BCR/ABL MRNA DETECTION RT-PCR QUANTITATIVE MONITORING CML
General Information
HLAB/HOL Code: BCRAB
UPHSM LIS Test #: 026319
Schedule:
Testing Time: 5-7 Days
Testing Lab: Labcorp
UPHSM LIS Test #: 026319
Schedule:
Testing Time: 5-7 Days
Testing Lab: Labcorp
Specimen Info
Only 1 specimen type required, unless otherwise specified
Volume: 3-5 mL Whole Blood or 1-2 mL Bone Marrow
Temperature: Ambient
Tube Type: Whole blood, Bone Marrow, or Cell Pellet
Collection Info:
Volume: 3-5 mL whole blood or 1-2 mL bone marrow
Minimum Volume: 1 mL whole blood or bone marrow
Container: Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube.
Collection: Submit at room temperature. Specimens should arrive in the performing laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
Storage Instructions: Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Temperature: Ambient
Tube Type: Whole blood, Bone Marrow, or Cell Pellet
Collection Info:
Volume: 3-5 mL whole blood or 1-2 mL bone marrow
Minimum Volume: 1 mL whole blood or bone marrow
Container: Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube.
Collection: Submit at room temperature. Specimens should arrive in the performing laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
Storage Instructions: Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
Specimen Acceptability
Cause for Rejection:
Specimen does not meet collection criteria; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material
Specimen does not meet collection criteria; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material
Methods
Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cDNA quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR-ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline (<0.0032%).
Clinical Utilities
This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, p210), as well as e1a2 (minor breakpoint, p190). 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. Results should be correlated with appropriate clinical and laboratory information as indicated.
CPT Codes
81206, 81207
* The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding
is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
Reference Range
See Report for Reference Ranges
