CHO-03-034 TCI-Lip-Glu_1
Contents
1. U 0 32 0 32 0 16 0 16 4 Aminoantipyrine ug 6 4 3 0 33 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 Equine muscle disodium form Glycerol phosphate oxidase U 0 29 Aerococcus viridans Magnesium chloride ug 0 76 Nonreactive ingredients Buffers and stabilizers Cassette Storage and Stability Cassettes must be stored in the sealed foil pouches Cassettes may be used until the date printed on the pouch when stored in a refrigerator 36 46 F 2 8 C Or the cassettes may be stored for up to 30 days at room temperature less than 86 F 30 C Once 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 Do not reuse cassettes Cassette Handling Cassettes should sit at room temperature for 10 minutes before opening 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 have2. of 4 5 or less is desirable A ratio greater than 6 0 suggests a high risk of CHD 2 Glucose The American Diabetes Association has modified the criteria for fasting plasma glucose FPG and the diagnosis of diabetes mellitus 14 FPG lt 110 mg dL FPG 110 and lt 126 mg dL FPG 126 mg dL Normal fasting glucose Intermediate fasting glucose Provisional diagnosis of diabetes confirmed by one of the three methods below The revised criteria for diagnosis of diabetes e Symptoms of diabetes plus casual plasma glucose concentration 200 mg dL 11 1 mmol L Casual is defined as any time of day without regard to time since last meal The classic symptoms of diabetes include polyuria polydipsia and unexplained weight loss e FPG gt 126 mg dL 7 0 mmol L Fasting is defined as no caloric intake for at least 8 hours e 2hr post glucose load 200 mg dL during an oral glucose tolerance test The test should be performed as described by WHO World Health Organization using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water Any of the above abnormal glucose levels must be confirmed on a subsequent day by any one of the three methods listed above When screening for diabetes any abnormal glucose result should be referred to a physician for further follow up Performance Characteristics Total Cholesterol Whole Blood heparin Within Run Precision Level 1 Level 2 n 10 10 X mg dL 184 299 S
3. well with the Cholestech LDX System If you use other controls you will need to set ranges for the Cholestech LDX System Handling e 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 also 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 previously received e With each new lot of cassettes e As otherwise required by your laboratory s standard quality control procedures e If you are not running the Cholestech LDX under CLIA waived status or if your local or state regulations require more frequent testing of quality control material then quality control must be performed in compliance with those regulations 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 If the controls do not perform as expected repeat the test or contact Cholestech Technical Service b
4. Cholestech LDX LIPID PROFILE GLU Total Cholesterol HDL Cholesterol Triglycerides and Glucose Panel Test Cassette 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 Catalog No 10 991 Indications For Use For the quantitative determination of total cholesterol HDL high density lipoprotein cholesterol triglycerides and glucose in whole blood A TC HDL total cholesterol HDL cholesterol ratio and estimated values for LDL low density lipoprotein and VLDL very low density lipoprotein 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 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 III 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 cho
5. D mg dL 4 6 Ta CV 2 5 2 4 Commercial Control Material Day to Day Precision Level 1 Level 2 n 20 20 X mg dL 161 244 SD mg dL 4 3 8 6 CV 2 7 35 HDL Cholesterol Whole Blood heparin Within Run Precision Level 1 Level 2 n 10 10 X mg dL 29 46 SD mg dL 1 0 2 2 CV 3 4 4 8 Commercial Control Material Day to Day Precision Level 1 Level 2 i 20 20 X mg dL 29 46 SD mg dL 1 3 2 9 CV 4 5 6 3 Triglycerides Whole Blood heparin Within Run Precision Level 1 Level 2 n 10 10 X mg dL 256 362 SD mg dL 4 0 13 1 CV 1 6 3 60 Commercial Control Material Day to Day Precision Level 1 Level 2 n 20 20 X mg dL 121 276 SD mg dL 2 8 8 7 CV 2 3 3 2 Glucose Whole Blood heparin Within Run Precision Level 1 Level 2 n 10 10 X mg dL 103 127 SD mg dL 6 4 5 7 CV 6 2 4 5 Commercial Control Material Day to Day Precision Level 1 Level 2 n 20 20 X mg dL 103 311 SD mg dL 3 6 15 4 CV 2 5 5 0 LDL Cholesterol Whole Blood heparin Within Run Precision Level 1 Level 2 n 10 10 X mg dL 87 197 SD mg dL 4 3 7 5 CV 49 3 8 Commercial Control Material Day to Day Precision Level 1 Level 2 n 20 20 X mg dL 108 143 SD mg dL 4 6 8 4 CV 4 3 5 9 VLDL Cholesterol Whole Blood heparin Within Run Precision Level 1 Level 2 i 10 10 X mg dL 51 72 SD mg dL 0 8 2 6 CV 1 6 3 6 C
