BCR-ABL1 RT-qPCR Major p210 Quant

Synonyms

BCR-ABL1 PCR Screen; BCR-ABL1 Major Breakpoint; p210 fusion transcript; CML

  • Tech Only CPT
  • Tech Pro CPT 81206, G0452
  • PowerPath Code BCR-ABL p210
  • Schedule Monday - Friday (Variable)
  • Turn Around Time 4-7 Days
  • Disease State Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML)
  • Methodology Reverse-Transcriptase and real-time (RT-qPCR) polymerase chain reaction to measure the quantity of BCR-ABL1 fusion transcripts p210 (b2a2/ b3a2)

Organs

Bone Marrow; Peripheral Blood

Specimen Requirements

Minimum of 1 mL whole blood in a purple (EDTA) or pink top tube (EDTA);
Minimum of 1 mL of bone marrow aspirate in a purple, pink, or green (heparin) top tube.

Diagnostic Utility

Presence of the BCR-ABL1 fusion transcript is seen in a majority of patients with CML, and in a subset of patients of B-ALL. Quantitative monitoring of the BCR-ABL1 transcript can act as a diagnostic tool and provide guidance during therapy.

Clinical Significance

BCR-ABL1 p210: Monitoring tyrosine kinase therapy in patients with CML with known e13a2 or e14a2 fusion transcripts. The transcript level for the major breakpoint (p210)is reported as a percentage of BCR-ABL1:ABL1 ratio using the International Scale (IS).

Required Patient Info

If patient has had BCR ABL testing previously please provide results, date and performing laboratory information.

Storage and Transportation

Refrigerated; specimens must be delivered to the lab within 72-hours of collection

Cause for Rejection

Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma,aliquots (previously open containers); bone marrow cores (fresh or FFPE); collection date >72-hours from receipt and RNA has shown signs of significant degradation.

Retention

One week - whole blood or bone marrow; RNA - 2 years

Comments

This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

Vendor

LDT