HumaMeter A1c HumaMeter A1c 1. Product Overview 2. HbA1c and Diabetes 3. Performing a Test 4. Basic Maintenance 5. Summary Page 2 HumaMeter A1c Product Overview HumaMeter A1c is a revolution in HbA1c measurement: It combines market-leading PoC analyser accuracy with low cost, easy to use technology. Page 3 HumaMeter A1c HumaMeter A1c Analyser Large backlit display Door with automatic switch Reagent cartridge Barcode scanner Page 4 HumaMeter A1c Product Features Easy to use Step by step instructions on display Multi-lingual menu Innovative blood collector allows easy sampling Page 5 HumaMeter A1c Practical Data Fast and accurate Stores up to 7,000 records Self-testing Results in 4 minutes Barcode identification Small sample size (4 μl) Imprecision: CV <3% at 7% A1c USB port for PC Compact size Weight: 0.7kg Barcode reader for calibration data, patient and operator ID Accessories Optional label printer Technical Information • Boronate Affinity methodology (interference free) • Traceable to the IFCC reference method • Imprecision: CV <3% (at 7% A1c) • Measuring range: 4-15% A1c (20-140 mmol/mol) • Unaffected by Hb variants (which do not result in reduced erythrocyte life span) • User selectable dual reporting. Choose from % DCCT, IFCC mmol/mol, % JDS, eAG mg/dL or eAG mmol/L • Optional printer Page 6 HumaMeter A1c HumaMeter A1c Reagent Test Cartridges • Small sample size required (4 μL) • Fast measuring time (approx. 4 minutes) • Reagent stability of 12 months at 2-8 °C; thereof up to 90 days @ room temp. (uncooled)* • Sold in compact boxes of 50 (2 * 25) reagent cartridges with 50+ sample sticks; imprinted calibration barcode *18 – 25°C Page 7 HumaMeter A1c Components and Accessories Ordering information: Product HumaMeter A1c analyzer Included HumaMeter HbA1c reagent kit 50 test cartridges, 50 sample sticks, 1 IFU, calibration barcode Analyzer, User Manual (GB, F, E, RUS), Barcode scanner, Power supply HumaMeter HbA1c control Ref. No. 16080 16085/50 16086 Optional accessories: Product Ref. No. Printer HumaMeter A1c 16081 Printer label rolls HumaMeter A1c (320 labels) 16082 Spare parts: There are no serviceable parts. If broken or lost, the following parts can be exchanged by the user: •Barcode scanner HumaMeter A1c (Ref. No. 16083) •Printer cable HumaMeter A1c (Ref. No. 16081/1) Page 8 HumaMeter A1c HbA1c and Diabetes HbA1c and Diabetes Diabetes mellitus (commonly : ”Diabetes”): -Diseases in which a person has high blood sugar (=Glucose) -Reasons: Body produces not enough insulin or cells do not respond to the insulin produced. -2 Types: • Type 1 diabetes (Insulin-dependent diabetes): Caused by loss of insulin-producing beta cells in pancreas. Usually young people. • Type 2 diabetes (Non-insulin dependent diabetes): Results from insulin resistance (cells fail to use insulin properly). Sometimes combined with insulin deficiency. Typically in adults over 40 and overweight patients. Page 10 HumaMeter A1c HbA1c and Diabetes Causes of Diabetes High Blood Pressure High blood triglyceride (fat) levels Poor diet (processed simple carbs and sugars) Sedentary lifestyle Obesity or being overweight Increasing age Pregnancy (gestational diabetes) Pancreatitis Page 11 HumaMeter A1c HbA1c and Diabetes Signs and Symptoms of Diabetes Excessive thirst Frequent urination Blurry vision Sedentary lifestyle Tingling or numbness in the hand and feet Wounds that don’t heal Extreme unexplained fatigue Page 12 HumaMeter A1c HbA1c and Diabetes Diabetes: High blood sugar (=Glucose) Blood Glucose level is used for DIABETES Diagnosis & DIABETES Monitoring Page 13 HumaMeter A1c HbA1c and Diabetes Functions of Blood: Transport → …of oxygen, nutrients, electrolytes, hormones and enzymes throughout the body Regulation → … of fluid and electrolyte balance, temperature