Afinion™ HbA1c - Drug testing supplies from CLIA waived,Inc, drug
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1. o y Measured mean value HbA1c 5 Mean recovery Theoretical value HbA1c X100 Table 2 Linearity of Afinion HbA1c Theoretical and measured mean value HbA1c Coefficient of Variation CV and recovery mean value Theoretical Measured CV Recovery Sample HbAte HbAtc 1 N A 179 3 8 N A 2 14 1 14 2 2 0 101 3 12 9 13 3 0 4 103 4 11 6 11 8 2 5 102 5 10 3 10 4 1 5 101 6 9 1 92 23 101 7 7 8 8 0 13 102 8 6 6 6 6 2 6 101 a N A 5 3 2 1 N A Native sample N A Not applicable 11 Method comparison A method comparison study comprising a total of 75 samples 4 9 14 1 HbA1c was performed at three physician office laboratories A capillary finger prick sample and a venous EDTA sample were collected from each donor The capillary blood samples were analyzed with the Afinion AS100 Analyzer The EDTA venous blood samples were analyzed with both the Afinion AS100 Analyzer and with another Point of Care Testing POCT system at the study sites Table 3 4 A total of 11 operators participated in the study Three Afinion AS100 Analyzers were used Table 3 Method comparison Afinion HbA1c y vs another POCT system x Linear regression analysis data N number of samples r correlation coefficient No sites N Regression line r 3 75 y 0 92x 0 21 0 98 Table 4 Capillary vs EDTA whole blood with Afinion HbA1c Linear regression analysis data2. Diagnosis and Management of Diabetes Mellitus Clin Chem 2002 48 436 472 LOT Lot number 5 Jeppsson JO et al Approved IFCC Reference Method for the Measurement of HbA1c in Human Blood Clin Chem Lab Med 2002 TEST CARTRIDGE Test Cartridge 40 1 78 89 o 6 European Reference Laboratory Manufacturer Check Up Certification of Afinion HbA1c 2005 7 Council Directive 67 548 EEC Council Directive 76 769 EEC Council Directive 1999 45 EC and Commission Directive 2001 60 EC 8 Little RR et al Relationship of glycosylated hemoglobin to oral glucose tolerance Implications for diabetes screening Diabetes 1988 37 1 60 64 Consult instructions for use 9 Little RR et al Glycated haemoglobin predicts progression to diabetes Contents are sufficient for one test Contents are sufficient for 15 tests mellitus in Pima Indians with impaired glucose tolerance Diabetologia Warnings and precautions 1994 37 252 256 a 10 Rohlfing CL et al Use of GHb HbA1c in Screening for Undiagnosed Expiration date year month Diabetes in the U S Population Diabetes Care 2000 23 2 187 191 0 11 American Diabetes Association Tests of Glycemia in Diabetes Diabetes 46 F Storage temperature store at 2 8 C Care 2004 27 Suppl 1 591 S93 2 C 36 46 F 36 F ml Manufacturer 16 17 18 19
3. for more than 30 days the control vial and Afinion HbA1c Test Cartridges have been stored according to recommendations e there is no evidence of bacterial or fungal contamination of he control vial Correct any procedural error and re test the control material If no procedural errors are detected e Examine the laboratory s quality control record to investigate he frequency of control failures Ensure that there is no trend in out of range quality control results e Re test the control material using a new control vial e Patient results must be declared invalid when controls do not perform as expected Contact your customer service representative for advice before analyzing patient samples TROUBLESHOOTING To ensure that correct HbA1c results are reported the Afinion AS100 Analyzer performs optical electronic and mechanical controls of the capillary the Test Cartridge and all individual pro cessing steps during the course of each analysis When problems are detected by the built in failsafe mechanisms the Analyzer terminates the test and displays an information code The table below contains the most common information codes Consult the Afinion AS100 Analyzer User Manual for information codes not listed in this table Code Cause 103 The hemoglobin concentration is below 6 0 g dL 104 The hemoglobin is above 20 0 g dL 105 The HbA1c value is below 4 0 106 The HbA1c value is
