G8 Variant EN Rev 09072013 01

Tosoh Automated
Glycohemoglobin Analyzer
HLC-723G8
Variant Analysis Mode
The Diabetes Epidemic and the role of HbA1c
Diabetes is recognised worldwide as a disease that is reaching epidemic proportions. (1)
The significance of HbA1c for the diagnosis and follow-up of diabetes has increased with the continuing rise in the
number of patients. This represents a significant workload challenge to many laboratories.
How to measure HbA1c?

One of the reference methods for HbA1c measurement
is “High Performance Liquid Chromatography”, better known
as “HPLC” (this method was also used in the DCCT and UKPDS trials). With this technique the different haemoglobin
fractions are separated based on charge.
When using the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (G8) separation of the haemoglobin
fractions is obtained by use of a negatively charged column and positively charged buffers that compete with the
different haemoglobins to bind to the column (=cation exchange). Tosoh offers you over 35 years of world leading
HPLC experience.
Diabetes IDF region
Adult Population (20-79) in 1000s
Diabetes cases (20-79) in 1000s
Diabetes national prevalence (%)
Undiagnosed
related deaths (20-79)
Mean diabetes-
Diabetics in 1000s
Undiagnosed
related expenditure Diabetics %
per person with diabetes (EURO)
WORLD 4,479,259 371,329 8.29 % 187,087 4.18 % 4,802,747 1,027
EUR 655,983 54,942 8.38 % 21,204 3.23 % 622,114 2,043
MENA 366,249 34,163 9.33 % 18,114 4.95 % 356,586 285
AFR 398,113 14,920 3.75 % 12,148 3.05 % 401,276 135
Flow HbA HH

V-2
Time H
bA
HV-1 H
bF
HV-0 L
-HbA
-HbA
bA
Why use HPLC?
Besides being the method used during the DCCT and UKPDS trials different arguments are raised in literature.
“The method of choice should measure HbA1c highly precisely; should be economical, automatable and simple to perform;
and should yield results that are comparable between different laboratories, ...one should use a method that meets the
following conditions: The Hb variant should be recognised; and HbA1c , HbA0 and Hb variants should be separated and
quantified reliably.” (2) “The advantage of HPLC lies in its ability to separate variant haemoglobins and, in doing so, allowing
better interpretation of the result!” (3)
The Importance of low CV%

HbA1c can be used for three specific applications*:
1. For identifying risk: HbA1c could

be used as a tool, among other parameters, to identify individuals at risk for
developing diabetes. The American Diabetes Association (ADA) suggested 5.7 – 6.4 % (39 – 47 mmol/mol) as the
high risk range. (4,5)

2. For Diagnosis.
An international expert committee assembled by the American Diabetes Association (ADA), International Diabetes
Federation (IDF), and European Association for the Study of Diabetes (EASD) has recommended the HbA1c assay as the
new test for the diagnosis of diabetes. An HbA1c value greater than or equal to 6.5 %, or 48 mmol/mol, is used as cut-off for
the diagnosis of diabetes. Diagnosis should be confirmed with a repeat HbA1c test. (4,5)

3. For treatment follow-up.

Lowering HbA1c to below or around 7 %, or 53 mmol/mol, has been shown to reduce micro-vascular and neuropathic
complications of type 1 and type 2 diabetes. HbA1c of
≥ 7 %, or 53 mmol/mol, should initiate or change therapy to reach an
HbA1c level
of < 7 %, or 53 mmol/mol. Relevant changes in serial measurements of HbA1c testing
serve as the guide to
changes in therapeutic regimes. (6,7)

The Coefficient of Variation (CV) determines the difference between two serial HbA1c measurements.
At a medical decision
point of 7 %, or 53 mmol/mol, a healthcare provider should be able to conclude that a significant difference of 0.5 %, or 5
mmol/mol, is caused by a change in glycaemic control of a patient and not by the analytical imprecision. For that reason the
CV% of the method should be ≤ 2.4 %. (8)
“...95 % of the laboratories using a method from Tosoh were able to meet the criteria of having an analytical CV% of ≤ 2.4 %!”
(8)
The G8 will deliver:

