Direct Bilirubin Flashcards

1
Q

Intended use

A

Diagnostic reagent for quantitative in vitro determination of direct bilirubin in human serum or heparin plasma on automated photometric systems

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2
Q

Method

A

Photometric test using 2,4-dichloroaniline (DCA)

Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution.

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3
Q

Components and Concentrations of Reagent 1

A

EDTA-Na2 - 0.1 mmol/L
NaCl - 150 mmol/L
Sulfamic acid - 100 mmol/L

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4
Q

Components and Concentrations of Reagent 2

A

2,4-Dichloroaniline - 0.5 mmol/L
HCl - 900 mmol/L
EDTA-Na2 - 0.13 mmol/L

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5
Q

Warnings and Precautions of Reagent 1 & 2:

A

H290 - may be corrosive to metals
P234 - keep only in original packaging
P390 - absorb spillage to prevent material damage

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6
Q

Other warnings and precautions:

A
  • In very rare cases, samples of patients with gammopathy might give falsified results
  • Eltrombopag medication leads to falsely low or high results in patient samples.
  • Please refer to the safety data sheets and take the necessary precautions for the use of laboratory reagents. For diagnostic purposes, the results should always be assessed with the patient’s medical history, clinical examinations and other findings
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7
Q

Specimen

A

Human serum or heparin plasma

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8
Q

Stability of specimen:

A

2 days at 20 – 25°C
7 days at 4 – 8°C
6 months at –20°C
in case of immediate freezing.

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9
Q

Assay Procedure:

Wavelength

A

545/658 nm

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10
Q

Assay Procedure:

Temperature

A

37°C

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11
Q

Assay Procedure:

Measurement

A

Endpoint

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12
Q

Assay Procedure:

Sample/Calibrator

A

3.5 µL

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13
Q

Assay Procedure:

Reagent 1

A

80 µL

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14
Q

Assay Procedure:

Reagent 2

A

20 µL

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15
Q

Assay Procedure:

Addition reagent 2

A

Cycle 19 (286 s)

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16
Q

Assay Procedure:

Absorbance 1

A

Cycle 17/18 (230/244 s)

17
Q

Assay Procedure:

Absorbance 2

A

Cycle 41/42 (586/600 s)

18
Q

Assay Procedure:

Calibration

A

Linear

19
Q

Calibrators and Controls:

Recommended for calibration

A

DiaSys TruCal U

20
Q

Calibrators and Controls:

Calibrator values has been made traceable to the manual ________.

A

Jendrassik-Gróf test

21
Q

Calibrators and Control:

Use ________ for internal quality control

A

DiaSys Trulab N and P

22
Q

When values exceed the measuring range of up to 10 mg/dL, samples should be

A

Diluted

Calculation: 1 + 1 with NaCl solution (9 g/L) and the result multiplied by 2

23
Q

Limit of Detection:

A

0.01 mg/dL

24
Q

Interfering substances:

A

Ascorbic acid - 30 mg/dL
Hemoglobin (interferes at low concentration)
Lipemia (TAG) - 600 mg/dL

25
Q

Reference range:

A

Adults - ≤ 0.2 mg/dL
Children - ≤ 3.4 µmol/L