BCR::ABL1 p210 Quantitation by Real-Time PCR and Report by IS

CPT Code(s)

81206; G0452

Synonym(s)

Hematopathology, CML, ALL, BCR::ABL1, p210, BCR-ABL1, t(9;22)

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

The assay can confirm the initial diagnosis of chronic myelogenous leukemia (CML) or p210 BCR::ABL1 positive acute lymphoblastic leukemia (ALL). The assay is also recommended for monitoring minimal residual disease in follow-up samples.

Methodology

RNA is isolated, reverse transcribed and amplified by real-time PCR using specific primers targeting the p210 BCR::ABL1 and ABL genes. Quantitative results are obtained by comparing relative levels of p210 BCR::ABL and ABL1 transcripts to standard curves. The p210 BCR::ABL1 results are reported as a percentage based on an international scale (IS). This assay can detect p210 BCR::ABL1 transcripts to a sensitivity of 0.001% international scale (IS).

Minimum Specimen Requirements

Collect

  • Peripheral blood (PB): 3-5 mL, in purple top (sodium EDTA) tube; yellow top tube (ACD) acceptable.
  • Bone marrow (BM): 1-3 mL, drawn into a syringe containing anticoagulant and then delivered in a purple top tube.

Transport Deliver immediately at 2-8°C (wet ice or cold packs). Do not freeze.

Stability Ambient – 1 hour; refrigerated – 48 hours. Note: for RNA based assays, samples should be transported to the laboratory within 8 hours of collection (optimal), or up to a maximum of 48 hours after collection to avoid RNA degradation. RNA integrity is critical, especially for samples used for monitoring minimal residual disease.

Unacceptable Conditions Serum or plasma; frozen PB or BM; clotted blood; severely hemolyzed samples.

Turnaround time

Five to seven working days

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