Prefer 2 ml bone marrow or 8 mL EDTA peripheral blood. Heparin specimens accepted but not preferred.
Special Handling
Keep refrigerated.
Specimen Preparation
A. A minimum of 3 ml of whole blood or 1 ml of bone marrow should be collected in a purple top (EDTA) vacutainer tube for optimal results.
B. A minimum of 5 x 106 white blood cells is recommended for optimal results.
C. Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
D. White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
E. Archival specimens should be stored at -80˚C.
Pediatric Collection
Same as adult collection.
Unacceptable Conditions
Samples not stored at the proper temperature.
Storage/Transport Temperature
Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
Archival specimens should be stored at -80˚C.
Stability (from collection to initiation)
Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
Archival specimens should be stored at -80˚C.
Performed
Analysis begun on Monday, Final Report by Pathologist on Friday.
Remarks
Sample must be received before Friday in order to be tested on the following Monday.
Ordering Recommendations
N/A
Performed
Analysis begun on Monday, Final Report by Pathologist on Friday.
Methodology
Reverse Transcription; Polymerase Chain Reaction
Reported
8-14 days
Notes
Refrigerated whole blood or bone marrow.
Section
Molecular Diagnostic Lab
Group Components
N/A
Medicare Regulated Tests
Yes
Reference Lab Notes
N/A
Reference Interval
Reference Range: Negative for BCR::ABL1 translocation.
Interpretive Data
Reporting Results:
BCR::ABL1 NOT detected
or
BCR::ABL1 detected and quantifiable. Detected and % IS > 0.00322%, the limit of quantification.
or
BCR::ABL1 detected but below the level of quantification. Detected and % IS less than 0.00322%, the limit of quantification.
or
Failed QC metrics. ABL1 copies/RT less than 50,000 on first run & repeat.
Critical value: Not applicable
CPT Codes
81206, 81207, G0452, 88240
Performing Lab
Molecular Diagnostics
Collection
Patient Preparation
N/A
Collect
Lavender EDTA, 4 mL
Alternate Specimens:
Prefer 2 ml bone marrow or 8 mL EDTA peripheral blood. Heparin specimens accepted but not preferred.
Special Handling
Keep refrigerated.
Specimen Preparation
A. A minimum of 3 ml of whole blood or 1 ml of bone marrow should be collected in a purple top (EDTA) vacutainer tube for optimal results.
B. A minimum of 5 x 106 white blood cells is recommended for optimal results.
C. Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
D. White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
E. Archival specimens should be stored at -80˚C.
Pediatric Collection
Same as adult collection.
Unacceptable Conditions
Samples not stored at the proper temperature.
Storage/Transport Temperature
Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
Archival specimens should be stored at -80˚C.
Stability (from collection to initiation)
Blood or bone marrow or residual sample from the flow cytometry laboratory should be stored at 4˚C until arrival and should be extracted to a white blood cell suspension in RNA Later™ as quickly as possible, but within 24 hours of collection.
White blood cells in RNA Later™ may be stored at 4˚C until the test is run (storage at 4˚C is possible up to one month).
Archival specimens should be stored at -80˚C.
Performed
Analysis begun on Monday, Final Report by Pathologist on Friday.
Remarks
Sample must be received before Friday in order to be tested on the following Monday.
Ordering
Ordering Recommendations
N/A
Performed
Analysis begun on Monday, Final Report by Pathologist on Friday.
Methodology
Reverse Transcription; Polymerase Chain Reaction
Reported
8-14 days
Notes
Refrigerated whole blood or bone marrow.
Section
Molecular Diagnostic Lab
Group Components
N/A
Medicare Regulated Tests
Yes
Reference Lab Notes
N/A
Result Interpretation
Reference Interval
Reference Range: Negative for BCR::ABL1 translocation.
Interpretive Data
Reporting Results:
BCR::ABL1 NOT detected
or
BCR::ABL1 detected and quantifiable. Detected and % IS > 0.00322%, the limit of quantification.
or
BCR::ABL1 detected but below the level of quantification. Detected and % IS less than 0.00322%, the limit of quantification.
or
Failed QC metrics. ABL1 copies/RT less than 50,000 on first run & repeat.
