Alpha-Fetoprotein (AFP), Spinal Fluid
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
An adjunct in the diagnosis of central nervous system (CNS) germinomas and meningeal carcinomatosis
Evaluating germ-cell tumors, including testicular cancer metastatic to the CNS in conjunction with beta-human chorionic gonadotropin measurement(1)
An adjunct in distinguishing between suprasellar dysgerminomas and craniopharyngiomas
A supplement to cerebrospinal fluid cytologic analysis
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Sterile vial
Specimen Volume: 1 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross OK
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|CSF||Frozen (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Alpha-fetoprotein (AFP) is an oncofetal glycoprotein, homologous with albumin that is produced both in early fetal life and in tumors arising from midline embryonic structures. AFP is synthesized in the yolk sac, liver, and gastrointestinal track of the fetus. In adults, the liver synthesizes AFP. AFP is not normally expressed in the central nervous system (CNS). AFP levels in liver are increased in hepatomas and hematocellular and colon carcinomas, as well as in germ-cell tumors arising from the ovaries and non seminomatous germ-cell tumors of the testes, testicular teratocarcinomas, and primary germ-cell tumors arising within the CNS. The presence of germinomas in the CNS and CNS involvement in metastatic cancer and meningeal carcinomatosis results in increased levels of AFP in cerebrospinal fluid.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Values for alpha-fetoprotein in cerebrospinal fluid have not been formally established for newborns and infants. The available literature indicates that by 2 months of age, levels comparable to adults should be reached (Ann Clin Biochem 2005;42:24-29).
Alpha-fetoprotein (AFP) concentrations that exceed the upper end of normal are consistent with the presence of central nervous system germinoma, meningeal carcinomatosis, or metastatic non seminomatous testicular cancer. AFP is not elevated in the presence of a craniopharyngioma.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Malignancy may occur without elevation of alpha-fetoprotien (AFP) concentration. AFP elevation occurs in approximately 70% of central nervous system germinomas. Measurement of beta-human chorionic gonadotropin is recommended to improve sensitivity of detection.
Values obtained with different assay methods or kits may be different and cannot be used interchangeably.
Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Jubran RF, Finlay J: Central nervous system germ cell tumors: controversies in diagnosis and treatment. Oncology 2005;19:705-711
2. Seregni E, Massimino M, Nerini Molteni S, et al: Serum and cerebrospinal fluid human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP) in intracranial germ cell tumors. Int J Biol Markers. 2002;17(2):112-118
3. Coakley J,Kellie SJ, et al: Interpretation of alpha-fetoprotein concentrations in cerebrospinal fluid of infants. Ann Clin Biochem 2005: 42:24-29
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is a Beckman Coulter Unicel DXI 800. The Access alpha-fetoprotein (AFP) immunoassay is a 2-site immunoenzymatic sandwich assay. A sample is added to a reaction vessel with mouse monoclonal anti-AFP alkaline phosphatase conjugate, and paramagnetic particles coated with a second mouse monoclonal anti-AFP antibody. The AFP in the sample binds to the immobilized monoclonal anti-AFP on the solid phase while, at the same time, the monoclonal anti-AFP-alkaline phosphatase conjugate reacts with different antigenic sites on the sample AFP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then a chemiluminescence substrate is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the amount of AFP in the sample. The amount of analyte in the sample is determined by means of a stored multipoint calibration curve. Because the protein matrix is less concentrated in cerebrospinal fluid, a "protein spike" is added to each specimen prior to analysis. A correction is made for the dilution effect prior to reporting.(Beckman-Coulter Assay Manual 2007)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-12 a.m., Saturday 6 a.m.-6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been modified from the manufacturer’s instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|