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Test Code: 503AFP (TUMOR MARKER)
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Performing Lab: SMA Specialty Medical Lab
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Clinical Significance: The Atellica IM AFP assay is not a screening test for cancer and must never be used as such. This test should not be used for interpretation of the Maternal Serum AFP. AFP testing is a safe and effective supplement to patient care when used as part of the overall management strategy for patients undergoing treatment for non-seminomatous testicular cancer or for patients being monitored after therapy is complete. Do not interpret serum AFP as absolute evidence of the presence of malignant disease. At time of presentation, patients with confirmed non-seminomatous testicular cancer may have serum AFP concentrations within the range observed in healthy individuals. Since elevated AFP levels are often found in patients with other malignant and non-malignant conditions, the physician should rule out all other conditions associated with elevated AFP levels prior to the use of the Atellica IM AFP values in non-seminomatous testicular cancer management. Conversely, low concentrations of AFP are not necessarily indicative of absence of disease, particularly post surgery or after chemotherapy. Testicular tumors that are histologically categorized as pure seminoma do not synthesize AFP. The Atellica IM AFP assay, as a useful adjunct in cancer management, is intended for the evaluation of non-seminomatous testicular cancer, or mixed tumors with non-seminomatous elements, but not for pure seminoma. Additionally, several histologic subtypes of non-seminoma either do not synthesize AFP (choriocarcinoma) or do so unpredictably (teratoma). Therefore, AFP levels should be used concurrently with other
diagnostic and clinical patient information.
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NotesValues obtained with different assay methodologies should not be used interchangeably
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Reference Ranges: <8.9 ng/dL
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Preferred Specimen: Serum collected in Serum Separator Tube or Red Top Tube
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Alternate Specimens: 
If a red-top tube is used, transfer separated serum to a plastic transport tube
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Minimum Volume: 2 mL
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Specimen Container: Gel Barrier Tube (Serum Separator Tube); Red Top Tube; Plastic Transfer Tube
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CollectionSeparate serum from cells within 45 minutes of collection
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Transport Temperature: Refrigerated
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Specimen Stability: Refrigerated: 7 days
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Causes for RejectionImproper labeling; plasma; hemolyzed sample; grossly lipemic sample
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Methodology: Chemiluminescent
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Setup Days: Monday-Saturday
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Setup Times: Every Shift
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Turnaround: 24 Hours
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CPT Code(s): 82040
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(The CPT codes provided 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 payer being billed.)
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InstrumentSIEMENS Atellica IM
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