humameter a1c product presentation rev 02 · nycocard infopia clover hemocue 501 (oem of clover)...

HumaMeter A1c

HumaMeter A1c

1. Product Overview

2. HbA1c and Diabetes

3. Performing a Test

4. Basic Maintenance

HumaMeter A1c

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.

HumaMeter A1c

HumaMeter A1c Analyser

Largebacklitdisplay

Door withautomaticswitch

Reagentcartridge

HumaMeter A1c

cartridge

Barcodescanner

Product Features

Practical Fast andData

HumaMeter A1c

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)

HumaMeter A1c

• 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

HumaMeter A1c

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:

HumaMeter A1c

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

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.

HumaMeter A1c

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)

HumaMeter A1c

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

HumaMeter A1c

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)

HumaMeter A1c

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

HumaMeter A1c

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.

HumaMeter A1c

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

HumaMeter A1c

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

HumaMeter A1c

• 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

HumaMeter A1c

• 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

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.

HumaMeter A1c

Performing a Test

Set Up

• Make sure a tray of cartridges & the analyserare equilibrated to working temperature(room temperature)

• Scan lot calibration barcode

HumaMeter A1c

• 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

HumaMeter A1c

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

HumaMeter A1c

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

HumaMeter A1c

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

HumaMeter A1c

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:

HumaMeter A1c

• 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.

HumaMeter A1c

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.

HumaMeter A1c

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

Basic Maintenance

Cleaning Procedure

• Clean the analyser with anon-abrasive lint free cloth.

• Use a mild detergent orcommercially available

HumaMeter A1c

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

HumaMeter A1c

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.

Competition

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 -

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






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

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






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

% 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

HumaMeter A1c

• 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?

humameter a1c product presentation rev 02 · nycocard infopia clover hemocue 501 (oem of clover)...

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