Test Catalog

Test Id : GAL2

Probability of Hepatocellular Carcinoma, Serum

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

Calculation of the probability for patients with chronic liver disease to develop hepatocellular carcinoma

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

Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum

 

Calculation

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Probability of HCC

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum

 

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.25 mL

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

Gross hemolysis Reject
Gross lipemia OK

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 Frozen (preferred) 90 days
Refrigerated 5 days

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

Calculation of the probability for patients with chronic liver disease to develop hepatocellular carcinoma

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

Biomarkers of hepatocellular carcinoma (HCC) include alpha fetoprotein (AFP), third electrophoretic form of lentil lectin-reactive AFP (AFP-L3), and des-carboxy-prothrombin (DCP).  The GALAD model combines these three biomakers with the patient’s gender and age to estimate the probability of HCC in patients with chronic liver disease based on the following equation  Z = -10.08 + 0.09 x age + 1.67 x sex + 2.34 log(10) (AFP) + 0.04 x AFP - L3 + 1.33 x log(10) (DCP), where sex = 1 for males, 0 for females. The probability estimate of HCC is calculated as follow Pr(HCC) = exp(Z)/(1 + exp[Z]).

 

The GALAD model has been demonstrated to have higher diagnostic accuracy for the detection of HCC when compared to the use AFP, AFP-L3, and DCP markers alone or in combination. The performance of the GALAD score has also been reported to be superior to ultrasound for HCC detection.

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.

Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum

 

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

The probability of the presence of hepatocellular carcinoma (HCC) is estimated from the GALAD model score. Higher GALAD model scores correlate with increased risk of HCC. The area under the curve (AUC) of a receiver operating characteristic (ROC) curve of the GALAD score was 0.95 for all HCC detection, and 0.92 for the detection of early stage HCC.  Additionally, the AUC of the GALAD score (0.95) was higher than that of ultrasound alone for all HCC detection (AUC of 0.82, P <0.01).

 

The sensitivity and specificity performance characteristics of the GALAD score for HCC will be influenced by the selected GALAD score cut-off.  For example at an optimal AUC cutoff of 0.76, the GALAD score had 91% sensitivity and 85% specificity for HCC detection. At a more specific GALAD score cutoff of 0.88, the observed sensitivity was 80% for HCC detection with an observed specificity of 97%.

 

The GALAD model was developed and validated in patient cohorts with a prevalence of HCC ranging from 35% to 49%. The performance of the model may be altered in populations with different HCC prevalence. In addition, the clinical performance of the GALAD score varies by etiology of HCC and therefore may be different in different regions of the world.

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

The total alpha-fetoprotein (AFP) and AFP-L3 test values must be obtained using the uTASWako i30 in the GALAD score calculation.

 

Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease. Total AFP and AFP-L3 values are not interpretable during pregnancy for the investigation of malignant disease.

 

Des-gamma-carboxy prothrombin (DCP) producing tumors other than hepatocellular carcinoma (HCC) can show elevated DCP values.

 

Medication containing vitamin K preparations may cause a negative bias with DCP values. Medication containing vitamin K antagonist or antibiotic may cause a positive bias with DCP values.

 

Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedures, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results. Whenever the test results do not fit the clinical picture, the laboratory should be consulted regarding possible assay interference.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Johnson P, Pirrie S, Cox T, et al: The detection of hepatocellular carcinoma using a prospectively developed and validated model based on serological biomarkers. Cancer Epidemiol Biomarkers Prev 2014 Jan;23(1):144-153

2. Berhane S, Toyota H, Tada T, et al: Role of the GALAD and BALAD-2 serologic models in diagnosis of hepatocellular carcinoma and prediction of survival in patients. Clin Gastroenterol Hepatic 2016 Jun;14(6):875-886

3. Yang JD, Addissie BD, Mara KC, et al: GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score. Cancer Epidemiol Biomarkers Prev 2019 Mar;28(3):531-538 doi: 10.1158/1055-9965

4. Leerapun A, Suravarapu S, Bida JP, et al: The utility of serum AFP-L3 in the diagnosis of hepatocellular carcinoma: Evaluation in a U.S. referral population. Clin Gastroenterol Hepatol 2007;5(3):394-402

5. Durazo FA, Blatt LM, Corey WG, et al: Des-gamma-carboxyprothrombin, alpha-fetoprotein and AFP-L3 in patients with chronic hepatitis, cirrhosis and hepatocellular carcinoma. J Gastroenterol Hepatol 2008;23:1541-1548

6. Chaiteerakij R, Addissie BD, Roberts LR: Update on biomarkers of hepatocellular carcinoma. Clin Gastroenterol Hepatol 2015 Feb;13(2):237-245 doi: 10.1016/j.cgh.2013.10.038

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

Testing for total alpha-fetoprotein (AFP), AFP-L3, and des-gamma-carboxy prothrombin (DCP) is performed using the uTASWako i30 instrument and the test system reagents.(Package insert: uTASWako i30 DCP. Wako Diagnostics, Richmond, VA. V 11.03.08K02)

 

The GALAD model is a statistical model for estimating the likelihood of hepatocellular carcinoma (HCC) in patients with chronic liver disease. The GALAD score is calculated based on gender, age, and measured concentrations of AFL-L3, AFP, and DCP. 

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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, Wednesday, Friday

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.

Same day/1 to 3 days

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

12 months

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

Rochester

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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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.

Not Applicable

LOINC® Information

Test Id Test Order Name Order LOINC Value
GAL2 Probability of HCC 96709-1
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
GAL2 Probability of HCC 96709-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports