The AFP-L3% assay is intended for use in the assessment of risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases.
Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy.
Samples from patients with acute hepatitis or fulminant hepatitis can show high values of AFP-L3% and AFP. Pregnancy can cause high values of AFP-L3% and AFP. AFP producing tumors other than HCC can show high values of AFP-L3% and AFP. Bilirubin at a concentration >20 mg/dL can cause a negative influence on the AFP-L3% and AFP values. Glucose at a concentration >600 mg/dL can cause a negative influence on AFP-L3% values. With regard to AFP, normal values apply only to males and nonpregnant females. Normal infants younger than 18 months of age may have higher values.
Results for this test should not be used as absolute evidence of presence or absence of malignant disease without confirmation of the diagnosis by another medically established diagnostic product or procedure. Values obtained with different assay methods or kits cannot be used interchangeably.
Immediately following collection, mix sample thoroughly by gentle inversion, 5 times
Gold serum separator (SST) tube
Refrigerated (preferred) - 9 days
Frozen - 9 days
Freeze/thaw cycles - stable x3
Ambient - 9 days
Liquid-phase Binding assay
AFP, serum *
Age |
Male |
Female |
AFP, Serum (ng/mL) |
AFP, Serum (ng/mL) |
|
0 – 7 days |
0.0–75,265.8 |
0.0–75,265.8 |
8 – 30 days |
0.0–32,556.4 |
0.0–32,556.4 |
1 month |
0.0–1,747.8 |
0.0–1,600.3 |
2 months |
0.0–391.1 |
0.0–550.0 |
3 months |
0.0–225.8 |
0.0–339.9 |
4 months |
0.0–230.6 |
0.0–230.6 |
5 months |
0.0–118.0 |
0.0–234.0 |
6 months |
0.0–97.2 |
0.0–97.2 |
7–11 months |
0.0–60.3 |
0.0–60.3 |
1 year |
0.0–21.4 |
0.0–21.4 |
2 years |
0.0–9.4 |
0.0–10.1 |
3 – 4 years |
0.0–5.5 |
0.0–5.5 |
5 years |
0.0–3.6 |
0.0–4.2 |
6 – 12 years |
0.0–3.9 |
0.0–3.9 |
13 – 17 years |
0.0–4.3 |
0.0–4.3 |
18 – 30 years |
0.0–5.7 |
0.0–4.7 |
31 – 50 years |
0.0–6.9 |
0.0–6.4 |
51 – 80 years |
0.0–8.4 |
0.0–9.2 |
>80 years |
0.0–6.4 |
0.0–8.7 |
* Normal values apply only to males and to non-pregnant females. These results are not interpretable for pregnant females.
AFP-L3%, serum
0.0 – 9.9