CLA-HBS200 Insert - Clarity Diagnostics
Contents
1. STS 4th Edition 2006 Page 524 Manufactured for Clarity Diagnostics LLC Boca Raton Florida 33487 Technical Customer Support 877 485 7877 Made in China Number 1150745701 Effective Date 201x xx xx2. ampie Level N Mem SD CV SD CV SD CV SD CV 1 80 9 37 0 10 1 11 0 00 0 00 0 05 0 55 12 1 24 2 80 13 70 0 22 1 58 0 00 0 00 0 09 0 66 23 1 3 80 17 29 0 35 2 03 0 00 0 00 0 19 1 09 AO 2 Site 2 Within Run Between Operator Between Day ampie reve N Mean SD CV SD CV SD CV SD CV 1 80 9 42 0 07 0 72 0 01 0 12 0 08 0 81 0 10 1 09 2 80 13 98 0 12 0 87 0 00 0 00 0 12 0 85 0 17 1 22 3 80 17 68 0 18 1 03 0 00 0 00 0 31 1 77 0 36 2 05 Site 3 Within Run Between Operator Between Day Total Sampla Laval N Mem SD CV SD CV SD CV SD CV 1 80 9 41 0 10 1 06 0 00 0 00 0 08 0 81 0 13 1 33 2 80 13 89 0 18 1 32 0 00 0 00 0 00 0 00 0 18 1 32 3 17 42 0 24 1 38 0 04 0 21 0 09 0 50 0 26 1 48 Sites Combined ON O Mean Within Run Between Operator Between Day Between Site Total Level SD CV SD CV SD CV SD CV SD CV 1 240 9 40 0 09 0 98 0 00 0 00 0 07 0 73 0 02 0 18 12 1 24 2 240 13 86 0 18 1 31 0 00 0 00 0 08 0 57 0 14 1 00 24 1 3 240 17 46 0 27 1 538 0 00 0 00 0 22 1 24 0 19 1 09 3 Precision study Fresh venous blood samples were collected into the tubes containing EDTA anticoagulant and adjusted Hb levels from low to high end of the measurement range The Hb value was confirmed with Sysmex hematology analyzer Each hemoglobin level was performed in 30 replicates Total three lots of test
3. cartridges were tested for this study The results are present in the table below ON Mean Within Run Between Run Between Lot Total Level SD CV SD CV SD CV SD CV 86 36 7 0 00 0 0 0 07 1 3 0 37 7 2 90 Accuracy Comparison Study Approximately 375 clinical specimens collected from adult subjects either via finger stick or venous at 3 clinical sites were tested with the Clarity HbCheck Hemoglobin Testing System and a predicate device Total 35 contrived blood specimen with adjusted Hb levels from low to high end of the measurement range were tested at 3 POL sites using the Clarity HoCheck Hemoglobin Testing System and predicate device The results are present in the table below Method Comparison Data Summary Clarity HbCheck vs HemoPoint HB g dL N LIMITATIONS The following substances do not affect the test results Substance ___ Amoun _______ Substance id 200 mg dl 1324 umolL Cholesterol Ascorbic Acid 60 mg dl 342 umol L Conjugated Bilirubin 20 mg dl 342 umol L 50 mg dl 4420 pmol L Methyldopa 500 mg dl 2425 umol L Pe i O 0 9 mg l 5 87 ymol L High concentrations of TRIG and SA can lead to low Hb value For anticoagulants only use heparin and EDTA K2 EDTA K3 and EDTA Na2 BIBLIOGRAPHY 1 McPherson R A and Pincus M R Henry s Clinical Diagnosis and Management by Laboratory Methods 22 Edition 2011 Page 1494 2 Alan H B Wu TIETZ CLINICAL GUIDE TO LABORATORY TE
4. e fill line and stop Note Do not squeeze the tube while collecting the blood Make sure that the blood covers the air vent of the tube if it does not it will be hard to squeeze the blood out 5 When the blood drop symbol flashes apply the blood 10 uL to the sample well Three 3 dashed lines will appear on the meter to show the test is in progress 6 Read the results on the screen after 15 seconds Note The hematocrit value is calculated using the formula Hct F x Hgb g dL with F 2 94 A true hematocrit test is not determined with this system The use of this formula is allowed only within the normal hemoglobin range means from 12 3 g dL 7 63 mmol L 17 5 g dL 10 86 mmol L If the Hb result is outside this range then the estimated hematocrit result will not be calculated and will appear INTERPRETATION OF RESULTS If you get unexpected or questionable results take the following steps e Ensure that the test cartridges are not expired e Compare results to controls with known levels Repeat the test using a new test cartridge If the problem still exists discontinue using the test cartridges Contact Customer Technical Support at 1 877 485 7877 QUALITY CONTROL The quality control test should be used to check that the meter and test cartridges are working together properly Follow the test procedure in your User s Manual to run a quality control test Three levels CTRL 0 CTRL 1 and CTRL 2 are shown on the contr
