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Order 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, S

Specimen Type

Serum

Specimen 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

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)