Quantitative Detection of BCR::ABL1, Major Form (p210)

Casandra

Casandra Test Code AR33161Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3005840CPT Code 81206

Quantitative Detection of BCR::ABL1, Major Form (p210)

Also known as: QNT BCRMAJ

Clinical Use

Order Test

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.

Test Details

New York Approved

Methodology

PCR-based (RT-qPCR)

Biomarkers

No genes

Gene

Fusion • Other • Binary (Detected / Not Detected)

LOINC Codes

Order Codes

31208-2

Result Codes

42714-6
69380-4
11526-1

Result Turnaround Time

5-9 days

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.