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Test ID: BILI3
Bilirubin, Serum

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

8452

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

Assessing liver function

 

Evaluating a wide range of diseases affecting the production, uptake, storage, metabolism, or excretion of bilirubin

 

Monitoring the efficacy of neonatal phototherapy

Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test IDReporting NameAvailable SeparatelyAlways Performed
BILITBilirubin Total, SYesYes
BILIDBilirubin, DirectYesYes

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

Photometric, Diazonium Salt

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

Bilirubin, S

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: 1 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

Bilirubin is 1 of the most commonly used tests to assess liver function. Approximately 85% of the total bilirubin produced is derived from the heme moiety of hemoglobin, while the remaining 15% is produced from 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 bilirubin mono- and diglucuronide, which are then excreted in the bile.

 

A number of inherited and acquired diseases affect one or more of the steps involved in the production, uptake, storage, metabolism, and excretion of bilirubin. Bilirubinemia is frequently a direct result of these disturbances.

 

The most commonly occurring form of unconjugated hyperbilirubinemia is that seen in newborns and referred to as physiological jaundice.

 

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.

 

The rare genetic disorders, Crigler-Najjar syndromes Type I and Type II, are caused by a low or absent activity of bilirubin UDP-glucuronyl-transferase. In Type I, the enzyme activity is totally absent, the excretion rate of bilirubin is greatly reduced and the serum concentration of unconjugated bilirubin is greatly increased. Patients with this disease may die in infancy owing to the development of kernicterus.

 

In hepatobiliary diseases of various causes, bilirubin uptake, storage, and excretion are impaired to varying degrees. Thus, both conjugated and unconjugated bilirubin are retained and a wide range of abnormal serum concentrations of each form of bilirubin may be observed. Both conjugated and unconjugated bilirubins are increased in 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.

DIRECT

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

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

 

TOTAL

Males

12 months: 0.1-0.9 mg/dL

> or =24 months: 0.1-1.0 mg/dL

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

Females

1-11 years: 0.1-0.9 mg/dL

> or =12 years: 0.1-1.0 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

The level of bilirubinemia that results in kernicterus in a given infant is unknown. In preterm infants, the risk of a handicap increases by 30% for each 2.9 mg/dL increase of maximal total bilirubin concentration. While central nervous system damage is rare when total serum bilirubin (TSB) is <20 mg/dL, premature infants may be affected at lower levels. The decision to institute therapy is based on a number of factors including TSB, age, clinical history, physical examination, and coexisting conditions. Phototherapy typically is discontinued when TSB level reaches 14 to 15 mg/dL.

 

Physiologic jaundice should resolve in 5 to 10 days in full-term infants and by 14 days in preterm infants.

 

When any portion of the biliary tree becomes blocked, bilirubin levels will increase.

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 decreased results may be seen.

 

Compounds that compete for binding sites on serum albumin contribute to lower serum bilirubin levels (eg, penicillin, sulfisoxazole, acetylsalicylic acid).

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

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

2. Scharschmidt BF, Blanckaert N, Farina FA, et al: Measurement of serum bilirubin and its mono- and diconjugates: Applications to patients with hepatobiliary disease. Gut 1982;23:643-649

3. American Academy of Pediatrics Provisional Committee on Quality Improvement and Subcommittee on Hyperbilirubinemia. Practice Parameter: Management of hyperbilirubinemia in the healthy term newborn. Pediatrics 1994;94:558-565

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

Total bilirubin is coupled with diazonium salt (2,5-dichlorophenyldiazonium tetrafluoroborate) in a strongly acid medium to produce azobilirubin. The intensity of the color of the azobilirubin produced is proportional to the total bilirubin concentration and is measured at 570 nm.(Package insert: Roche Bilirubin reagent; Roche Diagnostic Corp., Indianapolis, IN, July 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

See Individual Unit Codes

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.

82247-Bilirubin, total

82248-Bilirubin, direct

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
BILITBilirubin Total, S1975-2