ENGLISH ‘Read this package insert careful befor use. Keep on hand fr Interpretation feferonce as netted, Tem Tarra aataieomta| [| De ea Intended Use and Summary [isco fSericanatve] Poo] Pv [soca] zo omalsoof olor Urile'S 11UA'e a urnalys fst stp with reagent pads forthe vue a) 2 2 etarminaton of Glucose, Albumin, Protn Ureblirogen, lab, anemia] bs Creatinine, pH, Blood, Ketones, Nitrite and Leukocytes. Uriflet S 11UA is for Abe value (mg/L) 10 [80] #0 [880] tae wih ie AUTON yston % aistaie sta] |» [te [ee S'AUTION MAX, AUTION ELEVEN rian oom 5 Sarena 70 [2 | 30 | s0 | [00200] 300s fo Principles of the Procedure outa sataommn] ae a> _|_ae [aw [ Glucote| Ths ost based on te aucoseoxidase-peroxidaso- rate chromogen reacton, which produces a purple color. [voter Sorina 2[s fa [|e | [ol [Albumin Albumin couples wth ye to form 8rd compound ra [Protein] hs ‘ost s based onthe potan-aror action ot pH indeator, aut smta] — [oe [2 ae tion produces s bie ctr tubs Serge [Urobilinogen ] A redaish brown azo dye is obtained by the coupling of value (magic) 05] 10|20] 30 [60] 60 [8.0] 00/08} trotiinages wth a dazonem sak [came Sarizantance] so [eo foo] 200}ao0foe [ Bilrubin | Arecesh brown azo dye is obtines by the couping of birubin vate mat. with a diazonium sal. [pa _[Mostusnentvake] 50 [55 ]e0[65|ro|rs|eo]es[ao] {creatinine A yellow dye is eleased by the reacon of creatine wih a faite Peo eye Syemetal complex : [pH] The reagent pad contains pH indicators which give colors ranging Jtcce [Samurai Jo2sfoos) 0 o2]05| 10 joes] {rom yelow io Bue wth the prt range of fo 8 ae [Blood ] This test is based on the pseudoperoxidase activity of hemoglobin {Env} 10 {20 60 00] tic eaatyes the oxidation of ewemogen The reacbon produces a lve uataesynto-[ = [19] ae] ae] ae etones. |Site 7 [Ketones ] Ketone reacis with sodium nitroprusside to form a purple complex. value (rigid) 10 | 20 | 40 | 60} 60 [ete] NUte reacts wih sulantamde forma azo compound when [Nason pata > [Te Te Epes wit NEDA 2HCIt9 forma ed azo dye esti yo [Leukocytes | Dus to esterase activity in leukocytes, indoxyl is released Lesooter| atten | -_ | 25 [75 ]250]500] from the substrate. The indoxy couples with dazonium salto form a purple azo dye, Reagents Reactive Ingredients (per 100 test strips) [Glucose | Glucose oxdase: 700 LU, Peroxidase: 175 P.U ‘Aminoantipyeine: 14.0 mo, ‘Napnthol-36-dsufone ac, disodium salt: 14.0 mg [Albumin ]4,5.6,7-Tetrachioro-2.2'8,7-telraladofvorescein disodium salt baamg [Protein } Totrabromophonol blue: 0.35 mg [Urebilinogen ] 3,3-dimethoxy-4,4°iphenybis(dazonium fetratuoroberat) 0.18 mg [Bilirubin | -Metty/S-nitoaniine: 1.9 mg, Sodium nite: 1.0 mg [Creatinine | 2,6:Diehloro--nydroxy-3,3°-dimethyl3-sufotuchsone-55"-dcarboxylle faci, tisodium salt 0.34 mg, Palladium (Il) chlorige: 0.10 mg [pH] Bromocresol green: 0.07 mg, Bromoxylenal blue: 0.72 mg [Blood ] Cumene hydroperoxide: 30.0 mg, 33,5.5-Tevrametnybensioine: 15.0 mg [ketones ] Socium ntropresside: 12.0 mq [Nitrite] Sufaniamide: 8.9 mg, N-1-Naphtnylethylenediamine Sinydrochloride: 0.3 mg [Leukocytes] 3.(N-ToluenesulfonytL-alanyloxy indole: 0.68 ma, 2-Mathoxy-4-(N-morpholino) benzenediazonium 0:38 mg Precautions This products fr in vitro agnostic use only. Storage and Stability Store a foom temperature (1 ~ 30°C). Avoid humility, direct sunlight or heat Improper storage may affect performance of test stps, Ths product stable trough fo the end ofthe month printed on each bole when stored in is original bate, nso ‘ar as lis used according to tha package inser Sample Handle samples as biohazardous material ‘Sample Collection and Preparation Goleet urine na clean container. Use uncentfuged, wellmixed and freshly voided urne. Precautions: + "Avoid direct sunight while handing the urine + Domnot use une containing antiseptic. + Use frstmoming urine or urine that has incubated inthe bladder forfour hour or more for nt tests ‘Sample Handling and Storage Perform the test within hour aftr voiding, Refrigerate urine if testing Cannot be performed withn nour aftr voicing, Allow it to return fo "oom temperature bofere use Testing Procedure atecale Provided 100 fst stips por bottle