4. with Afinion AS100 Analyzer Afinion HbA1c Control REF 1115178 Standard blood collection equipment Description of the Afinion HbA1c Test Cartridge The main components of the Test Cartridge are the sampling device 1 and the reaction container 3 The Test Cartridge has a handle 4 a barcode label with lot specific information 5 and an ID area for sample ID 7 See Figure 1 below Par ag Left side Right side Figure 1 Afinion HbA1c Test Cartridge Component Function composition 1 Sampling device For collection of patient sample or control a Closed position b Lifted position 2 Capillary 1 5 pL glass capillary to be filled with sample material 3 Reaction container Contains reagents necessary for one test Tube with a polyethersulfone membrane c Washing solution Morpholine buffered sodium chloride solution with detergents and preservative d Reconstitution HEPES buffered sodium chloride with wa i OR OS ANO te cL A ens e Empty N A 4 Handle The correct place to hold the Test Cartridge 5 Barcode label Contains assay and lot specific information for the Analyzer 6 Optical reading area Area for transmission measurement 7 ID area Space for written or labeled sample identification WARNINGS AND PRECAUTIONS For in vitro diagnostic use Do not use Test Cartridges after the expiry date or if the Tes
5. 0 9 0 2 1 1 Sample 2 20 10 0 0 7 0 0 1 1 Based on 17 days of analysis due to hemolysis of the sample External study A precision study was performed at three physician office labora tories site 1 3 with three levels of HbA1c EDTA blood sample A C The study was performed over 10 consecutive days Afinion HbA1c Lot 1 was used the first five days and Lot 2 the next five days Each day six replicates of the samples were mea sured Eleven operators participated in the study Three Afinion AS100 Analyzers were used one at each study site Table 7 Results from analysis of three blood samples at three physician offices Within day within site and total precision N number of parallels CV Coefficient of Variation Sample Lot Site Average Within day Within site Total HbAlc N 6 CV CV CV 5 0 1 7 19 1 2 5 0 29 29 25 A 3 49 1 5 2 0 51 1 1 1 2 2 12 5 0 1 8 2 0 2 2 3 49 1 6 1 8 6 2 24 24 1 2 6 1 2 0 2 0 23 B 3 6 0 1 2 14 6 3 1 3 1 8 2 2 6 2 1 2 12 1 7 3 6 2 0 8 0 9 9 1 1 3 1 4 1 2 8 8 14 1 6 2 6 c 3 8 7 2 0 19 9 1 0 9 1 0 2 2 8 8 1 1 1 0 2 0 3 8 8 1 1 1 0 Based on the experience obtained from internal and external documentation of Afinion HbA1c a precision of lt 3 expressed by the coefficient of variation CV is expected in a controlled laboratory setting 13 Between instruments precision T
6. Afinion HbA1c REF 1115015 Hemoglobin A1c test For use with the Afinion AS100 Analyzer ce Please consult the Afinion AS100 Analyzer User Manual for information related to the general operation of the Analyzer and Afinion Test Cartridge handling Technical Support The manufacturer provides a toll free line for technical support Call 1 877 4 Afinion or 1 877 423 4646 The toll free number is available for use only in the United States of America US Technical Support AS Afinion HbAlc For use with the Afinion AS100 Analyzer CLIA statement Afinion HbA1c is waived under the Clinical Laboratory Improvement Amendment of 1988 CLIA 88 A CLIA Certificate of Waiver is needed to perform testing in a waived setting If the laboratory does not have a Certificate of Waiver the Appli cation for Certification Form CMS 116 can be obtained from the U S Department of Health amp Human Services Centers for Medicare amp Medicaid Services The form should be sent to the local State Agency of the State in which the laboratory resides If the laboratory modifies the Afinion test or Afinion Analyzer System instructions the test no longer meets the requirements for waived categorization A modified test is considered to be highly complex and is subject to all applicable CLIA requirements PRODUCT DESCRIPTION Intended use Afinion HbAlc is an in vitro diagnostic test for quantitative determi
7. N number of samples r corre lation coefficient No sites N Regression line r 3 74 y 0 99x 0 07 1 00 In a second method comparison study 39 blood samples 4 9 11 7 HbA1c were analyzed with an affinity HPLC High Pressure Liquid Chromatography system by the European Reference Laboratory for Glycohemoglobin ERL The samples were analyzed using the Afinion AS100 Analyzer Table 5 Table 5 Method comparison Afinion HbA1c y vs an affinity HPLC system x Linear regression analysis data N number of samples r correlation coefficient N Regression line r 39 y 0 96x 0 33 0 99 Precision Precision studies were performed by the staff at three separate physician office sites external study and by the manufacturer internal study The CLSI Clinical and Laboratory Standards Institute Guideline EP5 A was followed Internal study performed Within run between day and total precision were determined for Afinion HbA1c Control C Control C Il and one EDTA sample assayed for 20 days and one EDTA sample assayed for 17 days The samples were analyzed in duplicate twice a day 12 Table 6 Within run between day and total precision N number of days CV Coefficient of Variation Sample N Average Within run Between day Total HbAlc CV CV ICV Control C I 20 6 5 0 9 0 6 14 Control C II 20 9 0 6 0 5 1 1 Sample 1 17 5 6
