VITROS Direct Bilirubin Instructions

Direct Bilirubin is a derived test used on the VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System to estimate the concentration of direct bilirubin in serum or plasma. Direct bilirubin is used for evaluating liver and biliary diseases. It is also used to determine if there are obstructions in the liver or bile ducts.

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INSTRUCTIONS FOR USE

Derived Result for Direct Bilirubin

DBIL

Direct Bilirubin

Rx ONLY

Intended Use

For in vitro diagnostic use only.

The derived test DBIL uses VITROS Chemistry Products BuBc Slides and VITROS Chemistry Products TBIL Slides on

VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System to estimate the concentration of direct bilirubin in serum or plasma.

Summary and Explanation of the Test

Direct bilirubin (DBIL) is used for evaluating liver and biliary diseases. An increased direct bilirubin occurs in both intrahepatic and extrahepatic biliary tract obstructions. Hepatocellular causes of elevation include hepatitis, cirrhosis, and advanced neoplastic states. Direct bilirubin is also increased in Dubin-Johnson syndrome and in Rotor syndrome.

Principles of the Procedure

The value for direct bilirubin, as reported by VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS

5600 Integrated System, includes all bilirubin fractions that react in the Jendrassik-Grof reaction without the addition of promoters. These include conjugated (mono- and diconjugates) and delta bilirubins.

VITROS Chemistry and Integrated Systems use two types of VITROS Slides (TBIL and BuBc) to determine the concentration of bilirubin components in human serum.

Total bilirubin (TBIL) is measured by the TBIL Slide as the diazo derivatives of unconjugated Bu, conjugated, and covalently protein-bound “delta” bilirubins. Conjugated and unconjugated bilirubins are measured simultaneously on the BuBc Slide using a dual-wavelength spectral measurement. Direct bilirubin values are calculated on the systems using these measured results and the following equation: direct bilirubin = TBIL – Bu

Test Type and Conditions

Derived

Reagents

VITROS TBIL and BuBc Slides are used to determine the concentration of direct bilirubin in human specimens.

IMPORTANT: For information on slide ingredients, labeling, handling, storage, stability, and preparation, refer to the Instructions for Use for the VITROS BuBc Slides and the

VITROS TBIL Slides.

Specimen Requirements

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Testing Procedure

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Calibration

Required Calibrators

VITROS Chemistry Products Calibrator Kit 4

Version 8.0

Pub. No. MP2-77_EN 1 of 4

DBIL

Direct Bilirubin

INSTRUCTIONS FOR USE

Quality Control

Calibrator Preparation, Handling, and Storage

Refer to the Instructions for Use for VITROS Calibrator Kit 4.

Calibration Procedure

Refer to the operating instructions for your system.

When to Calibrate

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Calculations

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Traceability of Calibration

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Quality Control

Do not monitor the derived test.

Results

Reporting Units and Unit Conversion

The VITROS Chemistry and Integrated Systems may be programmed to report DBIL results in conventional, SI, and alternate units.

Conventional Units mg/dL

SI Units

µmol/L (mg/dL x 17.1)

Alternate Units mg/L (mg/dL x 10.0)

Limitations of the Procedure

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

Expected Values

Reference Interval

This reference interval is the central 95% of results from an internal study of 110 apparently healthy adults from a working population (85 females and 25 males).

Note: Do not use this derived test for specimens from neonatal patients less than 14 days old. Refer to the TBIL Test Methodology.

Conventional Units

(mg/dL)

0.0–0.4

SI Units

(μmol/L)

0–7

Alternate Units

(mg/L)

0–4

Each laboratory should confirm the validity of these intervals for the population it serves.

Performance Characteristics

Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.

2 of 4 Pub. No. MP2-77_EN Version 8.0

INSTRUCTIONS FOR USE

Glossary of Symbols

DBIL

Direct Bilirubin

Revision History

Date of Revision

2015-10-12

2014-09-05

2012-02-28

2010-11-01

2008-09-18

2004-09-13

2003-06-30

Version

8.0

7.0

6.0

5.0

4.0

3.0

2.0

Description of Technical Changes*

• Prescription Use statement added.

• Updated EC Representative address.

• Added USA to legal manufacture address

Glossary of Symbols: added Date of Manufacture

Glossary of Symbols: updated

Added information for the VITROS 4600 Chemistry System

• Added information for the VITROS 5600 Integrated System

• Glossary of Symbols – Updated

• Minor wording and formatting changes

• Calibration Procedure – updated operator’s manual to operating instructions

• Glossary of Symbols – updated data

• New organization and sections consistent with IVD Directive

• Summary and Explanation of the Test – corrected wording

• Principles of the Procedure – corrected wording

• Calibration – updated

• Quality Control – updated

• Performance Characteristics – changed to “Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides.”

Version 8.0

Pub. No. MP2-77_EN 3 of 4

DBIL

Direct Bilirubin

INSTRUCTIONS FOR USE

Revision History

Date of Revision

2002APR19

Version

1.0 – English

Description of Technical Changes*

New format, technically equivalent to 11/96.

only

* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory policies, as appropriate.

Signature

Obsolete Date

Ortho-Clinical Diagnostics

Felindre Meadows

Pencoed

Bridgend

CF35 5PZ

United Kingdom

Ortho-Clinical Diagnostics, Inc.

100 Indigo Creek Drive

Rochester, NY 14626

USA

VITROS is a registered trademark of Ortho-Clinical Diagnostics,

Inc.

4 of 4 Pub. No. MP2-77_EN Version 8.0

Key features

Derived test
Measures direct bilirubin concentration
Uses VITROS BuBc and TBIL slides
Calculated from TBIL and unconjugated bilirubin
Evaluates liver and biliary diseases
Suitable for serum or plasma samples
Includes conjugated and delta bilirubins
Dual-wavelength spectral measurement
Requires calibration with VITROS Chemistry Products Calibrator Kit 4

Frequently asked questions

Direct Bilirubin (DBIL) is used to evaluate liver and biliary diseases. It measures the concentration of direct bilirubin in serum or plasma. An increased direct bilirubin occurs in both intrahepatic and extrahepatic biliary tract obstructions and can indicate conditions such as hepatitis, cirrhosis, and advanced neoplastic states. It is also increased in Dubin-Johnson syndrome and Rotor syndrome.

The reference interval for DBIL is 0.0–0.4 mg/dL (0–7 μmol/L). However, each laboratory should confirm the validity of these intervals for the population it serves. It is important to note that this derived test is not intended for use with specimens from neonatal patients less than 14 days old.

DBIL is measured using VITROS Chemistry and Integrated Systems. These systems use two types of VITROS Slides (TBIL and BuBc) to determine the concentration of bilirubin components in human serum. Total bilirubin (TBIL) is measured by the TBIL Slide as the diazo derivatives of unconjugated Bu, conjugated, and covalently protein-bound “delta” bilirubins. Conjugated and unconjugated bilirubins are measured simultaneously on the BuBc Slide using a dual-wavelength spectral measurement. The DBIL value is then calculated using the following equation: direct bilirubin = TBIL – Bu.

Substances that interfere with the measurement of total bilirubin or unconjugated bilirubin, as indicated in the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides, will affect the results for direct bilirubin. Refer to the Instructions for Use for the VITROS BuBc Slides and the VITROS TBIL Slides for more information on potential interferences.