Cholesterol Test Devices
Contents
1. Guidelines National Institutes of Health May 2001 4 ATP III NCEP Guidelines for CHD Risk JAMA 2001 285 2486 2509 Number 1150685901 Effective date 2013 xx xx INDEX OF SYMBOLS Consult instructions for use Use by Store between 2 30 C For in vitro diagnostic use only Lot number Control range Code number Manufacturer REF Catalog Contents sufficient for lt n gt tests MODEL Model number Do not reuse Authorized representative 0123 MDSS GmbH Schiffgraben 41 30175 Hannover Germany ACON Laboratories Inc 10125 Mesa Rim Road San Diego CA 92121 USA2. the expiration date printed on the foil pouch Compare results to controls with known levels and repeat the test using a new test device If the problem persists discontinue using the test devices immediately and contact your local distributor PERFORMANCE CHARACTERISTICS Linearity Ten replicate assays were drawn from three test device lots and tested on the Cholesterol Monitoring Systems y using ten concentration levels of heparin preserved venous blood specimens Several Cholesterol Monitoring Systems were used to perform tests at each concentration n 5 The same specimens were also tested using a market leader analyzer x Linearity results are presented below Total Cholesterol Test Device Lot Linearity Equation R Lot 1 Y 0 9985x 0 7805 0 998 Lot 2 Y 0 9992x 0 4052 0 997 Lot 3 Y x 0 0062 0 998 High Density Lipoprotein Test Device Lot Linearity Equation R Lot 1 Y 1 0137x 1 121 0 994 Lot 2 Y 1 002x 0 2461 0 997 Lot 3 Y 0 9962x 0 2157 0 998 Triglycerides Test Device Lot Linearity Equation R Lot 1 Y 0 9996x 0 2864 0 996 Lot 2 Y 1 0055x 5 9755 0 998 Lot 3 Y 1 0096x 10 233 0 998 Reproducibility and Precision Ten replicate assays were tested Fresh heparin preserved venous blood specimens at three concentration levels were used with three test device lots producing the following within run precision and total precision estimates Within run precision using wh
3. Cholesterol Test Devices Package Insert 3 1 Lipid Panel CHOL Total Cholesterol TRIG Triglycerides HDL High Density Lipoprotein English REF C131 2041 REF C131 2011 REF C131 2021 REF C131 2031 MODEL CCS 114 MODEL CCS 111 MODEL CCS 112 MODEL CCS 113 For testing cholesterol in human whole blood plasma or serum For in vitro diagnostic use only INTENDED USE The Mission Cholesterol Test Devices work with the Mission Cholesterol Meter to measure the lipid concentration in whole blood plasma and serum For professional use or self testing using fingertip blood The 3 1 Lipid Panel is used to measure the concentrations of Total Cholesterol CHOL High Density Lipoprotein HDL and Triglycerides TRIG It is also used to calculate LDL CHOL HDL and CHD values Note CHD calculation function is only for professional use refer to the Mission Cholesterol Monitoring System User s Manual for detailed instructions 3 seperate test devices can measure the concentrations of CHOL HDL and TRIG individually Lipid measurements are used in the diagnosis and treatment of atherosclerotic coronary artery disease and in the diagnosis of metabolic disorders involving lipids and lipoproteins MEASUREMENT RANGE Measurement range Total Cholesterol 100 500 mg dL 2 6 12 9 mmol L High Density Lipoprotein 15 100 mg dL 0 39 2 59 mmol L Triglycerides 45 650 mg dL 0 51 7 34 mmol L For total cholesterol and high density lipoprot
