Package Insert - Health Management Systems, Corp.
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1. Cholestech LDX LIPID PROFILE GLU Total Cholesterol HDL Cholesterol Triglycerides and Glucose Panel Test Cassette LIPID PROFILE Total Cholesterol HDL Cholesterol and Triglycerides Panel Test Cassette REF 10 991 REF 10 989 TC HDL GLU TC HDL eo et eae a Total Cholesterol and HDL Panel and Glucose Panel Test Cassette Test Cassette FEF 10 990 REF 10 987 TC GLU TC Total Cholesterol and Glucose Total Cholesterol Test Cassette Panel Test Cassette REF 10 986 REF 10 988 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 Alere www alere 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 INTENDED 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 non HDL cholesterol are calculated by the Alere Cholestech LDX Analyzer SUMMARY and EXPLANATION Cholesterol is a major cause of coronary heart disease CHD and large clinical trial2. Canada 1 613 271 1144 CANproductsupport alere com US 1 877 308 8289 USproductsupport alere com Alere Customer Service Contact the following Alere Service Care Center or your local distributor for order and billing assistance You may also contact us at www alere com Phone E Mail Address 1 877 441 7440 clientservices alere com PERFORMANCE CHARACTERISTICS Day to Day Precision Commercial Control Material 20 20 430 86 Within Run Precision Whole Blood heparin Precision ACCURACY METHOD aaa The 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 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 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 cassette estimated LDL was compared to that calculated from the above validated total cholesterol HDL cholesterol and triglycerides methods The range of values tested mg dL were as follows TC 120 3
3. cholesterol Fatty acids Cholesterol oxidase 3 Cholesterol O Cholest 4 ene 3 one H O Peroxidase y 2 H O 4 Aminoantipyrine TOOS Quinoneimine dye 4 H O The Alere 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 The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol Lipase 5 Glycerol kinase Mo Glycerol phosphate Oxidase Triglycerides H O Glycerol Free fatty acids Glycerol ATP Glycerol 3 phosphate ADP Glycerol 3 phosphate O Dihydroxyacetone phosphate H O Peroxidase y 2 H O 4 Aminoantipyrine TOOS Quinoneimine dye 4 H O The Alere 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 gt Glucose O o D gluconolactone H O Peroxidase 2 H O 4
4. 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 it is 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 Alere Minipet Pipette Use this procedure to apply a venous blood sample or control calibration verification or proficiency testing materials to the cassette Any pipette that can deliver 40 uL may be used 1 Firmly attach the pipette tip to the end of the 40 uL MiniPet Pipette Use a new tip for each sample 2 To fill 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
5. 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 NOTE Pressing the RUN button will erase the previous result RESULTS Test results will be displayed on the screen when the test is complete Calculated results are displayed 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 LDL 38 664 38 664 GLU 18 018 18 018 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 Alere Cholestech LDX System Choice of Materials Liquid Level 1 and Level 2 controls that work well with the Alere Cholestech LDX System are available If you use other controls you will need to establish ranges for the Alere 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 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 whenever the laboratory director has any quest
6. 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 NOTE If the plunger is released before the pipette tip is out of the sample well it will remove the sample just dispensed NOTE Keep the cassette horizontal at all times after applying the sample Running a Test 1 Ifthe 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 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 NOTE Gloves should be worn whenever working with blood samples 4 Press RUN The analyzer will do a selftest and the screen will display 5 The cassette drawer will open and the screen will display 6 Place the sample into the cassette well Use an Alere Cholestech LDX Capillary Tube for fingerstick samples Use a 40 uL pipette for venous blood samples and quality control calibration verification and proficiency testing materials NOTE Fingerstick samples must be applied within eight 8 minutes or the blood will clot 7 Keep the cassette flat after the sample has been applied WARNING Allowing the sample to sit in t
7. 00 HDL 26 85 TRG 40 500 GLU 25 575 Results X Reference Method serum Y Alere Cholestech LDX Analyzer venous whole blood No of Correlation Analyte Pairs Slope y intercept Coefficient Bias at Total cholesterol 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 Ill 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 Hagele EO Ziegenhorn J Wahlefeld AW 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 Ch
8. 26 mg dL 7 0 mmol l Fasting is defined as no caloric intake for at least 8 hr e 2 h plasma glucose gt 200 mg dL 11 1 mmol L during an OGTT The test should be performed as described by the World Health Organization using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water e Ina patient with classic symptoms of hyperglycemia or hyperglycemic crisis a random plasma glucose gt 200 mg dL 11 1 mmol L In the absence of unequivocal hyperglycemia diagnosis should be confirmed by repeat testing When screening for diabetes any abnormal glucose result should be referred to a physician for further follow up LIMITED WARRANTY For the applicable warranty period Alere warrants that each product shall be I of good quality and free of material defects Il function in accordance with the material specifications referenced in the product manual and Ill approved by the proper governmental agencies required for the sale of products for their intended use the Limited Warranty If the product fails to meet the requirement of the limited warranty then as a customer s sole remedy Alere shall either repair or replace at Alere s discretion the product Except for the limited warranty stated in this section Alere disclaims any and all warranties express or implied including but not limited to any warranty of merchantability fitness for a particular purpose and non infringement regarding the pro
9. Aminoantipyrine TOOS Quinoneimine dye 4 H O A brown magnetic stripe on each cassette contains the calibration information required for the Alere Cholestech LDX Analyzer to convert the reflectance reading R to the total cholesterol HDL cholesterol triglycerides and glucose concentrations REAGENTS Materials Provided Alere Cholestech LDX Lipid ProfileeGLU Lipid Profile TCce HDLeGLU TCeHDL TCeGLU or TC Cassettes Each cassette contains a minimum of TC HDL TRG GLU Dextran sulfate 50 000 M W ug 17 2 Magnesium acetate ug 153 Cholesterol esterase U 0 287 0 287 Pseudomonas species Lipase U 53 9 Bacterial source Cholesterol oxidase U 0 049 0 049 Pseudomonas species Peroxidase horseradish U 0 266 0 266 0 133 0 133 4 Aminoantipyrine ug 5 39 2 52 2 173 511 N Ethyl N sulfohydroxypropyl 77 0 16 2 16 1 32 3 m toluidine sodium salt yg Glycerol kinase U 0 399 Cellulomonas species Glucose oxidase U 0 539 Cellulomonas species Adenosine triphosphate ug 18 8 Bacterial source Glycerol phosphate oxidase U 0 238 Aerococcus viridans Magnesium chloride ug 1 37 Nonreactive ingredients buffers and stabilizers Materials Required But Not Provided Alere Cholestech LDX System Alcohol swabs and gauze for cleaning puncture site Lancets for capillary blood collection Alere Cholestech LDX 40 uL Lithium Heparin Capillary Tube
10. an CS Richmond W Fu PC Enzymatic determination of total serum cholesterol Clin Chem 1974 20 470 5 7 _Roeschlau P Bernt E Gruber W Enzymatische bestimmung des gesamtcholesterins im serum Z Klin Chem Klin Biochem 1974 12 226 8 Fossati P Prencipe L Serum 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 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 American Diabetes Association Diagnosis and classification of diabetes mellitus Diabetes Care 2010 33 Suppl 1 S62 9 GLOSSARY of SYMBOLS REF Catalog Number Batch Code CE a CE Mark Manufacturer Authorized Representative in the European Community In Vitro Diagnostics an 2 n Consult Instr
11. duct Alere s maximum liability with any customer claim shall not exceed the net product price paid by customer Neither party shall be liable to the other party for special incidental or consequential damages including without limitation loss of business profits data or revenue even if a party receives notice in advance that these kinds of damages might result The Limited Warranty above shall not apply if the Customer has subjected the Product to physical abuse misuse abnormal use use inconsistent with the Product Manual or Insert fraud tampering unusual physical stress negligence or accidents Any warranty claim by Customer pursuant to the Limited Warranty shall be made in writing within the applicable Limited Warranty period RETURN POLICY Please contact Alere Product Support prior to returning any defective components Refer to Contact Alere section for additional information CONTACT ALERE Alere Product Support Contact one of the following Alere Product Support Care Centers or your local distributor if you have any questions regarding the use of your Alere product You may also contact us at www alere com Region Phone E Mail Address Europe amp Middle East 44 161 483 9032 EMEproductsupport alere com Asia Pacific 61 7 3363 7711 APproductsupport alere com Africa Russia amp CIS 972 8 9429 683 ARCISproductsupport alere com Latin America 57 01800 094 9393 LAproductsupport alere com
12. he cassette will cause inaccurate results Immediately 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 Doo RUN The drawer will close During the ieee Ja sop gt e j 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 Alere Cholestech LDX System User Manual if this happens Please call Alere Product Support to report any problems or if you have questions about the operation of the Alere Cholestech LDX System 14 When 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 NOTE If you do not want to run another test and the drawer is open press STOP to close
13. ion 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 Alere Product 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 e As otherwise required by your laboratory s standard quality control procedures e 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 Alere Cholestech LDX System User Manual if they are not Please call Alere Product Support to report any problems or if you have any questions about quality control LIMITATIONS For results outside the measuring Analyte Measuring Range range the LDX displays mg dL mmol L Low High TC 100 500 lt 100 mg dL gt 500 mg dL 2 59 12 9 lt 2 59 mmol L gt 12 9 mmol L HDL 15 100 lt 15 mg dL gt 100 mg dL 0 39 2 59 lt 0 39 mmol L gt 2 59 mmol L TRG 45 650 lt 45 mg dL gt 650 mg dL 0 51 7 34 lt 0 51 mmol L gt 7 34 mmol L GLU 50 500 lt 50 mg dL gt 500 mg dL 2 78 27 8 lt 2 78 mmol L gt 27 8 mmol L Additional Limitations That Displa
14. ng Glucose levels decrease 5 to 10 mg dL 0 28 to 0 55 mmol L per hour in whole blood at room temperature 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 Alere 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 Alere Cholestech LDX User Manual for instructions NOTE 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 Put a capillary plunger into the end of a Alere Cholestech LDX 40 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 warm 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 the blood to the fingertip 4 Clean the site with an alcohol swab Dry thoroughly with a gauze pad before pricking the finger 5 Firmly prick the selected site with a
