Test Id : BILI3
Bilirubin, Serum
    
        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,
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 Id | Reporting Name | Available Separately | Always Performed | 
|---|---|---|---|
| BILIT | Bilirubin Total, S | Yes | Yes | 
| BILID | Bilirubin, Direct | Yes | Yes | 
    
        Method Name
            
                
                
                    
                    A short description of the method used to perform the test
                
            
    
    Total Bilirubin: Photometric, Diazonium Salt
Direct Bilirubin: Colorimetric Diazo Method
    
        NY State Available
            
                
                
                    
                    Indicates the status of NY State approval and if the test is orderable for NY State clients.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        Serum
    
        Shipping Instructions
    
    Ship specimen in amber vial to protect from light.
    
        Necessary Information
    
    Patient's age and sex are required.
    
        Specimen Required
            
                
                
                    
                    Defines the optimal specimen required to perform the test and the preferred volume to complete testing
                
            
    
    Supplies: Amber Frosted Tube, 5 mL (T915)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Amber vial
Specimen Volume: 1 mL
Collection Instructions:
1. Serum gel tubes should be centrifuged within 2 hours of collection.
2. Red-top tubes should be centrifuged, and the serum aliquoted into an amber vial within 2 hours of collection.
    
        Forms
    
    If not ordering electronically, complete, print, and send a Kidney Transplant Test Request with the specimen. 
    
        Specimen Minimum Volume
            
                
                
                    
                    Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
                
            
    
    0.25 mL
    
        Reject Due To
            
                
                
                    
                    Identifies specimen types and conditions that may cause the specimen to be rejected
                
            
    
    | Gross hemolysis | Reject | 
    
        Specimen Stability Information
            
                
                
                    
                    Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
                
            
    
    | Specimen Type | Temperature | Time | Special Container | 
|---|---|---|---|
| Serum | Refrigerated (preferred) | 24 hours | LIGHT PROTECTED | 
| Ambient | 6 hours | LIGHT PROTECTED | |
| Frozen | 30 days | LIGHT PROTECTED | 
    
        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,
Monitoring the efficacy of neonatal phototherapy
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    Bilirubin is one of the most frequently 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 red blood cell 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 1 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 uridine 5'-diphospho--glucuronosyltransferase. 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, 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 Bilirubin
> or =12 months: 0.0-0.3 mg/dL
Reference values have not been established for patients who are younger than 12 months of age.
 
Total Bilirubin
0-6 days: Refer to www.bilitool.org for information on age-specific (postnatal hour of life) serum bilirubin values.
7-14 days: 0.0-14.9 mg/dL
15 days to 17 years: 0.0-1.0 mg/dL
> or =18 years 0.0-1.2 mg/dL
    
        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 less than 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 is typically 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
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Rifai N, Chiu RWK, Young I, Burnham CD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023
2. Scharschmidt BF, Blanckaert N, Farina FA, Kabra PM, Stafford BE, Weisiger RA. Measurement of serum bilirubin and its mono- and diconjugates: Applications to patients with hepatobiliary disease. Gut. 1982;23(8):643-649
3. Practice parameter: management of hyperbilirubinemia in the healthy term newborn. American Academy of Pediatrics. Provisional Committee for Quality Improvement and Subcommittee on Hyperbilirubinemia [published correction appears in Pediatrics 1995 Mar;95(3):458-61]. Pediatrics. 1994;94(4 Pt 1):558-565.
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with 3,5-dichlorophenyl diazonium in a strongly acidic medium. The color intensity of the red azo dye formed is directly proportional to the total bilirubin and can be determined photometrically.(Package insert: Bilirubin Total Gen. 3, 09/2016. Roche Diagnostics, Indianapolis, IN)
 
Direct bilirubin in the presence of 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 red color of azobilirubin is measured photometrically and is proportional to the direct (conjugated) bilirubin concentration.(Package insert: Cobas Direct Bilirubin, June 2015, Roche Diagnostics, Indianapolis, IN)
    
        PDF Report
            
                
                
                    
                    Indicates whether the report includes an additional document with charts, images or other enriched information
                
            
    
    
    
        Day(s) Performed
            
                
                
                    
                    Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
                
            
    
    Monday through Sunday
    
        Report Available
            
                
                
                    
                    The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        Fees :
            
                
                
                    
                    Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
                
            
    
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        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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
                
            
    
    This test has been cleared, approved, or is exempt by the US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
                
            
    
    CPT codes are provided by the performing laboratory.
82247-Bilirubin, total
82248-Bilirubin, direct
    
        LOINC® Information
            
                
                
                    
                    Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
                
            
    
    | Test Id | Test Order Name | Order LOINC Value | 
|---|---|---|
| BILI3 | Bilirubin, S | 34543-9 | 
| Result Id | Test Result Name | 
                            Result LOINC Value
                                 
                                        
                                        Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
                                     
                                 | 
                    
|---|---|---|
| BILID | Bilirubin, Direct | 1968-7 | 
| BILIT | Bilirubin Total, S | 1975-2 |