Test Code GAL2 Probability of Hepatocellular Carcinoma, Serum
Specimen Required
Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum.
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Â Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Secondary ID
606833Useful For
Calculation of the risk for patients with chronic liver disease to develop hepatocellular carcinoma
Method Name
Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum
Calculation
Reporting Name
Probability of HCCSpecimen Type
SerumSpecimen Minimum Volume
0.25 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Frozen (preferred) | 90 days | |
Refrigerated | 5 days |
Reject Due To
Gross hemolysis | Reject |
Gross lipemia | OK |
Gross icterus | OK |
Clinical Information
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 (gender, age, AFP-L3, AFP, des-gamma-carboxy prothrombin) model combines these three biomarkers with the patient's gender and age to estimate the risk 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 GALAD score is calculated using the lower limit of quantitation (LLOQ) when one or more of the following values are below the LLOQ: %L3, Total AFP, or Des-Gamma-Carboxy Prothrombin. In the event this occurs, the GALAD score is resulted as (<)GALAD score.
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
Only orderable as part of a profile. For more information see HCCGS / Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum
Not applicable
Interpretation
Higher GALAD (gender, age, AFP-L3, AFP, des-gamma-carboxy prothrombin) model scores correlate with increased risk of hepatocellular carcinoma (HCC). The area under the curve (AUC) of a receiver operating characteristic 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.
Method Description
The GALAD (gender, age, AFP-L3, AFP, des-gamma-carboxy prothrombin) model is a statistical model for estimating the likelihood of hepatocellular carcinoma in patients with chronic liver disease. The GALAD score is calculated based on gender, age, and measured concentrations of AFL-L3, AFP, and DCP.
Day(s) Performed
Monday, Wednesday, Friday
Performing Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
Not ApplicableLOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
GAL2 | Probability of HCC | 96709-1 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
GAL2 | Probability of HCC | 96709-1 |