Lab Dept:

Anatomic Pathology

Test Name:

11q23 GENE REARRANGEMENT

General Information

Lab Order Codes:

11Q

Synonyms:

11q23; AF4/MLL; MLL/AF9; MLL Gene Mutation, Molecular

CPT Codes:

83892 (x2) - Molecular diagnostics; enzymatic digestion

83896 - Molecular diagnostics; nucleic acid probe, each

83894 (x4) – Separation by gel electrophoresis

83902 – Reverse transcription

83898 (x2) – Amplification of nucleic acid

83891 (x2)– Isolation or extraction of highly purified nucleic acid (if both DNA and RNA testing are done)

83897 – Nucleic acid transfer

Test Includes:

RT/PCR for detection of MLL/AF4 [t(4;11)], and MLL/AF4 [(9;11)]; Southern blot analysis for MLL gene rearrangements.

Logistics

Test Indications:

Useful for the diagnosis and detection of minimal residual disease of MLL gene rearrangements associated with acute lymphoblastic and acute myeloid leukemias.

Lab Testing Section:

Anatomic Pathology - Sendouts

Referred to:

Fairview-University Diagnostic Laboratories; Molecular Diagnostics (Fairview Order Code: MD - 11Q23)

Phone Numbers:

Minneapolis:

Saint Paul:

612-813-6280

651-220-6550

Test Availability:

Monday - Friday; for best results specimen should arrive by 1400 Friday

Turnaround Time:

10 - 21 days

Special Instructions:

N/A

Specimen

Specimen Type:

Blood, bone marrow, or frozen tissue

Container:

Yellow (ACD, Solution A) tube available from the lab

Draw Volume:

Peripheral blood: 10 mL (Minimum: 5 mL)

Bone marrow aspirate: 5 mL (Minimum: 2 mL)

Tissue: 5mm x 5 mm x 5 mm (Minimum: 3mm x 3mm x 3 mm)

Processed Volume:

Same as Draw Volume

Collection:

Peripheral blood: Collect 10 mL blood in yellow ACD tube

Bone marrow aspirate: Aspirate ACD solution into syringe from open ACD tube; collect 5 mL bone marrow into syringe. Deliver to laboratory in syringe.

Tissue: Collect in sterile container; deliver to the laboratory within 1 hour, or freeze specimen (liquid nitrogen or dry ice) and transport to the laboratory frozen (-70ºC).

Special Processing:

Store at room temperature. Do Not freeze. Contact laboratory prior to shipping.

Ship blood and bone marrow at room temperature. Must arrive within 24 hours. Ship fresh tissue at room temperature to arrive within 1 hour; alternatively, ship in dry ice to arrive within 24 hours.

Patient Preparation:

Physician preference

Sample Rejection:

Specimen more than 3 days old, clotted specimen, insufficient volume, incorrect tube, frozen, mislabeled or unlabeled specimens

Interpretive

Reference Range:

Results are reported as negative (germline or no rearrangement noted by Southern), positive (clonal rearrangement indicating clonal cell populations present by Southern) or specific rearrangement as detected by RT/PCR. Correlations with immunophenotypic, histopathologic, and cytogenetic data will be included with the interpretation of the molecular data when available.

Limitations:

The use of anticoagulant other than ACD may interfere with the assay.

Methodology:

RNA reverse transcription, DNA amplification and Southern blot.

Contraindications:

N/A

References:

Fairview-University Diagnostic Laboratory Web Page March 2009

Updates:

1/17/2006: 2006 CPT updates, EDTA is no longer an acceptable tube type.
3/20/2006: 2007 CPT update
3/4/2009: Specimen rejection criteria updated.