~n O.OlO inch and 0.030 inch. Ful~ ..nre, step 28 size is p~^ti~lly limited to sQmPthing smaller than would extend into the LFDs 12 or the illl~...in~l;Qn a~l~ ,s 16. In one e.~ rnt the length of each st~p side 30,32 was chosen to be 0.020 inch. The number of steps 28 is not fi~ed but 15 desirably there are a sufficiPnt rlulllber of steps 28 to extend the entire length of the staircase baffle 26. The total length of the ~t~il~ baffle 26 is a function of g~mPtry. lU~n--l~ g limit~tinn~ set a ,--;n;.--l~ s.~ n ~lict~nce belween the ~ P~s 12 and the light sensor 24. Knowing the .n;ni...n... s~ ion AiQt~n~e and the rli~t~n~e from the ~ PI)s 12 to the reagent test pad 14 along with the fact that the 20 steps 28 are at an angle ~ of 45 degrees allows a simple ~lc~ ti~n of the ~i~t~nce the steps 28 must cover. Thus, in one en ho~liment there are 7 individual steps 28 as PA in Figures 1, 2 and 4.

~5SE-2112 The steps 28 are position~ on a side of staircase baffle 26 closest to the LEDs 12. This is bec~..~ it has been found that most of the stray light enters an apellule leading to the sensor 24 on the close side and t-h-at having the steps there filters out most of stray light.
S A key adv~-~ge to the use of steps 28 for the staircase baffle 26 is the ease in mqmlfq,ctllre over the prior art. Steps 28 can easy be formed from a mold while prior art threads are not so easily formed in the rP~ lhP~l 10 mqt~oriql.
Once refl~t~l light 13 passes through the st~r~ baffle 26 it reaches the light sensor 24. Note that no transfer optics are required between the reagent pad 14 and the sensor 24 becau~ of the design advantages of the present invention.
Devices that can be employed as the sensor 24 include charge coupled devices (CCDs), photocell~ and ~hot~liodes. In one elllbcY~ ont of the present invention a OPTlOlW-R sensor from Burr-Brown, Tn~e.~ nql Ai~port ~ndll~triql Park, 6730 South Tucson Blvd., Tucson, Arizona 85706, is employed as the light sensor 24.
The sensor 24 has an el~ctrirql l~ Spon~ that is p.opollional to the refl~t~d light 13 eceived. The e1~trirq1 l~rn~ is in~ ted by ~s~.;ng electronics (not shown). The p,w~ing electronics convert the analog el~tri~ ql r~4n~ of the sensor 24 into digital data. The pl~ g electronics also include a micruprocessor(not shown) w-hich stores and utilizes the digital data to c~qlrulqte CQ~ t Vqri-qti-~nc 20 in~liC~J~d by the sensor 24. In one emho~l;u--t, the change in color is used to d~tr-..-ine a conr~n~ ;on of glucose in a blood sarnple.
Thus, there has been de.~ibed herean a ~l;rr~d light refl~t-qnre re~qtlhe~ 10.

I~SE-2 112 Many m~ific~tinnc and v~ri~til~n~ of the ~ ion as he~einberul~, set forth can be made without del?~ling from the spirit and scope thereof and ~ .c;fole only such limit~tionc should be i..-l~s~ as are indic~t~ by the appended claims.

Claims (5)

What is claimed is:
1. A diffused light reflectance readhead for detecting diffuse light reflected off of a reagent test pad reacted with an analyte, comprising:
illuminating means, having a beam axis, for illuminating said reagent test pad;
supporting means for supporting said reagent test pad in a temporarily fixed position with respect to said beam axis;
an exit aperture positioned adjacent said illuminating means;
a staircase optical baffle positioned only on the side of said exit aperture nearest said illuminating means, said baffle rejecting stray light and passing desirable diffuse reflected light from said reagent test pad through said aperture; and a light sensor positioned to receive said diffuse reflected light and capable of converting said received light into corresponding electrical signals; and interpretation means for interpreting said corresponding electrical signals to detect the presence of said analyte.
2. The diffused light reflectance readhead of claim 1 wherein said staircase optical filter has a plurality of steps each having a top side and a vertical side.
3. The diffused light reflectance readhead of claim 2 wherein said top side and said vertical side are each between 0.010 inch and 0.030 inch in length.
4. The diffused light reflectance readhead of claim 3 wherein said top side and said vertical side are approximately 0.020 inch in length.
5. The diffused light reflectance readhead of claim 1 wherein the readhead detects the presence of an analyte when said reagent test pad is reacted with a sample of body fluid.
CA002184313A 1995-09-05 1996-08-28 Diffused light reflectance readhead Expired - Fee Related CA2184313C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/523,271 US5518689A (en) 1995-09-05 1995-09-05 Diffused light reflectance readhead
US523,271 1995-09-05

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CA2184313C true CA2184313C (en) 1999-10-19

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