ALT•AST (GPT•GOT)
Contents
1. Til in vitro diagnostisk brug Medisinsk utstyr for in vitro diagnostikk e In Vitro tan sal tibbi cihaz e Tia in vitro diayvwotikn xprjon e Na in vitro diagnostick pou itie eCatalog Number e N mero de cat logo e Katalognummer e Numero di catalogo e Num ro de catalogue allegato e N mero de cat logo e Katalognummer e Katalognummer e Katalognummer e Katalog numaras Api u kataA you e Katal gov slo REF AN eCaution consult accompanying documents e Precauci n Consulte los documentos adjuntos e Achtung lesen Sie die beigelegten Dokumente e Attenzione Consultare la documentazione in e Attention Consulter les documents joints e Aten o Consulte as instru es de utiliza o OBS Se bruksanvisningen e Forsigtig les medf lgende dokumenter Forsiktig se medf lgende dokumentasjon e Dikkat beraberindeki belgelere bak n 1pocoyri ouuBouAeure re Ta ouvo eutik Eyypaga e Pozor Pozri n vod na pou vanie D e Do not reuse No reutilizar Nicht zur Wiederverwendung Non riutilizzare Ne pas r utiliser N o reutilizar Ateranvand ej M ikke genbruges eTil engangsbruk Do not use if package is damaged or open e No utilizar si el envase est abierto o da ado Nicht verwenden wenn Verpackung ge ffnet oder besch digt ist e Non usare se la confezione aperta o danneggiata Ne pas utiliser si l emballage est ouvert ou endommag e2. a los 30 d as de ponerse el producto a dicha temperatura e Verfallsdatum bei Raumtemperatur Anfangsdatum der Lagerung bei Raumtemperatur plus 30 Tage Data di scadenza a temperatura ambiente 30 giorni dopo la data di scadenza a temperatura ambiente e Date de p remption temp rature ambiante date temp rature ambiante plus 30 jours e Prazo de validade temperatura ambiente 30 dias ap s a data de colocac o temperatura ambiente Utgangsdatum vid rumstemperatur datum for placering i rumstemperatur plus 30 dagar Udlgbsdato ved stuetemperatur dato ved stuetemperatur plus 30 dage e Utlopsdato ved romtemperatur romtemperatur dato pluss 30 dager e Oda S cakl nda son kullan m tarihi oda s cakl na yerle tirildi i tarih art 30 g n e Huepounvia Arj amp nc oe Oeppokpaocia Swpatiou nuspounv a oe Beppokpaocia Swyatiou ouv 30 ny pec D tum exspir cie pri izbovej teplote datum uskladnenia pri izbovej teplote plus 30 dn Lii Consult instructions for use e Consulte las instrucciones de uso Gebrauchsanweisung beachten e Consultare le istruzioni per l uso Consulter le mode d emploi e Consultar as instru es de utiliza o e Konsultera bruksanvisningen e Se brugsanvisningen e Se bruksanvisningen e Kullanma talimat na ba vurun e YupBoudeuteite Tic o ny ec YOnONG e Pre tajte si n vod na pou vanie V Contains sufficient for n tests Cantidad
3. CO H O Peroxidase Indicator H O Colored Blue Dye H O The Cholestech LDX Analyzer measures aspartate aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al Aspartic acid aminotransferase catalyzes the transfer of amino groups from L Aspartic acid to alpha Ketoglutarate producing oxaloacetate and glutamate Oxaloacetate Decarboxylase converts the Oxaloacetate to Pyruvate by the removal of CO2 Pyruvate oxidase in the presence of oxygen oxidizes the pyruvate to acetylphosphate and hydrogen peroxide In a reaction catalyzed by horseradish peroxidase the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the AST concentration of the sample The resultant color in the reaction is measured by reflectance photometry Aspartate Aminotransferase L Aspartic acid alpha Ketoglutarate Oxaloacetate Decarboxylase Oxaloacetate Pyruvate CO Pyruvate Oxidase Oxaloacetate Glutamate Pyruvate Phosphate O H O Acetylphosphate CO H O Peroxidase Indicator H O Colored Blue Dye H O A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the ALT and AST concentrations in U L 37 C 99 F REAGENTS AND MATERIALS Materials Provided Cholestech LDX ALTeAST Cassettes Each ALTeAST Cassette contains a minimum of ALT AST L Alanine ug 24 5
