humameter a1c. page 2 humameter a1c 1.product overview 2.hba1c and diabetes 3.performing a test...
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HumaMeter A1c
HumaMeter A1cPage 2
HumaMeter A1c
1. Product Overview
2. HbA1c and Diabetes
3. Performing a Test
4. Basic Maintenance
5. Summary
HumaMeter A1cPage 3
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 A1cPage 4
HumaMeter A1c Analyser
Large backlit display
Door with automatic switch
Reagent cartridge
Barcode scanner
HumaMeter A1cPage 5
Product Features
AccessoriesOptional label
printer
HumaMeter A1cPage 6
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
• 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 A1cPage 7
HumaMeter A1c Reagent Test Cartridges
HumaMeter A1cPage 8
Components and Accessories
Product Included Ref. No. HumaMeter A1c analyzer Analyzer, User Manual (GB, F, E, RUS), Barcode
scanner, Power supply16080
HumaMeter HbA1c reagent kit 50 test cartridges, 50 sample sticks, 1 IFU, calibration barcode
16085/50
HumaMeter HbA1c control 16086
Product Ref. No.
Printer HumaMeter A1c 16081
Printer label rolls HumaMeter A1c (320 labels) 16082
Optional accessories:
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)
Ordering information:
HbA1c and DiabetesBild durch Klicken auf Symbol hinzufügen
HumaMeter A1cPage 10
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 A1cPage 11
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 A1cPage 12
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 A1cPage 13
HbA1c and Diabetes
Blood Glucose level
is used for
DIABETES Diagnosis & DIABETES Monitoring
Diabetes: High blood sugar (=Glucose)
HumaMeter A1cPage 14
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 A1cPage 15
HbA1c and Diabetes
Components of BloodRed Blood Cells (RBC) or Erythrocytes – ~99% of
blood cellsRBC 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 ThrombocytesCrucial for blood clotting & wound healing.
PlasmaYellow fluid that carries all blood cells; makes up
~55% of blood.
HumaMeter A1cPage 16
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 A1cPage 17
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.
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!
HumaMeter A1cPage 19
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 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.
Performing a Test
HumaMeter A1cPage 21
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.
Close lid.
Results in 4 minutes.
Take blood sample.
Insert into cartridge and snap the stick.
HumaMeter A1cPage 22
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 A1cPage 23
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.
HumaMeter A1cPage 24
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.
HumaMeter A1cPage 25
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.
HumaMeter A1cPage 26
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.
HumaMeter A1cPage 27
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 A1cPage 28
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 A1cPage 29
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.
Basic MaintenanceBild durch Klicken auf Symbol hinzufügen
HumaMeter A1cPage 31
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 A1cPage 32
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.
CompetitionBild durch Klicken auf Symbol hinzufügen
Competitor analysis I
Page 34
Axis Shield Nycocard
Infopia Clover Hemocue 501 (OEM of Clover)
Boditech i-CHROMA
Ceragem Labona Check™
Ceragem Cera-Stat 2000
Bio-Rad IN2ITHumaMeter A1c
CERTIFICATIONNGSP and IFCC
certification
NGSP certified Barcode calibration
NGSP certified Barcode calibration NGSP certified
NGSP and IFCC certification NGSP certified NGSP certified
METHODOLOGY
Boronate Affinity
Boronate Affinity reflectance
Boronate Affinity Boronate Affinity
Immunological
Boronate Affinity with optical reflectance
Boronate Affinity with optical reflectance
Boronate Affinity
Fluorescence Quenching
Inverse Amperometry
Inverse Amperometry Chromato-graphy
TIME TO RESULT <4 mins 3 mins 5 mins 5 mins >12 mins 3 mins 3 mins 10 mins
MEASUREMENT RANGE % A1C 4 - 15% 4 - 15% 4 - 14% 4 - 14% 4 - 15% 4 - 15%
HbA1c: 4 % - 15 %, Hemoglobin: 5 - 26
g/dL 4 - 14%SAMPLE VOLUME 4 µl 5 µl 4 µl 4 µl 5 µl 5 ul 5 ul 10 ul
IMPRECISION, CV AT 7% A1C
<3% 8.5% <3% <3% <5% 2.8 - 3.8% No info <4%
SPECIMEN TYPE Capillary & venous Finger & venous Capillary Capillary Capillary Capillary & venous Capillary & venous Capillary & venous
AFFECTED BY HB VARIANTS*
No No No No Yes No No No
REAGENT TYPE Cartridge: Test disc: Cartridge: Cartridge: Lateral flow stripSample capillary with hemolysis
vials or step dropper, 2 liquid
reagents, pipette, cartridge
Sample capillary with hemolysis
vials or step dropper, 2 liquid
reagents, pipette, cartridge
Cartridge:
Ready to use Add reagents to sample and disc
Shake reagents before taking
sample
Shake reagents before taking
sample
Ready to use
Competitor analysis II
Page 35
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 200 P 300 results 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 Room temperature 2 - 8°C 20 months 2 - 8°C
2 - 8°C 30 days at room temperature
OPERATING CONDITIONS 18 - 30°C 18 - 30°C 17 - 32°C 17 - 32°C 10 - 40°C
20 - 25 °C; Humidity:15 - 75%
20 - 25 °C; Humidity:15 - 75% 18 - 30°C
PATIENT/USER ID Yes No Optional Optional No NoNo (Patient ID manual entry)
No
PRINTER External No External External ExternalIntegrated thermal
printerIntegrated thermal
printer External
POWER AC AC
AC or DC9 AC or DC9
AC or 12v battery AC ACAC or 4 type AA
batteriesbattery battery
QUALITY CONTROL 2 levels 2 levels No No No 2 levels 2 levels2 levels Must be
diluted
SELF-TEST
During start up Optics check
before each test Calibration checkCheck cartridge
suppliedCheck cartridge
supplied Yes Yes Yes Optics check
PC INTERFACE USB port Serial portSerial port, USB
portSerial port, USB
port Serial port None NoneSerial port, USB
port
Competitor analysis III
Page 36
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-
ISTICSMultilingual
display
DCCT reporting only
Dual reporting Dual reporting DCCT reporting only
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 NoCRP, D-Dimer, Micro Albumin
Blood glucose Optional module
PSA, D-dimer, HS-CRP, TROP No Hemoglobin No No
APPROVALS CE 510(k) 510(k) CE CE CLIA waived
CLIA waived CLIA waived
MAXIMUM TIME PERMITTED AFTER BLOOD
7 minutes
30 seconds 5 minute 5 minute 10 seconds 10 secondsCOLLECTION
SIZE AND WEIGHT
95x205x135 mm 0.7kg
200x170x170mm 0.54kg
200x200x139mm 1.4kg
185x80x250mm 1.3kg
178x195x77mm 0.73 kg
178x195x77mm 0.73 kg
140x100x145mm 0.84kg
140x100x145mm 0.84 kg
OTHEREasy 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 processMulti-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
HumaMeter A1cPage 37
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?