GluCoA1c Analyzer

Product and Sales Training

 All those years
1969
Iranian scientist Samuel Rahbar.
Discovery of HbA1c as a marker of Glycemic status in persons with diabetes

1976
HbA1c become as a marker for diabetes.

1983-1993

DCCT (Diabetes Control and Complications Trial): for Type I diabetes patients, intensive
therapy to control the level of blood glucose and HbA1c can significantly reduced the
complications.
 1996
Formation of NGSP (National Glycohemoglobin Standardization Program):
standardize HbA1c test results to those of the Diabetes Control and Complications
Trial (DCCT).

2000

UKPDS (The United Kingdom Prospective Diabetes Study): The study focusing on type II
diabetes showed that
Every 1% decrease in HbA1c, the risk of complications drop by 35% .

2004

ADA/EASD/IDF Working Group of the A1c Assay introduce the concept of eAG
(Estimated Average Glucose)

eAG(mg/dl)= (28.7*HbA1c)-46.7
 2007
In 2007, the IFCC recommended that IFCC HbA1c be expressed as mmol HbA1c/mol Hb.

2010

The ADA recommends using HbA1c to diagnose diabetes and prediabetes

 Brief of HbA1c

-Glycohemoglobin , also referred as HbA1c

-Formed by hemoglobin's exposure to blood glucose

-HbA1c formation is stable for 60-120 days

-HbA1c can determine average blood level over the previous 3-months
 Clinical Significance of HbA1c

Through which can know the control of the blood glucose in the recently 2-3 months

The HbA1c is the golden standard of diagnosing and controlling the diabetes.

Improve diabetes outcomes, and has strong predictive value for complications.
Lowering HbA1c reduces complications.
Every 1% decrease in HbA1c, the risk of complications drop by 35% .
Assesses the effectiveness of therapy, more timely treatment change

IDF
IDF(International Diabetes
(International Diabetes Federation)
Federation)

Measuring HbA1c every two to six months depending on

level, stability of blood glucose control and changes in
therapy
 Three ways to diagnose diabetes

1. Fasting Plasma Glucose (FPG)

Diabetes is diagnosed at fasting blood glucose of greater than or equal to 126 mg/dl

Result Fasting Plasma Glucose (FPG)

Normal less than 100 mg/dl

Prediabetes 100 mg/dl to 125 mg/dl

Diabetes 126 mg/dl or higher

Deficiency:
-Need fasting for at least 8 hours;
-Fluctuated because of random factors, has risks of prediabetes or diabetes undiagnosed.
 2. Oral Glucose Tolerance Test (also called the OGTT)
Checks your blood glucose levels before and 2 hours after you drink a special sweet drink

Diabetes is diagnosed at 2 hour blood glucose of greater than or equal to 200 mg/dl

Oral Glucose Tolerance

Result
Test (OGTT)
Normal less than 140 mg/dl
Prediabetes 140 mg/dl to 199 mg/dl
Diabetes 200 mg/dl or higher

Deficiency:
- Need fasting for at least 8 hours;
- Complicated test procedures and time consuming.
- Test experience is poor
3. HbA1c Test

Group HbA1c (NGSP) HbA1c (IFCC)

Normal < 5.7% < 39 mmol/mol
Prediabetes 5.7 - 6.5% 39 - 48 mmol/mol
Diabetes ≥ 6.5% ≥ 48 mmol/mol

-Not need of fasting

-Quick and easy operation Advantages
-Result is stable and reliable

ADA (American Diabetes Association)

from 2010

EASD (European Association for IDF (International Diabetes Federation)

the Study of Diabetes)

WHO (World Health Organization) CDS (Chinese Diabetes Society)

 Facts & Figures
In 2017

-Approximately 425 million adults (20-79 years) were living with diabetes; by 2045 this will
rise to 629 million

-1 in 2 (212 million) people with diabetes were undiagnosed

-Diabetes caused 4 million deaths

-Diabetes caused at least USD 727 billion dollars in health expenditure in 2017 – 12% of
total spending on adults

-More than 1.1 million children were living with type 1 diabetes

-352 million people were at risk of developing type 2 diabetes

Data Source from “IDF Diabetes Atlas 8th Edition 2017 Global fact
sheet”
Why is HbA1c Testing at Point of Care?

Preliminary screening for effective prevention of diabetes

1

Timely diagnosis for early treatment of diabetes

2

Regular monitoring to improve self-management of patients

3

Timely adjustment of therapy to reduce complications

4

Facilitating physician-patient communication, data collection

5
and diabetes management

6 Reduce the outpatient-feedback time, reduce the anxiety of

patients
 What’s our unique?

Afinion AS100 Bio-Rad in2it

Siemens DCA Vantage
i-CHROMA Reader

NycoCard Reader II CERA-STAT 2000

Infopia Clover A1c

A1c POCT Family

 We Are World Only Handheld
HbA1c Analyzers

A1c EZ 2.0 GlucoA1c Analyzer

Handheld= Convenience &make revolution happens

Protest! I’m also
handheld -Meter will be discarded every 10-20
tests. Not economic and high-cost

-Test cartridge stored in refrigerator

-Immuno-assay methodology POCT, easily

be interfered by many factors.
PTS Diagnostics A1CNow
 Our advantages (Sales points)
Key Technology
“Boronate affinity chromatography on a Strip”.
Make it possible:
1. Make boronate affinity methodology performed on handled analyzer.
(Boronate affinity’s performance is more close to HPLC than immunoassy)

2. Dry chemical strip. Reagents and test strips stored at room temperature for 18 months.

3. Non- quantitative sampling.

4. Testing cost down. Excellent Quality/Price ratio for HbA1C POCT .

5. Wide working condition range:10-40 ℃.

While we still keep outstanding performance
 Precision : CV < 3%

 Test range from 4% to 14%

 5 minutes for the test time

 Accuracy : certificated by NGSP and IFCC

 Mainstream A1c Analyzers in the market

HPLC
Large-scale
Analyzers

Tosoh HLC-723 G8 Bio-Rad D-10 ARKRAY A1c HA-8180 PRIMUS Ultra2 HbA1c Drew Scientific DS5 Runda MQ-2000PT

LPLC
Large-scale
Analyzers

Main Competitors
AUDICOM AC6600 Laola JL－760 Lifotronic GH-900Plus

Immunoassay
POCT
Analyzers

PTS Diagnostics Siemens DCA Vantage Wanfu PCT FS112 i-CHROMA Reader GOLDSITE Genius PA50 HORRON H618 SD A1cCare
A1CNow NEPHSTAR PLUS

Boronate
Affinity POCT
Analyzers

Afinion AS100 NycoCard Reader II CERA-STAT 2000 Infopia Clover A1c Bio-Rad in2it GlucoA1c
Confidential
 Siemens Alere Alere Infopia Bio-Rad BioHermes
PTS Diagnostics
Products
A1CNow DCA NycoCard
Reader II Afinion AS100 Clover A1c in2it GlucoA1c
Vantage

Methodology Immunoassay Boronate Affinity

About 3 µL
Blood volume 5 µL 1 µL 5 µL 1.5 µL 4 µL 10 µL
（Non-quantitative）

Test Time 5 min 6 min 4 min 3 min 5 min 10 min 5 min

CV < 4% < 3% < 5% < 3% < 4% < 4% < 3%

Test Range 4.0-13.0% 2.5%-14.0% 4.0-15.0% 4.0-15.0% 4.0-14.0% 3.0-18.0% 4.0-14.0%

Working condition 18~28 °C 15~32 °C 18~25 °C 15~32 °C 17~32 °C 18~27 °C 10~40 °C

Storage Condition
2-8°C 2-8°C 2-8°C 2-8°C 2°C~32°C 2-8°C Room temperture
before expired

14 days for
Reagents Storage at
4 month 3 months R1;8 weeks 3 months N/A 1 month 18 months
RT
for R2

International NGSP,
NGSP, IFCC NGSP, IFCC NGSP, IFCC NGSP, IFCC NGSP, IFCC NGSP, IFCC
Certificates IFCC
Printing Support N/A Yes No Yes Yes Yes Yes
Data Transfer USB USB USB USB USB USB Bluetooth, USB
Data Storage
N/A 4,000 N/A 500 200 200 1,000
Capacity
Voice prompt No No No No No No Yes

25.4 x 28.7 x
20 x 17 x 7 32 x 17 x 17 cm, 5 20 x 20 x 13.9 cm, 10 x 13 x 12 12.6 x 6.46 x 2.35
Size and Weight N/A 27.7 cm,
cm, 540g kg 1.4kg cm, 840g cm, 99.5g
3.88kg
 Applied Markets of GluCoA1c

 OTC market
Before: limitations of cost and convenience almost blank for HbA1c in OTC
market in most countries.
-HbA1c combined with glucose testing make GlucoA1c more easily to penetrate to
OTC market.
GlucoA1c Analyzer makes the popularization of HbA1c home testing possible.
Greatly improve patient self-management of diabetes.
 GP (general practitioner)

Primary medical institutions

Before: Limitations of test devices and environment
lead to a low penetration rate of HbA1c monitoring.