8. above 15 0 202 Excess sample on the sampling device exterior 204 Hemolyzed or coagulated sample Analyzer failure Follow the actions listed in the User Manual to correct the error 10 Important The manufacturer must be notified of any test system that is perceived or validated to be outside of the performance specifications outlined in the instructions Technical support The manufacturer provides a toll free line for technical support Call 1 877 4 Afinion or 1 877 423 4646 The toll free number is available for use only in the United States of America PERFORMANCE CHARACTERISTICS Linearity The linearity of the Afinion HbA1c assay was verified using two fresh EDTA blood samples Varying amounts of sample 1 17 9 HbA1c and sample 9 5 3 HbA1c were mixed in different proportions to obtain a total of 9 samples Sample 2 8 were ana lyzed in triplicate while sample 1 and sample 9 native samples were analyzed in six replicates A linear regression was calculated based on the theoretical vs measured HbA1c values The results are shown in Table 1 Table 1 Linear regression of Afinion HbA1c measured y vs theoretical x HbA1c values N number of samples r correlation coefficient N Regression line r 9 y 1 01x 0 07 1 00 The mean recovery of the measured HbA1c values compared to the theoretical values Table 2 were calculated for each sample using the following equation
9. greement 2 6 to 25 1 9 to 5 2 2 5 to 5 8 Precision Afinion HbA1c Control The precision of the Afinion HbA1c Control C and Control C ll were evaluated externally at three study sites Each study site measured each control in six replicates on five subsequent days The within day within site and between site precisions were calculated The results are shown in Table 10 14 Table 10 External validation of Afinion HbA1c Control at three study sites Within day within site and between site precision CV Coefficient of variation N Number of analysis Mean ore Bi Mean a Within day Within site Between site Afinion HbAtc Site HbAtc cy CV HbAtc cy N 30 N 90 1 6 0 14 1 4 Control CI 2 6 0 1 2 1 3 6 0 1 3 3 6 0 1 0 12 1 9 0 1 2 1 1 Control CII 2 8 9 0 9 14 9 0 1 5 3 9 1 1 6 1 6 Expected CLIA Waiver performance CLIA waived studies were performed at three non laboratory sites The 68 participants were a demographically diverse population had no previous laboratory experience and received no training for the study Three blood samples sample A C were analyzed by each operator The Allowable Limits of Error A L E Tonks Limit were calculated and the observed results compared to these limits The results are shown in Table 11 Tonks Limit ALE A normal range Mean of normal range RUN U where normal
10. he between instrument precision of the Afinion HbA1c assay was evaluated by five operators analyzing two fresh EDTA sam ples on 10 randomly selected Afinion AS100 Analyzers Sample 1 and sample 2 were analyzed in six replicates on each Analyzer The mean HbA1c and coefficient of variation CV were calcu lated for each sample on each Analyzer and for all 10 Analyzers The results are shown in Table 8 Table 8 Afinion AS100 between instrument precision Mean HbA1c and coefficient of variation CV of six replicates Sample 1 Sample 2 Analyzer HbAte CV HbAtc CV 1 52 2 102 13 2 51 12 104 16 3 51 08 103 28 4 53 0 104 14 5 52 0 107 34 6 51 10 104 16 7 52 17 102 16 8 53 2 107 17 9 52 7 108 13 10 52 10 104 08 All 5 2 2 0 10 4 27 Lot to lot variation The consistency between different manufacturing lots of Afinion HbA1c was evaluated by measuring 16 fresh EDTA samples in duplicate using three different lots of Afinion HbA1c The study was performed using one Afinion AS100 Analyzer A Bland Altman analysis comparing two lots at the time was per formed The bias and the limits of agreement with 95 confiden ce were calculated The results are shown in Table 9 Table 9 Bias and 95 limits of agreement calculated for three lots of Afinion HbA1c using the Bland Altman analysis Lot 1 Lot 2 Lot 3 Lot 2 Lot 3 Lot 1 Bias 0 0 1 7 1 7 95 Limits of a
