Product Insert
Contents
1. Tips for applying a fingerstick blood sample to the meter e A single blood drop of at least 15ul of blood must be applied e DO NOT remove the test strip to apply the blood sample the test strip must stay inserted in the meter The meter may be lifted to the patient s finger for blood application e DO NOT touch the finger directly to the test spot membrane e DO NOT overfill the test spot add enough blood to completely fill the test spot only e DO NOT add more blood once blood has already been applied to the test spot Note If a sample is obtained from a venipuncture apply a blood drop free of bubbles to the test spot from the syringe opening or needle Do not touch the syringe Opening or needle directly onto the test spot Step 9 Read Result The blood sample will soread and the meter will automatically begin the test While the test is in progress do not disturb or move the meter or test strip or press any of the meter buttons The result will be displayed as hemoglobin units as defined in SET UP OPTIONS in the User s Manual in either g dL or mmol L in less than 30 seconds The test result will be displayed for 2 minutes after test completion After test is completed remove the test strip and dispose according to standard methods for biohazard control The meter will automatically shut off after 2 minutes of inactivity or can be turned off by pressing the C button The test result will be stored2. Hgb Pro Professional Hemoglobin Testing System Package Insert For in vitro diagnostic use CLIA Category Waived INTENDED USE The Hgb Pro Professional Hemoglobin Testing System consists of a portable battery operated meter and single use test strips for the quantitative measure t of total hemoglobin from capillary and venouS wh blood The Hgb Pro Professional He lobin hesting System is designed for near patieaftes ina professional facility and is not int nded f e use SUMMARY AND EXPLANATION Hemoglobin is the oxygen carrying protein in red blood cells The quantitative measurement of hemoglobin is indicated and clinically useful in acute illness as well as in general care The normal range hemoglobin values as reported in medical literature are gender and age dependent Adult males 13 5 18 0g dL Adult females 12 0 16 0 g dL Infants Ranging from 14 5 22 5 g dL after birth to 11 1 14 1 g dL at 6 months Children Gradual change from infant to adult levels Low hemoglobin levels may indicate conditions such as anemia or hemorrhage Elevated hemoglobin levels may indicate conditions such as polycythemia A hemoglobin test may be used as part of a general screen for many types of patient populations including the elderly children and women of child bearing age and prior to giving or receiving transfusions Due to differences among patient populations we recommend that each clinical site establish i
3. the Hgb Pro User s Manual for proper technique and procedure for performing tests and using the meter 6 While the test is in progress do not disturb or move the meter or test strip or press any of the meter buttons 7 The Hgb Pro System is designed for storage and operation within a recommended temperature range of 15 C to 30 C Do not expose the meter test strips or patient blood sample to temperature extremes as such exposure could affect performance OPERATING INSTRUCTIONS Before performing any test the user should refer to the Hgb Pro hemoglobin meter User s Manual for detailed instructions SPECIMEN COLLECTION Fresh or EDTA anticoagulated capillary or venous whole blood may be used If an EDTA treated sample is refrigerated allow it to come to room temperature prior to use EDTA treated blood samples should be tested within 24 hours and thoroughly mixed using end to end inversion at least 8 times prior to use Hemolyzed blood samples should not be used Anticoagulants other than EDTA are not recommended for use Follow the Test Procedure section in this package insert for obtaining fingerstick samples Refer to NCCLS Documents H4 A4 Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture For fresh whole blood venous samples collect approximately 0 1cc into an anticoagulant free plastic syringe and apply a blood drop to the test spot from the syringe in place of steps 7 and 8 of th
