Mol Diagn Ther 2010; 14 (1): 49-51

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ª 2010 Adis Data Information BV. All rights reserved.

Lucica GA-L Glycated Albumin Assay Kit

A New Diagnostic Test for Diabetes Mellitus
Takuji Kohzuma1 and Masafumi Koga2
1 Diagnostics Department, Asahi Kasei Pharma Corporation, Tokyo, Japan
2 Department of Internal Medicine, Kinki Central Hospital, Hyogo, Japan

Contents
Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
1. Disease Background and Need for Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
2. Current Diagnostic Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3. New Diagnostic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.1 Clinical Trial Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.2 Place in the Treatment Paradigm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Abstract Lucica® GA-L glycated albumin assay kit – key features

Diabetes mellitus is a worldwide healthcare issue, with the num- Diagnostic indication
ber of diabetic patients continuing to increase. Monitoring of glycemic control
Strict control of plasma glucose levels is critical in order to avoid Assay characteristics
the potentially severe complications of diabetes, making tests for Technology basis Enzymatic method
monitoring of glycemic control essential in the management of the
Measured parameter Glycated albumin
disease.
Sample type Plasma and serum
Glycated hemoglobin (HbA1c) measurement is currently the
most commonly used test to monitor glycemic control in patients Performance measures

with diabetes. Based on the results of the Diabetes Control and Linearity Glycated albumin concentration 0 –40 g/L,
Complications Trial (DCCT), an HbA1c level of <7% has been albumin concentration 0–80 g/L

recommended to prevent the onset and progression of chronic Reproducibility Between-run coefficients of variation 0.63 – 0.93%
diabetic complications. However, HbA1c may not be suitable for Specificity Addition of up to 30 mg/dL of bilirubin,
evaluating short-term variations in glycemic control, because of 800 mg/dL of triglycerides, 5.0 g/dL of glucose,
the long lifespan of erythrocytes (120 days). 75 mg/dL of ascorbic acid, 385 mg/dL of
hemoglobin, and 2.0 g/dL of human serum
Glycated albumin (GA) is an indicator of diabetes that is more γ-globulins did not affect the assay
sensitive to change in plasma glucose than HbA1c.
Requirements
Lucica GA-L is a new diagnostic test for measuring GA. The
Test location Laboratory
test is based on an enzymatic method that uses liquid reagents
requiring no preparation. Equipment Biochemical autoanalyzer

Measuring the GA level should provide useful information on Training Ability to use a biochemical autoanalyzer
glycemic control when monitoring effects of therapy for patients Time to result 10 minutes
with gestational diabetes, unstable plasma glucose levels, variant Cost
hemoglobins or diseases that shorten the lifespan of erythrocytes.
Similar testing cost compared with measuring glycated hemoglobin
50 Kohzuma & Koga

1. Disease Background and Need for Diagnostics
Diabetes mellitus continues to be an important healthcare
issue worldwide. Once diabetes has developed, treatment is dif-
ficult. If left untreated, diabetes can lead to complications such as
retinopathy, nephropathy, and neuropathy. In the terminal stage,
diabetes may result in blindness and a need for hemodialysis.
Intensive glycemic control is associated with a steady de-
crease in complications associated with diabetes.[1-3] Tests that
accurately reflect changes in levels of plasma glucose over time
are necessary for monitoring the glycemic control status.
2. Current Diagnostic Methods
Analysis of glycated hemoglobin (HbA1c), fructosamine,
glycated albumin (GA), and 1,5-anhydrogulucitol (1,5-AG)
levels can be used to monitor the glycemic status, and tests
measuring these analytes are mainly performed in the labora-
tory. HbA1c and fructosamine levels reflect the average gly-
cemic control status over periods of 2 months and 2 weeks,
respectively. 1,5-AG is a validated marker of short-term gly-
cemic control. 1,5-AG competes with glucose for reabsorption
in the kidneys, and is more tightly associated with glucose
fluctuations and postprandial glucose than the other markers.
HbA1c is the current standard indicator for monitoring
chronic glycemic control[4,5] and is an important target for the
treatment of diabetic patients.[6] However, HbA1c may not be
suitable for evaluating short-term variations in glycemic control,
because of the long lifespan of erythrocytes (120 days). In addi-
tion, HbA1c measurement is known to be affected by diseases
that reduce the lifespan of erythrocytes, such as hemolytic ane-
mia and renal anemia, as well as hemoglobin variants, and thus it
may not provide an accurate indication of glycemic control.[7,8]
Fructosamine is a short-term glycemic control index, but its
concentration is strongly influenced by the concentrations of
protein and low-molecular-weight substances coexisting in the
blood (e.g. bilirubin, hemoglobin, uric acid, etc.).[9] Since 1,5-AG
is reabsorbed in the renal tubules, its level is influenced by kidney
function and the renal threshold for glucosuria.
levels change too slowly. GA is measured to confirm the ef-
fectiveness of therapy and to adjust medication dosage in the
laboratory, and would be measured every 2 weeks when start-
ing antidiabetic therapy.
Moreover, measurement of GA levels provides correct in-
formation on glycemic control in cases of variant hemoglobins
and diseases that shorten the lifespan of erythrocytes, as HbA1c
does not properly represent the status of glycemic control in
patients with such diseases.[7,8]
Employing an enzymatic assay, the Lucica GA-L kit offers
exceptional reproducibility and specificity. Since GA values are
expressed by a ratio (%) of GA to total albumin, differences
among individuals and albumin concentrations have negligible
influences on the results.
The Lucica GA-L kit can be applied to automated general
biochemical analyzers. The kit reagents are liquid; therefore,
prior preparation is unnecessary. Since both serum and
plasma can be used as samples for measuring GA, GA can be
analyzed along with common biological markers including
glucose, cholesterol, and triglyceride, without requiring a
separate blood collection.
3.1 Clinical Trial Data
A total of eight patients with untreated type 2 diabetes were
recruited from outpatients at Kinki Central Hospital (Hyogo,
Japan). GA and HbA1c were simultaneously measured before
and 2 weeks after intensive insulin therapy. HbA1c values before
and after therapy were 10.9 – 2.1% and 10.0 – 1.4% (mean – SD),
respectively, showing a 0.9% decrease. In contrast, GA values
before and after therapy were 35.6 – 7.7% and 25.0 – 3.8%
(mean – SD), respectively, showing a 10.6% decrease (figure 1).
HbA1c
GA
a b
16
50 10.6
14
40
35.6 12
30 10
(%)