4. L Aspartic acid ug 26 0 alpha Ketoglutaric acid ug 2 43 2 43 Sodium phosphate monobasic ug 2 93 3 08 Oxaloacetate decarboxylase U 0 11 Pyruvate oxidase Aerococcus viridans U 0 64 0 67 Peroxidase horseradish U 0 96 1 01 Ascorbate oxidase Cucurbita sp U 0 53 0 56 Indicator 2 3 5 di tert butyl 4 hydroxyphenyl 4 5 bis 4 dimethylaminophenyl imidazole ug 2 36 2 36 Nonreactive ingredients buffers and stabilizers e Materials Required But Not Provided Cholestech LDX Analyzer and power supply Alcohol swabs and gauze for cleaning puncture site Lancets for capillary blood collection Cholestech LDX 35 uL Capillary Tubes with lithium heparin anticoagulant Cholestech LDX Capillary Plungers Gloves Biohazard waste containers Quality control material MiniPet Pipette and tips or micropipetter that will deliver 35 uL for use with venipuncture samples and quality control material e Vacuum collection tubes needles tube holders and sample tubes if the sample is to be collected by venipuncture PRECAUTIONS For professional n vitro diagnostic use only All blood samples containers capillary tubes and materials that have come in contact with blood should be handled as if capable of transmitting infectious disease and discarded into a biohazardous waste container after use STORAGE AND HANDLING Cassette Storage and Stability Cassettes must be stored in the sealed foil pouches Place cassettes in the refri
5. N o utilizar se a embalagem se apresentar aberta ou danificada e F r inte anv ndas om f rpackningen skadats eller e Tekrar kullanmay n ppnats e Mnv enavaypnotporote te e Nepou vajte opakovane abnet e M ikke anvendes hvis pakken er beskadiget eller e M ikke brukes hvis innpakningen er skadet eller pen LOT Lot Number N mero de lote Chargennummer Codice del lotto Num ro de lot N mero de lote Partinummer Lotnummer e Partinummer e Parti numaras Api8udc rapr ac e slo ar e e Paket hasarl veya a lm sa kullanmay n e Mn ypnoiporoie re edv n ovokevaoia yet unoore Qnpu rj y amp avotyte Nepouz vat ak je obal poskodeny alebo otvoreny Use By e Fecha de caducidad Verfallsdatum e Utilizzare entro Date de p remption e Utilizar at e Anv nd fore e Holdbar til e Bruk innen e Son kullanma tarihi Huepopnvia Mj amp nc e Pou i do 1 Temperature Limitation L mite de temperatura Temperaturbereich Limiti di temperatura Limite de temp rature Limites de temperatura Temperaturbegr nsning Temperaturbegraensning Temperaturbegrensning e S cakl k s n rlamas e Opio Beppokpaoia Obmedzenie teploty wl e Manufacturer e Fabricante Hersteller e Fabbricante e Fabricant e Fabricante Tillverkad av e Fremstillet af e Produsent e retici e KataokeuaoT h e V robca IEC REP A
6. Pokyny v anglictine ziskate z disku CD ktor sa nachadza v baliku analyzatora Cholestech LDX Pokyny m zete tiez ziskat od miestneho distrib tora INTENDED USE An in vitro diagnostic for the quantitative determination of alanine aminotransferase ALT and aspartate aminotransferase AST in whole blood SUMMARY AND EXPLANATION Alanine aminotransferase is an enzyme that catalyzes the conversion of alanine to pyruvate Aspartic acid aminotransferase is an enzyme that catalyzes the conversion of aspartic acid to oxaloacetate Both are found in cardiac and skeletal muscle the liver and other tissues ALT is most prevalent in the liver ALT and AST levels are a reflection of alterations in liver function and therefore are a valuable measurement of damage to the liver Liver damage may be due to chronic alcohol or drug ingestion or infection There are a number of lipid lowering drugs available to treat hyperlipidemia A side effect of such therapy can be a persistent increase in serum ALT and or AST to more than 3 times the upper limit of normal in about 126 of patients receiving lipid lowering therapy It is suggested that patients undergoing lipid lowering drug therapy should be tested for ALT and AST before baseline and shortly after initiation of therapy and then periodically thereafter to determine the ALT and AST levels Alanine aminotransferase and aspartic acid aminotransferase can be measured from a single drop of blood using
