BCR/ABL1 (T(9;22)) RNA Quantitative with Interpretation, Blood
Order Code: BCRQNT
Epic Lab Code: LAB7393
Order Form: A-1a Molecular Pathology/Diagnostics or Epic Req
Molecular Pathology
6004 BT GH
384-9568
Specimen(s):
Whole Blood
Collection Medium:
or and
Pink top tube Lavender top tube 3 mL (EDTA) Lavender top tube 3 mL (EDTA)
Minimum:
6 mL whole blood in ONE pink top tube or TWO lavender top tubes
Rejection Criteria:
Sample MUST be received by laboratory within 48 hours of collection due to lability of RNA.
Delivery Instructions:
Deliver to laboratory immediately after collection.
Testing Schedule:
Monday - Friday only, no holidays, no weekends.
Turn Around Time:
7 working days
Reference Range:
Negative
Comments:
Serial analysis of BCR-ABL mRNA levels by real-time quantitative polymerase chain reaction (QRT-PCR) during and/or after therapy (imatinib, dasatinib, nilotinib, or stem cell transplantation) accurately reflects the levels of disease suppression and is an effective method for monitoring treatment efficacy.

Major Molecular Response (MMR) reflects a patient's response to CML treatment and MMR is defined as greater than or equal to a 3-log reduction in BCR-ABL/control gene ratio from a standardized median baseline value. In the International Randomized Interferon versus STI571 (IRIS) study, patients with a ratio at or below MMR within 18 months of starting treatment were 100% free from progressing to accelerated phase or blast crisis at 60 months. The laboratory employs an MMR reference value that has been validated with the WHO International Standard.

Interassay Variability: Above MMR: less than 2-fold, Below MMR: less than 4-fold

Sensitivity: One tumor cell in 1 x 104 normal cells

Limit of Quantitation: 30 BCR-ABL copies

The laboratory reports the BCR-ABL/ABL raw ratio, the percent ratio standardized to the International Standard (%IS), the BCR-ABL copy number, and the ABL copy number as separate values that can be trended using Epic graph function. Breakpoint determination will be performed and reported for new diagnosis specimens only.
Test Limitations:
Ambient: 1 hour (Samples must be refrigerated within one hour and reach the laboratory within 48 hours of draw time- due to lability of RNA).
Methodology:
Quantitative real-time Polymerase Chain Reaction
CPT Code:
81206
 
See Additional Information:
Specimens Requiring Immediate Delivery