BCR-ABL1 Panel by qPCR

Synonyms

BCR-ABLE1 PCR Screen; BCR-ABL1 Major & Minor Breakpoint; p210 fusion transcript; p190 fusion transcript; CML

  • Tech Only CPT
  • Tech Pro CPT 81206, 81207
  • PowerPath Code BCR-ABL Screen
  • Schedule Monday, Wednesday, Friday
  • Turn Around Time 4-7 days
  • Disease State Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML)
  • Methodology PCR

Specimen Requirements

Container Type: Lavender top tube (EDTA)Specimen Type: Whole Blood; Bone MarrowPreferred Volume: 5mL Whole Blood; 3 mL Bone MarrowMinimum Volume: 1 mL Whole Blood; 1 mL Bone Marrow

Clinical Signifigance

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 apercentage of BCR-ABL1:ABL1 ratio by using theInternational Scale (IS). BCR-ABL1 p190: Monitoring therapy in patients with CML or other BCR-ABL1 positive neoplasms with known ela2 fusion trasncript. The transcript level for the minor breakpoint (p190) is reported as the NCN% ratio of BCR-ABL1 to ABL1.

Required Patient Info

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

Storage and Transportation

Refrigerate and deliver to the lab within 72 hours of collection for optimal results.

Cause for Rejection

Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma,aliquots (previously open containers).

Retention

One week - whole blood. 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.