CHO-03-034 TCI-Lip-Glu_1-CE.qxd - Drug testing supplies from
Contents
1. Fingerstick whole blood Collect the sample from a fingerstick into a Cholestech LDX Capillary Tube See the Fingerstick Procedure in the Cholestech LDX System User Manual Place the blood into the cassette within 8 minutes of collection 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 NOTE Do not use a tube with any other additives because it may cause poor 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 PRECAUTION All blood samples and 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 biohazard waste container after use Calibration No calibration is done by the user Test information is on the brown stripe of the cassette The brown stripe is read by the Cholestech LDX 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 System User Manual for instructions TEST PROCEDURE Materials Provided Test Cassettes pola Materials Required Cholestech LDX Analyzer and power supply Alcohol swabs and2. oO The cassette estimated LDL cholesterol was compared to that calculated from the Do not reuse Do not use if package is damaged or open Ce sea ede ellen oue ree CV 2 7 3 5 above validated total cholesterol HDL cholesterol and triglyceride methods ee ee ee ae mg dL to mmol L mmol L to mg dL j Bly a el el ad Nicht E ras oder one ist me f mg dL m IL Classification eon riutilizzare eNon utilizzare se la confezione aperta o danneggiata divide mg dL by multiply mmol L by mgar mmol L widssilicalion HDL Cholesterol The range of values tested mg dL were as follows eNe pas r utiliser eNe pas utiliser si l emballage est ouvert ou endommag _ TC 38 664 38 664 LDL cholesterol e N o reutilizar e N o utilizar se a embalagem se apresentar aberta ou danificada HDL 38 664 38 664 lt 100 lt 2 59 Optimal o o Whole Blood heparin TC 120 300 Kun til engangsbrug e M ikke anvendes hvis pakken er beskadiget eller bnet TRG 88 54 88 54 100 129 2 59 3 34 Near optimal above optimal Within Run Precision Level Level2 ADE KOVRP i cha ide trike Were nines T es LDL 38 664 38 664 130 159 3 36 4 11 Borderline high n 10 10 TRG 40 500 e Myv ertavaxonoworotette eMn xpnorponoreite edv n cuokeuaota xet unoote CnULA xel avotyTe GLU 18 018 18 018 160 189 4 14 4 89 High X mg dL 29 46 GLU 25 575 gt 190 24 91 Very high Sp mpak y Result wl LOT CV 3 4 4 8 esults LIMITATIONS Total cholesterol tas lt 200 lt 5 18 Desirable Com
3. to set 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 procedure External Quality Control External controls must be used to demonstrate that the reagents and the assay procedure perform properly Liquid Lipid Glucose Level 1 and Level 2 Controls are available from Cholestech Controls must be tested e With each new shipment of cassettes even if cassettes are from the same lot Uric Acid 15 Lovastatin 4 e 2hr post glucose load 200 mg dL during an oral glucose tolerance test The test Commercial Control Material 13 Kinosian B Glick H Garland G Cholesterol and coronary heart disease previously received Creatinine 30 Dipyrone 10 should be performed as described by WHO World Health Organization using a Day to Day Precision Level 1 Level 2 predicting risks by levels and ratios Ann Intern Med 1994 121 641 7 e With each new lot of cassettes Glutathione 1 Methotrexate 450 glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water n 20 20 14 Report of the Expert Committee on the Diagnosis and Classification of Diabetes e As otherwise required by your laboratory s standard quality control procedures Cimetidine l 7 5 Nitrofurantoin 2 Any of the above abnormal glucose levels must be confirmed on a subsequent day by X mg dL 103 311 Mellitus Diabetes Care 2