25.0 8
3. New Diagnostic p = 0.0002
20 6

The Lucica GA-L test is used for monitoring the glycemic 10.9
10.0 4
10
control status by measuring GA levels in serum. GA is an im- 2 0.9
p = 0.0077
portant indicator of diabetes,[10] which is more sensitive to 0 0
changes in plasma glucose than HbA1c. Measuring the GA level Before After HbA1c GA

should provide useful information on glycemic control when

Fig. 1. (a) Glycated albumin (GA) and glycated hemoglobin (HbA1c) values
monitoring the effects of therapy in patients with gestational before and 2 weeks after the therapy. (b) Changes in GA and HbA1c values
diabetes or unstable plasma glucose levels in whom HbA1c before and 2 weeks after the therapy.

ª 2010 Adis Data Information BV. All rights reserved. Mol Diagn Ther 2010; 14 (1)
Lucica GA-L Glycated Albumin Assay Kit
The change in GA was about ten times larger than that in
HbA1c. The GA level clearly provides useful information on
glycemic control when monitoring the effects of therapy in
patients whose HbA1c levels change too slowly.
3.2 Place in the Treatment Paradigm
Use of the Lucica GA-L kit can have an influence on the
choice and implementation of diabetes treatments, particularly
when monitoring effects of therapy for patients with gestational
diabetes, unstable plasma glucose levels, hemoglobin variants,
and diseases that shorten the lifespan of erythrocytes, such as
hemolytic and renal anemia.
The kit allows for faster confirmation of results following
diet, exercise, or medication for diabetes, permitting timely
adjustment of the medication dose.
Such knowledge can reinforce to patients that their treat-
ment strategy is having the desired effect, thereby increasing
motivation to comply with treatment.
Acknowledgments
Dr. Kohzuma is an employee of Asahi Kasei Pharma Corporation,
manufacturer of the Lucica GA-L kit. Dr. Koga declares no conflicts of
interest directly relevant to the content of this review.
References
1. Diabetes Control and Complications Trial Research Group. The effect
of intensive treatment of diabetes on the development and progression of
ª 2010 Adis Data Information BV. All rights reserved.
51
long-term complications in insulin-dependent diabetes mellitus. N Engl J
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2. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose
control with sulphonylurea or insulin compared with conventional treat-
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Lancet 1998; 352: 837-53
3. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control and Compli-
cations Trial/Epidemiology of Diabetes Interventions and Complications
(DCCT/EDIC) Study Research Group: intensive diabetes treatment and
cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;
353: 2643-53
4. Koenig RJ, Peterson CM, Jones RL, et al. Correlation of glucose regulation and
hemoglobin A1c in diabetes mellitus. N Engl J Med 1976; 295: 417-20
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6. American Diabetes Association. Standards of medical care in diabetes.
Diabetes Care 2004; 27: S15-35
7. Jeffcoate SL. Diabetes control and complications: the role of glycated hae-
moglobin, 25 years on. Diabet Med 2004; 21: 657-65
8. Bry L, Chen PC, Sacks DB. Effects of hemoglobin variants and chemi-
cally modified derivatives on assays for glycohemoglobin. Clin Chem 2001;
47: 15363
9. Reed P, Bhatnager D, Dhar H, et al. Precise measurement of glycated serum
albumin by column affinity chromatography and immunoturbidmetry. Clin
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10. Guthrow CE, Morris MA, Day JF, et al. Enhanced nonenzymatic glucosy-
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Correspondence: Takuji Kohzuma, PhD, Asahi Kasei Pharma Corporation,
Diagnostics Department, Science & Technology Group, 1-105 Kanda
Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan.
E-mail: kouzuma.tb@om.asahi-kasei.co.jp
Mol Diagn Ther 2010; 14 (1)