Diagnostics Applications

Diabetes is a chronic metabolic disease characterized by elevated blood glucose levels, and long-term high blood glucose can damage the heart, blood vessels, eyes, kidneys, and nerves (WHO, 2024). The number of adults living with diabetes worldwide has surpassed 800 million, more than quadrupling since 1990 (WHO/NCD-RisC, 2024). This increasing global burden continues to drive demand for reliable blood glucose monitoring, ketone testing, and related diagnostic technologies.

For manufacturers developing self-monitoring blood glucose systems, ketone meters, cholesterol test kits, or biochemical analyzers, enzyme selection is a critical factor in assay design. Diagnostic enzymes support specific substrate recognition, signal generation, colorimetric or UV detection, and electrochemical measurement in in vitro diagnostic applications.

Amano supplies high-purity and high-quality enzymes for diagnostics. We utilize microbial cultivation, purification, and genetic recombinant technological know-how we have developed in this field for over 50 years.

Our enzymes are used for colorimetric and UV quantification, and for electrochemical measurement in biochemical tests for various components such as sugar, cholesterol, protein, and enzymes using bodily fluids as samples.

We are ISO13485 certified, an international standard for quality assurance of medical devices.

Blood glucose monitoring systems for self-testing are used in diabetes management and measure glucose concentration in capillary blood sample. Amano offers glucose-related diagnostic enzymes, including Glucose Oxidase and Glucose Dehydrogenase, for blood sugar and glucose-related diagnostic applications. These enzymes are suitable for R&D teams developing blood glucose meters, glucose test strips, electrochemical biosensors, and in vitro diagnostic reagent systems.

Blood ketone monitoring is relevant in type 1 diabetes management, and NICE recommends that children and young people with type 1 diabetes are offered blood ketone testing strips and a blood ketone meter. Insufficient insulin can increase ketone levels, which may lead to diabetic ketoacidosis if untreated (NICE, 2015; updated 2023).

Amano offers 3-Hydroxybutyrate Dehydrogenase “Amano” 5 for ketone body measurement applications. This enzyme supports diagnostic development for ketone body assays and blood ketone monitoring systems.

High cholesterol has no symptoms, and cholesterol levels can be checked with a simple blood test. High total cholesterol is defined as 240 mg/dL or more (CDC, 2024).

Enzymatic cholesterol assays commonly use cholesterol esterase and cholesterol oxidase. In a typical cholesterol reagent system, cholesterol esters are hydrolyzed by cholesterol esterase to cholesterol and free fatty acids, and cholesterol is then oxidized by cholesterol oxidase to generate hydrogen peroxide for downstream colorimetric measurement.

Amano offers cholesterol-related diagnostic enzymes, including Cholesterol Esterase, Cholesterol Oxidase, and Cholesterol Dehydrogenase, for cholesterol measurement applications. These enzymes support R&D and production of cholesterol test kits, lipid-related assays, and biochemical testing systems.