4. 004 Vol 27 Supplement 1 S5 10 e If you are not running the Cholestech LDX under CLIA waived status or if your Oxytetracycline 4 Gentisic Acid 0 5 SD mg dL 36 15 4 j j i 3 any one of the three methods listed above When screening for diabetes any abnormal mg ocal or state regulations require more frequent testing of quality control material Lactose 100 Methyldopamine 0 5 oe JN x gt glucose result should be referred to a physician for further follow up CV 3 5 5 0 then quality control must be performed in compliance with those regulations Cysteine 2 5 Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about test system integrity or operator technique e g when reagents may have been stored or handled in a way that can degrade their performance or when operators have not performed a particular test in recent weeks Hematocrits between 30 and 52 do not affect results Blood collection tubes with glycerol should not be used for the triglyceride test Hand creams and soaps with glycerol may cause falsely high triglyceride results The triglyceride test measures triglycerides and free glycerol Free glycerol usually is less than 20 mg dL 9 10 PERFORMANCE CHARACTERISTICS Precision Total Cholesterol Whole Blood heparin ACCURACY METHOD COMPARISON The cassette total cholesterol was compared with a validated method traceable to t
5. 982 28 2077 80 Certificado pela CRMLN pal di n a ambiente data a ey Bites ic i i i i e ifi eConteudo suficiente para lt n gt shown FPG 126 mg dL Provisional diagnosis of diabetes confirmed SD mga L 4 6 8 4 9 Jessen RH Dass CJ Eckfeldt JH Do enzymatic analyses of serum triglycerides pi ate ae Se aapiion eps tire anne date testes a Substanee Concentration mg l by one of the three methods below CV 4 3 5 9 really need blanking for free glycerol Clin Chem 1990 36 1372 5 eCRMLN sertifisert temp rature ambiante plus 30 jours e Indeholder nok til lt n gt test l oo e j Prazo de validade a t t biente 30 di eTillrackligt inneh ll f test The revised criteria for diagnosis of diabetes 10 G a a Guide to Laboratory Tests 2nd ed Philadelphia Pa WB Motonomp vo kata CRMLN o a e E eine i E T 7 nholdt ea cn ay er ie els i gt cemhornzi 15 e Symptoms of diabetes plus casual plasma glucose concentration 200 mg dL Glucose aun i O ae regs dato ved ae enapk c yua lt n gt L Dopa l 0 8 Bilirubin 5 11 1 mmol L Casual is defined as any time of day without regard to time since Whole Blood heparin By enen ae TA PEREO ee a eae Opa a E PUNE e Utg ngsdatum vid rumstemperatur datum f r Ascorbic Acid l Probucol 32 5 last meal The classic symptoms of diabetes include polyuria polydipsia and Within Run Precision Level 1 Level 2 serum skin puncture plasma and venous serum compared and effects of rumstemperatur plu
6. LDX TC TC HDL GLU Total Cholesterol Test Cassette Total Cholesterol HDL Cholesterol and REF 10 986 Glucose Panel Test Cassette REF 10 990 Lk koed and Glucose Panel LIPID PRO FILE Test Cassette Total Cholesterol HDL Cholesterol and REF 10 988 Triglycerides Panel Test Cassette REF 10 989 Le ae and HDL Panel LIPID PROFILE GLU Test Cassette Total Cholesterol HDL Cholesterol REF 10 987 Triglycerides and Glucose Panel Test Cassette REF 10 991 CLIA WAIVED These tests are waived under CLIA 88 regulations If a laboratory modifies the test system instructions then the test is considered highly complex and subject to all CLIA requirements For professional in vitro diagnostic use C Distributed by CLIAwaived com San Diego CA 92121 tel 858 481 5031 toll free 888 882 7739 www cliawaived com One or more of the following patents may apply U S Patents 4 477 575 4 816 224 5 110 724 5 213 964 5 316 916 5 451 370 5 786 164 6 214 570 and 6 171 849 Canada 2023926 Israel 95497 Japan 232286 90 the Soviet Union 4831419 14 Germany P3929032 8 and the European patent O 415 298 B1 effective in Austria Belgium France Germany Italy the Netherlands Spain Sweden Switzerland and the United Kingdom EC REP Authorized Representative AR MED Ltd Runnymede Malthouse Egham TW20 9BD United Kingdom Refer to the CD in the analyzer package for instructions in English Th
7. LDX System combines enzymatic methodology4 and solid phase technology to measure total cholesterol HDL cholesterol triglycerides and glucose Samples used for testing can be whole blood from a fingerstick collected in a lithium heparin coated capillary tube or venipuncture The sample is applied to a Cholestech LDX 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 A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads Simultaneously plasma flows to the left side of the cassette where the low density lipoproteins LDL and VLDL are precipitated with dextran sulfate 50 000 MW and magnesium acetate precipitating reagent The filtrate containing both glucose and HDL cholesterol is transferred to both the glucose and HDL cholesterol reaction pads The Cholestech LDX Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al 6 and Roeschlau Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid Cholesterol oxidase in the presence of oxygen oxidizes free cholesterol to cholest 4 ene 3 one and hydrogen peroxide In a reaction catalyzed by horseradish peroxidase the peroxide reacts with 4 Aminoantipyrine and N Et
