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AFP, SERUM, TUMOR MARKER
Message"If patient is pregnant, include approximate gestational age on the test request form and order test 010801. Values obtained with different assay methodologies should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor a patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number (480012) to order.
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Test Code
2253
Alias/See Also
"AFP, Serum
Alpha-Fetoprotein (AFP), Serum, Tumor Marker
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Alpha-Fetoprotein (AFP), Serum, Tumor Marker
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CPT Codes
82105
Preferred Specimen
"Serum
0.8 mL
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0.8 mL
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Minimum Volume
"0.3 mL (Note: This volume does not allow for repeat testing.)
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Instructions
"If a red-top tube is used, transfer separated serum to a plastic transport tube.
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Transport Container
"Red-top tube or gel-barrier tube
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Transport Temperature
Refrigerated
Specimen Stability
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Room temperature
14 days
Refrigerated
14 days
Frozen
14 days
Freeze/thaw cycles
Stable x3
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Room temperature
14 days
Refrigerated
14 days
Frozen
14 days
Freeze/thaw cycles
Stable x3
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Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Citrate plasma specimen; improper labeling
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Methodology
"Electrochemiluminescence immunoassay (ECLIA) "
Limitations
"The measured AFP value of a patient's sample can vary depending on the test procedure used. The laboratory finding must, therefore, always contain a statement on the AFP assay method used. AFP values determined on patient samples by different test procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.
In patients receiving therapy with high biotin doses (ie, >5 mg/day), no sample should be taken until at least eight hours after the last biotin administration.12 As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or who have received them for diagnostic purposes.12 In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur.12 The test contains additives, which minimize these effects.
For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings
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In patients receiving therapy with high biotin doses (ie, >5 mg/day), no sample should be taken until at least eight hours after the last biotin administration.12 As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or who have received them for diagnostic purposes.12 In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur.12 The test contains additives, which minimize these effects.
For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings
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Reference Range
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Tumor marker normals: 0.0-8.3 ng/mL. Normal values apply only to males and to nonpregnant females. These results are not interpretable for pregnant females
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Tumor marker normals: 0.0-8.3 ng/mL. Normal values apply only to males and to nonpregnant females. These results are not interpretable for pregnant females
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Clinical Significance
"The most important application of AFP testing in cancer management is for testicular cancer. Although not present in pure seminoma,1 elevated serum AFP is closely associated with nonseminomatous testicular cancer.2-4 The measurement of AFP in serum, in conjunction with serum hCG, is an established regimen for monitoring patients with nonseminomatous testicular cancer.5-8 In addition, monitoring the rate of AFP clearance from serum after treatment is an indicator of the effectiveness of therapy.9,10 Conversely, the growth rate of progressive cancer can be monitored by serially measuring serum AFP concentration over time.11 Serial serum AFP testing is a useful adjunctive test for managing nonseminomatous testicular cancer
The Elecsys AFP assay is intended for the in vitro quantitative determination of a1-fetoprotein in human serum and plasma to aid in the management of patients with nonseminomatous germ cell tumors.12 The determination of AFP to screen the general population for cancer is, however, not to be recommended.
A1-fetoprotein, an albumin-like glycoprotein with a molecular weight of 70,000 daltons, is formed in the yolk sac, nondifferentiated liver cells, and the fetal gastrointestinal tract.13-15 Seventy percent to 95% of patients with primary hepatocellular carcinoma have elevated AFP values.16 The later the stage of nonseminomatous germ cell tumors, the higher the AFP values. Human chorionic gonadotropin (hCG) and AFP are important parameters for estimating the survival rate of patients with advanced, nonseminomatous germ cell tumors.17-19
No correlation between the AFP concentration and tumor size, tumor growth, stage, or degree of malignancy has so far been demonstrated. Greatly elevated AFP values generally indicate primary liver cell carcinoma. When liver metastasis exists, the AFP values are generally <350-400 IU/mL.20 As the AFP values rise during regeneration of the liver, moderately elevated values are found in alcohol-mediated liver cirrhosis and acute viral hepatitis as well as in carriers of HBsAg
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The Elecsys AFP assay is intended for the in vitro quantitative determination of a1-fetoprotein in human serum and plasma to aid in the management of patients with nonseminomatous germ cell tumors.12 The determination of AFP to screen the general population for cancer is, however, not to be recommended.
A1-fetoprotein, an albumin-like glycoprotein with a molecular weight of 70,000 daltons, is formed in the yolk sac, nondifferentiated liver cells, and the fetal gastrointestinal tract.13-15 Seventy percent to 95% of patients with primary hepatocellular carcinoma have elevated AFP values.16 The later the stage of nonseminomatous germ cell tumors, the higher the AFP values. Human chorionic gonadotropin (hCG) and AFP are important parameters for estimating the survival rate of patients with advanced, nonseminomatous germ cell tumors.17-19
No correlation between the AFP concentration and tumor size, tumor growth, stage, or degree of malignancy has so far been demonstrated. Greatly elevated AFP values generally indicate primary liver cell carcinoma. When liver metastasis exists, the AFP values are generally <350-400 IU/mL.20 As the AFP values rise during regeneration of the liver, moderately elevated values are found in alcohol-mediated liver cirrhosis and acute viral hepatitis as well as in carriers of HBsAg
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