4. Note Streck control ranges are provided in G L The Wal unit can be converted to mmol L by dividing the Wal value by 6 45 REFERENCES 1 Vengelen Tyler V ed Technical Manual 13th Ed Bethesda MD American Association of Blood Banks 1999 753 754 2 Neuberger A and E L Tatum Ed Frontiers of Biology North Holland Publishing Co 1970 p 18 Hemoglobin and Myoglobin in their Reactions with Ligands Antoini E and M Brunori 3 NCCLS Document H4 A4 Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture 4 NCCLS Document H3 A5 Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture 5 NCCLS Document EP6 A Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach 6 NCCLS Document EP5 A Evaluation of Precision Performance of Clinical Chemistry Devices 7 NCCLS Document EP7 A Interference Testing in Clinical Chemistry CLIA Warvedcom CLIAwaived com 4332 Corte de la Fonda San Diego CA 92130 Toll Free 888 882 7739 Phone 858 481 5031 FAX 801 720 7568 www cliawaived com
5. Prepare the Test Strip Remove a test strip from its container Examine the strip Do not use if there are tears wrinkles or debris Do not touch the test membrane Reseal remaining strips in the original container Step 5 Insert the Test Strip Insert the test strip into the strip holder with the notched end in first and the printing facing up The blue stripe on the top of the strip should no longer be visible when the test strip is correctly and fully inserted i Step 6 Prepare the Meter for Sample Application The meter will automatically perform a background blank reading It will display a flashing prompt a blood drop next to a test strip to indicate it is ready to receive a sample The meter will allow 2 minutes for application of the blood sample Step 7 Perform a Fingerstick Incise the underside of the fingertip as highlighted by arrow Wipe away the first drop of blood Apply light pressure to obtain another drop of blood Avoid milking Note f fresh venous whole blood s to be used perform venipuncture and collect the sample in an anticoagulant tree plastic syringe Step 8 Apply Blood Sample to the Test Strip Immediately add a drop of blood to the test strip by touching the hanging blood drop to the test spot Make sure the blood drop is large enough to completely cover the test spot A capillary transfer pipet may also be used to transfer the blood sample from the finger to the test strip
6. as tested repeatedly for 20 days with commercially available controls as per NCCLS Document EP5 A The testing for the protocol evaluated three levels of commercial controls in four 4 instruments with two lots of Hgb strips The data in Table 1 was obtained for within run and total precision of the Hgb Pro System Table 1 Level I n 80 Level II n 80 Level III n 80 Precision ithi Within Total 15 63 0 29 1 86 Additionally precision of the Hgb Pro system was calculated from testing of freshly prepared whole blood controls created to specified hemoglobin concentrations Samples were prepared from normal donor blood hemodiluted or hemoconcentrated to manipulate hemoglobin concentration Multiple Hgb Pro instruments were tested repeatedly for 3 days The hemoglobin levels of the daily prepared controls were confirmed with the Coulter Laboratory instrument Beckman Coulter Fullerton CA and are shown in Table 2 as Range Three levels of venous whole blood samples were tested with 5 instruments each day Over the 3 days a total of 9 instruments and 3 unique lots of strips were evaluated Precision across strip lots instruments and days is shown in Table 2 Accuracy The clinical performance of the Hgb Pro Professional Hemoglobin Testing System was evaluated with venous samples collected from 4 physician office sites and 1 hospital site as shown in Figure 1 Populations consisted of adults neonate
7. automatically with its date and time stamp upon meter shutoff The meter must be reset shut off restart between each test Test results can be tagged viewed or erased Follow instructions under TAG VIEW AND ERASE TEST RESULTS in the Hgb Pro User s Manual REPORTABLE RANGE The reportable range for the Hgb Pro Professional Hemoglobin Testing System is from 4 0 g dL to 24 0 g dL Results under 4 0 g dL and over 24 0 g dL will be displayed as Lo and Hi respectively to indicate out of range results PERFORMANCE CHARACTERISTICS Linearity The linearity of the Hgb Pro System was tested using one lot of Hgb Pro strips and 7 hemoglobin concentrations prepared from a single normal donor Multiple Hgb Pro instruments n 5 were tested twice at each concentration The data were analyzed using the NCCLS guideline EP6 A Evaluation of the Linearity of Quantitative Analytical Methods The Hgb Pro Hemoglobin Testing System is linear between 4 0 g dL to 24 0 g dL within 5 of the estimated linear regression line at a 95 confidence level The linearity regression curve is Y 0 974x 0 264 r 0 99 y 0 974 0 264 R 0 998 v a gt o a a a x gt A a2 o a E a x 10 0 15 0 20 0 Hemoblobin by Coulter MD8 g dL Precision studies The total precision of the Hgb Pro Professional Hemoglobin Testing System was calculated from testing of commercial controls on multiple days The Hgb Pro System w
