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DISCRETPAK™ REAGENTS - Amylase

Intended Use

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

                                                          α-Amylase
                                       5 CNP-G3 ────────> 3 CNP + CNP-G2 + 2 G3 + 2 G

 

Method Principle                                         

As shown above, α-Amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside (CNP-G3) to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside (CNP-G2), maltotriose (G3) and glucose (G). The rate of formation of the 2-chloro-p-nitrophenol can be detected spectrophotometrically at 405 nm to give a measurement of α-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.

Amylase

Within-Run Precision

Total Precision

MEAN

SD

CV

SD

CV

U/L

U/L

%

U/L

%

105

2.34

2.21

2.46

2.35

257

4.91

1.90

4.98

1.94

448

7.48

1.65

11.70

2.61

 

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.

Correlation Data

Parameter

Data Observed

N

48

Range

10-255 U/L

Regression

Y = 0.994x + 1.44

Correlation

  r = 0.994