8. amp NG EPLOPLOLOG BEpLoKPactac ATAOKEUGOTHG pLeL6c napt a 0 39 2 59 lt 0 39 mmol L gt 2 59 mmol L 150 199 1 69 2 25 Borderline high Within Run Precision Level 1 Level 2 15 650 A eae 200 499 2 26 6 64 High nE 10 10 REFERENCES EC REP Cii Professional Use Only TRG 0 51 7 34 lt 0 51 mmol L gt 7 34 mmol L 2500 25 65 Very high X mg dL 256 362 Authorized representative in European Consult instructions for use e Professional Use Only ee SD mg dL 4 0 13 1 1 Expert Panel on Detection Evaluation and Treatment of High Cholesterol in oy sass cH Consulte las instrucciones de uso a ee GLU 50 500 lt 50 mg dL gt 500 mg dL The ATP II identified HDL cholesterol levels below 40 mg dL 1 03 mmol L as CV L6 a6 Adults Executive summary of the Third Report of the National Cholesterol oaamuridad Eiropes pee ie ae Fachleute vorgesehen 2 78 27 8 lt 2 78 mmol L gt 27 8 mmol L Pane alae i of a heart Se ie i us i M Education Program NCEP Expert Panel on Detection Evaluation and abevollindcttiaterin de euiopsisshen sGoneilter le mode denna SEs einen aLI iti imitati i Ig cholesterol level greater than or equal to ov mg 09 MMOS Treatment of High Cholesterol in Adults Adult Treatment Panel III JAMA Gemeinschaft Consultar as instru es de professionale Additional Limitations That Display N A protective and decreases CHD risk EE aT a An SOOT one AREF Rappresentante autorizzato per la utiliza o os un ai
9. ator 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 930 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 The new expiration date is the date the cassettes are placed at room temperature 30 days e Once cassettes have been stored at room temperature they should not be returned to the refrigerator e Do not use a cassette that has been stored at room temperature for more than 30 days e Do not use a cassette beyond the printed expiration date 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 Sample Type Please Note 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 you will be classified as moderately complex and will have to comply with the regulations for moderate complexity See the Cholestech LDX System User Manual for a summary of these regulations Sample Handling e Sample Volume 35 uL of whole blood e When testing triglycerides or glucose the subject should fast for 9 12 hours before the sample is collected
10. e instructions are available from your local distributor Le CD contenu dans l emballage de l analyseur inclut les directives d utilisation en fran ais Le mode d emploi est disponible aupr s du distributeur local Anweisungen auf Deutsch befinden sich auf der CD in der Verpackung des Analyseger ts Die Anleitung ist von Ihrem H ndler erh ltlich Fare riferimento al CD nella confezione dell analizzatore per istruzioni in italiano Le istruzioni sono disponibili presso il distributore di zona Consulte el CD incluido en el envase del analizador para obtener instrucciones en espa ol Tambi n puede pedir las instrucciones a su distribuidor local Consulte o CD no pacote do analisador para instru es em Portugu s As instru es est o dispon veis junto do seu distribuidor local Der henvises til den vedlagte CD i analysatorpakken for instruktioner p dansk Instruktionerne f s hos den lokale forhandler Se CD n i analysatorf rpackningen betr ffande instruktioner p svenska Instruktionerna finns att f hos din lokala terf rs ljare For instruksjoner p norsk henvis til CD en vedlagt i analysatorpakken Instruksjonene f s hos din n rmeste forhandler Avatp te oto CD otn ouokeuaoia tou avaAuTH yra odnyies ota EA nvik OL odnyies var LaAG OLEG AM TOV TOTILKO LAVOM A OAG INTENDED USE For the quantitative determination of total cholesterol HDL high density lipoprotein cholesterol triglyceride
