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Enzymes for Standardization
Product
Multi-Enzyme (Human) Calibrator
Introduction
With the multiplicity of measurement methods and conditions employed in the field of clinical chemistry, measurement values of the same sample differ between laboratories. The elimination of interlaboratory differences is sought through the standardization of test results. Among routine diagnostic tests, variations are more prominent with enzymatic tests in particular than with electrolytic tests. To eliminate differences seen with enzymatic testing, the promotion of Recommended Methods to be used as Reference Methods and the distribution of Reference Materials as reference points are necessary.

The Japan Society for Clinical Chemistry has promoted its Consensus Methods for six types of enzymes (AST, ALT, gamma-GT, ALP, CK, LD). Since 1997 the Japan Association of Clinical Reagent Industries has distributed the Japan Working Enzyme Reference Material with recombinant enzymes. Through these efforts, the interlaboratory differences in enzymatic testing have been largely corrected in Japan.

Asahi Kasei Corporation produces a lyophilized preparation with recombinant enzymes in a BSA matrix as an enzyme calibrator, which occupies a position immediately below Reference Materials. After further development in the areas of handling and safety, Asahi Kasei now introduces its latest recombinant enzyme calibrator as described below.
Composition
Lyophilized form composed of multipleenzymes along with BSA
Product Information
Multi-Enzyme Calibrator
Origin of Enzymes 8 kinds
(AST, ALT, gamma-GT, ALP, CK, LD I, p-AMY, Lipase)
recombinant E. coli
recombinant mammalian cell
Matrix bovine serum albumin (BSA)
---non-biohazard
Form lyophilized
Packaging 3 ml/vial (tentative)
Reactivity similar to human serum
Physicochemical properties
1) specific gravity
2) viscosity
similar to human serum
similar to human serum
Stability more than 18 months at 5°C
8 hours at 5°C after reconstitution
Characteristics
1 Human gene recombinant
AST, ALT, gamma-GT, ALP, CK, LD (isozyme I type), p-AMY, p-Lipase
Data - Isozyme Type and Source
2 Minimal loss of activity after reconstitution
Data - Activity following Reconstitution
3 Excellent calibration effect
Data - Example of Calibration Effect
4 Similar reactivity as human sera
Data - Recombinant Enzyme Correlation with Human Sera
5 Homogeneity
Data - Vial-to-Vial Difference of Each Enzyme Among 20 Vials
6 Long-term Stability
Data - Stability at 5°C
Isozyme Type and Source.
Enzyme Isozyme type Source Lyophilized Lyophilized
Type A Type B
AST Cytosolic recombinant E. coli + +
ALT Cytosolic recombinant E. coli + +
gamma-GT II (liver) recombinant mammalian cell + +
ALP liver recombinant mammalian cell + +
CK MM recombinant E. coli + +
LD I, II, III human red blood cell + -
I recombinant E. coli - +
P,S-AMY Pancreatic, saliva human urine, human saliva - -
P,S-AMY Pancreatic, saliva recombinant yeast, human saliva + -
P-AMY Pancreatic recombinant yeast - +
Lipase Pancreatic recombinant mammalian cell + +
[Return to Characteristics]
Activity following Reconstitution
AST ALT
gamma-GT ALP
CK LD
AMY  
[Return to Characteristics]
Example of Calibration Effect
Example of calibration effect
[Return to Characteristics]
Recombinant Enzyme Correlation with Human Sera
ALP(1) ALP(2)
ALT AST
CK gamma-GT
LD  
[Return to Characteristics]
Vial-to-Vial Difference of Each Enzyme Among 20 Vials
N = 20 AST ALT gamma-GT ALP CK LD AMY
CV (%) 0.69 0.93 0.78 0.59 0.71 0.77 0.62
[Return to Characteristics]
Stability at 5°C
Stability at 5°C
[Return to Characteristics]
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Asahi Kasei Pharma Corporation. All rights reserved.