7. whenever the laboratory director has any question about test system integrity reagent storage conditions or the reliability of any test result If the controls do not perform as expected repeat the test or contact Cholestech Technical Service before testing patient samples Controls should be tested e With each new lot of cassettes e With every new shipment of cassettes even if the lot has been received previously e When reagents may have been stored or handled in a way that can degrade their performance As otherwise required by your laboratory s standard quality control procedures As otherwise required by federal state and local guidelines Record the results in a Quality Control Log The quality control results should be in range before testing patient samples See the Cholestech LDX System User Manual if they are not Please call Cholestech Technical Service at 1 877 441 7440 or 1 321 441 7200 to report any problems or if you have any questions about quality control RESULTS ALT and AST test results will be displayed on the screen when the test is complete Calculated results are displayed after the DATA button is pressed LIMITATIONS e The measuring range for ALT is 10 400 U L 99 F 37 C Results outside this range will appear as 10 U L or gt 400 U L e he measuring range for AST is 10 400 U L 99 F 37 C Results outside this range will appear as 10 U L or gt 400 U L e Performance of the Choles
8. 8 169 Within run CV 3 2 3 1 3 4 Total CV 5 4 4 6 6 5 Whole Blood Within run Precision X U L 55 SD U L 23 CV 4 2 Aspartate Aminotransferase Commercial Commercial Control Material Control Material Frozen Level 1 Level 2 Serum Pool X U L 31 106 277 Within run CV 6 196 3 596 3 896 Total CV 8 896 4 496 5 296 Whole Blood Within run Precision X U L he SD U L 2 8 CV 4 8 Accuracy method comparison ALT measured using the Cholestech LDX cassette was compared with a validated comparison method traceable to the IFCC reference method and with a bench top point of care chemistry analyzer Alanine Aminotransferase X Comparison Method serum Y Cholestech LDX Analyzer Sample No of Correlation Range Type Pairs Slope y intercept Coefficient of Values Venous Whole Blood 53 1 001 0 3 0 966 10 349 Serum 54 1 007 2 8 0 960 14 391 Fingerstick 24 1 013 3 5 0 930 15 65 X Bench top Point of care Analyzer Y Cholestech LDX Analyzer Sample No of Correlation Range Type Pairs Slope y intercept Coefficient of Values Venous Whole Blood 53 0 916 0 3 0 975 10 349 Serum 52 0 914 0 5 0 971 19 383 Fingerstick 24 0 921 4 3 0 931 15 65 AST measured using the Cholestech LDX cassette was compared with a validated comparison method traceable to the IFCC reference method Asparate Aminotransferase X Comparison Method serum Y Cholestech LDX Analyzer Sample No of Correlation R
9. LDX ALTeAST GPT GOT Alanine Aminotransferase Glutamate Pyruvate Transaminase and Aspartate Aminotransferase Glutamate Oxaloacetate Transaminase Test Cassette 12 788 CLIA WAIVED This test is waived under CLIA 88 regulations Each laboratory or testing site using this test system must have a CLIA Certificate of Waiver To obtain a Certificate of Waiver refer to CMS website http www cms hhs gov CLIA or Cholestech www cholestech com for an application Laboratories must follow the manufacturer s instructions If a laboratory modifies the test system instructions then the test is considered high complexity and subject to all CLIA requirements Biosite Incorporated 9975 Summers Ridge Road San Diego CA 92121 Cholestech LDX and the Inverness Medical logo are registered trademarks of the Inverness Medical U S A group of companies MiniPet is a trademark of Tel 1 377 441 7440 TriContinent Scientific Inc 2010 Inverness Medical All rights reserved Fax 1 321 441 7400 www cholestech com 22959en Rev A Protected by patents US 5110724 other rights granted EC REP MDSS GmbH and pending Schiffgraben 41 30175 Hannover Germany gm minverness medical Refer to the CD in the Cholestech LDX analyzer package for instructions in English The instructions are also available from your local distributor Le CD contenu dans l emballage de l analyseur Cholestech LDX inclut les directives d utilisation en fra
