Glucertain® Blood Glucose Test Strips Product Insert
Contents
1. 7 Make changes to the patient s diabetes control program only with consultation with the physician SUPPLIES FOR TESTING YOUR BLOOD GLUCOSE Glucertain Meter Glucertain Test Strips Glucertain Safety Lancets Glucertain User s Manual Glucertain Glucose Control Solutions SAMPLE COLLECTION AND PREPARATION This system is for use in venous blood or fresh capillary blood Use the blood sample immediately The blood sample volume requires at least 0 6 micro liters To obtain a drop of blood follow these steps DNNE NS CuO o o Step 1 Wash amp dry your hands thoroughly and glove per facility protocols Step 2 Obtain a new Glucertain Safety Lancet Step 3 Clean patient s fingertip with an alcohol swab Be sure that the finger is entirely dry before lancing Step 4 Puncture and get a drop of blood Once puncture is achieved remove the lancet from the punctured site ALTERNATE SITE TESTING AST 1 AST results may differ from fingertip results when glucose levels are changing rapidly e g after a meal after taking insulin or during or after exercise Use AST only during steady state blood glucose conditions Perform AST only under the following conditions Testing before a meal In a fasting state 2 hours or more after a meal 2 hours or more after insulin dosing 2 hours after physical activity Fingertip test only If sick If blood glucose is low After exercis2. Within run For each test range Use 10 Meters 2 lots of test strips 10 pcs test strips at each lot N 10 Meters x 2 lots x10 tests X 6 glucose levels 1200 N GlucertainBG System SD mg dL Range mg dL 111 150 mg dL 137 0 151 250 mg dL 223 5 251 400 mg dL 399 8 17 5 120 mg dL concentration is 11 9 mg dL 401 600 mg dL 512 4 Total run Prepare 10 Meters 2 lots of test strip level 1 2 and 3 control solutions Test each control level twice a day once in the morning and once in the afternoon for 10 days N 10 Meters x 2 Lots x 2 tests x10 days X 3 control solutions 1200 Control N _ mean mg dL SD mg dL CV 7 45 120 7 2 56 349 8 2 07 This shows that Glucertain BG System has good repeatability ACCURACY STUDY The accuracy of the Glucertain BG System was assessed by comparing to laboratory results The following results were obtained by 103 subjects with diabetes at three independent clinical sites The regression statistics are derived from a plot of fingertip capillary data versus YSI Yellow Springs Instrument Co plasma data Slope 1 0100 Intercept Number of subjects 153 R square Range tested 58 5 433 5 mg dL Glucose level lt 100mg dL withint10mg dL 111 180 61 7 Glucose level 100mg dL within 10 357 438 81 5 0 9679 mg dL 0 9696 withint5mg dL withint15mg dL 175 180 97 2 55 180 30 6 withint15 422 438 96 3 withint5 220 438
3. 50 2 In comparison to the YSI Glucertain BG System meets the EN ISO 15197 2013 standard whereby 95 of the blood glucose values measured must lie within the following ranges either 15 mg dL of the measured average value when using the reference measuring procedure for blood glucose concentrations lt 100 mg dL or 15 for blood glucose concentrations of 2100 mg dL 99 of the individual measured blood glucose values must fall within zones A and B of the Consensus Error Grid CEG for diabetes type 1 Thenar testing Slope 0 9688 Intercept 4 8241 mg dL Number of subjects 153 R square 0 9481 Range tested 55 459 mg dL Glucose level 75mg dL withint5mg dL within 10mg dL withint15mg dL 12 19 63 16 17 19 89 47 Glucose level gt 75mg dL withint10 withint15 99 134 73 88 121 134 90 30 19 19 100 withint20 129 134 96 27 withint5 63 134 47 01 Hypothenar testing Slope 1 0896 Intercept 11 7596 mg dL Number of subjects 153 R square 0 9584 Range tested 53 517 mg dL Glucose level 75mg dL withint5mg dL within 10mg dL withint15mg dL 9 19 47 37 16 19 84 21 Glucose level gt 75mg dL 18 19 94 74 within 5 within 10 within 15 within 20 66 134 49 25 95 134 70 90 113 134 84 33 129 134 96 27 Arm testing Slope 1 0263 Intercept 4 6425 mg dL Number of subjects 153 R square 0 9503 Range tested 50 514 mg dL Glucose level 75mg dL withint5mg dL within 10mg dL wit
4. 2 0 U test strip Potassium ferricyanide Non reactive ingredients 56 w w 38 w w STORAGE AND HANDLING 1 Glucertain BG Test Strips should be stored at 36 86 F 2 30 C and 40 85 RH Keep out of direct sunlight and heat DO NOT freeze Write the date on the bottle when initially opened Discard test strips 6 months after the initial opening date Replace the cap quickly after taking the test strip from the bottle Handle the test strip only with dry and clean hands Store your test strips in their original bottle only Do not move them to any other bottle or container Use this system at temperatures between 50 F and 104 F 10 C and 40 C Outside this range the system may get inaccurate results 10 If strips are stored in the refrigerator the strips should be brought to room temperature before testing WARNINGS AND PRECAUTIONS For in vitro diagnostic use only Do not swallow Do not use the test strip after the expiration date Do not re use test strips Do not cut bend scratch or alter the test strip in any way The Glucertain Blood Glucose Meter should be cleaned and disinfected after every use Please refer to the User s Manual for information regarding the frequency and instructions of cleaning and disinfection 6 If the readings are not consistent with the patient s symptoms check the user manual for the meter Make sure you have followed all instructions and then contact the physician