6. ational Heart Lung and Blood Institute issued the Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III in May 2001 1 The ATP III report presented the NCEP s updated clinical guidelines for cholesterol testing and management and described the following classifications for cholesterol and trigylceride testing mg dL mmol L Classification LDL cholesterol lt 100 lt 2 59 Optimal 100 129 2 59 3 34 Near optimal above optimal 130 159 3 36 4 11 Borderline high 160 189 4 14 4 89 High gt 190 24 91 Very high Total cholesterol lt 200 lt 5 18 Desirable 200 239 5 18 6 19 Borderline high gt 240 26 22 High HDL cholesterol lt 40 lt 1 03 Low gt 60 21 55 High Triglycerides lt 150 lt 1 69 Normal 150 199 1 69 2 25 Borderline high 200 499 2 26 5 64 High gt 500 5 65 Very high The ATP III identified HDL cholesterol levels below 40 mg dL 1 03 mmol L as associated with increased risk of coronary heart disease CHD in men and women A high HDL cholesterol level greater than or equal to 60 mg dL 1 55 mmol L is protective and decreases CHD risk TC HDL Ratio The ATP III report does not comment on use of the ratio of total to HDL cholesterol Various authors have suggested that the TC HDL ratio is the strongest lipid risk factor and can be a useful summary of CHD risk 1213 A ratio
7. ch LDX Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al 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 Ethyl 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 O2 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 acid
8. efore testing patient samples The quality control results must be in range before testing patient samples See the Cholestech LDX System User Manual if they are not Please call Cholestech Technical Service at 800 733 0404 if you have any questions about quality control RESULTS Test results will show on the screen when the test is complete Calculated results are shown after the DATA button is pressed To convert mg dL to mmol L mmol L to mg dL divide mg dL by multiply mmol L by TC 38 664 38 664 HDL 38 664 38 664 TRG 88 54 88 54 GLU 18 018 18 018 LIMITATIONS e The measuring range for total cholesterol is 100 500 mg dL Results outside this range will appear as lt 100 mg dL or gt 500 mg dL e The measuring range for HDL cholesterol is 15 100 mg dL Results outside this range will appear as lt 15 mg dL or gt 100 mg dL e The measuring range for triglycerides is 45 650 mg dL Results outside this range will appear as lt 45 mg dL or gt 650 mg dL e The measuring range for glucose is 50 500 mg dL Results outside this range will appear as lt 50 mg dL or gt 500 mg dL e Ifthe triglycerides are gt 400 mg dL the estimated LDL will not be calculated If the total cholesterol HDL cholesterol or triglyceride result is outside the measuring range the LDL will appear as N A If the triglycerides are gt 650 the HDL result may not be accurate and will appear as N A e The glucose test is specific for D glucose Other s
9. erum triglycerides determined colorimetrically with an enzyme that produces hydrogen peroxide Clin Chem 1982 28 2077 80 9 Jessen RH Dass CJ Eckfeldt JH Do enzymatic analyses of serum triglycerides really need blanking for free glycerol Clin Chem 1990 36 1372 5 10 Tietz NW ed Clinical Guide to Laboratory Tests 2nd ed Philadelphia Pa WB Saunders Co 1990 11 Blumenfeld TA Hertelendy WG Ford SH Simultaneously obtained skin puncture serum skin puncture plasma and venous serum compared and effects of warming the skin before puncture Clin Chem 1977 23 9 1705 10 12 Castelli WP Abbott RD McNamara PM Summary estimates of cholesterol used to predict coronary heart disease Circulation 1983 67 730 4 13 Kinosian B Glick H Garland G Cholesterol and coronary heart disease predicting risks by levels and ratios Ann Intern Med 1994 121 641 7 14 Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus Diabetes Care 1997 20 1183 97 z In vitro diagnostic medical device JJ TI TI Catalog number Attention See instructions for use Single use Do not use if package is damaged or open Lot number Use by K E Qe CHOLESTECH 3347 Investment Blvd Hayward CA 94545 U S A Tel 800 733 0404 Fax 510 732 7227 www cholestech com Authorized Representative AR MED Ltd Runnymede Malthouse Egham TW20 9BD United Kingdom Cholestech LDX is a registered tradema