11. gauze for cleaning puncture site Lancets for capillary blood collection Cholestech LDX 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 and tube holders if sample is to be collected by venipuncture Running a Test Let cassette sit at room temperature for 10 minutes 5 Remove the cassette from its pouch Hold the cassette by the short side only Do not touch the black bar or the brown magnetic stripe Put the cassette on a flat Surface NOTE Gloves should be worn when working with blood samples 3 Press RUN If the analyzer has been idle for more than 4 minutes in a few seconds the screen will display 4 The cassette drawer will open The screen will display Glucose levels decrease 5 to 10 mg dL per hour in whole blood at room temperature 5 Place the sample into the cassette well Use a Cholestech LDX Capillary Tube for fingerstick samples Use the MiniPet Pipette for controls or venous blood samples NOTE Fingerstick samples must be applied within eight 8 minutes or the blood may clot 6 Keep the cassette flat after the sample has been applied Place the cassette into the drawer of the Analyzer immediately The black bar must face the Analyzer T
12. he CDC modified Abell Kendall reference method traceable to National Institute of Standards and Technology NIST standards eJn Vitro diagnostic medical device e Dispositivo m dico para diagn stico in vitro e n vitro Diagnostikum e Dispositivo medico diagnostico REF eCatalog Number e N mero de cat logo e Katalognummer eNumero di catalogo e Num ro de catalogue A eCaution consult accompanying documents ePrecauci n consulte los documentos adjuntos e Attenzione consultare la documentazione allegata eAchtung lesen Sie die beigelegten Dokumente e There may be a 6 7 difference in the glucose levels of fingerstick and venous aver bas a in vitro e N mero de cat logo eAttention consulter les documents joints The quality control results must be in range before testing patient samples See blood 11 i i Within Run Precision a cae The cassette HDL cholesterol was compared with a validated method utilizing dextran e Dispositif m dical de diagnostic in vitro Katalognummer eAten o consultar os documentos inclusos the Cholestech LDX System User Manual if they are not Please call Cholestech n sulfate magnesium chloride precipitation and enzymatic cholesterol determination The e Dispositivo m dico para diagn stico REAN ara eee ee i i i i i X mg dL 184 299 HDL cholesterol comparison method is based on the selected method fo
13. he LDX displays N A for the LDL estimate Software oe a gemenskapen version 2 02 calculates LDL estimates with measured TRG values as aunar CO R l l Autorisert representant i Det low as 30 mg dL 0 34 mmol L non HDL LDL Cholesterol 4 Siedel J Hagele EO Ziegenhorn J Wahlefeld AW Reagent for the enzymatic europeiske felleskap ATP Ill identifies non HDL cholesterol total cholesterol minus HDL cholesterol as a Whole Blood heparin determination of serum total cholesterol with improved lipolytic efficiency Clin OUDON OTTAA i Tv Evpwraikn KowdTTa e The glucose test is specific for D glucose Other sugars that may be present in the secondary target of therapy in persons with high triglycerides 2200 mg dL The goal Within Run Precision Level 1 Level 2 Chem 1983 29 1075 80 blood do not react in the glucose test i e fructose lactose ata o rr a ki pi n A m at F level n 10 10 5 Warnick GR Benderson J Albers JJ Dextran sulfate Mg2 precipitation e Samples with total cholesterol HDL cholesterol triglyceride or glucose values ye ee an t a BF cholesterol on the premise that a cholesterol leve X mg dL 87 197 procedure for quantitation of high density lipoprotein cholesterol Selected 9 30 C 7 outside the measuring range should be sent to a laboratory for testing See eres ee SD mg dL 4 3 7 5 Methods for Clinical Chemistry 1983 10 91 9 e Performance of the Cholestech LDX Syste
