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BCR-ABL1 Gene Rearrangement (P210 Transcript Only) Quantitative PCR
Test Code39025
CPT Codes
81206<br /> *** RESTRICTED USE *** This code is available to Client 55557 and 55447 ONLY.
Preferred Specimen
4 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
Whole blood: 4 mL
Bone marrow: 2 mL
Extracted RNA: 20 uL
Bone marrow: 2 mL
Extracted RNA: 20 uL
Other Acceptable Specimens
Whole blood or bone marrow collected in sodium heparin (green-top) or ACD-B (yellow-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube
Instructions
Do not reject specimens, send to laboratory for screening.
Collect 4 mL of whole blood or 3 mL bone marrow in EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.
Clotted specimens are unacceptable. Do not reject. Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.
Collect 4 mL of whole blood or 3 mL bone marrow in EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.
Clotted specimens are unacceptable. Do not reject. Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.
Transport Temperature
Room temperature
Specimen Stability
Whole blood/Bone marrow
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Methodology
Quantitative Real-Time Polymerase Chain Reaction
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Nichols. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M.
Clinical Significance
The Philadelphia chromosome (Ph) is a translocation between chromosome 9 and 22 t(9;22) (q34;q11) that is found in more than 90-95% of chronic myeloid leukemia (CML), and in 20-25% of adult and 2-10% of childhood acute lymphoblastic leukemia (ALL). In CML, most translocations fall in the major breakpoint cluster region of the BCR gene, and result in either of two BCR-ABL1 mRNA molecules having an e13a2 or an e14a2 junction that encodes the p210 BCR-ABL1 fusion protein. In ALL, about two thirds of the BCR breakpoints fall in the minor breakpoint cluster region, and the hybrid BCR-ABL1 transcript contains an e1a2 junction which is translated as a p190 BCR-ABL1 fusion protein. Monitoring of response to TKI and result interpretation is based on the changes of BCR-ABL1 expression levels over time. These changes are measured in fold change or more commonly in log10 change. For example, a change in per cent ratio (100 x BCR-ABL1/ABL1) from 50% to 0.5% corresponds to a 100-fold decrease or a 2-log decrease. The international Scale (IS) was established in 2005 to standardize the quantitative BCR-ABL1 measurements (P210) across tests and laboratories. The IS is anchored to the baseline BCR-ABL1 expression level from the International Randomized Study of Interferon vs STI571 (IRIS) trial (100% IS) with a major molecular response (MMR) corresponding to 0.1% IS. Data from the IRIS trial and follow up studies have demonstrated that achieving a 3-log reduction (a 1000-fold decrease) in BCR-ABL1 expression from the baseline level is a key clinical outcome.