10. for controls or venous blood samples Keep the cassette flat after the sample has been applied Place the cassette into the drawer of the Analyzer at once The black bar must face the Analyzer The brown stripe must be on the right Press RUN The drawer will close During the test the screen will read Put everything that touched the blood sample or control in a biohazard waste container When the test is complete the Analyzer will beep The screen will read Press DATA to show more results When the results are outside the measuring range the screen will read If there is a problem with the test a message will appear on the screen See the Cholestech LDX System User Manual if this happens When the drawer opens remove the cassette Put it in a biohazard waste container Leave the Analyzer drawer empty when not in use Record the results To run another cassette press RUN The screen will read Repeat the test procedure Otherwise after 4 minutes a beep will sound and the screen will read If the RUN button is not pushed within 15 seconds the drawer will close Then the screen will go blank QUALITY CONTROL Quality control 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 A high and a low control for each analyte is preferred Cholestech recommended controls work
11. is read by the Cholestech LDX each time a cassette is run An optics check should be done on the Analyzer each day See the Cholestech LDX System User Manual for instructions TEST PROCEDURE Materials Provided Lipid Profile GLU cassettes Additional Materials Required Cholestech LDX Analyzer and power supply Alcohol swabs and 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 50 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 1 2 Let cassette sit at room temperature for 10 minutes Remove the cassette from its pouch Do not touch the black bar or the brown stripe Put the cassette on a flat surface NOTE Gloves should be worn when working with blood samples 3 NOTE Fingerstick samples must be applied within five 5 minutes or the blood will clot 6 10 11 12 13 14 15 16 17 Press RUN In a few seconds the screen will read The cassette drawer will open The screen will read Place the sample into the cassette well Use a Cholestech LDX Capillary Tube for fingerstick samples Use the MiniPet Pipette
12. lesterol 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 and 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 devel
13. ommercial Control Material Day to Day Precision Level 1 Level 2 n 20 20 X mg dL 24 55 SD mg dL 0 6 1 7 CV 2 5 3 1 Accuracy Method Comparison The Lipid Profile GLU cassette total cholesterol was compared with a validated method traceable to the CDC modified Abell Kendall reference method traceable to National Institute of Standards and Technology NIST standards The Lipid Profile GLU cassette HDL cholesterol was compared with a validated method utilizing dextran sulfate magnesium chloride precipitation and enzymatic cholesterol determination The HDL cholesterol comparison method is based on the selected method for HDL cholesterol and has documented agreement with the CDC Reference Method The Lipid Profile GLU cassette triglyceride test was compared with a validated method utilizing hydrolysis with lipase The comparison method has documented agreement with a CDC Reference Method The Lipid Profile GLU cassette glucose was compared with a hexokinase reference method The Lipid Profile GLU cassette estimated LDL cholesterol was compared to that calculated from the above validated total cholesterol HDL cholesterol and triglyceride methods The range of values tested mg dL were as follows TC 120 300 HDL 26 85 TRG 40 500 GLU 25 575 Results X Reference Method serum Y Cholestech LDX Analyzer venous whole blood No of Correlation Analyte Pairs Slope y intercept Coefficient Bias at Total choleste