14. he brown stripe must be on the right 7 Press RUN The drawer will close During the test the screen will display LDX 8 Put everything that touched the blood sample oss See or control in a biohazard waste container aea kd i 9 When the test is complete the Analyzer will beep The screen will display 10 Press DATA to show more results 11 When the results are outside the measuring range the screen will display 12 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 13 When the drawer opens remove the cassette Put it in a biohazard waste container Leave the Analyzer drawer empty when not in use 14 Record the results 15 To run another cassette press RUN The screen will display 16 Repeat the test procedure 17 Otherwise after 4 minutes a beep will sound and the screen will display If the RUN button is not pushed within 15 seconds the drawer will close Then the screen will go blank QUALITY CONTROL External quality control should be run routinely to show that your system is giving accurate results Cholestech recommends the following quality control procedures for the LDX System Choice of Materials A high and a low control for each analyte is preferred Cholestech recommended controls work well with the Cholestech LDX System If you use other controls you will need
15. hyl N sulfohydroxypropyl m toluidine sodium salt TOOS to form a purple colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample Cholesterol esterase Cholesterol esters H20 Free cholesterol Fatty acids Cholesterol oxidase Cholesterol O Cholest 4 ene 3 one H202 Peroxidase 2 H202 4 Aminoantipyrine TOOS Quinoneimine dye 4 H20 The Cholestech LDX Analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids Glycerol in a reaction catalyzed by glycerol kinase is converted to glycerol 3 phosphate In a third reaction glycerol 3 phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide 8 The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol Lipase Triglycerides H20 Glycerol Free fatty acids Glycerol kinase Mg2 Glycerol ATP Glycerol 3 phosphate ADP Glycerol phosphate Glycerol 3 phosphate O Dihydroxyacetone phosphate H202 Oxidase Peroxidase 2 H202 4 Aminoantipyrine TOOS Quinoneimine dye 4 H20 The Cholestech LDX Analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide The color reaction utilizing horseradish peroxidase is the same as that for total choles
16. m has not been tested on samples from Glucose CV 4 9 3 8 6 Allain CC Poon LS Chan CS Richmond W Fu PC Enzymatic determination of Room ba lee oa date date at room Balada ty lt n gt tests b a ee a oO temperature plus 30 days Contient du mat riel en quantit A Bea euie neronmed araida S000 Tackhavenotbesn The American Diabetes Association has modified the criteria for fasting plasma glucose total serum cholesterol Clin Chem 1974 20 470 5 eCRMLN Certified Fecha de caducidad a temperatura ambiente a los suffisante pour lt n gt tests 0d amp p FPG and the diagnosis of diabetes mellitus 14 Commercial Control Material 7 Roeschlau P Bernt E Gruber W Enzymatische bestimmung des gesamt Certificaci n CRMLN 30 dias de ponerse el producto a dicha e Enth lt gen gend f r lt n gt Tests validated Day to Day Precision Level 1 Level 2 cholesterins im serum Z Klin Chem Klin Biochem 1974 12 226 i De tia es E E a sufficiente per lt n gt Some substances may cause false results with enzymatic tests The substances listed FPG lt 100 mg dL Normal fasting glucose n 20 20 8 Fossati P Prencipe L Serum triglycerides determined colorimetrically with an E cat eau der Lagerung bei Raumtemperatur plus 30 Tage Cantidad suficiente para lt n gt below were tested for all analytes Less than 10 interference was seen at the levels FPG 100 125 mg dL Impaired fasting glucose X mg dL 108 143 enzyme that produces hydrogen peroxide Clin Chem 1
