Alpha-Fetoprotein (AFP) and AFP-L3
Test Summary
This assay is intended for use in the assessment of risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver disease.
Aliases
- N/A
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Patient Preparation
Storage
Transport Temperature
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 5 days
- Frozen: 2 years
Limitations
1. Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference and can potentially cause an anomalous result. The Wako uTAS System has been formulated to minimize the risk of the interference; however, potential interactions between rare sera and ingredients can occur.
2. For diagnostic purposes, the results obtained from this assay should always be used and interpreted in conjunction with clinical examination, patient medical history, and other findings.
3. Pregnancy can cause high values of AFP-L3% and AFP is not interpretable in pregnant females.
4. AFP producing tumors other than HCC can show high values of AFP-L3% and AFP.
5. Samples from patients having acute hepatitis and fulminant hepatitis can show high values of AFP-L3% and AFP.
6. It is recommended that this assay be used in conjunction with imaging studies for clinical diagnosis.
7. Liver diseases caused by other etiologies such as alcoholic liver disease, hemochromatosis, Wilson's disease, autoimmune hepatitis and steatohepatitis have not been studied with this assay.
8. The assay is linear for AFP concentration of 0.3 to 1000 ng/mL.
9. Values obtained with different assay methods or kits cannot be used interchangeably.
Other Acceptable Specimens
Unacceptable Specimens
Order Code
EPIC (Premier) Code
Includes
CPT Code
- 82107
Billing Code
- 700000
CPT Statement
Methodology
FDA Status
Physician Attestation of Informed Consent
Testing Laboratory
33608 Ortega Highway
San Juan Capistrano CA, 92675
Reference Range
| AFP | 1.6-4.5 ng/mL |
| AFP-L3 | 0.5-9.9 % |
Setup Schedule / Expected Turnaround Time
Specimen Collection
Special Instructions
Preferred Specimen
Minimum Volume
Instructions
Patient Preparation
Storage
Transport Temperature
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: 5 days
- Frozen: 2 years
Limitations
1. Heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference and can potentially cause an anomalous result. The Wako uTAS System has been formulated to minimize the risk of the interference; however, potential interactions between rare sera and ingredients can occur.
2. For diagnostic purposes, the results obtained from this assay should always be used and interpreted in conjunction with clinical examination, patient medical history, and other findings.
3. Pregnancy can cause high values of AFP-L3% and AFP is not interpretable in pregnant females.
4. AFP producing tumors other than HCC can show high values of AFP-L3% and AFP.
5. Samples from patients having acute hepatitis and fulminant hepatitis can show high values of AFP-L3% and AFP.
6. It is recommended that this assay be used in conjunction with imaging studies for clinical diagnosis.
7. Liver diseases caused by other etiologies such as alcoholic liver disease, hemochromatosis, Wilson's disease, autoimmune hepatitis and steatohepatitis have not been studied with this assay.
8. The assay is linear for AFP concentration of 0.3 to 1000 ng/mL.
9. Values obtained with different assay methods or kits cannot be used interchangeably.
Other Acceptable Specimens
Unacceptable Specimens
Result Information
Methodology
Testing Laboratory
Reference Range
| AFP | 1.6-4.5 ng/mL |
| AFP-L3 | 0.5-9.9 % |