Intended Use
It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosomes X and Y via fluorescence in situ hybridization (FISH) in interphase nuclei and metaphase spreads obtained from bone marrow specimens in subjects who received opposite-sex bone marrow transplantation for chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder (MPD), myelodysplastic syndrome (MDS), acute and lymphoid leukemia (ALL), or hematological disorder not otherwise specified (HDNOS).
Patient Preparation
- Sample collection: Non-diluted bone marrow aspirate. Collect in a sodium heparinized Vacutainer.
- Specimen preparation: Do not freeze or expose to extreme temperatures.
- Bone Marrow: Transfer 3 mL bone marrow to a Green (Sodium Heparin). (Min: 1 mL)
- Whole Blood: Transport 5 mL whole blood. (Min: 2 mL)
- Storage/Transport Temperature: Room temperature.
- Unacceptable Conditions: Frozen specimens. Clotted specimens.
- Remarks:
- Stability: Ambient: 48 hours; Refrigerated: 48 hours; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Sample received to report Turnaround time (TAT)
3 working days
Reference Interval
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Interpretive Data
The most recent WHO classification of Tumours of Hematopoietic and Lymphoid Tissues (Revised 5th edition) is used for interpretation criteria for evaluation.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report