5. ol solution bottle label All three levels of control solutions CTRL 0 CTRL 1 and CTRL 2 must be tested and all levels must be within the assigned value ranges ONOaRWNDM e Test Cartridges e Code Chip e Package Insert e Safety Lancets e Hb Meter e Alcohol Swab CAUTION If your quality control test result falls outside the control ranges shown on the control solution bottle label DO NOT use the system to test your blood This may be a sign that the system is not working properly If you cannot correct the problem please call Customer Technical Support at 1 877 485 7877 PERFORMANCE CHARACTERISTICS Linearity 8 blood samples with adjusted Hb levels from low to high end of measurement range were tested with Clarity HoCheck Hemoglobin Testing System Each level of the blood sample was tested in 18 replicates 3 lots of Clarity HoCheck Hemoglobin Test Cartridges were tested The results are present in the table below Cartridge Lot Linearity Equation Po Rb rangetested ____ Reproducibility and Precision Clarity HoCheck Hemoglobin Control Solutions with 3 Hb levels were blind labeled with ID number and provided to 3 clinical study sites Each level of the control solution was performed with the Clarity HoCheck Hemoglobin Testing System in separated 2 runs by 2 operators each day for 20 days at each site Results are present in the tables below Site 1 Within Run Between Operator Between Day Total S
6. pied Hemoglobin Test Cartridges ul Package Insert 1y HbCheck For testing Hb in human whole blood For in vitro diagnostic use only INTENDED USE The Clarity HoCheck Hemoglobin Testing System is for the quantitative determination of hemoglobin in non anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA K2 K3 Na2 or sodium heparin The testing system is designed for point of care use in primary care settings Estimation of hematocrit is only for hemoglobin values from 12 3 to 17 5 g dL 123 to 175 g L This device has not been evaluated for pediatric subjects SUMMARY Hemoglobin is the main transporter of oxygen in red blood cells Measuring hemoglobin concentrations is useful in the clinical diagnosis of diseases such as anemia and polycythemia PRINCIPLE AND REFERENCE VALUES Red blood cells in the specimen are lysed to release Hb which is converted into MHb The shade of the color produced depends on the concentration of Hb Reference values are listed in the table below 13 5 18 g dL 135 180 g L 8 38 11 17 mmol L 12 16 g dL 120 160 g L 7 45 9 93 mmol L All results below 5 6 g dL or above 23 5 g dL must be confirmed by a suitable laboratory method Reference ranges for children under the age of 18 have not been validated Reference ranges may vary between laboratories Every laboratory should establish its own reference range as needed REAGENTS The concent
7. rations given may vary within manufacturing tolerances Composition Sodium deoxycholate 3 w w Sodium nitrite 1 5 w w Non reactive Ingredients 95 5 w w PRECAUTIONS Use only Clarity HoCheck Hemoglobin Test Cartridges with a Clarity HoCheck Hemoglobin meter Keep the test cartridges in the closed canister until use Discard the test cartridges if they are past the expiration date on the canister label Do not touch the test area of the test cartridges Discard any discolored or damaged test cartridges All specimens should be considered potentially hazardous Handle in the same manner as an infectious agent Used test cartridges should be discarded according to local regulations after testing Check the code chip before performing a test Make sure to use the code chip that is included with the canister of test cartridges Insert the code chip into the code chip slot STORAGE AND STABILITY Store in the closed canister at the temperature or refrigerate 36 86 F 2 30 C Avoid direct sunlight Remove only enough test cartridges for immediate use Close the canister immediately and tightly DO NOT FREEZE Do not use past the expiration date Note Once the canister has been opened the test cartridges may be used for up to 3 months In high humidity conditions the test cartridges may expire sooner SPECIMEN COLLECTION AND PREPARATION e Acceptable specimens include fresh capillary or venous blood e Fresh blood specimens mus
8. t be collected and tested immediately e Whole blood with EDTA or heparin may be used Preserved specimens must be kept in a closed container and must be used within 8 hours after collection Mix stored specimens adequately before testing e To get accurate results use a capillary transfer tube to collect capillary blood MATERIALS Materials Provided e Capillary Transfer Tubes Materials Required But Not Provided e Gauze for Puncture Site e Latex Gloves DIRECTIONS FOR USE Please make sure the test cartridge specimen and or controls reach the temperature 59 86 F 15 30 C before testing Refer to the User s Manual for detailed instructions 1 Insert the code chip into the meter To avoid inaccurate results please make sure the number on the code chip is the same as the one printed on the test cartridge canister label 2 Remove the test cartridge from the canister Close the canister immediately after removing the test cartridge 3 When the test cartridge symbol flashes insert the test cartridge as far as it will go into the meter Follow the same direction as the Insert Arrows on the top of the test cartridge The test cartridge arrows should be parallel with the two arrows on the cartridge holder 4 Wipe away the first drop of blood Collect 10 uL of blood by using a capillary transfer tube Hold the tube slightly downward Touch the tip of the tube to the blood drop Blood will automatically be drawn into the tube to th
Download Pdf Manuals
Related Search