Alpha-Fetoprotein (AFP) and AFP-L3

Test Code
19529

Preferred Specimen
1.5 mL serum

Minimum Volume
0.5 mL

Transport Container
Plastic screw-cap vial

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 2 years

Methodology
Liquid-Phase Binding Assay System

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 hte 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% adn 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, hemachromatosis, Wilson's disease, autoimmune hepatitis and steatohepatisis 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.



Reference Range
AFP 1.6-4.5 ng/mL
AFP-L3 0.5-9.9 %


Clinical Significance
This assay is intended for use in the assessment of risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver disease.

Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.