Specimen:

Plasma

Collection Medium:

Alternate
Collection Media:

Call laboratory for additional acceptable specimen collection 
containers.

Minimum:

3 ml whole blood

Testing
Schedule:

24 hrs/day, 7 days a week, including holidays.

Analytic Time:

4 hours (upon receipt in laboratory)

Reference Range:

Adult males and non-pregnant females: <9.0 ng/ml

Comments:

Please print, complete and submit the Advance Beneficiary Notice 
(ABN) along with the Laboratory Requisition before shipping the 
specimen.

Test
Limitations:

The Roche assay is a valuable aid in the management of nonseminomatous 
testicular cancer patients when used in conjunction with information 
available from the clinical evaluation and other diagnostic procedures.  
Increased serum AFP concentrations have also been observed in ataxia 
telangiectasia, hereditary tyrosinemia, primary hepatocellular 
carcinoma, teratocarcinoma, gastrointestinal tract cancers with and 
without liver metastases, and in benign hepatic conditions such as 
acute viral hepatitis, chronic active hepatitis, and cirrhosis. 
Specimens from patients who have received preparations of mouse 
monoclonal antibodies for diagnosis or therapy may contain human 
anti-mouse antibodies (HAMA).  Such specimens may show either falsely 
elevated or depressed values when tested with assay kits which employ 
mouse monoclonal antibodies.  These specimens should not be assayed 
with the Roche assay.  Heterophilic antibodies in serum have the 
potential to cause interference in immunoassay systems.  Infrequently, 
AFP levels may appear elevated due to heterophilic antibodies present 
in the patient's serum or to nonspecific protein binding.  If the AFP 
level is inconsistent with clinical evidence, additional AFP testing is 
suggested to confirm the result.

Methodology:

Electrochemiluminescence ImmunoAssay

Sample
Processing:

Centrifuge at 3000 RPM for 10 minutes.
Aliquot plasma into labeled container and cap.

Sample
Storage:

Refrigerate.

Transport
Instructions:

Place specimen into zip-lock type bag, seal bag.
Place requisition into outside pocket of bag.
Transport in cooler with refrigerated coolant packs.

CPT Code:

82105