CML FISH Reflex to JAK2V617F Mutation Analysis, Quantitative, With Reflex to CALR Mutation Analysis, JAK2 Exon 12-15 Mutation Analysis and MPL Mutation Analysis by NGS

Casandra

Casandra Test Code LC87919Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 512221

CML FISH Reflex to JAK2V617F Mutation Analysis, Quantitative, With Reflex to CALR Mutation Analysis, JAK2 Exon 12-15 Mutation Analysis and MPL Mutation Analysis by NGS

Clinical Use

Use

This test is used to confirm the diagnosis of CML, establish the chronic phase karyotype for comparison with blast crisis alterations and monitor residual disease.

Special Instructions

Not provided.

Limitations

This test will not detect molecular mutations or chromosomal alterations not targeted by the included probes. Additionally, the test's performance characteristics were internally determined by Labcorp and have not been cleared or approved by the Food and Drug Administration, which may limit its application in certain regulatory environments.

Test Details

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

5 components

FISH Analysis for CML • FISHJAK2V617F Mutation Analysis • FISHCALR Mutation Analysis • FISHMPL Mutation Analysis • FISH+1 more

LOINC Codes

Order Codes

31208-2
48672-0
50398-7
51867-0
62360-3
62361-1

Result Codes

62361-1
62360-3
51867-0
50398-7
31208-2
48672-0

Result Turnaround Time

3-7 days

Specimen

Bone Marrow

Volume

2 mL

Minimum Volume

1 mL

Container

Green-top sodium-heparin tube

Collection Instructions

Utilize sterile technique and Labcorp transport kits when possible.

Storage Instructions

Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze.