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Test Code GAL1 GALAD Score, Serum


Specimen Required


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

 

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: 

Preferred: Serum gel  

Acceptable:  Red top 

Submission Container/Tube: Plastic vial 

Specimen Volume: 0.5 mL 

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

Calculation of the GALAD (gender, age, alpha-fetoprotein L3% [AFP-L3], AFP, des-gamma-carboxy prothrombin) model score for hepatocellular carcinoma development in patients with chronic liver disease

Method Name

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

 

Gender, Age, Alpha-fetoprotein L3% (AFP-L3), AFP, Des-gamma-carboxy prothrombin (GALAD) Model Score Calculation

Reporting Name

GALAD Model Score

Specimen Type

Serum

Specimen 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 (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

The total alpha-fetoprotein (AFP) and AFP-L3% test values must be obtained using the uTASWako i30 in the GALAD (gender, age, AFP-L3, AFP, des-gamma-carboxy prothrombin) 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 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.

 

In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

Method Description

The GALAD (gender, age, alpha-fetoprotein L3% [AFP-L3], AFP, des-gamma-carboxy prothrombin) 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 AFP-L3, AFP, and DCP.

Day(s) Performed

Monday, Wednesday, Friday

Report Available

Same day/1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

Not Applicable

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GAL1 GALAD Model Score 96450-2

 

Result ID Test Result Name Result LOINC Value
GAL1 GALAD Model Score 96450-2