Clover A1c

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• The sugar in your blood is called glucose.

When glucose builds up in


your blood, it binds to the hemoglobin in your red blood cells. The
A1c test measures how much glucose is bound.
• Red blood cells live for about 3 months, so the test shows the average
level of glucose in your blood for the past 3 months.
• If your glucose levels have been high over recent weeks, your
hemoglobin A1c test will be higher.
Hemoglobin terglikasi (HbA1c)

Glycation is the nonenzymatic


addition of glucose to amino
groups of proteins.

HbA1c is a glycated hemoglobin


in which glucose is bound
specifically to the N-terminal
valine of the hemoglobin β
chain.

HbA1c Orang normal 4-6%


DM 8-20%
Hemoglobin

HbF (α2,ᵧ2) HbA (α2,ß2) HbA2 (α2,2)


(0.5% of Hb) (97% of Hb) (2.5% of Hb)

HbA0 HbA1
(94% of HbA) (6% of HbA)
Non Glycated
hemoglobin
HbA1a HbA1b HbA1c
(0.4% of HbA) (0.4% of HbA) (5% of HbA)

HbA1a1 HbA1a2 Glycated hemoglobin

(0.2% of HbA) (0.2% of HbA)


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Setting Goals for A1c Levels
• The target A1c level for people with diabetes is usually less than 7%. The higher the hemoglobin A1c,
the higher your risk of having complications related to diabetes. Someone who has had untreated
diabetes for a long time might have a level above 8%.

• If you have diabetes and your level is above your target, your doctor may change your treatment
plan to get your level down.
• A combination of diet, exercise, and medication can bring your levels down.
• People with diabetes should have an A1c test every 3 months to make sure their blood sugar is in
their target range. If your diabetes is under good control, you may be able to wait longer between
the blood tests. But experts recommend checking at least two times a year.
• People with diseases affecting hemoglobin, such as anemia, may get misleading results with this
test. Other things that can affect the results of the hemoglobin A1c include supplements such as
vitamins C and E and high cholesterol levels. Kidney disease and liver disease may also affect the
test.
https://www.webmd.com/diabetes/guide/glycated-
hemoglobin-test-hba1c
Distinguishing between Glycated Hemoglobin, Glycated Albumin, and Blood Glucose

For Confirming Diabetes Treatment Efficacy


Directly measures blood glucose at a single point in
time
Blood Glucose Test The blood glucose test measures the amount of blood
glucose at the time the blood sample is drawn. Blood
glucose fluctuates depending on food intake, level of
physical activity, and physical condition.

Provides an index by which treatment efficacy can be


Glycated Albumin evaluated and treatment regimens assessed.
(GA) Test The GA test measures mean glycemic control over the
previous three weeks.

Assesses average glycemia over an extended time


period
Glycated
Hemoglobin The HbA1c test measures mean glycemic control over
(HbA1c) Test the previous two months. Short-or medium-term
changes in average blood glucose cannot be suitably
assessed with the HbA1c test.
Page  11
What are the benefits of lowering HbA1c?

Improving HbA1c for people suffering from Diabetes cuts the


risk of complications such as:

benefits of lowering HbA1c


https://www.lalpathlabs.com/blog/importance-of-hba1c-
blood-test/
Proces to standardisation 1995 IFCC –
WG HbA1c standardisation
reference procedure with purified primary calibrators,
network of reference laboratories and implementation of
traceability to the IFCC reference system
defined analyte - βN1-deoxifructosyl-haemoglobin
recommended units - mmol/mol 1996 – NGSP
initiated to standardise GHb test results among
laboratories to DCCT-equivalent values
manufacturers of HbA1c assays should follow
traceability to the IFCC reference method 1997 –
IFCC Committee
higher-order reference method and reference materials
2001 – Method approved (manufacturers)
Variety of changes in reporting HbA1c E
1. A1C test results should be standardized worldwide,
including the reference system and results reporting.
2. The new IFCC reference system for A1C represents the
only valid anchor to implement standardization of the
measurement.
3. A1C results are to be reported worldwide in IFCC units
(mmol/mol) and derived NGSP units (%), using the IFCC-
NGSP master equation.
4. If the ongoing “average plasma glucose study” fulfils its
a priori–specified criteria, an A1C-derived average glucose
(ADAG) value calculated from the A1C result will also be
reported as an interpretation of the A1C results.
5. Glycemic goals are expressed in IFCC units, derived
NGSP units, and as ADAG. Consensus on
reporting HbA1c results International consensus
agreement among the ADA, EASD, IDF, and IFCC signed in Milan, Italy, in 2007.
Diabetes Care 2007; 39(9): E.Topić, 2014
Standardization of HbA1c Assays

• The Diabetes Control and • The IFCC Working Group on HbA1c


Complications Trial (DCCT) has Standardization prepared primary
reference materials and developed a
demonstrated that HbA1c is an reference method for HbA1c. According
indicator for the development of to the consensus agreement of
diabetes [1]. The National international and national diabetes
Glycohemoglobin Standardization associations from May 2007 [3], all IVD
Program (NGSP) has introduced a manufacturers should implement
standardization  based on the traceability to the IFCC reference
system for HbA1c. In future, IFCC
DCCT reference method results should be reported in
improving the inter-laboratory mmol/mol (SI unit) and NGSP units in %
comparability of HbA1c using the IFCC-NGSP master equation.
• The CLOVER A1c Test Cartridge is composed of a Cartridge and a Reagent Pack containing the reagents necessary for
the determination of hemoglobin A1c, with a collection leg for blood sample collection.

The Reagent Pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse
erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin. Blood
sample (4µL) is collected at the collection leg of the Reagent Pack, then the Reagent Pack is inserted into the Cartridge,
where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin. The
assembled Cartridge is inserted into the CLOVER A1c Analyzer and rotated so that the blood sample mixture is placed at
the measurement zone of the Cartridge, where the amount of total hemoglobin in the blood sample is measured by the
reflectance of the photo sensor LED (Light Emitting Diode) and PD (Photo Diode).

Then, the assembled Cartridge is rotated so that the washing solution washes out non-glycated hemoglobin from the blood
sample, thus the amount of glycated hemoglobin can be photometrically measured.

The ratio of glycated hemoglobin with respect to total hemoglobin in the blood sample is calculated.

Fully Automatic
Boronate Affinity
Spectrophotometry
4µL Blood Sample
Test Result in 5 Minutes

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