humameter a1c product presentation rev 02 · nycocard infopia clover hemocue 501 (oem of clover)...
TRANSCRIPT
HumaMeter A1c
1. Product Overview
2. HbA1c and Diabetes
3. Performing a Test
4. Basic Maintenance
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4. Basic Maintenance
5. Summary
Product Overview
HumaMeter A1c is a revolution in HbA1c measurement:
It combines market-leading PoC analyser accuracy with lowcost, easy to use technology.
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HumaMeter A1c Analyser
Largebacklitdisplay
Door withautomaticswitch
Reagentcartridge
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cartridge
Barcodescanner
Product Features
Practical Fast andData
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Easy to use
Step by stepinstructions on
display
Multi-lingual menu
Innovative bloodcollector allowseasy sampling
Practical
Compact size
Weight: 0.7kg
Self-testing
Small sample size (4μl)
Fast andaccurate
Results in4 minutes
Imprecision:CV <3% at 7% A1c
Data
Stores up to 7,000records
Barcodeidentification
USB port for PC
Barcode reader forcalibration data,
patient andoperator ID
Accessories
Optional labelprinter
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)
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• 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 with50+ sample sticks; imprinted calibration barcode
HumaMeter A1c Reagent Test Cartridges
50+ sample sticks; imprinted calibration barcode
*18 – 25°C
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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
Optional accessories:
Ordering information:
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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)
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.
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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.
HbA1c and Diabetes
Causes of Diabetes
High Blood Pressure
High blood triglyceride (fat) levels
Poor diet (processed simple carbs and sugars)
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Sedentary lifestyle
Obesity or being overweight
Increasing age
Pregnancy (gestational diabetes)
Pancreatitis
HbA1c and Diabetes
Signs and Symptoms of Diabetes
Excessive thirst
Frequent urination
Blurry vision
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Sedentary lifestyle
Tingling or numbness in the hand and feet
Wounds that don’t heal
Extreme unexplained fatigue
HbA1c and Diabetes
Blood Glucose level
is used for
DIABETES Diagnosis &DIABETES Monitoring
Diabetes: High blood sugar (=Glucose)
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DIABETES Monitoring
HbA1c and Diabetes
Functions of Blood:
Transport → …of oxygen, nutrients, electrolytes,
hormones and enzymes throughout the body
Regulation → … of fluid and electrolyte balance, temperature
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Regulation → … of fluid and electrolyte balance, temperature
Protection → …against bacteria, viruses, toxins
Wound healing → …through clotting mechanism
HbA1c and Diabetes
Components of Blood
Red Blood Cells (RBC) or Erythrocytes – ~99% of blood cellsRBC contain hemoglobin, an oxygen-carrying protein. Oxygenbinds to hemoglobin in lungs and is the transported to the tissues.
White blood cells (WBC) or LeukocytesInitiate immune responses, < 1% of blood cells.
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Platelets (PLT) or ThrombocytesCrucial for blood clotting & wound healing.
PlasmaYellow fluid that carries all blood cells; makes up ~55% of blood.
HbA1c and Diabetes
Hemoglobin and Glucose
• Glucose rapidly diffuses into RBC by
facilitated diffusion.
• N terminal valine of hemoglobin
alpha chain is available for
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alpha chain is available for
irreversible glycation:
Hemoglobin Hb → HbA1c
• Hb glycation level (= HbA1c level)
is proportional to glucose
concentration in plasma !
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
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• 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 affectede.g. by RBC lifespan, which may bedecreased 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• 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
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• 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/molIFCC) for effective management of diabetes and to minimize long-term diabetic complications.
Performing a Test
A Few Easy Steps … plus fool-proof display-guidance
Scan lot calibration,remove cartridge foil
and insert intoanalyser.
Press reagent beadinto the cartridge.
Close lid.
Results in 4 minutes.
Take blood sample.
Insert into cartridgeand snap the stick.
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Performing a Test
Set Up
• Make sure a tray of cartridges & the analyserare equilibrated to working temperature(room temperature)
• Scan lot calibration barcode
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• Scan lot calibration barcode
• Remove foil lid from cartridge
• Place cartridge into analyser
• When prompted, press reagent bead into thecartridge with blunt end of the sample stick
Performing a Test
Preparing to Take a Blood Sample
1. Make sure your patient sits comfortably.
2. There should be good blood circulation inthe hand from which the sample is to be
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taken.
3. The hand should be warm and relaxed.If in doubt, warm the hand in lukewarmwater.
Performing a Test
Stimulating Blood Circulation
1. Lightly massage the fingers in order tostimulate the circulation.
2. Operator should wear protective gloves.
3. Middle or ring finger should be used for
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3. Middle or ring finger should be used fortaking a sample. Patient should not wear aring on the finger used for sampling.
4. Disinfect the puncture site and allow it todry completely.
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
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3. A lancet that will create a blood flow of 10-20 μl isrecommended.
4. Blot away the first drop of blood.
5. If necessary, press the finger gently again to get a seconddrop of blood which is large enough to fill the capillary .
6. Avoid ‘milking’ the finger for blood.
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
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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.
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:
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• Lot calibration can be done:
• When the analyser is idle
• When the analyser requests it =
When “Scan Lot Barcode” appears
on the screen
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.
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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
Performing a Test
Measuring Procedure
1. Insert the blood collector end of thesample stick into the cartridge that is inthe analyser.
2. Snap off the sample stick handle.
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2. Snap off the sample stick handle.