11. lecting a sample Sampling from the Afinion b HbA1c Control vial qi e Allow the control material to reach ambient operating temperature 18 30 C 64 86 F before use which akes approximately 30 minutes e Mix the control material thoroughly c by shaking the vial for 30 seconds Fr e Extract a sample from the vial or the Important Bring the tip of the capillary just beneath the surface of the blood drop sample material as shown in e a figures a b and c e Be sure that the capillary is AX completely filled as shown in figure d It is not possible to overfill the capillary Avoid air bubbles Do not wipe off the capillary TEST RESULT REPORTING Afinion HbA1c measures the total glycated hemoglobin and the total hemoglobin concentration The ratio between them is proportional to the HbA1c of the sample The Analyzer calculates the ratio and the test result is displayed as HbA1c The Afinion HbA1c reportable range is 4 0 15 0 HbAlc The HbA1c results are displayed in 0 1 intervals The hemoglobin measuring range is 6 20 g dL If the patients HbA1c or hemoglobin value is outside range no test result will be reported and the corresponding information code will be displayed If accurate results outside the Afinion HbA1c range are required the sample must be analyzed using another method Expected values For methods reporting DCCT traceable values the u
12. nation of glycated hemoglobin hemoglobin A1c HbA1c in human whole blood The measurement of HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus Summary and explanation of the test The human erythrocyte is freely permeable to glucose Within each erythrocyte a slow continuous non enzymatic process between hemoglobin A and various sugars takes place The product formed is known as glycated hemoglobin or glyco hemoglobin The chronic elevated blood sugar level of persons with diabetes mellitus will over time cause damage to the small vessels of the body This damage develops slowly over years and is known to cause late complications Good metabolic control i e lowering the HbA1c has proven to delay the onset and slowing the progression of diabetes late complications Principle of the assay Afinion HbAlc is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c in human whole blood The Afinion HbA1c Test Cartridge contains all of the reagents necessary for the determination of HbA1c The sample material is collected with the integrated sampling device before the Test Cartridge is placed in the cartridge chamber of the Afinion AS100 Analyzer The blood sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes The hemoglobin precipitates This sample mixture is
13. ol Test procedure overview e Switch on the Afinion AS100 Analyzer Allow the Afinion HbA1c Test Cartridge to reach operating temperature 64 86 F Open the foil pouch just before use Be sure to properly label the Test Cartridge with sample ID The Test Cartridge has a dedicated ID area Collect a specimen following the specimen collection pro cedure described below Once the capillary is filled analysis of the Test Cartridge must start within 1 minute Insert the Test Cartridge in the Analyzer The analysis time is 3 minutes and 20 seconds e Record the test results in the proper place according to the laboratory guidelines The results will be stored in the Analyzer electronic result records e Remove the Test Cartridge from the Analyzer Important Do not use test cartridges that have been accidentally dropped on the floor or lab bench after specimen collection Specimen collection Blood sampling from finger e Always use gloves Clean the finger using alcohol Allow the area to air dry e Use a lancet and firmly prick the finger a Properly dispose the lancet Allow a good drop of blood to form before sampling b Apply direct pressure to the wound site with a clean gauze pad Sampling from a tube e Patient samples stored refrigerated can be used without equilibration to room temperature e Mix the sample material well by inverting the tube 8 10 times before col
14. ollection Interference No significant interference lt 5 was observed up to the following concentrations e Bilirubin 342 mol L 20 mg dL e Triglycerides 15 7 mmol L 1389 mg dL Cholesterol 9 1 mmol L 351 mg dL e Glucose 27 8 mmol L 500 mg dL e Fructosamine 680 umol L e Hemolysis 5 0 Anticoagulants EDTA heparin and citrate at concentrations normally used in blood collection tubes Over the counter and prescription drugs Acetaminophen 1 7 mmol L 056 ug mL Ibuprofen 1 8 mmol L 372 pg mL Acetylsalicylic acid 3 3 mmol L 599 pg mL Salicylic acid 4 3 mmol L 593 pg mL Glyburide 3 9 umol L Metformin 310 umol L No significant interference lt 5 was observed at expected serum levels for the above