Materials Reauired But Not Provided Urine contamners Qvaration Procedure Follow the operation procedure to obtain accurate testing results IMPORTANT: De net ouch reagent pads. + ‘Avald contamination caused by volatile chemicals, + Dornot use deteriorates, alscolored or blackened test sips. + Use test stips as soon as possible afer opening the cote ‘Remove only the number a test strips required for testing. Clase the bolle Immediately (win about 5 seconds) aller removing the test Sips, + The tes sips are for single use only. Do not reuse. + The test sips shall be used by or under the rection of healthcare professionals. 1 Remove only the necessary numberof test strips from the bottle Place trem int the instrument. 2 Follow the instructions inthe operating manual for the instrument Testing reslls are printed automaticaly. Quality Control Qualty conta tasting should be performed according tothe procedures defined by each laboratory, Use & commercial or laboratory convo. As Aafcial adatves are included i commeretal contol wine, is reactivity may Gor rom that of real urine. Limitations of the Procedures AAs‘with all aboratory tests, dotintve diagnostic o: therapeutic decisions ‘Should not be based on any single result or method Interferences [Glucose | Large amounts of ascorbic acd [Albumin, Protein] Acidic urine (pH <3) [Bilirubin] Ascorbic aci, Uric acd, Nite [Blood J Large amounls of ascorbic acd, Urine wth elevated specific fgravity, Urine with elevatea proven {Nitrite Ascorbe act, Urine with elevated specie gravity [Leukozytes ] Glucose (2 500 mgldL), Proto (2 300 mld, Acidic urine, Urine with elevated spectic gravity Substances which may cause flee POSITIVE results [Glucose | Oxa:zing substances such as hypochiarta and chlorine, Acisic lutine (5 4) [Albumin J Akaline urine (pH 2 8), Large amounts of hemoglobin and myoglobin [Protein Akalino urine (pH 8), Large amounts of hemoglobin, Contrast medium, High molecular substances, Disinfectant including quaternary ‘ammonium compound [Urobitinegen | Carsapenem, Pyrdium (phenazopyriine) [Bilirubin | Urobiinegen. Ethodola, Pyrisium (pherazopyrcina) [ Blood } Oxadizng substances such as mypochlote and chlorine [Ketones ] -DOPA, BSP, PSP, Phenyiketone, Cephalosporine, Aldose Feductive antionzyme, Bucilamine TLeukoeytes | Formaldehyde, Blin (Other factors that may affect esting results: Fighly concentrated or ated rine may produce higher or lower results. Albumin, Creatinine | Contrast medum, high molecular substances, anlisptc, disinfectant, drug and chromaturia may affect toting results. [[Urobilinogen ] Urine wih a high level of bilirubin may cause the ‘evelopment of green color. [[Blieubin J Blirubin's unstable in ght. [pH] Old urine ineroasos alkalinity [Blood, Nitrite, Loukoeytes I the urine sl for lng perods of ie, testing results may be affected. Traceability of test results Rank values ate basod on the materials and moasurement methods specified by the company. Expected Values [Glucose | small amount of glucose may bo detected in normal urine. ‘Tho concentration ls 2-30 mg Note that fhe concentration is higher ‘than 20000 mala, incorrect resus may be obtaned. [Albumin A small amount of albumin may be detected in normal une, ‘The concentration is ess than 20 mg. Aburin may bo excreted lemporary due to srenvous exercise and other factors. [Protein] A small amount of pratin may be excreted temporary due to Brenuovs exerese, paycnological stress, an excessive meat sist ng @ hat bath and before a menstual pelos, [Urebitinogen } Positve resuls may be obtained alter exercise or crinking, ‘or may be due to fatigue or constipation. Healry indvduals may excrete a Small amount of uroblinogen.A result of zero cannet be obtained for hs item, [Bilicubin } Even a small amount of bilirubin detected in urine should be considered signicant [Crestinine | Heath individuals excrete 10 - 300 mg/dL. of creatinine. The oncentraton is higher in concentrated urine and first morning ura, and Toworin dlisted urine. [pH ] Normal urne is acid with pH around 8, The pH ranges from 5 to 8, figpending on dictary condiions. [Blood }A blue-green dated reaction shows tha