BCR/ABL1 (T(9;22)) RNA Quantitative with Interpretation
| Label Mnemonic: | BCRQNT |
| Epic code: | LAB7393 |
| Order form: | Comprehensive Hematopathology Requisition |
| Supply order: | Supply Order Form |
| Billing: | Billing Policies |
| CPT code: | 81206 |
Specimen(s):
Whole Blood
Collection Medium:
 |
| Pink top tube 6 mL (K2-EDTA) |
Minimum:
6 mL whole blood in ONE pink top tube (EDTA)
Rejection Criteria:
Sample MUST be received by laboratory within
48 hours of collection due to lability of RNA.
Testing
Schedule:
Monday - Thursday 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.
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
Sample
Processing:
Refrigerate within 1 hour of collection.
Label transport tube with two patient identifiers, date and time of collection.
Maintain sterility and forward promptly to lab.
Specimen should be collected and packaged as close to shipping time as possible.
Label transport tube with two patient identifiers, date and time of collection.
Maintain sterility and forward promptly to lab.
Specimen should be collected and packaged as close to shipping time as possible.
Sample
Storage:
Refrigerate.
Transport
Instructions:
Place coolant packs into Styrofoam container.
Place requisition into outside pocket of bag.
DO NOT FREEZE, protect specimen by wrapping in bubble-wrap or toweling.
Recommend early AM overnight shipping or equivalent if not on courier service.
Ship refrigerated.
Place requisition into outside pocket of bag.
DO NOT FREEZE, protect specimen by wrapping in bubble-wrap or toweling.
Recommend early AM overnight shipping or equivalent if not on courier service.
Ship refrigerated.
CPT Code:
81206