HumaMeter A1c Analyser

Report
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

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