10. ange Type Pairs Slope y intercept Coefficient of Values Serum 109 0 97 1 6 0 983 12 396 Accuracy Sample Type The results from venous whole blood and fingersticks were compared to the serum values obtained on the LDX X Serum on the Cholestech LDX Analyzer Y Whole Blood or Fingerstick on the Cholestech LDX Analyzer Sample No of Correlation Range Type Pairs Slope y intercept Coefficient of Values Venous Whole Blood 46 1 08 0 3 0 998 13 343 Fingerstick 21 0 86 4 4 0 934 13 65 ALT Waiver Data A consumer accuracy study was done with 60 lay untrained people who reported no medical or laboratory experience These people were asked to perform one ALT test each by following the directions in the package insert The samples used for testing were 60 whole blood samples that were either native samples or samples spiked with ALT A total of 3 professional trained people also assayed the 60 samples 20 samples per trained person in order to obtain comparative data between trained and untrained populations The results were analyzed by Deming regression statistics as described below ALT Consumer Accuracy Study trained x axis vs untrained y axis Slope 95 y Intercept 95 n Slope confidence interval y intercept confidence interval r 60 0 976 0 934 to 1 019 1 0 1 4 to 3 3 0 996 AST Waiver Data An untrained user study was conducted in which participants were given only the test instructions and asked to per
11. ell Use a Cholestech LDX Capillary Tube for fingerstick samples Use a 35 uL MiniPet Pipette for venous blood samples and quality control calibration verification and proficiency testing materials IMPORTANT Fingerstick samples must be applied within five 5 minutes or the blood will clot 7 Keep the cassette flat after the sample has been applied WARNING Allowing the sample to sit in the cassette will cause inaccurate results mmediately place the cassette into the drawer of the Analyzer The black reaction bar must face toward the Analyzer The brown magnetic stripe must be on the right 8 DO NOT PUSH IN THE DRAWER Press RUN The drawer will close During the test the screen will display 9 Put everything that touched the blood samples or control calibration verification or proficiency testing material into a biohazardous waste container 10 When the test is complete the Analyzer will beep and the screen will display 11 Press DATA to view additional results 12 When the results are outside the measuring range of the test the screen will display 13 If there is a problem with the test a message will appear on the screen See the Troubleshooting section of the Cholestech LDX System User Manual if this happens Please call Cholestech Technical Service at 1 877 441 7440 or 1 321 441 7200 to report any problems or if you have questions about the operation of the Cholestech LDX System 14 Whe
12. form testing of 3 blinded randomized samples The samples consisted of serum pools prepared at three levels The participants were not given any training on the use of the test A total of 72 participants were enrolled from three sites representing a diverse demographic educational age gender etc population The table below presents the summary of the performance Level 1 Level 2 Level 3 N 72 71 72 Mean 52 9 U L 187 4 U L 289 8 U L CV 7 4 4 4 5 1 Observed Range 244 346 170 211 244 346 Percent of 97 2 70 72 100 71 71 98 6 71 72 Results in the 9596CI 9596CI 95 CI Range 15 90 3 to 99 7 94 9 to 100 97 5 to 100 REFERENCES 1 Mosbach K Ed Methods in Enzymology Vol 137 Academic Press Inc Harcourt Brace Jovanovich 1988 2 Bergmeyer HU Horder M Rej R Approved Recommendation 1985 on IFCC Methods for the Measurement of Catalytic Concentration of Enzymes Part 3 IFCC Method for Alanine Aminotransferase J Clin Chem Clin Biochem 24 481 495 1986 3 Wu AHB ed Tietz Clinical Guide to Laboratory Tests 4th ed St Louis W B Saunders Company 2006 4 NCCLS Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guidelines 1999 Para uso diagn stico in vitro e n vitro Diagnostikum e Esclusivamente per uso diagnostico in vitro e Pour usage diagnostique in vitro Para utiliza o em diagn stico in Vitro e F r diagnostisk anv ndning jn vitro
