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HelpOrder 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 |
|---|---|---|
| Serum | Frozen (preferred) | 90 days |
| Refrigerated | 5 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
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
Method Description
Testing is performed using the uTASWako i30 instrument and the test system reagents.
Alpha-Fetoprotein L3:
Total alpha-fetoprotein (AFP) is measured by laser-induced fluorescence with separation of the lentil lectin-reactive AFP-L3 and lectin nonreactive forms of AFP by isotachophoresis of their immune-complexes. Results are expressed as the percent ratio of AFP-L3 to total AFP.(Package insert: uTASWako i30 AFP-L3. Wako Diagnostics; 21.11.18K17, 12/2021)
Des-Gamma-Carboxy Prothrombin:
Sample is added to the reagent well with the fluorescent dye labeled antihuman prothrombin antibody (mouse monoclonal) to form the primary immunocomplex. The second labeled antibody solution, anion-conjugated antihuman des-gamma-carboxy prothrombin (DCP) antibody (mouse monoclonal), is concentrated by isotachophoresis when voltage is applied. The concentrated anion-conjugated antibody then reacts with the primary immunocomplex to form the secondary immunocomplex. This secondary complex is further concentrated during isotachophoresis and is separated from unbound fluorescent dye-labeled antibody by capillary gel electrophoresis. The remaining dye labeled DCP is measured by laser-induced fluorescence. The concentration of DCP in the specimen is directly proportional to the amount of fluorescence.(Package insert: uTASWako i30 DCP. Wako Diagnostics; V 21.11.18K15, 12//2021)
Gender, Age, AFP-L3, AFP, DCP, and (GALAD) Model Score:
The GALAD 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 AFP-L3, AFP and DCP.
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
82107
83951
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)