BCR/ABL1 (T(9;22)) RNA Quantitative with Interpretation
| Label Mnemonic: | BCRQNT |
| Epic code: | LAB7393 |
| Downtime form: | Doctor/Provider Orders - Pathology Molecular |
Molecular Pathology
6240 RCP
384-9568
6240 RCP
384-9568
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:
Specimens must be received within 72 hours of collection. Optimal results are achieved if specimen is received within 48 hours of collection.
Delivery Instructions:
Deliver to laboratory immediately after collection.Testing Schedule:
Monday - Thursday only, no holidays, no weekends.
Turn Around Time:
7 working days
Reference Range:
Negative
Test Limitations:
Ambient: 1 hour
Samples must be refrigerated within one hour and must be received within 72 hours of collection. Optimal results are achieved if specimen is received within 48 hours of collection.
Methodology:
Quantitative real-time Polymerase Chain Reaction
CPT Code:
81206
See Additional Information:
Specimens Requiring Immediate Delivery
Specimens Requiring Immediate Delivery
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.