INTENDED USE
NS Biotec bilirubin reagent is intended for the in vitro quantitative determination of total and direct bilirubin in serum or plasma on manual system.
LINEARITY
When run as recommended, the assay is linear up to 25 mg/dl (0.428 mmol/l).
If result exceeds 25 mg/dl (0.428 mmol/l), specimen should be diluted with 0.9% NaCl solution and reassayed. Multiply the result by the dilution factor.
SENSITIVITY
The sensitivity is defined as the change of analytical response (∆A/min) per unit change in analyte concentration at a pathlength of 1 cm.
When run as recommended the sensitivity of this assay is 0.01 mg/dl (0.17 mol/l).
WARNING & PRECAUTIONS
- NS Biotec bilirubin reagent is for in vitro diagnostic use only. Normal precautions exercised in handling laboratory reagents should be followed.
- The reagent and sample volumes may be altered proportionally to accommodate different spectrophotometer requirements.
- Valid results depend on an accurately calibrated instrument, timing, and temperature control.
- All specimens must be protected from light. Serum bilirubin will decrease 50% in one hour if kept at room temperature and at direct sunlight.
- Don’t use the reagent if it is turbid.
Stability
All reagents are stable up to the expiry date given on label when stored at room temperature.
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