13. gerator after receipt Cassettes may be used until the date printed on the pouch when stored in a refrigerator 36 46 F 2 8 C The cassettes may be stored for up to 30 days at room temperature 48 86 F 9 30 C The new expiration date is the date the cassettes are placed at room temperature plus 30 days Write the new expiration date on the side of the cassette box in the space provided IMPORTANT Once the cassettes have been stored at room temperature they should not be returned to the refrigerator e Do not use a cassette beyond the printed expiration date Do not use a cassette that has been stored at room temperature for more than 30 days e Do not reuse cassettes Cassette Handling Cassettes should sit at room temperature for 10 minutes before opening the pouch Use the cassette as soon as the pouch is opened SPECIMEN COLLECTION AND HANDLING Sample Type The Cholestech LDX System is CLIA waived for fingerstick or venous whole blood unprocessed samples only If you run serum or plasma on the Cholestech LDX System you will have to comply with the regulations for moderate complexity See the Cholestech LDX System User Manual for a summary of these regulations Sample Requirement e Sample Volume 35 uL of whole blood Fingerstick whole blood Collect the sample from a fingerstick into a Cholestech LDX 35 uL Capillary Tube See the Fingerstick Procedure below Place the blood into the cassette within 5 minutes after c
14. ipette that can deliver 35 uL may be used l Firmly attach the pipette tip to the end of the 35 uL MiniPet Pipette Use a new tip for each sample 2 Tofill the pipette push the plunger down as far as you can Place the pipette tip midway into the sample and slowly release the plunger Confirm that no air bubbles are in the pipette tip 3 Place the pipette tip into the cassette sample well Dispense the sample into the cassette sample well by pressing the plunger down Move the pipette tip out of the sample well before releasing the plunger again 4 Remove the pipette tip and throw it away in a biohazard waste container IMPORTANT If the plunger is released before the pipette tip is out of the sample well it will remove the sample just dispensed IMPORTANT Keep the cassette horizontal at all times after applying the sample pu a Test If the cassettes have been refrigerated allow them to come to room temperature at least 10 minutes before opening Make sure the Analyzer is plugged in and has warmed up 3 Remove the cassette from its pouch Hold the cassette by the short sides only Do not touch the black bar or the magnetic stripe Place the cassette on a flat surface IMPORTANT Gloves should be worn whenever working with blood samples 4 Press RUN The Analyzer will do a selftest and the screen will display b The cassette drawer will open and the screen will display 6 Place the sample into the cassette w
15. n the drawer opens remove the cassette and put it in a biohazardous waste container Leave the Analyzer drawer empty when not in use 15 Record the results on the appropriate form 16 To run another cassette press RUN The screen will display 17 Repeat step 3 and steps 6 through 15 IMPORTANT If you do not want to run another test and the drawer is open press STOP to close the drawer 18 Otherwise after four minutes a beep will sound and the screen will display 19 If necessary press the DATA button to view the results from the last cassette used IMPORTANT Pressing the RUN button will erase the previous result QUALITY CONTROL External quality control material should be run routinely to show that your system is giving accurate results We recommend the following quality control procedures for the Cholestech LDX System Choice of Materials Liquid Level 1 and Level 2 controls that work well with the Cholestech LDX System are available If you use other controls you will need to establish ranges for the Cholestech LDX System Handling Follow the instructions that come with your controls e Check the expiration date before use Do not use if expired e See Running a Test for the procedure External Quality Control External control material should be used to demonstrate that the reagents and the assay procedure perform properly Good Laboratory Practice principles suggest that controls should be run