15. o 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 Alere Cholestech LDX System is CLIA waived for fingerstick or venous whole blood unprocessed samples only If you run serum or plasma on the Alere Cholestech LDX System you will have to comply with the regulations for moderate complexity See the Alere Cholestech LDX System User Manual for a summary of these regulations Sample Requirement e Sample Volume 40 uL of whole blood Fingerstick whole blood e When testing triglycerides or glucose the subject should fast for 9 12 hours before the sample is collected e Collect the sample from a fingerstick into a Alere Cholestech LDX 40 uL Capillary Tube See the Fingerstick Procedure below e Place the blood into the cassette within 8 minutes after collection e Blood from the fingerstick should flow freely Too much squeezing of the finger may cause inaccurate 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 inaccurate results Use a 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 gently inverting at least 7 times before testi
16. ple is applied to an Alere Cholestech LDX cassette The cassette is then placed into the Alere 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 and very 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 Alere Cholestech 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 3 Cholesterol esters H O Free
17. rt 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 Ill 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 A ratio of 4 5 or less is desirable A ratio greater than 6 0 suggests a high risk of CHD Non HDL ATP Ill identifies non HDL cholesterol total cholesterol minus HDL cholesterol as a secondary target of therapy in persons with high triglycerides 200 mg dL The goal for non HDL cholesterol in persons with high serum triglycerides can be set at 30 mg dL higher than that for LDL cholesterol on the premise that a VLDL cholesterol level lt 30 mg dL is normal Glucose The American Diabetes Association has identified categories of increased risk for diabetes based upon glucose e Fasting plasma glucose FPG 100 125 mg dL 5 6 6 9 mmol L impaired fasting glucose e 2 hr plasma glucose in the 75 g oral glucose tolerance test OGTT 140 199 mg dL 7 8 11 0 mmol L impaired glucose tolerance For these tests risk is continuous extending below the lower limit of the range and becoming disproportionately greater at higher ends of the range The American Diabetes Association has criteria for the diagnosis of diabetes mellitus based upon glucose e FPG 21
18. s Alere Cholestech LDX Capillary Plungers Gloves Biohazard waste containers Quality control material MiniPet Pipette and tips or micropipetter that will deliver 40 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 WARNINGS and PRECAUTIONS For professional in 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 refrigerator after receipt Cassettes may be used until the date printed on the pouch when stored in a refrigerator 86 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 NOTE 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 e Do not use a cassette that has been stored at room temperature for more than 30 days e D
19. s 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 cholesterol should be estimated from measurement of total and HDL cholesterol and triglycerides using the Friedewald formula 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 virt
20. tion 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 e There may be a 6 7 difference in the glucose levels of fingerstick and venous blood EXPECTED VALUES Cholesterol and Triglycerides The National 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 Ill in May 2001 1 The ATP III report presents NCEP s updated clinical guidelines for cholesterol testing and management and describes the following classifications for cholesterol and triglyceride testing Analyte mg dL mmol L LDL cholesterol Classification 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 2190 24 91 Very high Total cholesterol lt 200 lt 5 18 Desirable 200 239 5 18 6 19 Borderline high gt 240 gt 6 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 2500 25 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 hea
21. ually all cells in the tissues and organs 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 Alere 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 TEST PRINCIPLE The Alere 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 sam
22. uctions Contains sufficient For Use for lt n gt tests Temperature Limitation Alere San Diego Inc MDSS GmbH paa 9975 Summers Ridge Road Schiffgraben 41 C San Diego CA 92121 USA 30175 Hannover www alere com Germany Protected by patents US 6171849 US 7795038 and US 7772007 other rights granted and pending The Alere Logo Alere and Alere Cholestech LDX are registered trademarks of the Alere group of companies MiniPet is a trademark of TriContinent Scientific Inc 2010 Alere All rights reserved 26196en Rev A 2010 12
23. y N A e If the measured value of TRG is gt 650 mg dL gt 7 34 mmol L the LDX displays N A for HDL e If the measured value of TRG is gt 400 mg dL gt 4 51 mmol L the LDX displays N A for the LDL estimate e If the measured value of TC HDL or TRG is outside the measuring range the LDX displays N A for the LDL estimate Software version 2 02 calculates LDL estimates with measured TRG values as low as 30 mg dL 0 34 mmol L e The glucose test is specific for D glucose Other sugars 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 Alere Cholestech LDX System has not been tested on samples from newborns e Blood glucose results performed at altitudes above 5000 feet have not been validated Some substances may cause inaccurate results with enzymatic tests The substances listed below were tested for interference with all analytes Less than 10 interference was seen at the levels shown Substance Concentration mg dL Ascorbic Acid 1 Hemoglobin 125 Bilirubin 5 Lactose 100 Creatinine 30 Lovastatin Mevacor 4 Cysteine 10 Nicotinic Acid Niacin 10 Fructose 30 Urea 500 Gemfibrozil Lopid 15 Uric Acid 15 Glutathione 1 e Hematocrits between 30 and 49 do not affect results e Blood collec
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