BCR-ABL1, CML/ALL, PCR, QUANT

Message

"Please direct any questions regarding this test to oncology customer service at 800-345-4363.
"

Test Code

480481

Alias/See Also

"Acute Lymphocytic Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative
Chronic Myelogenous Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative
Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL
"

CPT Codes
81206; 81207

Preferred Specimen

"Whole blood, bone marrow, or cell pellet
3-5 mL whole blood or 1-2 mL bone marrow
"

Minimum Volume

"1 mL whole blood or bone marrow
"

Instructions

"Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form.
"

Transport Container

"Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube
"

Transport Temperature

room temp

Specimen Stability

"If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.
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Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

"Specimen more than 48 hours old; clotted blood
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Methodology
"Reverse transcription polymerase chain reaction (RT-PCR) "

Limitations

"In vitro studies have indicated that this assay has an analytical sensitivity that allows for the detection of approximately 1 cell containing the p190/p210 BCR-ABL1 fusion gene transcript in a background of 100,000 normal cells. 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.
"

Clinical Significance

"The b2a2 (e13a2) and b3a2 (e14a2) fusion transcripts values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABLIS and the major molecular response (MMR) is 0.1% BCR-ABLIS. This test is used to quantify BCR-ABL1 transcript levels of the b2a2/b3a2 (p210) and e1a2 (p190) fusion transcripts. These BCR-ABL1 fusion transcripts are found in patients with CML and Philadelphia-positive ALL. This quantitative test is used to monitor the response of patients to imatinib mesylate or other therapies.
"

The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.