16. ncais Le mode d emploi est galement disponible aupres du distributeur local Anweisungen auf Deutsch befinden sich auf der CD in der Verpackung des Cholestech LDX Analyseger ts Die Anleitung ist auch von Ihrem Handler erh ltlich Fare riferimento al CD nella confezione dell analizzatore Cholestech LDX per istruzioni in italiano Le istruzioni sono disponibili presso il distributore di zona Consulte el CD incluido en el envase del analizador Cholestech LDX para obtener instrucciones en espa ol Tambi n puede pedir las instrucciones a su distribuidor local Consulte o CD no pacote do analisador LDX Cholestech para instruc es em portugu s As instru es est o dispon veis junto do seu distribuidor local Der henvises til den vedlagte CD i Cholestech LDX analysatorpakken for instruktioner p dansk Instruktionerne f s hos den lokale forhandler Se CD n i Cholestech LDX analysatorf rpackningen betr ffande instruktioner p svenska Instruktionerna finns att fa hos din lokala terf rs ljare Hvis du vil ha flere instruksjoner kan du se CDen som fglger med i Cholestech LCX analysatorpakken Instruksjonene fas ogs hos din n rmeste forhandler T rk e talimat i in Cholestech LDX Analiz r paketindeki CD ye bak n z Talimat yerel distrib t r n zden elde edilebilir Avatp gte oto CD oTn cuokseuac a Tou Ava ut Cholestech LDX yia odnyies ota EAAnvika Oi odnyies var S1aGECIPES ATTO TOV TOTTIKO IAVO A cag
17. ollection e Blood from the fingerstick should flow freely Too much squeezing of the finger may cause poor results Venous whole blood e Collect blood into a green top tube heparin anticoagulant IMPORTANT Do not use a tube with any other additives because it may cause inaccurate results Use a MiniPet Pipette and tip to place blood into the cassette Whole blood should be used within 30 minutes Samples should be at room temperature for testing Mix all samples by inverting gently 7 8 times before testing TEST PROCEDURE Calibration No calibration is performed by the user Test information is encoded on the brown Stripe of the cassette The brown magnetic stripe is read by the Cholestech LDX Analyzer each time a cassette is run An Optics Check should be run on the Analyzer each day that patient samples are tested See the Cholestech LDX User Manual for instructions IMPORTANT A warm hand and good blood flow from the puncture site are essential in order to collect a good capillary sample WARNING Squeezing the finger excessively may cause inaccurate test results Fingerstick Procedure 1 The patient should sit quietly for five minutes before the blood sample is collected 2 Puta capillary plunger into the end of a Cholestech LDX 35 uL Capillary Tube with the red mark Set aside 3 Choose a spot that is on the side of one of the center fingers of either hand The fingers and hands should be warm to the touch To wa
18. rm the hand you can a Wash the patient s hand with warm water or b Apply a warm not hot compress to the hand for several minutes or c Gently massage the finger from the base to the tip several times to bring to blood to the fingertip 4 Clean the site with an alcohol swab Dry thoroughly with a gauze pad before pricking the finger b Firmly prick the selected site with a lancet 6 Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid 7 Squeeze the finger gently again while holding it downward until a second large drop of blood forms Do not milk the finger The puncture should provide a free flowing drop of blood 8 Hold the capillary tube horizontally or at a slightly descending angle by the end with the plunger Touch it to the drop of blood without touching the skin The tube will fill by capillary action to the black mark Do not collect air bubbles If itis necessary to collect another drop of blood wipe the finger with gauze then massage again from base to tip until a large drop of blood forms 9 Fill the capillary tube within 10 seconds 10 Wipe off any excess blood from the finger and have the patient apply pressure to the puncture until the bleeding stops Using the Cholestech MiniPet Pipette Use this procedure to apply a venous blood sample or control calibration verification or proficiency testing materials to the cassette Any p
19. suficiente para n pruebas Enth lt eine ausreichende Menge f r n Tests e Sufficiente per n test Contient du mat riel en quantit suffisante pour n tests Conte do suficiente para n testes e Inneh ller tillr cklig m ngd f r lt n gt tester e Indeholder nok til lt n gt test e Innholdet er nok til lt n gt tester e lt n gt test i in yeterli miktar i erir e epiey pevo enapk yia n ECETACEIC e Obsahuje material posta uj ci na lt n gt testov