5. Glucertain Blood Glucose Test Strips Instructions INTENDED USE Glucertain Blood Glucose Test Strips are intended for the quantitative measurement of glucose in venous blood or fresh capillary whole blood samples drawn from the fingertips palm or forearm Glucertain Blood Glucose Test Strips must be used with the Glucertain Blood Glucose Meter Testing is done outside the body In Vitro diagnostic use The Glucertain Blood Glucose Monitoring System is indicated for use in clinical settings by healthcare providers as an aid to monitor the effectiveness of diabetes control The Glucertain Blood Glucose Monitoring System is not to be used on neonates nor for the diagnosis of or screening for diabetes mellitus Alternate site testing can only be used during steady state blood glucose conditions PRINCIPLE Apply a blood sample to the blood collection area at the tip of the strip The test strip will draw the blood sample into the reaction zone The FAD binding glucose dehydrogenase catalyzes the glucose dehydrogenation It will produce gluconolactone During the reaction a mediator transfers electrons to the electrode surface and generates a current The amount of the current is proportional to the amount of glucose present in the blood sample After 5 seconds the Glucertain meter will show glucose concentration on the screen REAGENT COMPOSITION Each test strip contains 6 w w FAD glucose dehydrogenase Aspergillus oryzae
6. hin 15mg dL 8 19 42 11 14 19 73 68 Glucose level gt 75mg dL withint10 withint15 97 134 72 39 112 134 83 58 19 19 100 withint20 128 134 95 52 withint5 59 134 44 03 REFERENCES 1 Cass A E G et al Anal Chem 56 1984 p 667 2 Tietz N Fundamentals of clinical chemistry 3 Ed W B Saunders Co Philadelphia PA 1987 p 427 3 American Diabetes Association Diagnosis and Classification of Diabetes Mellitus Position Statement Diabetes Care 34 Supp 1 S66 2011 4 American Diabetes Association Standards of medical care in diabetes Table 10 Diabetes care 2011 Vol 34 Suppl 1 S21 IMPORTANT Please read these instructions and the manual before using the test strips If you have any questions please contact Technical Services Toll Free 866 203 2761 Eastern Standard Time Mon Fri 8 00AM 5 00PM Glucertain is a registered trade mark of CellEra LLC Cincinnati Ohio USA
7. ing 2 hours or less after eating If you often do not notice when blood glucose is low When basal insulin is most active After injecting rapid acting insulin 2 hours or less 3 Consult with the physician before you test palm and forearm 4 Measurements from alternate site testing should never be used to calibrate a continuous glucose monitor CGM or entered into insulin dose calculators for insulin dosing recommendations PRIOR TO TESTING BLOOD GLUCOSE LEVEL To ensure that the meter is working properly we recommend performing a test with the meter and control solution prior to testing Use the Glucertain Glucose Control Solutions to check Glucertain BG system performance Please follow the Control Solution Test section in the Users Manual Do not use other manufacturer s control solutions as they may provide incorrect results When the results fall within the specified ranges printed on the strip bottle label the system is working properly If control solution readings are outside the range repeat the control solution test Results that fall outside the range may be caused by Expired or contaminated control solution Error in performing the test Meter malfunction Test strip deterioration Contact Customer Service to verify a meter malfunction ney TESTING BLOOD GLUCOSE LEVEL Please follow these steps to test Step 1 Insert Test Strip Take a test strip out and recap the bottle quickly Insert the tes
