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HelpTest Code HCCGS Hepatocellular Carcinoma Risk Panel with GALAD Score, Serum
Ordering Guidance
GALAD (gender, age, alpha-fetoprotein [AFP]-L3, AFP, des-gamma-carboxy prothrombin [DCP]) score testing (this test) should not be performed for patients who are pregnant, as alpha-fetoprotein results are elevated during pregnancy.
Necessary Information
Sex and age are required.
Specimen Required
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
Risk assessment for development of hepatocellular carcinoma in patients with chronic liver disease
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| L3AFP | AFP-L3% and Total AFP, S | Yes | Yes |
| DCP | Des-Gamma-Carboxy Prothrombin, S | Yes | Yes |
| GAL1 | GALAD Model Score | No | Yes |
Method Name
L3AFP and DCP: Isotachophoresis with Laser-Induced Fluorescence
GAL1: Calculation
Reporting Name
HCC Risk Panel with GALAD Score, SSpecimen Type
SerumSpecimen Minimum Volume
0.25 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 90 days | |
| Refrigerated | 5 days |
Reference Values
TOTAL ALPHA-FETOPROTEIN (AFP):
<4.7 ng/mL
AFP L3-PERCENT:
<10%
DES-GAMMA-CARBOXY PROTHROMBIN:
<7.5 ng/mL
GAL1:
Not applicable
Interpretation
Alpha-fetoprotein (AFP)-L3 results of 10% or more are associated with a 7-fold increased risk of developing hepatocellular carcinoma (HCC). Patients with AFP-L3 levels of 10% or more should be monitored more intensely for evidence of hepatocellular carcinoma according to current practice guidelines.
Total serum AFP results above 200 ng/mL are highly suggestive of a diagnosis of HCC. In patients with liver disease, a total serum AFP level above 200 ng/mL is near 100% predictive of HCC. With lower total AFP levels, there is an increased likelihood that chronic liver disease, rather than HCC, is responsible for the AFP elevation.
Based on a retrospective study at Mayo Clinic, for patients with total AFP levels 200 ng/mL or less, AFP-L3 specificity approaches 100% for HCC when its percentage exceeds 35% of the total AFP.(4)
AFP concentrations over 100,000 ng/mL have been reported in normal newborns, and the values rapidly decline in the first 6 years of life.
Des-gamma-carboxy prothrombin:
In patients with an elevated des-gamma-carboxy prothrombin (DCP) result (≥7.5 ng/mL), the risk of developing HCC is 36.5% (95% CI 23.5%-49.6%). The risk of developing HCC with a negative DCP result (<7.5 ng/mL) is 7.6% (95% CI 4.4%-10.8%).
Gender, Age, AFP-L3, AFP, DCP (GALAD) Score:
Higher GALAD model scores correlate with increased risk of 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.
Clinical Reference
1. Okuda K: Hepatocellular carcinoma. J Hepatol. 2000;32(Suppl 1):225-237
2. Kawai K, Kojima T, Miyanaga N, et al. Lectin-reactive alpha-fetoprotein as a marker for testicular tumor activity. Int J Urol. 2005;12(3):284-289
3. Noda K, Miyoshi E, Kitada T, et al. The enzymatic basis for the conversion of nonfucosylated to fucosylated alpha-fetoprotein by acyclic retinoid treatment in human hepatoma cells: activation of alpha 1-6 fucosyltransferase. Tumor Biol. 2002;23(4):202-211
4. Leerapun A, Suravarapu SV, Bida JP, et al. The utility of Lens culinaris agglutinin-reactive alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: evaluation in a United States referral population. Clin Gastroenterol Hepatol. 2007;5(3):394-402
5. Carr BI, Kanke F, Wise M, Satomura S: Clinical evaluation of Lens culinaris agglutinin-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin in histologically proven hepatocellular carcinoma in the United States. Dig Dis Sci. 2007;52(3):776-782
6. Durazo FA, Blatt LM, Corey WG, et al. Des-gamma-carboxy prothrombin, alpha-fetoprotein and AFP-L3 in patients with chronic hepatitis, cirrhosis and hepatocellular carcinoma. J Gastroenterol Hepatol. 2008;23(10):1541-1548
7. Marrero JA, Feng Z, Wang Y, et al. Alpha-fetoprotein, des-gamma carboxyprothrombin, and lectin-bound alpha-fetoprotein in early hepatocellular carcinoma. Gastroenterology. 2009;137(1):110-118
8. Bertino G, Ardiri AM, Calvagno GS, Bertino N, Boemi PM. Prognostic and diagnostic value of des-y-carboxy prothrombin in liver cancer. Drug News Perspect. 2010;23(8):498-508
9. Johnson PJ, Pirrie SJ, Cox TF, et al. The detection of hepatocellular carcinoma using a prospectively developed and validated model based on serological biomarkers. Cancer Epidemiol Biomarkers Prev. 2014;23(1):144-153
10. Berhane S, Toyoda 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 Hepatol. 2016;14(6):875-886
11. 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;28(3):531-538. doi:10.1158/1055-9965
12. Chaiteerakij R, Addissie BD, Roberts LR. Update on biomarkers of hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2015;13(2):237-245 doi:10.1016/j.cgh.2013.10.038
Day(s) Performed
Monday through Friday
Report Available
1 to 4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
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
82107
83951
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HCCGS | HCC Risk Panel with GALAD Score, S | 96452-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| TAFP | Total AFP, S | 1834-1 |
| DCP | Des-Gamma-Carboxy Prothrombin, S | 34444-0 |
| GAL1 | GALAD Model Score | 96450-2 |
| L3 | %L3 | 42332-7 |
| INT67 | Interpretation | 69048-7 |
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Gastroenterology and Hepatology Test Request (T728)
-Oncology Test Request (T729)