3. Close the lid of the analyser.
4. The result will appear on the screenwithin ~4 minutes.
Basic Maintenance
Cleaning Procedure
• Clean the analyser with anon-abrasive lint free cloth.
• Use a mild detergent orcommercially available
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commercially availabledisinfectant if necessary.
• Always turn off the analyserby unplugging the powersupply before performing anycleaning operation.
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
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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.
Competitor analysis I
Axis ShieldNycocard
Infopia CloverHemocue 501
(OEM of Clover)Boditech i-CHROMA
Ceragem LabonaCheck™
Ceragem Cera-Stat 2000
Bio-Rad IN2ITHumaMeter A1c
CERTIFICATIONNGSP and IFCC
certificationNGSP certified
Barcode calibrationNGSP certified
Barcode calibration NGSP certifiedNGSP and IFCC
certification NGSP certified NGSP certified
METHODOLOGY
Boronate Affinity
Boronate Affinityreflectance
Boronate Affinity Boronate Affinity
Immunological
Boronate Affinitywith opticalreflectance
Boronate Affinitywith opticalreflectance
Boronate Affinity
FluorescenceQuenching
InverseAmperometry
InverseAmperometry Chromato-graphy
TIME TO RESULT <4 mins 3 mins 5 mins 5 mins >12 mins 3 mins 3 mins 10 mins
MEASUREMENTHbA1c: 4 % - 15
%, Hemoglobin: 5 -
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RANGE % A1C 4 - 15% 4 - 15% 4 - 14% 4 - 14% 4 - 15% 4 - 15% 26 g/dL 4 - 14%SAMPLE VOLUME 4 µl 5 µl 4 µl 4 µl 5 µl 5 ul 5 ul 10 ul
IMPRECISION, CVAT 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 HBVARIANTS*
No No No No Yes No No No
REAGENT TYPE Cartridge: Test disc: Cartridge: Cartridge: Lateral flow stripSample capillarywith hemolysis
vials or stepdropper, 2 liquidreagents, pipette,
cartridge
Sample capillarywith hemolysis
vials or stepdropper, 2 liquidreagents, pipette,
cartridge
Cartridge:Ready to use Add reagents to
sample and discShake reagents
before takingsample
Shake reagentsbefore taking
sample
Ready to use
Competitor analysis II
Axis ShieldNycocard
Infopia CloverHemocue 501
(OEM of Clover)Boditech i-CHROMA
Ceragem LabonaCheck™
Ceragem Cera-Stat 2000
Bio-Rad IN2ITHumaMeter A1c
MEMORY: PATIENT& QUALITYCONTROL 7,000 P & QC Last Patient 200 P 200 P 300 results 300 results 200 P & QC
REAGENTSTORAGE
12 months @ 2 -8°C; thereof 90days at roomtemperature
2 - 8°C 90 days atroom temperature Room temperature Room temperature 2 - 8°C 20 months 2 - 8°C
2 - 8°C 30 days atroom temperature
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STORAGE temperature room temperature Room temperature Room temperature 2 - 8°C 20 months 2 - 8°C room temperature
OPERATINGCONDITIONS 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 IDmanual 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 upOptics 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
Axis ShieldNycocard
Infopia CloverHemocue 501
(OEM of Clover)Boditech i-CHROMA
Ceragem LabonaCheck™
Ceragem Cera-Stat 2000
Bio-Rad IN2ITHumaMeter A1c
DEVICECHARACTER-
ISTICSMultilingual
display
DCCT reportingonly
Dual reporting Dual reporting DCCT reportingonly
Reporting eitherDCCT or IFCC,touch screen
Reporting eitherDCCT or IFCCand Hb, touch
screen
Symbols andcodes used on
display
Dual Reporting,user selectableunits % DCCT,
mmol/mol IFCC,% JDS, eAG
Requires multiplepipette steps
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% JDS, eAGmg/dl and eAG
mmol/l
OTHER ANALYSIS NoCRP, D-Dimer,Micro Albumin
Blood glucoseOptional module
PSA, D-dimer,HS-CRP, TROP No Hemoglobin No No
APPROVALS CE 510(k) 510(k) CE CECLIA waived
CLIA waived CLIA waived
MAXIMUM TIMEPERMITTEDAFTER BLOOD
7 minutes 30 seconds 5 minute 5 minute 10 seconds 10 secondsCOLLECTION
SIZE AND WEIGHT
95x205x135 mm0.7kg
200x170x170mm0.54kg
200x200x139mm1.4kg
185x80x250mm1.3kg
178x195x77mm0.73 kg
178x195x77mm0.73 kg
140x100x145mm0.84kg
140x100x145mm0.84 kg
OTHER Easy operation
Reagents stableat room
temperature for 1month
Multi-step manualprocess
OEM of Clover
Reagents stablefor 20 months
Multi step manualprocess
Updated nycocardwith multi-step
manual processMulti-step manual
process
Noisy in use
Noisy in use
Bulky cartridgestake up lots of
refrigerator space
Insert cartridgeinto machine then
insert reagentpack with sample(2 steps instead
of 1)
Bulky cartridgestake up lots offridge space
1 cartridge mustbe 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
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• Why must the reagent cartridges be removed from storage40 minutes before use?
• Which fingers should be used for taking a blood sample?
• How long does HumaMeter A1c take to provide results?