Alpha-Fetoprotein (AFP), Tumor Marker

Test Code

AFPTM

Alias/See Also

Epic: LAB559

CPT Codes
82105

Preferred Specimen

Specimen Type: Serum
Collection Container: Serum gel
Specimen Volume: 3 mL

Minimum Volume

0.25 mL

Instructions

Centrifuge and separate cells after clot formation and within 4 hours of collection.

Transport Container

Plastic vial

Specimen Stability

Room temperature: 3 days
Refrigerated: 7 days
Frozen: Undefined

Avoid more than 5 freeze/thaw cycles

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Unlabeled, mislabeled, wrong tube type, hemolyzed, QNS, exceeds specimen stability requirements.

Methodology

Chemiluminescent Microparticle Immunoassay

Setup Schedule

Daily

Report Available

Same day

Limitations

Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies and may produce anomalous values when tested with assay kits such as ARCHITECT AFP that employ mouse monoclonal antibodies.
Do not use heat-inactivated or pooled specimens.
Gross hemolysis, icterus and lipemia are not cause for immediate rejection. Literature states <2% interference at levels between 10-1000 ng/ml.

Reference Range

0.9 - 8.8 ng/mL

Clinical Significance

The Alinity i AFP assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of alpha-fetoprotein (AFP) on the Alinity i analyzer in: Human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with nonseminomatous testicular cancer.

For patients in clinical remission following treatment, AFP levels generally decrease. Post-operative AFP values which fail to return to normal strongly suggest the presence of residual tumor. Tumor recurrence is often accompanied by a rise in AFP before progressive disease is clinically evident.

AFP testing is not recommended as a screening procedure to detect cancer in the general population.

At Inova Laboratories, this assay is used only for Tumor Marker testing. It has not been validated for Prenatal testing.

Performing Laboratory

Inova Laboratories
2832 Juniper Street
Fairfax, VA 22031

Last Updated: March 3, 2023
Last Review: N. Wolford, March 3, 2023

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.