• Precision Direct determination of stable HbA1c with
less than 1 %
CV.
• Speed Stable HbA1c result
with variant detection in 1.6 minutes, Time to first result is 3.5 minutes.
• Operational Simplicity With cap piercing, positive sample identification, automated maintenance, the G8 is
simplicity itself.
• Absence of Interference In the presence of the most common haemoglobin variants, HbF or haemoglobin derivatives
such as labile and carbamylated haemoglobin, HbA1c results
are unaffected.
* Official guidelines on the use of HbA1c may

vary from country to country.
Speed A high quality and productivity HPLC solution f
Simply load sample racks and press ‘Start’, it’s that easy!
• Automated daily maintenance.
• A user friendly touch screen enables easy instrument operation.
• Simple finger tight connectors permit quick, convenient and easy replacement of columns and
pre-filters.
• Constant visual monitoring of buffer consumption with customisable alarm to notify when buffers
need replacing.
Compact W 530
mm D 515 mm H
482 mm 34 kg
The G8 can manage an ever increasing workload and easily adapts to

changing laboratory needs!
• The analyser is available with a 90 or 290 sample loader.
• A built-in STAT position allows emergency samples to be analysed without disrupting routine
analysis.
• Different sample types and sizes can be loaded continuously onto the system together with
secondary tubes, in any order in any rack.
• Complements with Tosoh’s HLC-723GX (GX) which is ideal for low volume HbA1c testing or as
backup analyser.
solution for dealing with your laboratory’s HbA1c

needs.
Buffer
ES Flex
The G8LA easily integrates in any open laboratory automation system, increasing:
• Analysing capacity and throughput
• Efficiency
• Flexibility
• Connection is achievable in combination with other lab analysers or as G8LA-only work cell.
G8LA workcell
U-TurnU-Turn
Unique software to ensure the most advanced data management capabilities!

• Bidirectional interfacing allows connection to the Laboratory Information Systems (LIS).
• Optional integration to Tosoh’s data management software allows full data management capabilities including:
• Patient linked result validation
• Chromatogram review with overlay and library facility
• Full QC-package including Levey-Jennings charts
• Reagent logging and audit trail
• Data storage and full result archiving
• Economical multi-instrument interfacing
Customisable alarm / flag system ensures an unparalleled level of patient safety!
• A highly developed flag check function allows easy programming of user-selectable levels to ensure easy
interpretation of results with increased security.
• Unique TSKgel column and peltier controlled column oven guarantee stable results.
• Customisable alarms offer a high level of security and aid in the interpretation of results.
The G8 is the ideal solution for reliable diabetic patient monitoring!
• HbA1c results are directly determined with less than 1 % CV and are reportable to 2 decimal places.
• HbA1c results are NGSP / DCCT and IFCC certified.
Intra-Assay precision Inter-Assay precision N = 20 Mean HbA1c (%) CV (%) Mean HbA1c (%) CV (%) Normal value
5.53 0.42 5.67 0.48
Intermediate value 8.25 0.44 8.54 0.25
Elevated value 10.39 0.40 12.44 0.36
Source: Evaluation of the G8 analyzer and PIANO software (Tosoh Bioscience) for glycated haemoglobin determination. Fonfrède et.al. Spectra Biologie October 2007, N° 161, page 38 - 45.
Best-in-class chromatographic separation!

• Separation of labile A1c from stable A1c is
achieved without the loss of precision or resolution and without
manipulating the sample or using mathematical artefacts (algorithms).
• Results are unaffected by the presence of the most common haemoglobin variants, HbF or haemoglobin derivatives
such as labile HbA1c and
carbamylated - or acetylated haemoglobin.
• Suspected presence of HbE will trigger a specific flag.
normal patient* Diabetic patient* hbAS patient*
For in depth analysis of patients presenting haemoglobin variants, you can just switch to the
“ß-Thalassaemia” analysis mode, allowing high resolution detection of this pathology.
CAL(IN) = 12.4025x - 19.0939
TP 620
NAME % TIME AREA FP 0.00 0.00 0.00 A1A 0.54 0.25 5.00 A1B 0.66 0.29 6.16 F 0.56 0.36 5.28 LA1C+ 1.34 0.47 12.46 SA1C 5.26 0.57 39.91 A0 93.19 0.89 869.01
TOTAL AREA 937.83
IFCC 34 mmol/mol
HbA1C 5.26%
CAL(IN) = 1.1165x + 0.5518
TP 646
NAME % TIME AREA FP 0.00 0.00 0.00 A1A 0.53 0.24 4.53 A1B 0.74 0.31 6.32 F 0.48 0.39 6.46 LA1C+ 1.46 0.49 12.59 SA1C 5.73 0.59 39.88 A0 90.74 0.88 780.13 H-V1 34.94 1.20 465.13
TOTAL AREA 937.83
IFCC 34 mmol/mol
HbA1C 5.26%
HbA1 6.46% HbF 0.56%
HbA1 19.5% HbF 0.7%
0% 15%
HbA1 6.99% HbF 0.48%
0% 15%
0.0
0.0
0.0
1.0 1.01.02.0P00 1.54 1.06 13.28
P01 0.35 1.35 3.04
* HbA1C result is reportable.

