Test Directory

This assay can detect two different types of BCR-ABL1 fusion transcripts e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, resulting in a p210 BCR-ABL protein). The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. 

Specimen Type: Whole Blood

Alternate Specimen Type: Bone Marrow

Collection Container: Lavender Top (EDTA)

Alternate Collection Container: Green Top (Sodium Heparin), Pale Yellow Top (ACD A), Tan Top (EDTA), or Pink Top (EDTA) 

Desired Specimen Volume: 5 mL whole blood

Alternate Specimen Volume: 2 mL bone marrow

1. Collect 2 lavender top (EDTA) tubes via venipuncture.

1. Transport 5 mL of whole blood in the original collection containers.
2. Specimens should be received at the reference lab within 48 hours.

Transport to the laboratory refrigerated. 

• Leaking tube
• Clotted blood or marrow
• Grossly hemolyzed
• Otherwise visibly degraded
• Contamination by another specimen
• Containing suspicious foreign material

See patient report.

In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline. A negative result does not rule out the presence of low levels of BCR-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay.

Results should be correlated with appropriate clinical and laboratory information as indicated.