BCR/ABL1 Gene Rearrangement, Quantitative, PCR
Also known as: P190 BCR-ABL transcript, MRDx BCR-ABL Test, t(9;22), Philadelphia Chromosome
Use
This test is used to detect and quantify the BCR‑ABL1 fusion transcript in patients with chronic myelogenous leukemia (CML) or acute lymphoblastic leukemia (ALL) that carry the t(9;22) Philadelphia chromosome. It detects both the P210 (e13a2 and e14a2) and P190 (e1a2) isoforms, and levels are expressed as the ratio of BCR‑ABL1 to ABL1 transcript, with P210 normalized to the international scale (IS) for monitoring molecular response.[turn0search0] It can detect a minimum of a 4.5‑log reduction (0.0032%) in transcript level relative to a universal baseline of 100%, with ≤0.1% corresponding to major molecular response (MMR).[turn0search0]
Special Instructions
If the BCR‑ABL1 fusion is detected on initial testing, subsequent testing will focus only on the previously detected isoform(s).[turn0search0]
Limitations
Approximately 1–3% of cases may harbor altered fusion transcripts (e.g., missing ABL1 exon A2) that the PCR assay cannot detect; FISH may be needed in these cases, such as for very rare P230 isoform or discordant PCR/FISH results.[turn0search0]
Methodology
PCR-based (RT-PCR)
Biomarkers
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
4‑6 mL
Minimum Volume
4 mL
Container
Lavender‑top (EDTA)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 Hours |
| Refrigerated | 72 Hours |
| Frozen | Unacceptable |
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