mentioned drugs Important It is possible that other substances and or factors not listed above may interfere with the test and cause false results QUALITY CONTROL Quality control testing should be done to confirm that your Afinion AS100 Analyzer System is working properly and pro viding reliable results Only when controls are used routinely and the values are within acceptable ranges can accurate results be assured for patient samples Each laboratory site can benefit from establishing a quality control plan The laboratory director should determine whether additional testing is appropriate for their laboratory It is recommended to keep a permanent record of all quality control results The Afini
15. on AS100 Analyzer automatically stores the control results in a separate record Consult the Afinion AS100 Analyzer User Manual Control material Afinion HbA1c Control REF 1115178 is recommended for routine quality control testing Consult the Afinion HbA1c Control Package Insert Frequency of control testing Controls should be analyzed e With each new shipment of Afinion HbA1c test kits e With each new lot of Afinion HbA1c test kits e Users with a low frequency of testing should analyze controls at least every 30 days e When training new operators in correct use of the Afinion HbA1c and the Afinion AS100 Analyzer e Anytime an unexpected test result is obtained If local state and or federal regulations require more frequent testing of control materials then quality control should be per formed in compliance with these regulations CLIA waived labora ories should follow the manufacturer s quality control guidelines Verifying the control results The measured value should be within the acceptable limits stated for the control material Consult the Afinion HbA1c Control package insert If the result obtained for the Afinion HbA1c Control is outside he acceptable limits make sure that patient samples are not analyzed until control results are within acceptable limits e the control vial has not passed its expiry date e the control vial has not been in use
16. pper limit of non diabetic normal range is approximately 6 HbA1c HbAlc Interpretation of results 4 6 Non Diabetic Range 7 ADA Target 8 12 Above Target ADA American Diabetes Association Interpretation of results Despite a reliable internal process control of the analysis each individual test result should be interpreted with careful conside ration to the patient s medical history clinical examinations and other laboratory results If the test result is questionable or if clinical signs and symptoms appear inconsistent with the test result analyze the Afinion HbA1c Controls and re test the specimen Analytical specificity The following hemoglobin Hb variants have been analyzed and found not to affect the Afinion HbA1c test result HbAC HbAD HbAE HbF HbA and HbAS Carbamylated hemoglobin does not affect the Afinion HbA1c test result Pre glycated hemoglobin does not affect the Afinion HbA1c result Limitations of the test Do not analyze diluted samples with the Afinion HbA1c Do not analyze hemolyzed or coagulated samples Do not use cold test cartridges Use the Test Cartridge within 10 minutes after opening the foil pouch e Place the Test Cartridge in the Afinion AS100 Analyzer within one minute after the capillary is filled with sample material Important Do not use test cartridges that have been accidentally dropped on the floor or lab bench after specimen c
17. range is 4 6 HbA1c Table 11 Allowable Limits of Error A L E N Number of measurements SD Standard Deviation CV Coefficient of Variation Sample A Sample B Sample C N 67 68 68 Mean HbA1c 6 0 7 6 52 SD 0 09 0 13 0 08 CV 1 6 1 7 1 6 Range HbA 1c 5 8 6 2 73 79 5 0 5 4 A LE HbA1c 5 4 6 6 6 8 8 4 4 7 5 7 No values within A L E 100 0 100 0 100 0 67 67 68 68 68 68 Test result for sample A was missing from one operator For each sample tested there was no statistically significant difference in the mean HbA1c values among sites F test 15 SYMBOLS BIBLIOGRAPHY The following symbols are used in the packaging material for 1 Lenzi S et al The Clinical Usefulness of Glycated Hemoglobin in Moni Afinion HbAlc toring Diabetes Mellitus A long Term Study Clin Chem 1987 33 55 56 2 Frantzen F Studies on glycated hemoglobin and new analytical Conformity to the European directive ee Dr philos thesis NTNU Trondheim C 98 79 EC on in vitro diagnostic medical 3 The Diabetes Control and Complications Trial Research Group The devices Effect of Intensive Treatment of Diabetes on the Development and E Progression of Long Term Complications in Insulin Dependent In Vitro Diagnostic Medical Device Diabetes Mellitus N Engl J Med 1993 329 977 986 4 Sacks DB et al Guidelines and Recommendations for Laboratory REF Catalog number Analysis in the