GlucoA1c Analyzer is conductive to diabetes screening

projects: timely diagnostics of diabetes.

Clinics (specialist Clinics, out-patient clinics , etc.)

Laboratories and hospitals

 Analyzer Overview
6.46 cm
（2.54 inch）

2.35cm
（0.93 inch）

12.6 cm
(4.96 inch)

Weight：99.5 g
 Glucose testing strip slot

Display Screen (Non-Touch Screen)

Code chip slot

Code chip

Buttons

Buffer Port
Sampler port
HbA1c testing strip slot
 Batteries charge interface

Code chip slot

BL-5C batteries
(3.7V Li-ion 800mAh)

Back Cover
Reagent Kit Overview-HbA1c Kit

Buffer A Buffer B Code Chip

Sampler
Testing strip
Reagent Kit Overview-Blood Glucose Kit

Testing strip
 Setting before Operation
Two ways to enter setting mode
(1) Re-install the batteries.
(2) When analyzer is ON, press and buttons together and
hold for 2 seconds .

Parameters setting include:

Date and Time, Audio, Bluetooth, Measurement unit,
Before/After meal mark, Glucose test alarm setting,
Hypoglycemia warning function, and ketone warning
function, etc.
 Real-time temperature Before/After meal mark

x
c
Glucose test alarms: maximum can set 5 alarms Hypoglycemia warning：if blood
glucose less than the setting
value, get warning.

Glucose test alarms: if the blood glucose is higher than 298

mmol/L (16.6mmol/L), get warning
 Perform a HbA1c Test

Materials preparation Hands washing

Code number on code chip,
package and display screen
should be the same.
When screen display “blinking
strip symbol” or hearing the voice
hint “please insert the test strip”,
insert the HbA1c strip and get
one sampler ready.

When the test strip is correctly inserted, the

analyzer will give voice hint “please collect
blood sample and add 3 drops of buffer A”.
Prick the finger to collect with sampler. Use
the sampler to absorb the blood sample fully,
waiting for applying.
 Vertically add 3 drops of buffer A to the buffer port.
Analyzer will start to count down for 10 seconds

When screen display “Add bld” or hearing the voice

hint “Please apply the blood sample” , press the
sampler onto the sampler port for 3 seconds.
 After applying the blood sample, 130 seconds
countdown will start after while.

When screen display “Add b” or hearing the voice

hint “Please apply 2 drops of buffer B to the buffer
port” , vertically add 2 drops of buffer B to the
buffer port.
About 40 seconds after adding the
buffer B, the analyzer will start a 130
seconds countdown, then give the
HbA1c result.
 Principle review of each step
• Key Notes：

- Boronate affinity chromatography on strip

- Two phases （A&B） chromatography

- 415nm LED detection in each phase

Phase A：Detect total Hb
Phase B：Detect Glyco-Hb
Carboxyl group

Boronate group

Non-Glyco Hb
(pH 6.5)

Glyco Hb
(pH 6.5)
Carboxyl group

Boronate group

Non-Glyco Hb
(pH 6.5)

Glyco Hb
(pH 6.5)
Glyco Hb
(pH 9.5)
 Boronate group
Carboxyl group

Glycohemoglobin
Glycohemoglobin
Hemoglobin

Carboxyl group

Glycohemoglobin Phase B light absorption

Hemoglobin
﹪＝ Phase A light absorption ﹪
 Operation Notices
Make sure the strip is inserted in the full place
Make sure no up-warp of strip after inserting
Make sure the sampler-thread absorb the blood fully
Vertically add the buffer drops
 Make sure the buffer port is not blocked or contaminated

Port clean and clear Port blocked

 Easy-Maintenance
Clean the analyzer surface, LED source area, large and small panels
with cotton swab or 75% alcohol swab if necessary.