17. mercial Conai Material X Reference Method serum eUse By eTemperature Limitation e Manufacturer eLot Number Measuring Range For results outside the measuring range 200 239 5 18 6 19 Borderline high ommercia ee ee Y Cholestech LDX Analyzer venous whole blood Fecha de caducidad eL mite de temperatura e Fabricante e N mero de lote i the LDX displays 2240 26 22 High Day to Day Precision Level 1 Level 2 Verfallsdatum Temperaturbereich e Hersteller Chargennummer Analyte mg dL g n 20 20 No of Correlation eUtilizzare entro eLimiti di temperatura e Fabbricante Codice del lotto HDL cholesterol 2 ici eUtiliser avant le eLimite de temp rature e Fabricant Num ro de lot mmol L Low men AO lt 1 03 L X mg dL 29 46 Analyte Pairs Slope y intercept Coefficient Bias at eUtilizar at eLimites de temperatura e Fabricante e N mero de lote u ia SD mg dL 1 3 2 9 Total cholesterol 40 0 98 2 41 0 97 200 1 eHoldbar til eTemperaturbegr nsning eFremstillet af eLotnummer TC 100 500 lt 100 mg dL gt 500 mg dL 260 21 55 High CV A5 6 3 HDL cholesterol 40 0 97 0 23 0 95 35 2 Anvand f re eTemperaturbegr nsning eTillverkad av e Partinummer Gau AA a i Ano Triglycerides Triglycerides Triglycerides 40 1 0 0 13 099 250 0 sBrukinnen sTemperaturbegrensning s Produsent Partnummer A g ne J i i HDL 15 100 lt 15 mg dL gt 100 mg dL lt 150 lt 1 69 Normal Whole Blood heparin Glucose 40 0 99 1 01 0 98 150 0 Hepopnvia A
18. nd triglycerides depending upon individual CHD risk factors Follow up measurement of these lipid parameters is necessary to ensure that individuals achieve treatment goals Glucose is the major energy source for the human body and is necessary for the growth development and maintenance of virtually all cells in the tissues and organs 3 Blood glucose levels are maintained within a relatively narrow range by a combination of interacting factors that decrease the glucose level when it gets too high and increase it when it drops too low Because this delicate homeostatic mechanism is able to keep glucose levels within such a narrow range values outside this range generally indicate a disease state Insulin is the principal hormone regulating glucose levels and any defect in the production or action of insulin can lead to one of the several forms of diabetes mellitus Persons with diabetes mellitus may develop a number of serious complications and some studies have shown that careful control of blood glucose levels may reduce the incidence or delay the onset of these complications Total cholesterol HDL cholesterol triglycerides and glucose can be measured simultaneously from a single drop of blood using the Cholestech LDX System s rapid accurate technology Estimated LDL cholesterol and non HDL cholesterol and a TC HDL ratio are calculated using the measured values with software version V3 0 and higher SUMMARY AND EXPLANATION The Cholestech
19. professionnel ay to Day Precision eve eve f l Comunit Europea eSe brugsanvisningen eApenas para utiliza o por ae measured value of TRG is gt 650 mg dL gt 7 34 mmol L the TC HDL Ratio n 20 20 2 Bachorik PS Ross JW for the National Cholesterol Education Program Working e Mandataire dans la Communaut Konsultera bruksanvisningen profissionais LDX displays N A for HDL 7 Group on Lipoprotein Measurement National Cholesterol Education Program europ enne eSe bruksanvisningen e Kun beregnet til faglig brug e f the measured value of TRG is gt 400 mg dL gt 4 51 mmol L the The ATP Ill report does not comment on use of the ratio of total to HDL cholesterol means 1 u recommendations for measurement of low density lipoprotein cholesterol Mandatario na Comunidade Europeia e2uyBoudeutette tig odnyleg Endast Tor professionel LDX displays N A for the LDL estimate Various authors have suggested that the TC HDL ratio is the strongest lipid risk factor SD mg dL 2 8 8 7 Pigs eam re 4 pop eRepressentant 1 det Eliropzsiske e anv ndning amp fth dwalue of TE EDL of TRG is outside th and can be a useful summary of CHD risk 2 13 A ratio of 4 5 or less is desirable A CV 23 3 2 R T E pees TEM F llesskab Kun til yrkesmessig bruk A a a A n re ratio greater than 6 0 suggests a high risk of CHD 12 3 Tietz NW ed Fundamentals of Clinical Chemistry Philadelphia Pa WB PAULON OO TOPTERENEATE EUISHE KA STEEN i KPA HOHON range t
