Bilirubin Total & Direct Reagent Kit

Diazo reagent for quantitative total and direct bilirubin in serum.

Method: Diazo (diazotised sulfanilic acid)
Sample: Serum free of haemolysis; heparinised plasma
Linear up to 20 mg/dL
Liquid stable, ready to use pack
Reads at 546 nm (secondary 630 nm)

For in vitro diagnostic use by laboratory and healthcare professionals only. Please refer to the instructions for use supplied with each product for complete protocol and performance details.

Overview

For in vitro quantitative determination of total and direct bilirubin in serum. Principle: Sulfanilic acid reacts with sodium nitrite to form diazotised sulfanilic acid. With an accelerator, conjugated and unconjugated bilirubin react to form azobilirubin (total bilirubin); without it, only conjugated bilirubin reacts (direct bilirubin). The absorbance increase at 546 nm is proportional to bilirubin concentration. If bilirubin exceeds 20 mg/dL, dilute the sample, re-assay and multiply by the dilution factor.

Intended use: For in vitro quantitative determination of total and direct bilirubin in serum.

Specifications

Specifications for Bilirubin Total & Direct Reagent Kit
Shelf life	12 months
Storage	2–8 °C, protected from light
Method	Diazo (diazotised sulfanilic acid)
Sample type	Serum free of haemolysis; heparinised plasma
Wavelength	546 nm (secondary 630 nm)
Reaction type	End point (increasing)
Reagent volume	1.02 mL
Sample volume	50 µL
Incubation	5 minutes
Reaction temperature	37 °C
Light path	1 cm
Standard	Not applicable (factors: total 28, direct 14)
Linearity	20 mg/dL
Reagent composition	Reagents T1 and T2 (total bilirubin); reagents D1 and D2 (direct bilirubin)
Reference interval	Total bilirubin (adults and children over 10 days): 0.3–1.2 mg/dL; direct: up to 0.2 mg/dL Reference intervals are indicative; each laboratory should establish its own (see the kit insert).
Blank	Sample blank