8. orking properly If control solution readings are outside the range repeat the control solution test Results that fall outside the range may be caused by 1 Expired or contaminated control solution 2 Error in performing the test 3 Meter malfunction 4 Test strip deterioration IMPORTANT If the control solution test results are outside the range your meter and test strip may not be working as a system Follow the correct procedures and repeat the control solution test Make sure the control solution is not Turbid Do not use the meter until test results fall within the appropriate range If the problem continues call Technical Services toll free at 866 203 2761 Eastern Time Mon Fri 8 00AM 5 00PM READINGS Test Results are displayed in milligrams per deciliter mg dL If a decimal point appears please call Technical Services Toll Free 866 203 2761 If LO appears on the screen your blood glucose level is lower than 20 mg dL If HI appears that your blood glucose level is higher than 600 mg dL When you get any questionable readings check the following items first and then repeat the test If the results are still questionable 1 Be sure the strips are within the expiration date 2 Make sure the drop of blood appears in the whole reaction zone If the results are still questionable consult the physician Expected Results The Glucertain Blood Glucose test strips are plasma referenced and calibrated for easie
9. r comparison to lab results For Non Diabetic Patients The American Diabetes Association recommends a post meal glucose level of less than 140 mg dL 7 8 mmol L and a pre meal glucose of less than 100 mg dL 5 6 mmol L For Non Pregnant Patients The American Diabetes Association recommends a post meal glucose level of less than 180 mg dL 10 0 mmol L and a pre meal glucose of 70 130 mg dL 3 9 7 2 mmol L All other patients not listed should consult with their physician on their recommended post meal and pre meal glucose levels CAUTION Any low or high blood glucose readings can indicate a potentially serious medical condition If the readings do not reflect the patient s symptoms repeat the test with a new test strip Contact the physician when the reading is A Not consistent with the patient s symptoms B Less than 60 mg dL C Higher than 240 mg dL LIMITATIONS When the test strips are used for fresh capillary whole blood samples 1 DO NOT use neonate blood sample 2 Extreme humidity may affect the results A relative humidity greater than 90 may cause incorrect results 3 DO NOT reuse the test strips The test strips are for single use only 4 Hematocrit HCT HCT between 20 and 60 will not significantly affect the results HCT below 20 may cause higher results HCT above 60 may cause lower results If patient s HCT is unknown consult the physician 5 Altitude up to 10 000 feet above sea level has no effec
10. t on readings 6 Interfering Substances depend on the concentration The below substances up to the test concentration will not affect the readings Exogenous Interference data Exogenous Substances Highest Conc Bias blood N tested Interference glucose Conc ole 14 2 80 mg dL The highest no interference 14 9 120 mg dL concentration is 7 mg dL Acetaminophen Yes Ascorbic Acid Dopamine 5 2 mg dL 31 0 80 mg dL The highest no interference Amg 18 2 120 mg dL concentration is 2 6 mg dL Gentisic Acid 6 mg dL NA Ibuprofen 50 mg dL NA 4 mg dL 16 3 80 mg dL The highest no interference L Dopa 11 4 120 mg dL_ concentration is 2 mg dL Methyldopa 2 mg dL NA Sodium Salicylate 50 mg dL NA Tetracycline Tolbutamide 1 5 mg dL NA 100 mg dL NA Galactose 20 mg dL NA Maltose 20 mg dL NA Xylose 8 mg dL 10 1 80 mg dL The highest no interference concentration is 6 mg dL Fructose 30 mg dL NA Manose 10 mg dL NA Sucrose 50 mg dL NA Xylitol 200 mg dL NA Glipizide 8 mg dL NA Bilirubin unconjugated 25 mg dL 500 mg dL 30 mg dL Cholesterol Creatinine Triglycerides 1000 mg dL 14 3 80 mg dL The highest no interference Uric Acid 15 9 mg dL PERFORMANCE CHARACTERISTICS The test range is between 20 to 600 mg dL We have validated the performance of test strips in both laboratory and clinical tests PRECISION
11. t strip into the slot of the meter The meter will turn on automatically Step 2 Apply Sample Follow the sample collection procedures to get a drop of blood While the appears touch the droplet of blood to the collection area The test strip will draw the blood sample into the reaction zone The meter will begin to run Step 3 Accurate Results after 5 seconds The result will appear on the screen after 5 seconds and be stored in the meter Step 4 Clean patient s fingertip and absorb any excess blood with absorbent material wash your hands after performing glucose testing per facility protocol QUALITY CONTROL It is recommended to run a control solution test whenever you 1 Begin using a new bottle of test strips 2 Note that blood glucose results do not match the patient s symptoms 3 Feel the meter does not seem to be working properly 4 Obtain blood glucose results that do not match suspect the meter or test strips are working incorrectly Drop the meter Expose the test strips to temperatures outside the storage conditions 36 F to 86 F 2 C to 30 C On Use the Glucertain Glucose Control Solutions to check Glucertain BG system performance Please follow the Control Solution Test section in the Users Manual Do not use other manufacturer s control solutions as they may provide incorrect results When the results fall within the specified ranges printed on the strip bottle label the system is w
Download Pdf Manuals
Related Search