4. L 10 l for single test of the second or third drop of capillary blood specimen using a Capillary Transfer Tube or pipette Refer to the User s Manual for details Hold the tube horizontally and touch the tip of the Capillary Transfer Tube to the blood drop Draw the sample and stop drawing when the sample comes to the fill line 6 While the meter is flashing the blood drop symbol apply 35 L 10 l for single test specimen to the Specimen Application Area of the test device or align the tip of the Capillary Transfer Tube with the Specimen Application Area of the test device to apply the blood 3 dashed lines will appear on the meter to show the test is in progress 7 Read the results on the screen in 2 minutes Refer to the User s Manual for detailed test procedures Note Avoid an environment with strong lighting during the test Be sure the alcohol dries completely before pricking the finger Hand lotions or creams on the finger should be cleaned enough before testing or the results of TRIG will be abnormally high Excessively squeezing the finger may alter the results For best results fasting for at least 12 hours is recommended Add 35 L 10 l for single test specimen to the test device at one time INTERPRETATION OF RESULTS The meter automatically measures concentrations of CHOL HDL and TRIG In the event of unexpected or questionable results the following steps are recommended Confirm that the test devices have been used within
5. ein 1 mmol l 38 66 mg dL for triglycerides 1 mmol L 88 6 mg dL Results below the ranges will show lt _ and results above the ranges will show gt _ When concentrations of specimens are above the test ranges values for CHOL HDL LDL will display PRINCIPLE AND REFERENCE VALUES Mission Cholesterol Test Devices use a timed endpoint method to measure the Total Cholesterol CHOL High Density Lipoprotein HDL Triglycerides TRIG concentrations in whole blood serum or plasma The concentration of Low Density Lipoprotein LDL is calculated by the values of CHOL TRIG and HDL The system monitors the change in absorbance at 630 nm at a fixed time interval The change in absorbance is directly proportional to the concentration of lipid in the sample CHOL In the reaction cholesterol esterase hydrolyzes cholesterol esters to free cholesterol and fatty acids The free cholesterol is oxidized to cholesten 3 one and hydrogen peroxide by cholesterol oxidase Peroxidase catalyzes the reaction of hydrogen peroxide with 4 aminoantipyrine and phenol to produce a colored quinoneimine product HDL The dextran slulphate Mg2 on the test device precipitates the chylomicrons VLDL and LDL leaving HDL in the sample The cholesterol concentration of this HDL is then determined enzymatically the same as CHOL TRIG Triglycerides in the sample are hydrolyzed to glycerol and free fatty acids by the action of lipase A sequence of three coupled
6. enzymatic steps using glycerol kinase GK glycerophosphate oxidase GPO and horseradish peroxidase HPO causes the oxidative coupling of 4 aminoantipyrine to form a blue dye LDL When the concentration of TRIG in the specimen is equal to or lower than 400mg dL LDL concentration can be calculated by the meter with the following equation2 LDL CHOL HDL TRIG 2 2 mmol L LDL CHOL HDL TRIG 5 mg dL Calculated LDL is an estimation of LDL Reference values are listed in the chart below3 4 Tests Desirble Borderline high High risk Total Cholesterol CHOL lt 5 2 mmol L lt 200 mg dL 5 2 6 2 mmol L 200 240 mg dL gt 6 2mmol L 240mg dL High Density Lipoprotein HDL 1 56 mmol L 60 mg dL Men 1 5 1 0 mmol L 60 40 mg dL Women 1 5 1 3 mmol L 60 50 mg dL Men lt 1 0 mmol L 40 mg dL Women lt 1 3 mmol L 50 mg dL Triglycerides TRIG lt 1 7 mmol L lt 150 mg dL 1 7 2 3 mmol L 150 200 mg dL gt 2 3 mmol L 200 mg dL Low Density Lipoprotein LDL lt 3 4 mmol L lt 130 mg dL 3 4 4 1 mmol L 130 160 mg dL gt 4 1 mmol L 160 mg dL Reference ranges may vary between laboratories Every laboratory should establish its own reference range as needed 1 Blood lipid levels will have big physiological fluctuations depending on food consumed or exercise REAGENTS AND PERFORMANCE CHARACTERISTICS Based on the dry weight at the time of impregnation the concentrations given may vary withi