20. r HDL in vitro de ae te ates atalognummer orsixtighelsalgard konsultera Medtoljande Technical Service at 1 800 733 0404 or 1 510 732 7200 if you have any questions 3 e Medicinsk udstyr til in vitro diagnostik Apt8yudc KataAoyou dokument about quality control EXPECTED VALUES SD mg dL 4 6 7 cholesterol5 and has documented agreement with the CDC Reference Method aMedicinteknick prodult avsedd i aForsiktig 8 medinlgcndedokumentasian CV 2 5 2 4 in vitro diagnostik 7 Tpoooxh ouu ouheute te Ta ouvo eutk Cholesterol and Triglycerides The cassette triglyceride test was compared with a validated method utilizing i aaa eee utstyr yypapa RESULTS The National Heart Lung and Blood Institute issued the Third Report of the National Commercial Control Material E T E E T E E yaoonosita ya yon in vito Test results will show on the screen when the test is complete Calculated results are Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Day to Day Precision Level 1 Level 2 ter ee Merion shown after the DATA button is pressed Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III in May n 20 20 Q 9 2001 1 The ATP III report presented the NCEP s updated clinical guidelines for X mg dL 161 244 The cassette glucose was compared with a hexokinase reference method cholesterol testing and management and described the following classifications for To convert holesterol And e esd i i eD ime d L A
21. s 30 dagar Urea 500 Nicotinic Acid 10 unexplained weight loss n 10 10 warming the skin before puncture Clin Chem 1977 23 1705 10 ue ved romtemperatur romtemperatur dato Fructose 30 Clofibrate 80 e FPG gt 126 mg dL 7 0 mmol L Fasting is defined as no caloric intake for at least X mg dL 103 127 12 Castelli WP Abbott RD McNamara PM Summary estimates of cholesterol used Learn oe Beppokpaoia Swpatiou 8 hours SD mg dL 6 4 57 to predict coronary heart disease Circulation 1983 67 730 4 Nuepounvia oe Bepuokpacia Swuatiou ouv 30 nu pec CV 6 2 4 5
22. s and glucose in whole blood A TC HDL total cholesterol HDL cholesterol ratio and estimated values for LDL low density lipoprotein and non HDL cholesterol are calculated by the Cholestech LDX INTRODUCTION Cholesterol is a major cause of coronary heart disease CHD and large clinical trials show that lipid lowering therapy substantially reduces risk for CHD 1 The National Institutes of Health periodically issues clinical guidelines for cholesterol testing and management as part of the National Cholesterol Education Program NCEP The most recent update the third report of NCEP s Adult Treatment Panel ATP II recommended that a fasting lipoprotein profile should be obtained at least every five years in all adults aged 20 years and older This lipid profile consists of total HDL and LDL cholesterol and triglycerides NCEP recommends that for routine patient evaluation and follow up LDL cholesterol should be estimated from measurement of total and HDL cholesterol and triglycerides using the Friedewald formula 2 While the major focus of ATP III is on lowering LDL cholesterol HDL cholesterol and triglycerides are identified as significant risk factors Low HDL cholesterol values increase CHD risk whereas high HDL values protect against CHD Elevated triglycerides are also a strong independent risk factor for CHD most often observed in individuals with metabolic syndrome The ATP Ill established therapeutic goals for LDL and HDL cholesterol a
23. terol HDL cholesterol and triglycerides The resultant color in all the reactions is measured by reflectance photometry Glucose oxidase Glucose O2 o D gluconolactone H202 Peroxidase 2 H20 4 Aminoantipyrine TOOS Quinoneimine dye 4 H20 A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading R to the total cholesterol HDL cholesterol triglycerides and glucose concentrations CASSETTES Each cassette contains a minimum of TC HDL TRG GLU Dextran sulfate ug 8 9 50 000 MW Magnesium acetate ug 79 5 Cholesterol esterase U 0 34 0 34 Pseudomonas species Lipase 80 Bacterial source Cholesterol oxidase U 0 058 Pseudomonas species Peroxidase horseradish U 0 32 0 32 0 16 0 16 4 Aminoantipyrine ug 6 4 3 0 3 3 6 08 N Ethyl N sulfohydroxypropyl 92 0 19 3 19 2 38 6 m toluidine sodium salt ug Glycerol kinase U 0 48 Cellulomonas species Glucose oxidase U 0 64 Cellulomonas species Adenosine triphosphate ug 22 4 Bacterial source Glycerol phosphate oxidase U 0 29 Aerococcus viridans Magnesium chloride ug 0 76 0 058 Nonreactive ingredients Buffers and stabilizers Cassette Storage and Stability Cassettes must be stored in the sealed foil pouches Place cassettes in the refriger
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