0% 15%
CAL(IN) = 12.6586x - 19.4494

TP 675
NAME % TIME AREA FP 0.00 0.00 0.00 A1A 0.40 0.31 5.88 A1B 1.30 0.40 17.57 F 0.70 0.53 8.59 LA1C+ 2.20 0.61 29.11 SA1C 17.70 0.74 197.17 A0 80.40 1.08 1058.60
TOTAL AREA 1316.91
IFCC 34 mmol/mol
HbA1C 5.26%
Traceability to International Standards HbA1c results obtained with the G8 are traceable to the “National Glycohemoglobin
Standardization Program (NGSP; DCCT-aligned)” and the “International Federation of Clinical Chemistry (IFCC)”.
References
1. International Diabetes Federation. IDF Diabetes Atlas, 5th edn, Brussels, Belgium: International Diabetes Federation, 2011. Update 2012 on website
www.idf.org. 2. Halwachs-Baumann G, Katzensteiner S, Schnedl W, Pürstner P, Pieber P, Wilders-Truschnig M: Comparative evaluation of three assay systems for automated determination of hemoglobin A1c.
Clinical Chemistry 1997; 43(3): 511-517. 3. Chapelle JP, Teixeira J, Maisin D, Assink H, Barla G, Stroobants AK, Delzenne B, van den Eshof W: Multicentre evaluation of the Tosoh HbA1c G8 Analyser. Clin Chem
Lab Med 2010; 48(3): 365-371. 4. The International Expert Committee. International expert committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care 2009; 32(7): 1327-1334. 5. World Health
Organisation. Use of Glycated Haemoglobin (HbA1c) in the diagnosis of Diabetes Mellitus, WHO/NMH/CHP/CPM/11.1. Geneva. World Health Organisation, 2011. 6. Standards of medical care in diabetes – 2011. Diabetes Care
2011; 34(Suppl 1): S11-S61. 7. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B ; American Diabetes Association; European Association for the Study of Diabetes: Medical management of
hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes.
Diabetes Care 2009; 32:193-203. 8. Lenters-Westra E, Weykamp C, Schindhelm RK, Siebelder C, Bilo HJ, Slingerland RJ: One in five laboratories using various hemoglobin A1c methods do not meet the criteria for optimal
diabetes
care management. Diabetes Technology & Therapeutics 2011;13(4):429-433.
tOSOh EUROPE n.V. Transportstraat 4 3980
Tessenderlo - BELGIUM Tel : +32 (0)13 66 88 30 Fax :
+32 (0)13 66 47 49 www.tosohbioscience.eu
tOSOh BIOSCIEnCE ltD The Business Centre Edward Street, Redditch

Worcestershire B97 6HA - UK Tel : +44 (0)1527 592901 Fax : +44 (0)1527 592902
www.tosohbioscience.eu
tOSOh CORPORAtIOn BIOSCIEnCE DIVISIOn Shiba-Koen First Bldg. 3-8-2,
Shiba, Minato-ku, Tokyo 105-8623 - JAPAN Tel : +81-3-5427-5181 Fax :
+81-3-5427-5220 www.tosoh.com

G8 Variant EN Rev 09072013 01

Uploaded by

Copyright:

Available Formats

G8 Variant EN Rev 09072013 01

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

G8 Variant EN Rev 09072013 01

Uploaded by

Copyright:

Available Formats

What are some of the arguments for using HPLC to measure HbA1c?

What are some of the arguments for using HPLC to measure HbA1c?

What are the three main applications of using HbA1c levels?

What are the three main applications of using HbA1c levels?

Tosoh Automated

How to measure HbA​1c​?

Flow ​H​bA HH​

The Importance of low CV%

1. For identifying risk: ​HbA​1c could

3. For treatment follow-up.

The G8 will deliver:

* Official guidelines on the use of HbA​1c may

Speed ​A high quality and productivity HPLC solution f

The G8 can manage an ever increasing workload and easily adapts to

solution for dealing with your laboratory’s HbA​1c

Unique software to ensure the most advanced data management capabilities!

Best-in-class chromatographic separation!

* HbA​1C ​result is reportable.

CAL(IN) = 12.6586x - 19.4494

tOSOh BIOSCIEnCE ltD ​The Business Centre Edward Street, Redditch

You might also like

How to measure HbA1c?

Flow HbA HH

1. For identifying risk: HbA1c could

* Official guidelines on the use of HbA1c may

Speed A high quality and productivity HPLC solution f

solution for dealing with your laboratory’s HbA1c

* HbA1C result is reportable.

tOSOh BIOSCIEnCE ltD The Business Centre Edward Street, Redditch