7. er testing Check the code chip before performing a test Make sure to use the code chip that is included with the package of test devices Insert the code chip into the code chip slot The code chip slot is located on the right side of the meter Check that the sample type displayed on the meter LCD is same as the sample type tested b before the two digitals test number equals to whole blood and S equals to serum and plasma Decisions of medical relevance are not to be taken without consultation of a doctor Changes to treatment should only be made after proper training STORAGE AND STABILITY Store as packaged in the sealed pouch either at room temperature or refrigerated 2 30 C Keep out of direct sunlight Test devices are stable through the expiration date printed on the foil pouch Remove only enough test devices for immediate use Replace cap immediately and tightly DO NOT FREEZE Do not use beyond the expiration date SPECIMEN COLLECTION AND PREPARATION For professional use Fresh capillary blood heparinized or EDTA venous whole blood serum and heparinized plasma specimens For self testing Fresh capillary blood Heparinized or EDTA venous whole blood serum and heparinized plasma must be kept in a closed container and must be used within 8 hours of collection Mix stored specimens adequately before testing Use fresh capillary blood immediately after collection Capillary Transfer Tube o
8. n manufacturing tolerances Tests Components Total Cholesterol Cholesterol esterase gt 0 3U cholesterol oxidase gt 0 16U POD horseradish gt 0 6U ascorbate oxidase gt 0 6U 4 aminoantipyrine gt 0 06mg Maos gt 0 06mg buffer High Density Lipoprotein Magnesium chloride gt 0 1mg dextran sulphate gt 0 01mg ascorbate oxidase gt 0 6U Cholesterol esterase gt 0 3U cholesterol oxidase gt 0 16U POD horseradish gt 0 6U 4 aminoantipyrine gt 0 06mg Maos gt 0 06mg buffer Triglycerides Lipoprotein lipase gt 0 35U glycerol kinase gt 0 5U glycerol phosphate oxidase gt 0 1U POD horseradish gt 0 6U ATP gt 0 2mg ascorbate oxidase gt 0 5U 4 aminoantipyrine gt 0 09mg Maos gt 0 06mg buffer The performance characteristics of these optical lipid devices have been determined in both laboratory and clinical tests This test has been developed to be specific for the parameters to be measured with the exception of the interferences listed Refer to the Limitations section for detailed information PRECAUTIONS For in vitro diagnostic use only The test devices should remain in the sealed pouch until use Do not use after the expiration date Do not touch the reagent area of the test device Discard any discolored or damaged test devices All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent The used test device should be discarded according to local regulations aft
9. ole blood specimens statistical analysis gives the mean standard deviations SD and coefficients of variation CV listed below Total cholesterol Precision Level I n 20 Level II n 20 Level III n 20 Lot Number Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Mean mg dL 86 88 84 194 192 190 389 394 396 SD CV 2 6 2 1 2 4 2 8 2 7 2 8 2 3 2 5 2 5 Total precision is listed below Test Level Level I n 60 Level II n 60 Level III n 60 Mean g dL 86 192 393 SD CV 3 2 2 8 2 5 High Density Lipoprotein Level I n 20 Level II n 20 Level III n 20 Precision Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Mean mg dL 19 19 16 38 39 39 93 96 96 SD mg dL or CV 1 25 0 81 0 8 3 6 3 0 2 8 2 1 2 4 2 4 Total precision is listed below Test Level Level I n 60 Level II n 60 Level III n 60 Mean g dL 18 38 95 SD mg dL or CV 1 53 3 5 2 7 Triglycerides Level I n 20 Level II n 20 Level III n 20 Precision Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Mean mg dL 67 68 61 150 146 156 315 306 312 SD mg dL or CV 2 1 2 41 2 09 3 2 2 7 2 6 3 0 2 6 2 0 Total precision is listed below Test Level Level I n 60 Level II n 60 Level III n 60 Mean g dL 65 151 311 SD mg dL or CV 3 74 3 8 2 8 Accuracy The Cholesterol Te
