Alpha-Fetoprotein, Tumor Marker

Test Code

237

CPT Codes
82105

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

Instructions

Please note: Do not use this Test Code for evaluation of open neural tube defects and Down syndrome. See Test Code 5059.

Administration of STRENSIQ may interfere in certain assays and may falsely elevate values. For patients receiving STRENSIQ, consideration should be given to using alternate methods.

Sputum, Synovial Fluid, Cyst Fluid, and Vitreous Fluid are unacceptable for this test.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 14 days
Refrigerated: 14 days
Frozen: 45 days

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

Grossly lipemic

Methodology
Immunoassay (IA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Tues-Sat; Report available: 2-3 days

Limitations

Patients who have received monoclonal mouse antibodies may have abnormal results. For any patient taking a high dose of biotin, the specimen should be drawn at least eight hours after the last dose.

Reference Range

	Male (ng/mL)	Female (ng/mL)
<1 Month*	0.5-16387.0	0.5-18964.0
1-11 Months	0.5-28.3	0.5-77.0
1-3 Years	0.5-7.9	0.5-11.1
>3 Years	<6.1	<6.1

*Pediatric range is based on full term neonates, values for premature infants may be higher.
The use of AFP as a tumor marker in pregnant females is not recommended.

Clinical Significance

Elevation of serum AFP above values found in healthy individuals occurs in several malignant diseases, most notably nonseminomatous testicular cancer and primary hepatocellular carcinoma. AFP is not recommended as a screening procedure to detect cancer in the general population.

Performing Laboratory

Quest Diagnostics Nichols Institute

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.