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.
The reagents are provided in a ready to use format.
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
- SPIN640 / SPIN640Plus Autoanalyzer.
- 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.
QUALITY CONTROL
Control sera are recommended to monitor the performance of assay
procedures: SPINTROL H Normal and Pathologic (Ref. 1002120 and
1002210). If control values are found outside the defined range, check
the instrument, reagents and calibrator for problems.
Each laboratory should establish its own Quality Control scheme and
corrective actions if controls do not meet the acceptable tolerances.
BIBLIOGRAPHY
1. Malloy H T. et al. The determination of bilirubin with the photoelectric
colorimeter. J. Biol Chem 1937; 112, 2; 481-491.
2. Martinek R. Improved micro-method for determination of serum bilirubin.
Clin Chim 1966: Acta 13: 61-170.
3. Young DS. Effects of drugs on Clinical Lab. Tests, 4th ed AACC Press,1995.
4. Young DS. Effects of disease on Clinical Lab. Tests, 4th ed AACC 2001.
5. Burtis A et al. Tietz Textbook of Clinical Chemistry, 3rd ed AACC 1999.
6. Tietz N W et al. Clinical Guide to Laboratory Tests, 3rd ed AACC 1995.
