Amylase Reagents – Vanguard Diagnostics

Reliable Amylase Reagents for Serum Enzyme Testing

Vanguard Diagnostics offers high-quality amylase reagents for the quantitative in vitro determination of α-amylase activity in human serum. These reagents are based on the CNPG3 substrate method, providing accurate, reproducible results and meeting the essential requirements of routine clinical chemistry testing.

Intended Use

The Amylase reagent kit is intended for the quantitative measurement of α-amylase activity in human serum. Elevated amylase levels are typically observed in pancreatic disorders and other digestive system conditions. This test is intended for in vitro diagnostic use only.

Product Specifications

Principle of the Test

α-Amylase catalyses the hydrolysis of CNPG3, releasing 2-chloro-4-nitrophenol (CNP), which is measured by its absorbance at 405 nm. The rate of increase in absorbance is directly proportional to the α-amylase activity in the sample.

Performance Characteristics

• Linearity: Up to 2000 U/L
• Sensitivity: Capable of detecting clinically relevant amylase levels
• Specificity: No significant interference from haemoglobin, bilirubin, or lipids under standard conditions

Storage and Stability

• Store at 2°C to 8°C
• Do not freeze
• Keep away from direct light
• Reagents are stable until the expiry date printed on the label when stored as recommended

Warnings and Precautions

• For in vitro diagnostic use only
• Avoid microbial contamination
• Do not ingest or allow contact with eyes
• Treat all human serum samples as potentially infectious
• Dispose of all waste materials as per local biomedical guidelines

Quality Control

It is recommended to use both normal and abnormal control sera to monitor accuracy and reproducibility. Laboratories should establish their own internal quality control procedures.

Ordering Information

• Product Name: Amylase Reagents
• Method: CNPG3-based kinetic UV method
• Pack Sizes: 5 × 20 ml and 5 × 50 ml
• Shelf Life: 12 months from manufacturing
• Storage Conditions: 2°C to 8°C

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Frequently Asked Questions (FAQs)

What are amylase reagents used for?

Amylase reagents are used for the quantitative determination of α-amylase in human serum. They assist in diagnosing pancreatic and digestive disorders.

What is the principle of the CNPG3 method?

The CNPG3 method measures α-amylase activity by tracking the release of 2-chloro-4-nitrophenol (CNP), which is detected at 405 nm using a spectrophotometer.

What is the measuring range of this test?

The assay has a linearity of up to 2000 U/L. Samples above this range should be diluted and reassayed for accurate results.

What are the storage requirements for amylase reagents?

Store the reagents between 2°C and 8°C. Do not freeze or expose to direct sunlight.

Can these reagents be used with any serum sample?

Yes, the test is intended for use with human serum samples only and should not be used with plasma or other fluids.