ARUP's Laboratory Test Directory
| 0055553: BCR-ABL, t(9;22) Translocation Qualitative by RT-PCR |
| Test Mnemonic: BCR-ABL | |
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Methodology: Reverse Transcription Polymerase Chain Reaction
Performed: RNA isolation: Sun-Sat; Assay: Varies Reported: 2-7 days |
| Specimen Required: | |
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Collect: One 5 mL lavender (EDTA), pink (K2EDTA), yellow (ACD Solution A), green (sodium or lithium heparin), lt. blue (sodium citrate), or 3 mL bone marrow.
Transport: 5 mL whole blood or 3 mL bone marrow at 2-8°C. Pediatric Collection/Transport: 1 mL whole blood or bone marrow at 2-8°C. Remarks: Specimens must be received within 48 hours of collection due to lability of RNA. Stability: Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable |
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| Reference Interval: |
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Negative: bcr/abl major and minor fusion transcripts are not detected. Positive [major]: Major bcr/abl fusion transcript is detected; minor bcr/abl minor transcript is not detected. Positive [minor]: Minor bcr/abl fusion transcript is detected; major bcr/abl minor transcript is not detected. |
| Interpretive Data: | |
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Patient RNA is isolated, purified, reverse transcribed (RT) into cDNA and subjected to PCR amplification using oligonucleotide primers specific for the bcr gene on chromosome 22 and the c-abl gene on chromosome 9. These primer sets are designed to detect two gene fusion products: p210 and p190. An additional RT-PCR amplification directed at a human c-abl gene segment is performed as a control for sample cDNA quality. Each assay includs a positive control reaction using cDNA from a cell line with a known t(9;22) translocation and a negative control reaction using cDNA from a cell line with no evidence of a t(9;22) trans- location. PCR products are analyzed by electrophoresis and UV transillumination of ethidium bromide stained gels. Positive and negative control reactions give appropriate results. 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. The limit of detection for this assay is at least 1 in 100,000 cells. This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. |
| Note: | |
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A positive result indicates the presence of the bcr/abl fusion transcript. A negative result indicates the absence of the bcr/abl fusion transcript in the sample. Generally, the bcr/abl fusion transcript is found in chronic myelogenous leukemia (CML), a distinct subset of acute lymphoblastic leukemia (ALL) and occasionally of acute myelogenous leukemia (mostly CML blast crisis). The bcr/abl fusion transcript may be detected by RT-PCR even when no chromosomal translocation t(9;22) or Philadelphia chromosome is observed by cytogenetics. For minimal residual disease testing, refer to bcr/abl t(9;22) Translocation Quantitative Assay by RT-PCR (0051066). |
| CPT Code(s): | |
| 83891 Isolation; 83902 Reverse transcription; 83913 RNA stabilization; 83898 x6 Amplification; 83894 x3 Gel separation; 83912 Interpretation and report - Additional CPT code modifiers may be required for procedures performed to test for oncologic or inherited disorders. |