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auto-Bilirubin-T liquicolor Performance Characteristics

Linearity: The assay is linear up to 30 mg/dl. For bilirubin concentrations
exceeding 30 mg/dl dilute the sample 1+4 with physiological saline (0.9%)
Photometric Test for Total (T) Bilirubin and repeat the assay. Multiply the result by 5.

Package Size The total bilirubin values in AUTOCAL are traceable to the re-optimized
Doumas bilirubin reference method.
[REF] 10742 375 ml Reagent Kit
Typical performance date can be found in the Verification Report,
[IVD]
accessible via
Principle www.human.de/data/gb/vr/su-abilt.pdf or
Indirect bilirubin is liberated by the detergent. Total bilirubin is coupled
www.human-de.com/data/gb/vr/su-abilt.pdf
with a diazonium compound, 3,5-dichlorophenyl-diazonium-tetrafluoro-
borate (DPD) to yield the corresponding azobilirubin. The absorbance of Reference ranges
this dye at 546 nm is directly proportional to the total bilirubin These ranges are given for orientation only; each laboratory should estab-
concentration in the sample. lish its own reference ranges.
Reaction Principle Age Conventional unit SI unit
Bilirubin + DPD + caffeine ⎯⎯→ TOTAL Azobilirubin adults 0.1 – 1.2 mg/dl 2 – 21 µmol/l
neonates 24 h up to 8.7 mg/dl up to 150 µmol/l
Contents
neonates 2nd day 1.3 – 11.3 mg/dl 22 – 193 µmol/l
[RGT1] 3 x 100 ml Detergent (green cap) (R1)
neonates 3rd day 0.7 – 12.7 mg/dl 12 – 217 µmol/l
Caffeine 5.2 mmol/l
neonates 4th – 6th
Detergent 0.1 – 12.6 mg/dl 2 – 216 µmol/l
day
Preservative
children > 1 month 0.2 – 1.0 mg/dl 3 – 17 µmol/l
[RGT2] 1 x 75 ml Colour reagent (black cap) (R2)
3,5-dichlorophenyl-diazonium-tetrafluoroborate 0.9 mmol/l Quality Control
Caffeine 5.2 mmol/l All control sera with bilirubin values determined by this method may be
Detergent employed.
Preservative We recommend to use our quality control sera HumaTrol based on animal
serum or our SERODOS based on human serum.
Additional Material not Supplied with the Kit
[REF] 13160 Notes
1. Bilirubin is light sensitive; samples should be kept in the dark.
[CAL] 4 x for 5 ml AUTOCAL
2. Bilirubin levels may be reduced if the samples are exposed to light.
lyophilised Calibrator for HUMAN Clinical Chemistry Systems
Hemolysis will also lower the bilirubin value due to the inhibitory effect
Reagent Preparation and Stability of hemoglobin on the diazo reaction.
[RGT1] (R1) and [RGT2] (R2) are ready for use. 3. The test can be run with 50 µl sample or [CAL]; the linearity is reduced
They are stable up to the given expiry date if sealed and stored at 2-8 °C. to 25 mg/dl.
Once opened, reagents stored on board the instrument at 2-8 °C are 4. The administration of Eltrombopag leads to false low or high patient
stable for 30 days. Protect [RGT2] (R2) from light. results.
Specimen Precautionary statements
Serum and heparinised plasma [RGT1]/R1, [RGT2]/R2
Specimen stability P234 Keep only in original packaging.
Bilirubin, when stored light-protected, is stable for 1 day at 20-25 °C, for P260 Do not breathe dust/fume/gas/mist/vapours/spray.
7 days at 2-8 °C or for up to 6 months at -20 °C.
P262 Do not get in eyes, on skin, or on clothing.
Avoid hemolytic and lipemic samples.
P281 Use personal protective equipment as required.
Assay P303+P361+P353 IF ON SKIN (or hair): Take off immediately all
Wavelength: 546 nm (520 - 560 nm) contaminated clothing. Rinse skin with water [or shower].
Optical path: 1 cm P305+P351+P338 IF IN EYES: Rinse cautiously with water for several
Temperature: 25 or 37 °C minutes. Remove contact lenses, if present and easy to do. Continue
rinsing.
Measurement: Against reagent blank
P337+P313 If eye irritation persists: Get medical advice/attention.
Pipetting Scheme
P401 Store in accordance with local/regional/national/international
The pipetting scheme for HumaLyzer 4000 can be accessed via:
regulations.
www.human.de/aps-cc.
P501 Dispose of contents/container in accordance with local/regional/
Analyzer settings (2-shot version) national/international regulations.
Proposals to apply the reagents on analyzers are available on request.
Each laboratory has to validate the application in its own responsibility. References
1. Tietz N.W., Clinical guide to laboratory tests, Saunders Co.
Manual Application
2. Thomas L., Clinical Laboratory Diagnostics, TH-Books (1998)
Pipette into cuvettes Reagent Blank (RB) Sample (S) or [CAL]
Sample or [CAL] -- 20 µl
SU-ABILT INF 1074201 GB 08-2024-12
dist. Water 20 µl --
[RGT1]/ R1 1000 µl 1000 µl
Mix thoroughly, incubate for 5 min. at 37°C or for 10 min at 25°C
Read absorbance A1.
[RGT2]/ R2 250 µl 250 µl
Mix thoroughly, incubate for 5 min. at 37°C or for 10 min at 25°C Read
absorbance A2. A = A2-A1.
Calculation
A546 = A S/[CAL] - A RB
A sample A sample
C = C [CAL] x ⎯⎯⎯⎯ [mg/dl] or C = C [CAL] x ⎯⎯⎯⎯⎯ [mmol/l]
A [CAL] A [CAL]
For calibration use AUTOCAL ([REF] 13160). Recalibrate, if control sera are
found outside the permitted ranges.
Human Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
Telefon +49 6122-9988-0 · Telefax +49 6122-9988-100 · e-Mail [email protected]