14. op 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 VLDL cholesterol and a TC HDL ratio are calculated using the measured values Test Principle The Cholestech LDX System combines enzymatic methodology 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 Choleste
15. rk of Cholestech Corporation MiniPet is a trademark of TriContinent Scientific Inc 2003 Cholestech Corporation 402 12314 Rev C
16. rol 40 0 98 2 41 0 97 200 1 HDL cholesterol 40 0 97 0 23 0 95 35 2 Triglycerides 40 1 0 0 13 0 99 250 0 Glucose 40 0 99 1 01 0 98 150 0 References 1 Expert Panel on Detection Evaluation and Treatment of High Cholesterol in Adults Executive summary of the Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Cholesterol in Adults Adult Treatment Panel III JAMA 2001 285 2486 97 2 Bachorik PS Ross JW for the National Cholesterol Education Program Working Group on Lipoprotein Measurement National Cholesterol Education Program recommendations for measurement of low density lipoprotein cholesterol executive summary Clin Chem 1995 41 1414 20 3 Tietz NW ed Fundamentals of Clinical Chemistry Philadelphia Pa WB Saunders Co 1987 4 Siedel J et al Reagent for the enzymatic determination of serum total cholesterol with improved lipolytic efficiency Clin Chem 1983 29 1075 80 5 Warnick GR Benderson J Albers JJ Dextran sulfate Mg2 precipitation procedure for quantitation of high density lipoprotein cholesterol Selected Methods for Clinical Chemistry 1983 10 91 9 6 Allain CC Poon LS Chan CSG et al Enzymatic determination of total serum cholesterol Clin Chem 1974 20 470 5 7 Roeschlau P Bernt E Gruber W Enzymatische bestimmung des gesamt cholesterins im serum Z Klin Chem Klin Biochem 1974 12 226 8 Fossati P Prencipe L S
17. s 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 cholesterol HDL cholesterol and triglycerides The resultant color in all the reactions is measured by reflectance photometry Glucose oxidase Glucose O o D gluconolactone H209 Peroxidase 2 H202 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 in mg dL LIPID PROFILE GLU Total Cholesterol HDL Cholesterol Triglycerides and Glucose Panel Cassette Each Lipid Profile GLU cassette contains a minimum of TC HDL TRG GLU Dextran sulfate 8 9 50 000 M W ug Magnesium acetate ug 79 5 Cholesterol esterase U 0 34 0 34 Pseudomonas species Lipase 80 Bacterial source Cholesterol oxidase U 0 058 0 058 Pseudomonas species Peroxidase horseradish
18. 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 50 uL of whole blood e The subject should fast for 12 hours before the sample is collected Fingerstick whole blood e 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 5 minutes of collection 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 Glucose levels decrease 5 to 10 mg dL per hour in whole blood at room temperature 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
19. ugars that may be present in the blood do not react in the glucose test i e fructose lactose e Samples with total cholesterol HDL cholesterol triglyceride or glucose values outside the measuring range should be sent to a laboratory for testing e Performance of the Cholestech LDX System has not been tested on samples from newborns e Glucose tests done at altitudes above 5 000 feet may give low results Some substances may cause false results with enzymatic tests The substances listed below were tested for all analytes Less than 10 interference was seen at the levels shown Substance Concentration mg dL Hemoglobin 125 Gemfibrozil 15 L Dopa 0 8 Bilirubin 5 Ascorbic Acid 1 Probucol 32 5 Urea 500 Nicotinic Acid 10 Fructose 30 Clofibrate 80 Uric Acid 15 Lovastatin 4 Creatinine 30 Dipyrone 10 Glutathione 1 Methotrexate 450 Cimetidine 75 Nitrofurantoin 2 Oxytetracycline 4 Gentisic Acid 0 5 Lactose 100 Methyldopamine Os Cysteine 25 e Hematocrits between 30 and 52 do not affect results e Blood collection tubes with glycerol should not be used for the triglyceride test e Hand creams and soaps with glycerol may cause falsely high triglyceride results e _ The triglyceride test measures triglycerides and free glycerol Free glycerol usually is less than 20 mg dL 21 e There may be a 6 7 difference in the glucose levels of fingerstick and venous blood EXPECTED VALUES Cholesterol and Triglycerides The N
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