10. r pipette must be used to collect capillary specimens for accurate results MATERIALS Materials Provided Test devices Code chip Package insert Materials Required But Not Provided Lancing device Sterile lancet Meter Gauze for puncture site Latex gloves Alcohol swab Capillary Transfer Tubes DIRECTIONS FOR USE Allow the test device specimen and or controls to reach operating temperature 15 40 C prior to testing Refer to the Mission Cholesterol Monitoring System User s Manual for detailed instructions 1 Insert the code chip into the meter and code the meter correctly Refer to Coding the Meter section in the User s Manual for details Compare the code number on the code chip with the code number printed on the test devices foil pouch and ensure the two numbers are identical to avoid inaccurate results 2 Check that the sample type displayed on the meter LCD is same as the sample type tested If not set the correct sample type Refer to the User s Manual for details 3 Remove the test device from the foil pouch 4 Wait for the meter to flash the test device symbol Insert the test device completely into the test device channel in the same direction as the arrows printed on the test device 5 Prepare the specimen to be tested For venous blood plasma serum specimens mix the specimen for about 10 minutes For capillary blood specimens wipe away the first drop of blood Collect 35
11. s performed or whenever a new package is first opened Each laboratory should establish its own goals for adequate standards of performance Contact your local distributor for information on specific controls for this product LIMITATIONS The following substances do not interfere with test results Substance Amount Substance Amount Acetaminophen 1324 mol L 20 mg dL Cholesterol 12 9mmol L 500 mg dL Ascorbic Acid 568 mol L 10 mg dL Tetracycline 6 7mmol L 600 mg dL Conjugated Bilirubin 240 mol L 20 mg dL Uric Acid 0 6mmol L 10 mg dL Creatinine 442 mol L 5 mg dL Hemoglobin 2g L 200 mg dL Ibuprofen 2425 mol L 50 mg dL Dopamine 5 87 umol L 0 09 mg dL Methyldopa 71 mol L 1 5 mg dL High concentrations of uric acid and ascorbic acid can lead to low measurements Anticoagulants such as heparin and EDTA are recommended for use with venous whole blood Do not use EDTA plasma which lead to higher results Do not use other anticoagulants such as iodoacetate sodium citrate or those containing fluoride Arterial blood isn t recommended for use Hemolyzed blood or thrombolytic therapy blood may lower the results Venous occlusion may increase the results and is not recommended to draw the blood BIBLIOGRAPHY 1 Henry J B Clinical Diagnosis and Management by Laboratory Methods 15 290 2001 2 Friedewald et al Clin Chem 1972 18 6 499 502 3 National Cholesterol Education Program 2001
12. st Devices were used by a trained technician to test heparin preserved venous blood specimens from 78 participants The same specimens were analyzed using a market leader lipid test analyzer x The results are compared below Total Cholesterol Specimen Slope Intercept R N Venous blood 1 0243 2 7846 0 994 78 High Density Lipoprotein Specimen Slope Intercept R N Venous blood 0 9728 1 6124 0 991 78 Triglycerides Specimen Slope Intercept R N Venous blood 0 9991 1 4849 0 993 78 In another study heparinized venous blood serum and heparinized plasma were collected from each patient and tested using a cholesterol test device by a trained technician A total of 40 patients took part in this study and results compared to those tested on the serum from same patients by the Abell Kendall method For CHOL and DCM method For HDL in a Cholesterol Reference Method Laboratory Network CRMLN laboratory The results were listed below Total Cholesterol Specimen Slope Intercept R N Venous blood 1 0286 6 5223 0 998 40 Plasma 1 0336 4 4486 0 998 40 Serum 1 0402 6 145 0 999 40 High Density Lipoprotein Specimen Slope Intercept R N Venous blood 1 0334 0 6386 0 995 40 Plasma 1 0441 0 7255 0 995 40 Serum 1 0438 0 8096 0 995 40 QUALITY CONTROL For best results performance of test devices should be confirmed by testing known specimens controls whenever a new test i
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