presence of erythrocytes, Uno trom monstruting females may give a positive resul. [Ketones ] Ketonos are not normally dotocted in healthy individuals However, fasting or strenuous exercise may eause a sightleant amount of ketones inthe urine [Nitrite] though nitrate-reducing bactria show a positive reaction, bactorurla wth low oF without nitrate reduction abity may cause a negative result A negative result may also occur during fasting, as irate may not Spear in ure [Leukocytes ] when pli or specie gravity is out ofthe normal range, lesting resus may not correlate to the numberof oukoeytes detormined via Sedimentation, depending onthe leukocyte conaiton. [ Ratio of Protein to Creatinine ] The rato of proten to creatinine in the lurine from healthy individuals is lass than 80 ma/gce. [ Ratio of Albumin to Creatinine ] The rao of abumin to eoatnine in the lune trom healthy Individuals is fos than 30 malar. When the rato 30 5300 mgigCr, this Incicates miccalbuminura. When the rato is over 300 mg/gCr. this indicates cnical albuminuria. Specific Performance Characteristics Speetie perfomance characterises are based on laboratory an clinical stules. 4, Sensitivity and Measurement Range [Stcsas [Oma = 7000 mai 0 mals [xburin [19m 10-150mot | 20mat Prats — [10 mgld 0-00 mai 25 mala Birubin [0 mata 5 10.0 mpi [0.5 maid [creatinine [10 moa. 0-300 mala. [WA c (05 unt win henge of 50-80 NA fooa | Seosben 83 mal Teragenin | Heraaabi Eryivanye appro 1Ociyat _[oaa- Tampa [Dove mai. ketones | Aceloacetc a mi. pestogetc acid | Acsloact Niko | Knott? boda: opprox. oF [08° 05 mui. | DOTS mate acl | Appron. 25 Luin 25-500 Loui [ 50 Loui "The minum a “2 Rasa igher ing rank was conrad by preparation of each specimen ihe extol! value ore nerpietea as peaks. 2 Specificity ‘When standard solution witha known concentration is measured, the Dbtained result corresponds tothe rank specified fr the concentration. [Glucose | This ests specticaly sensitive to f-D-alucose ang s not affected by reducing metabolies, sucrose laclose and fructose. [Albumin } This tests especialy sensive to albumin. The falling proteins do not affect testing rests at equal oor less than te following Eoncentrations ‘Concentration Protein 30 mai. Transferrin 50 mai Hapioglabutin, a1-Antrypsin, Retina-binaing protein 0 mai 2-Microglobuin, Prealbursn, at-heide glycoprotein, Bence-Jones protein. Tamm Horsfall glycoprotein 10 mglL__at-Microglobutn, immunoglobulin, Lysozyme [Protein] This testis especially senstve to albumin but less sensitive to Slobulin, Bence-Jones protein ane mucopreteln. { Urobilinogen j Ths tes is sensitive fo urobinogen [ Biticubin } This tests sensitive to direct bilrubin. [ Creatinine ] This tests sensive to creatinine [ pH] Determination of pH by 0.5 unt is possole witrin the range of pH 5-9. [Blood } Tris testi mare sensitive ta hemoglobin and myoglobin than to erythrocytes. Total absonce of homolysis may cause a negative result, despite the presence of erythrocytes in sedimentation, [ Ketones] This ests ot sensitive to B-hyeroxyoutyrie acid. The reactivity fa acatone s 1/10 of that of acatoacatc aia [ Nitrite} Ths testis sensitive to nite, Color development ie ot proportional to the number of bacteria, [Leukocytes ] This ests specifealy sensitive to esterase in he granular leukocytes 3. Reproducibity Vimen standard solution wth a known concentration is measured fve times, ‘he same results obtained tnroughout the measurement Disposal of Biohazardous Waste ‘Aer using test sips, aispase of them according to your local regulations on bbonazardous waste References 4, Free, AH. eta, Clinical Chemisty. 3,716 (1957) 2. Free, HIN. stl Ciiical Chemisty. 6, 952 (7280) 53. ¥- Hayashi: Modem Medical Technology, Basic Clinical Technology and Analytical Toxicology. Igaku-shoin (1973) 4.4. Hayashi, etal. Journal of Japan Diabetes Society. 35, 819 (1982) 5. IsMion.et al Chem. Pharm, Bul, 7389 (1983) 6.C. Naka otal. Rinsho Byer, 53, 810 (2005) 7 Sakai H. etal, Journal othe Japan Diabotos Society. 44, 467 (2001) 8, American Diabotos Association, Diabetes Care, 27, $79 (2008) Issued: AUG, 2016 Revision: FEB. 20:7 (CPO73501-243A ( CPOT3501-244A)