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Test ID: BILID
Bilirubin Direct, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

81787

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Evaluation of jaundice and liver functions

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

Method Name A short description of the method used to perform the test

Photometric, Diazotized Sulfanilic Acid

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Bilirubin, Direct

Aliases Lists additional common names for a test, as an aid in searching

Direct Bilirubin, Serum

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Amber vial (Supply T192)

Specimen Volume: 0.5 mL

Collection Instructions: Protect specimen from light.

Additional Information: Patient's age and sex are required.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.25 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild reject; Gross reject

Lipemia

NA

Icterus

NA

Other

NA

 

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)24 hours
 Frozen 30 days
 Ambient 6 hours

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Approximately 85% of the total bilirubin produced is derived from the heme moiety of hemoglobin while the remaining 15% is produced from the RBC precursors destroyed in the bone marrow and from the catabolism of other heme-containing proteins. After production in peripheral tissues, bilirubin is rapidly taken up by hepatocytes where it is conjugated with glucuronic acid to produce mono- and diglucuronide, which are excreted in the bile. Direct bilirubin is a measurement of conjugated bilirubin.

 

Jaundice can occur as a result of problems at each step in the metabolic pathway. Disorders may be classified as those due to: increased bilirubin production (eg, hemolysis and ineffective erythropoiesis), decreased bilirubin excretion (eg, obstruction and hepatitis), and abnormal bilirubin metabolism (eg, hereditary and neonatal jaundice).

 

Inherited disorders in which direct bilirubinemia occurs include Dubin-Johson syndrome and Rotor Syndrome. Jaundice of the newborn where direct bilirubin is elevated includes idiopathic neonatal hepatitis and biliary atresia. The most commonly occurring form of jaundice of the newborn, physiological jaundice, results in unconjugated (indirect) hyperbilirubinemia. Elevated unconjugated bilirubin in the neonatal period may result in brain damage (kernicterus). Treatment options are phototherapy and, if severe, exchange transfusion.

 

The increased production of bilirubin that accompanies the premature breakdown of erythrocytes and ineffective erythropoiesis results in hyperbilirubinemia in the absence of any liver abnormality. In hepatobiliary diseases of various causes, bilirubin uptake, storage and excretion are impaired to varying degrees. Thus both conjugated and unconjugated bilirubin is retained and a wide range of abnormal serum concentrations of each form of bilirubin may be observed. Both conjugated and unconjugated bilirubin are increased in hepatocellular diseases, such as hepatitis and space-occupying lesions of the liver; and obstructive lesions such as carcinoma of the head of the pancreas, common bile duct, or ampulla of Vater.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

> or =12 months: 0.0-0.3 mg/dL

Reference values have not been established for patients who are <12 months of age.

Interpretation Provides information to assist in interpretation of the test results

Direct bilirubin levels must be assessed in conjunction with total and indirect levels and the clinical setting.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Specimens should be protected from light and analyzed as soon as possible; grossly hemolyzed specimens should be rejected because hemoglobin inhibits the diazo reaction and falsely low results may be seen.

 

It is important to remember that in addition to the mon- and diglucuronide fraction, the direct bilirubin assay will also measure the delta bilirubin fraction. Delta bilirubin is a conjugated bilirubin that is covalently bound to albumin. Therefore, the clearance of delta bilirubin from the serum is similar to the clearance of albumin which has a half-life of approximately 21 days.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Tietz Textbook of Clinical Chemistry. Edited by CA Burtis, ER Ashwood. Philadelphia, PA, WB Saunders Company, 1994

2. Roche/Hitachi Modular Analytics Reference Guide, Vol 7

Method Description Describes how the test is performed and provides a method-specific reference

Acidified sodium nitrite produces nitrous acid which reacts with sulfanilic acid (in acidic solution) to form a diazonium salt. The diazotized sulfanilic acid then reacts with bilirubin to form isomers of azobilirubin. In the direct bilirubin assay, only conjugated bilirubin is converted by the diazotized sulfanilic acid. The intensity of the color of azobilirubin is measured photometrically at 570 nm and is proportional to the direct (conjugated) bilirubin concentration.(Package insert: Roche Direct Bilirubin reagent; Indianapolis, IN, October 1999)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Sunday; Continuously

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

82248

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
BILIDBilirubin, Direct1968-7