Reference Interval:
Negative: t(8;21) fusion transcript is not detected. There is no evidence of the t(8;21) by RT-PCR analysis. A negative result does not entirely exclude the presence of the t(8;21).
Positive: t(8;21) fusion transcript is detected. There is evidence of the t(8;21) by RT-PCR analysis.
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| Interpretive Data: |
Patient RNA is isolated, reverse transcribed, and subjected to PCR amplification using specific oligonucleotide primers. An additional PCR amplification directed at a housekeeping gene transcript is performed as a control for the sample cDNA quality. Each assay includes a positive control reaction using cDNA from a sample or cell line known to contain the t(8;21) and a negative control reaction using cDNA from a reactive tissue sample or cell line with no evidence of t(8;21). PCR products are detected by fluorescence using a specific pair of hybridization probes. The limit of detection for this assay is 1 in 500 cells.
Results of this test must always be interpreted in the context of morphologic and other relevant data, and should not be used alone for a diagnosis of malignancy.
This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.
Please refer to Statement B in the Compliance Statements section in the front of the Laboratory Test Directory.
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| CPT Code(s): |
83891 Isolation; 83902 Reverse transcription; 83898 x2 Amplification; 83896 x4 Nucleic acid probes; 83912 Interpretation and report - Additional CPT code modifiers may be required for procedures performed to test for oncologic or inherited disorders.
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