Small and large panels

LED light source area

Perform a blood glucose test and HbA1c
test together

Materials preparation Hands washing

Code number on code chip,
package and display screen
should be the same.
 Insert the strip: pay attention to
the inserting direction

Insert the HbA1c strip and

get one sampler ready

sampler
 Get the result after 5 seconds
countdown and gives the
blood glucose result

-Press the button to enter

the HbA1c test model.
-The analyzer will give voice hint
“please collect blood sample
and add 3 drops of buffer A”
-Use the sampler to absorb the
blood sample fully, waiting for
applying.
 Vertically add 3 drops of buffer A to the buffer port.
Analyzer will start to count down for 10 seconds

When screen display “Add bld” or hearing the voice

hint “Please apply the blood sample” , press the
sampler onto the sampler port for 3 seconds.
 After adding the buffer A, 130 seconds countdown
will start after while.

When screen display “Add b” or hearing the voice

hint “Please apply 2 drops of buffer B to the buffer
port” , vertically add 2 drops of buffer B to the
buffer port.
About 40 seconds after adding the
buffer B, the analyzer will start a 130
seconds countdown, then give the
HbA1c result.
 Popular methodologies for HbA1c Testing

 Ion exchange
Technology: High Performance Liquid Chromatography (HPLC).

Boronate Affinity HPLC

 Boronate Affinity

Non-HPLC

lmmuno-turbidimetry
 Immunoassay:
fluoroimmunoassay
 Ion exchange HPLC
HP Pump

Sample Port

Separation Column based

on ion-exchange
Under pH 6.0-6.5 condition:
-Glyco Hb and Non-Glycoh Hb
has different number of positive charges

-Non-Glyco Hb more easily to bind onto the Detector

column

- Glyco Hb and Non-Glyco Hb thus be separated

 HbA1c peak area
HbA1c ﹪＝ Total peak area
﹪

HbA0

HbA1c
 Ion-exchange HPLC products

ARKRAY A1c HA-

Tosoh HLC-723 G8 Bio-Rad D-10 8180

PRIMUS Ultra2 HbA1c

Advantages and disadvantages of Ion-exchange
HPLC method
a. High accuracy
b. good repeatability (CV)
c. Usually full-automatic and high-throughput
Gold standard to for HbA1c detection

a. Expensive
b. Affected by hemoglobin variants
Boronate Affinity
 Boronate Affinity: HPLC
HP Pump

Sample Port

Separation Column based

on boronate affinity

Glyco Hb and Non-Glycoh Hb has different affinity to

the boronate group stabilized on the column

-Glyco Hb more easily to bind onto the column while

Detector
Non-glyco Hb be washed out

- Glyco Hb and Non-Glyco Hb thus be separated

 Boronate affinity method products
Boronate Affinity HPLC

Premier Hb9210™
Trinity Biotech
Boronate Affinity Non-HPLC

Afinion NycoCard CERA-STAT Infopia Bio-Rad BioHermes

AS100 Reader II 2000 Clover A1c in2it GlucoA1c
Advantages and disadvantages of boronate
affinity method
a. Least affected by hemoglobin variants
b. Good CV performance
c. High correlation with HPLC method
d. Convenient, quick and cost-effective

a. Not directly measure HbA1c：

measure total Glyco-Hb first then
transfer to HbA1c through
formula.
b. Not provide additional variants
information as HPLC do.
 Immunoassay method
lmmuno-turbidimetry

HbA1c makes Latex

Particles aggregated

The more aggregated the

less light pass through
 Immunoassay method products
lmmuno-turbidimetry

PTS Diagnostics Siemens DCA Vantage

A1CNow

Fluoro-immunoassay

SD A1cCare
i-CHROMA
Reader
Advantages and disadvantages of immunoassay-
method

a. Good sensitivity and specificity

b. Can be integrated to biochemical apparatus

a. Easily be affected by components

in the blood samples, such as:
cholesterol and icterus.
b. Easily be cross-contaminated。
 Biohermes’ Vision and Mission
Vision To be the most reputable IVD medical company in
the world.

Mission To provide most convenient, accurate, and affordable

A1C tests to the people for prevention of diabetes.

Focus on HbA1c testing development and innovation