Quantitative Detection of BCR::ABL1, Major Form (p210)
Also known as: QNT BCRMAJ
Use
This quantitative test is used for therapeutic monitoring of BCR::ABL1 major (p210) positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). It is designed to meet the current National Comprehensive Cancer Network (NCCN) guidelines and is recommended for detection of minimal residual disease (MRD). BCR::ABL1 translocations with breakpoints in the major cluster region result in the p210 fusion protein, commonly seen in CML and some cases of ALL.
Special Instructions
For patients with uncertain diagnoses or unknown forms of BCR::ABL1 fusion transcripts, consider ordering Diagnostic Qualitative BCR::ABL1 Assay with Reflex to p190 or p210 Quantitative Assays. This test should be used for patients with an established diagnosis and for monitoring minimal residual disease.
Limitations
This assay does not detect transcripts resulting from a rare BCR::ABL1 rearrangement with a BCR exon 19 breakpoint or the minor breakpoint (p190). It also does not detect rare major fusion transcripts (p210) involving ABL1 other than exon 2. Results should not be used alone for a diagnosis of malignancy and must be interpreted in the context of morphological and other relevant data. The test is a Laboratory Developed Test (LDT) and is not FDA-approved, being performed in a CLIA-certified laboratory.
New York Approved
Methodology
PCR-based (RT-qPCR)
Biomarkers
LOINC Codes
- 31208-2
- 42714-6
- 69380-4
- 11526-1
Result Turnaround Time
5-9 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5 mL
Minimum Volume
3 mL
Container
Lavender (EDTA) tube
Storage Instructions
Refrigerate immediately. Specimens must be received within 48 hours of collection due to RNA lability.
Causes for Rejection
Serum, plasma, extracted DNA, CSF, FFPE tissue, ambient whole blood, or frozen specimens. Collected in anticoagulants other than EDTA, or if severely hemolyzed or clotted.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | 48 hours |
| Frozen | Unacceptable |