Bilirubin_dpd_total_liquid

BILIRUBIN TOTAL (DPD)
Reagent kit for the quantitative determination of direct bilirubin in serum. DPD
Quality control
A quality control program is recommended for all clinical laboratories. The analysis of control material in both the normal and abnormal ranges with each assay is recommended Principle
for monitoring the performance of the procedure. Each laboratory should establish Indirect bilirubin is liberated by the detergent. Total bilirubin is coupled with the 3,5- corrective measures to be taken if values fall outside the limits. dichlorophenyl-diazonium-tetrafluoroborate azobilirubin. The absorbance of this dye at 546 nm is directly proportional to the total PERFORMANCES DATA
The following data were obtained using Cobas Mira Plus analyzer Reference value

Linearity
The test is linear up to 670 µmol/l (39 mg/dl) It is recommended that each laboratory should assign its own normal range. Sensitivity
Reagents
It is recommended that each laboratory establishes its own range of sensitivity as this is limited by the sensitivity of the spectrophotometer used. Under manual condition the change of 0,001 absorbance is equivalent to 2 µmol/l (0,1 mg/dl) bilirubin concentration Precision
Reproducibility
Safety instructions:
Repeatability
Reagent 1:
S26 In case of contact with eyes, rinse immediately with plenty of water and Correlation
Reagent 2:
Comperative studies were done to compare our reagent with another commercial bilirubin S26 In case of contact with eyes, rinse immediately with plenty of water and Linear regression: y=0,975x+3,4 (x=other commercial reagent, y=own reagent) Serum free of haemolysis or EDTA, citrate plasma. Heparin plasma not recommended. Specificity
Bilirubin in serum is light sensitive and it is recommended that serum be stored in the
Ascorbic acid 2,5 mg/dl, hemoglobin 60 mg/dl don’t interfere with the assay up to the Procedure
Avoid direct exposure to light!
Do not use reagents after the expiry date stated on each reagent container label. Do not use products, test solution and reagents described above for any purpose other than descsribed Assay Conditions
For in vitro diagnostic use only!
Pipette into cuvette
Calibrator
Reagent 1
Calibrator
Mix and incubate for 3 minutes, read the absorbance (A1). Calibrator
Bibliography
Reagent 2
Tietz N.W., Clinical guide to laboratory tests, Saunders Co. Thomas L., Clinical Laboratory Diagnostics, TH-Books (1998) Mix and incubate for 5 minutes, read absorbance (A2).∆A=A2-A1 Calibration: (37°C, DPD)
S1:Distilled water
S2: Diagnosticum DunaCal or
Roche C.F.A.S. (Calibrator for automated system)
Calibration is recommended:
- after reagent lot change,
- as required following quality control procedures.
Calculation using calibration
A = Absorbance, C = Concentration


Bilirubin total DPD stable liquid reagent

Source: http://www.clinichem.hu/documents/Bilirubin_DPD_total_liquid.pdf