8. e fingerstick procedure Refer to NCCLS Document H3 A5 Procedure for the Collection of Diagnostic Blood Specimens by Venipuncture TEST PROCEDURE The user should review all instructions in the Hgb Pro User s Manual prior to using the meter Follow the instructions in SET UP OPTIONS in the Hgb Pro User s Manual for setting the time date and reporting units prior to the first use of the meter See Product Use Tips under TROUBLESHOOTING in the Hgb Pro User s Manual for more information on handling of the test strip and blood sample application Materials Provided and Materials Needed But Not Provided Catalog No Catalog No HGBPROKIT HGBMETER Materials e Hgb Pro Meter e Hgb Pro Meter Catalog No HGBTEST100 e Hgb Pro Provided Hgb Pro User s Manual e Hgb Pro User s Hemoglobin e Hgb Pro Hemoglobin Manual Test Strips Test Strips e EZ Guide e Hgb Pro e Hgb Pro Package Insert Package Insert e EZ Guide e Training CD ROM e Hgb Pro Meter e Hgb Pro Materials e Hgb Pro Hemoglobin Needed i Test Strips But Not O Test Strip Package Provided Insert Users Manual i Gh Quality Controls see Section QUALITY CONTROL On or fingerstick device e Alcohol pad e Gauze e Bleach for cleaning the meter Step 1 Start the Meter Press the button to turn the meter on The meter automatically monitors its internal circuitry and components during a brief s
9. e meter prior to use see Lot Code Entry under TEST PROCEDURE in the Hgb Pro User s Manual for instructions CAUTION Follow universal precautions and institutional guidelines for handling of blood samples including the use of protective gloves All used test strips should be considered potentially infectious handled with care and disposed of using standard policies for disposal of medical waste Reagent Preparation and Storage 1 Hgb Pro test strips are ready to use No additional preparation is required 2 Test strips are stable at ambient room temperature 15 C 30 C until the marked expiration date Discard test strips that are past the marked expiration date 3 Hgb Pro test strips are moisture sensitive A dessicant is provided in the container lid The remaining test strips should be resealed in their original container in order to retain the marked expiration dating Remove only those strips needed for testing PRECAUTIONS 1 For 7 vitro diagnostic use 2 The Hgb Pro test strips are designed for use only with Hgb Pro meter 3 Poor blood collection technique and inadequate mixing of EDTA treated samples may affect results 4 As with all diagnostic tests Hgb Pro test results should be evaluated with the specific patient s condition Any results demonstrating inconsistency with the patient s clinical status should be repeated or supplemented with additional test data 5 Review all instructions in
10. elf check The meter is ready when the test strip prompt Lot Code time and date are displayed Note To conserve the battery the meter will automatically shut off after 2 minutes of inactivity Step 2 Lot Code Entry A specific Lot Code is assigned to each lot of Hgb Pro hemoglobin test strips to ensure optimal lot to lot reproducibility Check the Lot Code displayed on the meter to ensure it matches the Lot Code printed on the test strip container ded with Saponin amp ostie usea Store g LOT CODE _ If the Lot Code displayed on the meter does not match the Lot Code printed on the test strip container in use change the Lot Code as follows Step 1 Press and hold the W button until CODE flashes in the upper left hand corner Release the V button Step 2 Press the A or W button so the displayed Lot Code matches the Lot Code printed on the test strip container in use Holding down the button will enable the numbers to scroll faster Release the button when the appropriate number is displayed Step 3 Accept the new Code by pressing the CD button to turn the meter off Step 4 Turn the meter on again to perform a test Step 3 Prepare for a Fingerstick Make sure the patient s hand is warm and relaxed Use the middle or ring finger Massage the patient s finger from the knuckle up to the tip to stimulate blood flow Clean the sample area with alcohol and wipe dry with a sterile gauze pad Step 4