Protection → …against bacteria, viruses, toxins Wound healing → …through clotting mechanism Page 14 HumaMeter A1c HbA1c and Diabetes Components of Blood Red Blood Cells (RBC) or Erythrocytes – ~99% of blood cells RBC contain hemoglobin, an oxygen-carrying protein. Oxygen binds to hemoglobin in lungs and is the transported to the tissues. White blood cells (WBC) or Leukocytes Initiate immune responses, < 1% of blood cells. Platelets (PLT) or Thrombocytes Crucial for blood clotting & wound healing. Plasma Yellow fluid that carries all blood cells; makes up ~55% of blood. Page 15 HumaMeter A1c HbA1c and Diabetes Hemoglobin and Glucose • Glucose rapidly diffuses into RBC by facilitated diffusion. • N terminal valine of hemoglobin alpha chain is available for irreversible glycation: Hemoglobin Hb → HbA1c • Hb glycation level (= HbA1c level) is proportional to glucose concentration in plasma ! Page 16 HumaMeter A1c HbA1c and Diabetes WHY HbA1c? • RBC lifespan: 8-12 weeks → HbA1c concentration indicates average blood glucose level over previous 8-12 weeks • HbA1c testing - one of the best ways to ensure good diabetes control as it reports an overall level, not a snap-shot concentration • HbA1c is not the same as a glucose measurement! Note: A patient’s HbA1c level is affected e.g. by RBC lifespan, which may be decreased in some conditions. Page 17 HumaMeter A1c Summary HbA1c principle - RBC Red blood cells, Hemoglobin & Glucose • RBC: Uptake, transport and release of oxygen • Oxygen bound to Hemoglobin Hb • Glucose easily moves between blood & RBC • Irreversible Glycation (=binding of Glucose) of Hb • Glycated Hb - HbA1c Level of Glycation ~ Glucose in plasma • RBC lifespan = 8-12 weeks: HbA1c concentration indicates average blood glucose levels last 8-12 weeks • HbA1c reports an “overall glucose concentration”, not only a “snap-shot concentration”! HbA1c testing - the best way to ensure good diabetes Discovery & Control! HbA1c and Diabetes HbA1c LEVELS • Commonly used clinical ranges for glycated hemoglobin (HbA1c) are: • Normal: < 5.7% • Pre-diabetes: 5.7% - 6.4% • Diabetic: 6.5% or higher • Targets should be set for each individual, taking into consideration their risk of severe hyperglycaemia, cardiovascular status and comorbidities. Note: The American Diabetes Association recommends a goal of less than 7% DCCT (53 mmol/mol IFCC) for effective management of diabetes and to minimize long-term diabetic complications. Page 19 HumaMeter A1c Performing a Test Performing a Test A Few Easy Steps … plus fool-proof display-guidance Scan lot calibration, remove cartridge foil and insert into analyser. Page 21 HumaMeter A1c Press reagent bead into the cartridge. Take blood sample. Close lid. Insert into cartridge and snap the stick. Results in 4 minutes. Performing a Test Set Up • Make sure a tray of cartridges & the analyser are equilibrated to working temperature (room temperature) • • • • Page 22 Scan lot calibration barcode Remove foil lid from cartridge Place cartridge into analyser When prompted, press reagent bead into the cartridge with blunt end of the sample stick HumaMeter A1c Performing a Test Preparing to Take a Blood Sample 1. Make sure your patient sits comfortably. 2. There should be good blood circulation in the hand from which the sample is to be taken. 3. The hand should be warm and relaxed. If in doubt, warm the hand in lukewarm water. Page 23 HumaMeter A1c Performing a Test Stimulating Blood Circulation 1. Lightly massage the fingers in order to stimulate the circulation. 2. Operator should wear protective gloves. 3. Middle or ring finger should be used for taking a sample. Patient should not wear a ring on the finger used for sampling. 