20. tech LDX System has not been tested on samples from newborns or pediatric patients Hemolysis breakdown of the red blood cells should be avoided as this will increase the level of ALT and AST and cause inaccurate results e Samples with ALT or AST enzyme activity greater than 1000 U L may consume the substrate prior to the measurement of enzyme activity and could yield falsely low results Some substances may cause false results with enzymatic tests The substances listed below were tested for interference with the ALTeAST test Less than 10 interference was seen at the levels shown Substance Concentration mg dL Ascorbic Acid 1 Hemoglobin 75 Bilirubin 5 Lactate 100 Creatinine 30 Lactose 100 Cysteine 7 Lovastatin Mevacor 4 Ditaurobilirubin 5 Nicotinic Acid Niacin 10 Fructose 30 Urea 500 Gemfibrozil Lopid 15 Uric Acid 15 Glutathione 1 e Hematocrits between 30 and 50 do not affect results EXPECTED VALUES Alanine Aminotransferase Males Females Reference Interval 99 F 37 C 10 40 U L 7 35 U L Aspartate Aminotransferase Males Females Reference Interval 99 F 37 C 15 40 U L 13 35 U L PERFORMANCE CHARACTERISTICS Precision A study was conducted according to NCCLS protocol EP5 A Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline 1999 4 Alanine Aminotransferase Commercial Commercial Control Material Control Material Frozen Level 1 Level 2 Serum Pool X U L 31 5
21. the Cholestech LDX System s rapid accurate technology An AST ALT ratio is calculated using the measured values PRINCIPLES OF THE PROCEDURE The Cholestech LDX System combines enzymatic methodology and solid phase technology to measure ALT and AST Samples used for testing can be whole blood from a fingerstick collected in a heparin coated capillary tube or venous whole blood The sample is applied to a Cholestech LDX ALT AST cassette The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells The plasma flows to both sides of the cassette and is transferred to the ALT and AST reaction pads The Cholestech LDX Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al Alanine aminotransferase catalyzes the transfer of amino groups from L alanine to alphaketoglutarate producing pyruvate and glutamate Pyruvate oxidase in the presence of oxygen oxidizes the pyruvate to acetylphosphate and hydrogen peroxide In a reaction catalyzed by horseradish peroxidase the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the ALT concentration of the sample The resultant color in the reaction is measured by reflectance photometry Alanine Aminotransferase L Alanine alpha Ketoglutarate Pyruvate 4 Glutamate Pyruvate Oxidase Pyruvate Phosphate O H O Acetylphosphate
22. uthorized Representative in the European Community e Representante autorizado en la Uni n Europea e Bevollm chtigter in der Europ ischen Union e Mandatario autorizzato per la Comunit Europea e Repr sentant autoris dans la Communaut europ enne e Mandat rio na Comunidade Europeia e Auktoriserad representant i Europeiska gemenskapen e Autoriseret repr sentant i den Europ iske Union e Autorisert representant i Det europeiske felleskap e Avrupa Toplulugu ndaki yetkili temsilci ECouclodotnp voc avtinp owno yia wv Euponaikr Koiv tnta e Autorizovan z stupca v Eur pskej nii Professional Use Only e Professional use only Para uso profesional solamente e Nur zum Gebrauch durch Fachleute vorgesehen Solo per uso professionale e R serv un usage professionnel e Apenas para utiliza o por profissionais e Endast f r professionell anv ndning e Kun beregnet til faglig brug e Bare til profesjonell bruk e Sadece mesleki kullan m e ia erayyeAuatikr xp on p vov e Len na odborn pou itie e Biological Risks e Riesgos biol gicos e Biologische Risiken e Rischi biologici e Risques biologiques e Riscos biol gicos e Biologiska risker e Biologiske risici e Biologisk risiko e Biyolojik riskler e Biohoyikoi kiv uvol e Biologick rizik Fel e Room Temperature expiration date date at room temperature plus 30 days e Fecha de caducidad a temperatura ambiente
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