INTENDED USE
Bilirubin T-DPD is an in vitro diagnostic medical device intended to be use
by healthcare professionals for the quantitative determination of total
bilirubin in serum or plasma.
PRINCIPLE OF THE METHOD
Bilirubin (both conjugated and unconjugated) couples with the diazo reagent
in the presence of a surfactant to form azobilirubin. The intensity of color
formed is proportional to the bilirubin concentration in the sample tested.
The increase of absorbance at 546 nm is directly proportional to the total
bilirubin concentration.
CLINICAL SIGNIFICANCE
Bilirubin is caused by the degradation of hemoglobin and exists in two forms.
Unconjugated bilirubin is transported to the liver bound by albumin where it
becomes conjugated (direct) with glucuronic acid and excreted.
Hyperbilirubinemia is the result of an increase of bilirubin in plasma.
Possible causes:
Total bilirubin: Increase hemolysis, genetic alteration, neonatal anemia,
erythropoiesis alterations and presence of drugs.
Direct Bilirubin: cholestasis liver, liver abnormalities and genetic.
Clinical diagnosis should not be made based on a single test result; it should
integrate clinical and other laboratory data.
STORAGE AND STABILITY
The reagents are stable until the expiry date stated on the label when stored
at 2-8ºC, protected from light and contaminations are prevented during their
use. Do not use reagents over the expiration date.
Signs of reagent deterioration:
- Presence of particles and turbidity.
ADDITIONAL EQUIPMENT
- Spectrophotometer or analyzer capable of measuring absorbance at 546nm.
- Cuvettes 1.0 cm light path.
- General laboratory equipment.
SAMPLES
The use of fresh serum and plasma free of hemolysis is recommended.
Protect samples from light.
The samples can be stored in the refrigerator (2-8ºC) for 4 days maximum.
For longer storage periods they must be kept frozen at –20ºC for 2 months.
Frozen samples should be totally thawed and brought to room temperature
before testing. Avoid repeated freezing and thawing of the samples.
INTERFERENCES
No interferences were observed for lipemia (Intralipid) up to 2000 mg/dL,
hemoglobin up to 1000 mg/dL and ascorbic acid up to 40 mg/L. A list of drugs and
other interfering substances with bilirubin has been reported by Young et. al 4,5.
NOTES
1. SPINREACT has instruction sheets for several automatic analyzers.
Instructions for many of them are available on request.