18. rtridge must reach an operating temperature of 18 30 C 64 86 F before use Upon removal from refrigerated storage leave the Test Cartridge in the unopened foil pouch for at least 15 minutes Information code 210 will be displayed and no test result obtained if the Test Cartridge is too cold when used Do not freeze Room temperature storage 15 25 C 59 77 F The Afinion HbA1c Test Cartridges can be stored in unopened foil pouches at room temperature for 90 days Note the date of removal from the refrigerator and the new expiry date on the kit container e Avoid exposure to direct sunlight Opened foil pouch The Test Cartridge should be used within 10 minutes after opening e Avoid exposure to direct sunlight SPECIMEN MATERIALS AND STORAGE The following sample materials can be used with the Afinion HbA1c test Capillary blood sample from finger prick e Venous whole blood with anticoagulants ethylenediamine tetra acetic acid EDTA heparin or citrate Specimen storage Capillary blood samples cannot be stored e Venous whole blood with anticoagulants EDTA heparin or citrate may be stored refrigerated for 10 days Do not freeze Note Information code 204 will be displayed and no result obtained if hemolyzed or coagulated samples are analyzed TEST PROCEDURE Consult the Afinion HbA1c Quick Guide for detailed instructions on how to collect and analyze a patient sample or contr
19. t Cartridges have not been stored in accordance with recom mendations Do not use the Test Cartridge if the foil pouch or the Test Cartridge itself has been damaged Each foil pouch contains a desiccant bag with 1 g silica gel This material shall not be used in the assay Discard the desiccant bag in a suitable container Do not swallow Do not use the Test Cartridge if the desiccant bag is damaged and desiccant particles are found on the Test Cartridge Do not wipe off Do not touch the Test Cartridge optical reading area figure 1 The Afinion HbA1c Test Cartridge contains sodium azide as a preservative The concentration is lt 0 1 which is below that which is considered hazardous in normal use In case of leakage avoid contact with eyes and skin Wash with plenty of water Do not re use any part of the Test Cartridge The used Test Cartridges sampling equipment patient samples and controls are potenitally infectious and should be disposed of immediately after use Proper handling and disposal met hods should be followed in accordance with local state and federal regulations Use personal protective equipment STORAGE AND STABILITY Refrigerated storage 2 8 C 36 46 F The Afinion HbA1c Test Cartridges are stable until the expiry date only when stored refrigerated in sealed foil pouches The expiry date is the last day of the month stated on the foil pouch and outer container The Afinion HbA1c Test Ca
20. transferred to a blue boronic acid conjugate which binds to the cis diols of glycated hemoglobin This reaction mixture is soaked through a filter membrane and all precipitated hemoglobin conjugate bound and unbound i e glycated and non glycated hemoglobin remains on the membrane Any excess of conjugate is removed with a washing reagent The Analyzer evaluates the precipitate on the membrane By measuring the reflectance the blue glycated hemoglobin and the red total hemoglobin color intensities are evaluated the ratio between them being proportional to the percentage of HbA1c in the sample The HbAlc is displayed on the Afinion AS100 Analyzer Standardization Afinion HbA1c is traceable to the International Federation of Clinical Chemistry and Laboratory Medicine IFCC Reference Method for Measurement of HbA1c HbATc values are reported according to the National Glycohemoglobin Standardization Program NGSP recommendations at DCCT Diabetes Control and Complications Trial level Afinion HbA1c meets the performance standards established by NGSP Materials provided contents per 15 tests unit 15 Test Cartridges packed separately in foil pouches with a desiccant bag 1 Package Insert Materials required but not provided with the kit Afinion AS100 Analyzer REF 1115175 Afinion AS100 Analyzer User Manual provided with Afinion AS100 Analyzer Afinion HbA1c Quick Guide provided
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