4. Disinfect the puncture site and allow it to dry completely. Page 24 HumaMeter A1c Performing a Test Lancing the Finger 1. Lance the finger on the side of the fingertip. This is less painful and the blood flow is better. 2. Press lightly on the fingertip and puncture it with a lancet. 3. A lancet that will create a blood flow of 10-20 μl is recommended. 4. Blot away the first drop of blood. 5. If necessary, press the finger gently again to get a second drop of blood which is large enough to fill the capillary . 6. Avoid ‘milking’ the finger for blood. Page 25 HumaMeter A1c Performing a Test Filling the Sample Stick 1. Hold the sample stick with the blood collector and lightly touch the pointed tip on the surface of the blood droplet. 2. Hold the stick in this position until it is filled completely with blood. 3. Check that the blood collector cavity is completely filled and is free of air bubbles. 4. Do not top-up the blood collector if it does not completely fill with blood. Instead, repeat the process with a fresh blood sample and stick. Page 26 HumaMeter A1c Performing a Test Calibration • Lot calibration is performed by scanning in the bar-code label found on of each cartridge box • Lot calibration can be done: • When the analyser is idle • When the analyser requests it = When “Scan Lot Barcode” appears on the screen Page 27 HumaMeter A1c Performing a Test Calibration (Cont.) • Each reagent lot is directly calibrated to IFCC standards received from the European Reference Laboratory. • Cartridge lot calibration is entered into the instrument by scanning the bar code on the box of reagents. Once the test is finished the results will be expressed in: • % HbA1c/total Hb traceable to DCCT • mmol/mol traceable to the IFCC standard • Reporting methods JDS, Mono-S and eAG also can be selected from set-up menu Page 28 HumaMeter A1c Performing a Test Measuring Procedure 1. Insert the blood collector end of the sample stick into the cartridge that is in the analyser. 2. Snap off the sample stick handle. 3. Close the lid of the analyser. 4. The result will appear on the screen within ~4 minutes. Page 29 HumaMeter A1c Basic Maintenance Basic Maintenance Cleaning Procedure • Clean the analyser with a non-abrasive lint free cloth. • Use a mild detergent or commercially available disinfectant if necessary. • Always turn off the analyser by unplugging the power supply before performing any cleaning operation. Page 31 HumaMeter A1c Basic Maintenance Storage • Turn off the analyser on a weekly basis for a minimum of 10 seconds so that when it is turned back on again, it will perform the internal self-checks. • If the instrument is stored when not in use, ensure that the mains cord is not liable to damage or kinking. • The analyser is calibrated by the manufacturer and there are no user-serviceable parts. • Reagent shelf-life of up to 90 days (un-refrigerated). Total Reagent stability of 12 months at 2-8 °C. Page 32 HumaMeter A1c Competition Competitor analysis I HumaMeter A1c CERTIFICATION Axis Shield Nycocard NGSP and IFCC certification METHODOLOGY TIME TO RESULT MEASUREMENT RANGE % A1C SAMPLE VOLUME IMPRECISION, CV AT 7% A1C SPECIMEN TYPE Hemocue 501 (OEM of Clover) NGSP certified NGSP certified Barcode calibration Barcode calibration Boronate Affinity Fluorescence Quenching <4 mins Infopia Clover Boronate Affinity reflectance 3 mins Boronate Affinity Boronate Affinity Inverse Amperometry 5 mins Inverse Amperometry 5 mins Boditech iCHROMA Ceragem Labona Check™ Ceragem CeraStat 2000 Bio-Rad IN2IT NGSP certified NGSP and IFCC certification NGSP certified NGSP certified Immunological >12 mins Boronate Affinity with optical reflectance 3 mins Boronate Affinity with optical reflectance 3 mins Chromato-graphy 10 mins 4 - 14% 10 ul <4% Boronate Affinity 4 - 15% 4 µl 4 - 15% 5 µl 4 - 14% 4 µl 4 - 14% 4 µl 4 - 15% 5 µl 4 - 15% 5 ul HbA1c: 4 % - 15 %, Hemoglobin: 5 26 g/dL 5 ul <3% 8.5% <3% <3% <5% 2.8 - 3.8% No info Capillary No Capillary No Capillary Yes Capillary & venous Finger & venous No No Capillary & venous Capillary & venous Capillary & venous No No No AFFECTED BY HB VARIANTS* REAGENT TYPE Page 34 Cartridge: Ready to use Test disc: Add reagents to sample and disc Cartridge: Shake reagents before taking sample Cartridge: Lateral flow strip Shake reagents before taking sample Sample capillary Sample capillary with hemolysis with hemolysis vials or step vials or step dropper, 2 liquid dropper, 2 liquid reagents, pipette, reagents, pipette, cartridge cartridge Cartridge: Ready to use Competitor analysis II MEMORY: PATIENT & QUALITY CONTROL REAGENT STORAGE OPERATING CONDITIONS PATIENT/USER ID PRINTER POWER QUALITY CONTROL SELF-TEST PC INTERFACE Page 35 HumaMeter A1c Axis Shield Nycocard Infopia Clover Hemocue 501 (OEM of Clover) 7,000 P & QC Last Patient 200 P 200 P Boditech iCHROMA Ceragem Labona Ceragem CeraCheck™ Stat 2000 300 results 12 months @ 2 8°C; thereof 90 days at room 2 - 8°C 90 days at temperature room temperature Room temperature Room temperature 2 - 8°C 20 months 18 - 30°C Yes 18 - 30°C No 17 - 32°C Optional 17 - 32°C Optional 10 - 40°C No External No External External External AC or DC9 AC or DC9 300 results Bio-Rad IN2IT 200 P & QC 2 - 8°C 30 days at room temperature 2 - 8°C 20 - 25 °C; 20 - 25 °C; Humidity:15 - 75% Humidity:15 - 75% No No (Patient ID manual entry) Integrated thermal Integrated thermal printer printer 18 - 30°C No External AC AC battery battery AC or 12v battery AC AC AC or 4 type AA batteries 2 levels 2 levels No No No 2 levels 2 levels 2 levels Must be diluted During start up Optics check before each test Calibration check Check cartridge supplied Check cartridge supplied Yes Yes Yes Optics check Serial port Serial port, USB port Serial port, USB port None Serial port, USB port USB port Serial port None Competitor analysis III HumaMeter A1c DEVICE CHARACTERISTICS Axis Shield Nycocard DCCT reporting only Infopia Clover Hemocue 501 (OEM of Clover) Boditech iCHROMA Dual reporting Dual reporting DCCT reporting only Multilingual display No CE Bio-Rad IN2IT Reporting either DCCT or IFCC, touch screen Reporting either DCCT or IFCC and Hb, touch screen Symbols and codes used on display Hemoglobin CE CLIA waived No CLIA waived No CLIA waived Requires multiple pipette steps Dual Reporting, user selectable units % DCCT, mmol/mol IFCC, % JDS, eAG mg/dl and eAG mmol/l OTHER ANALYSIS APPROVALS Ceragem Labona Ceragem CeraCheck™ Stat 2000 CRP, D-Dimer, Micro Albumin 510(k) Blood glucose PSA, D-dimer, Optional module HS-CRP, TROP 510(k) No CE MAXIMUM TIME PERMITTED AFTER BLOOD COLLECTION SIZE AND WEIGHT 7 minutes 30 seconds 95x205x135 mm 200x170x170mm 200x200x139mm 185x80x250mm 0.7kg 0.54kg 1.4kg 1.3kg OEM of Clover OTHER Page 36 5 minute 178x195x77mm 0.73 kg 5 minute 10 seconds 10 seconds 178x195x77mm 140x100x145mm 140x100x145mm 0.73 kg 0.84kg 0.84 kg Noisy in use Insert cartridge into machine then insert reagent Easy operation pack with sample Bulky cartridges Noisy in use (2 steps instead Reagents stable take up lots of Reagents stable of 1) fridge space at room for 20 months Updated nycocard Bulky cartridges temperature for 1 Multi-step manual 1 cartridge must Multi step manual with multi-step Multi-step manual take up lots of month process be assembled process manual process process refrigerator space RECAP • • • • Name some of the most common causes of diabetes. Name some of the symptoms of diabetes. What does HumaMeter A1c measure? Why must the reagent cartridges be removed from storage 40 minutes before use? • Which fingers should be used for taking a blood sample? • How long does HumaMeter A1c take to provide results? Page 37 HumaMeter A1c