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DISCRETPAK™ REAGENTS - Bilirubin, Total

Intended Use

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

Method Principle

Bilirubin from the serum sample mixes with diazo-reagent (2,4-dichloroaniline) to form an azo-Bilirubin complex. The increase in absorbance is monitored at 550 nm. The reaction scheme illustrates the reaction that occurs in this method.

  H+  
Bilirubin + diazo-reagent (DCA) ──────────> azo-Bilirubin Complex Surfactant
     


Method Performance Characteristics

Sensitivity: The sensitivity of this method is 0.040 - 0.051 absorbance units per mg/dL.
Linear Range: In this method there is no significant nonlinearity over the range of 0-30 mg/dL.
Precision: Within-run and day-to-day precision is summarized below.

T. Bili

Within-Run Precision

Total Precision

MEAN

SD

CV

SD

CV

mg/dL

mg/dL

%

mg/dL

%

0.80

0.02

2.3

0.80

3.10

13.16

0.12

0.87

0.16

1.20

26.50

0.18

0.68

0.41

1.55


Correlation

Using an automated analyzer and a reference method based on the procedure of VandenBerg and Muller resulted in the following regression statistics:

Correlation Data

Parameter

Data Observed

N

40

Range

0.16 - 26.60

Regression

Y = 1.05x + 0.13

Correlation

  r = 0.998

Sy,x

0.22