Intended Use

For IN VITRO diagnostic use in the  quantitative determination of Amylase in serum using manual or automated applications.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                                                                        

 

 

Correlation

A comparison of the Catachem Amylase method using an automated analyzer and a reference method based on the CNP-G3 substrate oxidation was conducted on a human sample population.  The following regression statistics were observed.

Method Principle                                         

As shown above, a-amylase hydrolyzes the 2-chloro-p-nitrophenyl-a-D-maltotrioside (CNP-G3) to release 2-chloro-p-nitrophenol and form                                                        2-chloro-p-nitrophenyl-a-D-maltoside (CNPG2), maltotriose (G3) and glucose (G). The rate of formation of the 2-chloro-p-nitrophenol can be detected spectrophotometrically at 405nm to give a measurement of a-amylase activity in the sample. 

Reagent Storage And Stability

Store the amylase reagents at 2-8°C. When stored as directed, this reagent is stable until the expiration date stated on the label. Upon opening, store the Amylase Working Reagent at 2-8°C. When stored as directed, the Amylase Working Reagent is stable for thirty days.

 

Method Performance Characteristics

Sensitivity: The sensitivity of this method is 0.00026-0.00031 absorbance units per u/L.

Linear Range: In this method there is no significant nonlinearity over the range of         0-2000 u/L.

Precision: Within-run and day-to-day precision is summarized below.

TO CONTACT US:

 

CATACHEM, INC.

955 Connecticut Avenue

Suite No. 4106

Bridgeport, CT  06607

 

Phone:     203-335-9277

Fax:         203-335-9977

 

Email:

catachem@catacheminc.com

 

URL:

www.catacheminc.com