Correlation

Using a reference method based on the procedure of Van den Berg and Muller. Linear regression analysis produced the following results:

Preparation Of Working Reagent

Catachem Direct Bilirubin Working Reagent is prepared by adding the contents of one vial of sodium nitrite to one bottle of Direct Bilirubin Diluent.

 

Reagent Storage and Stability

Catachem Direct Bilirubin Reagents are stored at 2-8°C. When stored as directed, the reagents are stable until the expiration date stated on the label. When prepared and stored as directed, the Direct Bilirubin Working Reagent is stable for  14 days at 2-8° C.

 

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 0-15 mg/dL.

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

* CV% values are not meaningful when average approaches zero.

Intended Use

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

 

Method Principle

The serum sample is mixed with diazotized sulfanilic acid to form the azo-Bilirubin complex. The increase in absorbance is monitored at 550nm. The reaction scheme illustrates the reaction that occurs in this method.

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:

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