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

1177-1062/10/0001-0049/$49.95/0

DIAGNOSTIC PROFILE

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

Abstract
Diabetes mellitus is a worldwide healthcare issue, with the number of diabetic patients continuing to increase.
Strict control of plasma glucose levels is critical in order to avoid
the potentially severe complications of diabetes, making tests for
monitoring of glycemic control essential in the management of the
disease.
Glycated hemoglobin (HbA1c) measurement is currently the
most commonly used test to monitor glycemic control in patients
with diabetes. Based on the results of the Diabetes Control and
Complications Trial (DCCT), an HbA1c level of <7% has been
recommended to prevent the onset and progression of chronic
diabetic complications. However, HbA1c may not be suitable for
evaluating short-term variations in glycemic control, because of
the long lifespan of erythrocytes (120 days).
Glycated albumin (GA) is an indicator of diabetes that is more
sensitive to change in plasma glucose than HbA1c.
Lucica GA-L is a new diagnostic test for measuring GA. The
test is based on an enzymatic method that uses liquid reagents
requiring no preparation.
Measuring the GA level should provide useful information on
glycemic control when monitoring effects of therapy for patients
with gestational diabetes, unstable plasma glucose levels, variant
hemoglobins or diseases that shorten the lifespan of erythrocytes.

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Lucica GA-L glycated albumin assay kit key features

Diagnostic indication
Monitoring of glycemic control
Assay characteristics
Technology basis

Enzymatic method

Measured parameter

Glycated albumin

Sample type

Plasma and serum

Performance measures
Linearity

Glycated albumin concentration 040 g/L,

albumin concentration 080 g/L

Reproducibility

Between-run coefficients of variation 0.63 0.93%

Specificity

Addition of up to 30 mg/dL of bilirubin,

800 mg/dL of triglycerides, 5.0 g/dL of glucose,
75 mg/dL of ascorbic acid, 385 mg/dL of
hemoglobin, and 2.0 g/dL of human serum
-globulins did not affect the assay

Requirements
Test location

Laboratory

Equipment

Biochemical autoanalyzer

Training

Ability to use a biochemical autoanalyzer

Time to result

10 minutes

Cost
Similar testing cost compared with measuring glycated hemoglobin

Kohzuma & Koga

50

1. Disease Background and Need for Diagnostics

Diabetes mellitus continues to be an important healthcare
issue worldwide. Once diabetes has developed, treatment is difficult. 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 decrease 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 laboratory. HbA1c and fructosamine levels reflect the average glycemic control status over periods of 2 months and 2 weeks,
respectively. 1,5-AG is a validated marker of short-term glycemic 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 addition, HbA1c measurement is known to be affected by diseases
that reduce the lifespan of erythrocytes, such as hemolytic anemia 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 effectiveness of therapy and to adjust medication dosage in the
laboratory, and would be measured every 2 weeks when starting antidiabetic therapy.
Moreover, measurement of GA levels provides correct information 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
40

12

35.6

10

(%)

30

3. New Diagnostic

p = 0.0002

2010 Adis Data Information BV. All rights reserved.

25.0

20

The Lucica GA-L test is used for monitoring the glycemic

control status by measuring GA levels in serum. GA is an important indicator of diabetes,[10] which is more sensitive to
changes in plasma glucose than HbA1c. Measuring the GA level
should provide useful information on glycemic control when
monitoring the effects of therapy in patients with gestational
diabetes or unstable plasma glucose levels in whom HbA1c

10.6

14

8
6

10.9
10

10.0

4
2

p = 0.0077

0.9

0
Before

After

HbA1c

GA

Fig. 1. (a) Glycated albumin (GA) and glycated hemoglobin (HbA1c) values
before and 2 weeks after the therapy. (b) Changes in GA and HbA1c values
before and 2 weeks after the therapy.
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 treatment 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

2010 Adis Data Information BV. All rights reserved.

51

long-term complications in insulin-dependent diabetes mellitus. N Engl J

Med 1993; 329: 977-86
2. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose
control with sulphonylurea or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).
Lancet 1998; 352: 837-53
3. Nathan DM, Cleary PA, Backlund JY, et al. Diabetes Control and Complications 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
5. Bunn HF, Gabbay KH, Gallop PM. The glycosylation of hemoglobin:
relevance to diabetes mellitus. Science 1978; 20: 21-7
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 haemoglobin, 25 years on. Diabet Med 2004; 21: 657-65
8. Bry L, Chen PC, Sacks DB. Effects of hemoglobin variants and chemically 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
Chem Acta 1986; 161: 191-9
10. Guthrow CE, Morris MA, Day JF, et al. Enhanced nonenzymatic glucosylation of human serum albumin in diabetes mellitus. Proc Natl Acad Sci
U S A 1979; 76: 4258-61

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)

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