11. onal Hemoglobin Testing System Liquid quality control testing should be performed upon receipt of a new lot of test strips and once per every 3 months of test lot usage Commercially available control material can be used for this purpose The Streck Laboratories PARA 4 Hematology Control is recommended phone 800 843 0912 or website www streck com The Streck PARA 4 Hematology Control product catalog 215110 consists of Normal Low Abnormal and High Abnormal levels Storage requirements expiration dating and acceptable performance ranges for the control material with the Hgb Pro meter should be obtained from this product s package insert Instructions for use of the Para 4 Control are as follows Step 1 Allow the PARA 4 control vials to come to room temperature prior to use Prepare the meter and test strip as instructed in Steps 1 2 4 and 5 under TEST PROCEDURE above Step 2 Mix the vial using end to end inversion until the red blood cells are completely suspended Do not shake or mix mechanically Step3 Remove the vial cap and discard the first drop of the control material Apply one drop of control material make sure the test spot is completely filled do not touch the test spot membrane with the vial tip The test will begin automatically Step 4 The Hgb Pro meter will display the result upon test completion Compare the displayed result to the range indicated on the PARA 4 package insert Record result
12. s and pediatric patients Specimens were split for testing on the Hgb Pro and the Coulter MD8 Correlations for the individual populations and combined are shown Correlation Plot Hgb Pro versus Coulter Hemoglobin g dL Hgb Pro 0 5 10 15 20 25 Hemoglobin g dL Coulter Adult m Neonate x Pediatric Linear Combined 162 1 049 0 885 26 0 984 0 156 Pediatric 38 0 962 0 042 Neonate Pediatric 64 0 988 0 248 Combined 226 1 005 0 371 LIMITATIONS 1 Plasma or serum cannot be used with the Hgb Pro Professional Hemoglobin Testing System Use of arterial whole blood has not been evaluated 2 Use of sodium citrate and dried heparin are not recommended INTERFERING SUBSTANCES During clinical studies a number of patients had identified elevated levels of bilirubin cholesterol and triglycerides The interferences of these substances were assessed using the interpretive guidelines of NCCLS Guidance Document EP7 A Interference Testing in Clinical Chemistry Approved Guideline There was no demonstrated interference of these substances on the hemoglobin determination in these analyses No interference was observed at upper threshold concentrations of bilirubin 20 mg dL cholesterol 450 mg dL and triglycerides 750 mg dL in supportive laboratory spiking studies QUALITY CONTROL A quality assurance program is recommended to assure the user of reliable performance of the Hgb Pro Professi
13. ts own expected ranges Point of care test systems using whole blood samples are especially useful for rapid patient assessment and determination of further appropriate medical care PRINCIPLE OF OPERATION The Hgb Pro meter utilizes optical reflectance at 522 nm for determination of total hemoglobin This wavelength is within the known hemoglobin absorption spectrum 500 600 nm The test strip is inserted into the meter when prompted A background blank reading is automatically determined A drop of whole blood is applied to the test spot on the strip Blood immediately disperses within the membrane contacting the reagent lysing the red blood cells and releasing the hemoglobin The meter s optical detectors automatically measure the change in membrane reflectance The intensity of reflectance is inversely proportional to the hemoglobin concentration The meter calculates and displays the total hemoglobin concentration in grams deciliter g dL or millimole liter mmol L based on a mathematical conversion The test result will be displayed in less than 30 seconds REAGENTS Each container of Hgb Pro Test Strips contains e 25 Test Strips The Hgb Pro Test Strip consists of a plastic carrier and a membrane preloaded with saponin surfactant and colorant The test strip container is stamped with a lot specific Lot Code and expiration date Note The Lot Code for the lot number of test strips in use must be entered into th
Download Pdf Manuals
Related Search