HumaMeter A1c

HumaMeter A1c Product Overview HbA1c and Diabetes Performing a Test Basic Maintenance Summary 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. HumaMeter A1c

HumaMeter A1c Analyser Door with automatic switch Large backlit display Reagent cartridge Barcode scanner HumaMeter A1c

Product Features Data Easy to use Practical Fast and accurate Step by step instructions on display Multi-lingual menu Innovative blood collector allows easy sampling Practical Compact size Weight: 0.7kg Self-testing Small sample size (4 μl) Fast and accurate Results in 4 minutes Imprecision: CV <3% at 7% A1c Data Stores up to 7,000 records Barcode identification USB port for PC Barcode reader for calibration data, patient and operator ID Accessories Optional label printer HumaMeter A1c

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 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 HumaMeter A1c

Components and Accessories Ordering information: Product Included Ref. No. HumaMeter A1c analyzer Analyzer, User Manual (GB, F, E, RUS), Barcode scanner, Power supply 16080 HumaMeter HbA1c reagent kit 50 test cartridges, 50 sample sticks, 1 IFU, calibration barcode 16085/50 HumaMeter HbA1c control 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) 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. 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 HumaMeter A1c

Tingling or numbness in the hand and feet Extreme unexplained fatigue 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 HumaMeter A1c

HbA1c and Diabetes Blood Glucose level is used for Diabetes: High blood sugar (=Glucose) Blood Glucose level is used for DIABETES Diagnosis & DIABETES Monitoring 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 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. 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 ! 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. 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 Normal: < 5.7% 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 co-morbidities. 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. 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. Press reagent bead into the cartridge. Take blood sample. Insert into cartridge and snap the stick. Close lid. Results in 4 minutes. HumaMeter A1c

Performing a Test Set Up Make sure a tray of cartridges & the analyser are equilibrated to working temperature (room temperature) 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 Make sure your patient sits comfortably. There should be good blood circulation in the hand from which the sample is to be taken. The hand should be warm and relaxed. If in doubt, warm the hand in lukewarm water. HumaMeter A1c

Performing a Test Stimulating Blood Circulation Lightly massage the fingers in order to stimulate the circulation. Operator should wear protective gloves. Middle or ring finger should be used for taking a sample. Patient should not wear a ring on the finger used for sampling. Disinfect the puncture site and allow it to dry completely. HumaMeter A1c

Performing a Test Lancing the Finger Lance the finger on the side of the fingertip. This is less painful and the blood flow is better. Press lightly on the fingertip and puncture it with a lancet. A lancet that will create a blood flow of 10-20 μl is recommended. Blot away the first drop of blood. If necessary, press the finger gently again to get a second drop of blood which is large enough to fill the capillary . Avoid ‘milking’ the finger for blood. HumaMeter A1c

Performing a Test Filling the Sample Stick Hold the sample stick with the blood collector and lightly touch the pointed tip on the surface of the blood droplet. Hold the stick in this position until it is filled completely with blood. Check that the blood collector cavity is completely filled and is free of air bubbles. 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. 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 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 HumaMeter A1c

Performing a Test Measuring Procedure Insert the blood collector end of the sample stick into the cartridge that is in the analyser. Snap off the sample stick handle. Close the lid of the analyser. The result will appear on the screen within ~4 minutes. 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. 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. HumaMeter A1c

Competition

Hemocue 501 (OEM of Clover) Competitor analysis I   Axis Shield Nycocard Infopia Clover Hemocue 501 (OEM of Clover) Boditech i-CHROMA Ceragem Labona Check™ Ceragem Cera-Stat 2000 Bio-Rad IN2IT HumaMeter A1c CERTIFICATION NGSP and IFCC certification NGSP certified Barcode calibration NGSP certified METHODOLOGY Boronate Affinity Boronate Affinity reflectance Immunological Boronate Affinity with optical reflectance Fluorescence Quenching Inverse Amperometry Chromato-graphy TIME TO RESULT <4 mins 3 mins 5 mins >12 mins 10 mins MEASUREMENT RANGE % A1C 4 - 15% 4 - 14% HbA1c: 4 % - 15 %, Hemoglobin: 5 - 26 g/dL SAMPLE VOLUME 4 µl 5 µl 5 ul 10 ul IMPRECISION, CV AT 7% A1C <3% 8.5% <5% 2.8 - 3.8% No info <4% SPECIMEN TYPE Capillary & venous Finger & venous Capillary AFFECTED BY HB VARIANTS* No Yes REAGENT TYPE Cartridge: Test disc: Lateral flow strip Sample capillary with hemolysis vials or step dropper, 2 liquid reagents, pipette, cartridge Ready to use Add reagents to sample and disc Shake reagents before taking sample

Hemocue 501 (OEM of Clover) Competitor analysis II   Axis Shield Nycocard Infopia Clover Hemocue 501 (OEM of Clover) Boditech i-CHROMA Ceragem Labona Check™ Ceragem Cera-Stat 2000 Bio-Rad IN2IT HumaMeter A1c MEMORY: PATIENT & QUALITY CONTROL 7,000 P & QC Last Patient 200 P 300 results 200 P & QC REAGENT STORAGE 12 months @ 2 - 8°C; thereof 90 days at room temperature 2 - 8°C 90 days at room temperature Room temperature 2 - 8°C 20 months 2 - 8°C 2 - 8°C 30 days at room temperature OPERATING CONDITIONS 18 - 30°C 17 - 32°C 10 - 40°C 20 - 25 °C; Humidity:15 - 75% PATIENT/USER ID Yes No Optional No (Patient ID manual entry) PRINTER External Integrated thermal printer POWER AC AC or DC9 AC or 12v battery AC or 4 type AA batteries battery QUALITY CONTROL 2 levels 2 levels Must be diluted SELF-TEST During start up Optics check before each test Calibration check Check cartridge supplied Optics check PC INTERFACE USB port Serial port Serial port, USB port None

Hemocue 501 (OEM of Clover) Competitor analysis III   Axis Shield Nycocard Infopia Clover Hemocue 501 (OEM of Clover) Boditech i-CHROMA Ceragem Labona Check™ Ceragem Cera-Stat 2000 Bio-Rad IN2IT HumaMeter A1c DEVICE CHARACTER-ISTICS Multilingual display DCCT reporting only Dual reporting Reporting either DCCT or IFCC, touch screen Reporting either DCCT or IFCC and Hb, touch screen Symbols and codes used on display Dual Reporting, user selectable units % DCCT, mmol/mol IFCC, % JDS, eAG mg/dl and eAG mmol/l Requires multiple pipette steps OTHER ANALYSIS No CRP, D-Dimer, Micro Albumin Blood glucose Optional module PSA, D-dimer, HS-CRP, TROP Hemoglobin APPROVALS CE 510(k) CE CLIA waived CLIA waived MAXIMUM TIME PERMITTED AFTER BLOOD 7 minutes 30 seconds 5 minute 10 seconds COLLECTION SIZE AND WEIGHT 95x205x135 mm 0.7kg 200x170x170mm 0.54kg 200x200x139mm 1.4kg 185x80x250mm 1.3kg 178x195x77mm 0.73 kg 140x100x145mm 0.84kg 140x100x145mm 0.84 kg OTHER Easy operation Reagents stable at room temperature for 1 month Multi-step manual process OEM of Clover Reagents stable for 20 months Multi step manual process Updated nycocard with multi-step manual process Noisy in use Noisy in use Bulky cartridges take up lots of refrigerator space Insert cartridge into machine then insert reagent pack with sample (2 steps instead of 1) Bulky cartridges take up lots of fridge space 1 cartridge must be assembled

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? HumaMeter A1c