PML-RARA Translocation by FISH

Casandra

Casandra Test Code AR43899Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 2002363CPT Codes 88271, 88275

PML-RARA Translocation by FISH

Also known as: FISH PML

Clinical Use

Order Test

Use

This test is a rapid confirmatory diagnostic test for acute promyelocytic leukemia (APL). The presence of the PML::RARA fusion due to translocation (15;17)(q24;q21) is consistent with the diagnosis of APL. It is performed using fluorescence in situ hybridization (FISH), which identifies and visualizes the specific chromosomal translocation associated with the condition, assisting in the proper diagnosis and treatment planning for patients suspected of having APL.

Special Instructions

Clinical indication or reason for testing and specimen type required with test order. If not provided, sample will still be processed, but appropriate culturing and reporting may be compromised or delayed. This test must be ordered using Oncology test request form #43099 or through your ARUP interface. A processing fee applies if the procedure is canceled after setup or if the specimen integrity is inadequate for culture growth. Bone Marrow/PBL Culture Processing Fee will be added if chromosome analysis is not performed at ARUP on the same sample, with additional charges applying if multiple FISH tests are ordered.

Limitations

Frozen, paraffin-embedded, or clotted specimens are unacceptable. The test has not been cleared or approved by the FDA. It was developed and its performance characteristics determined by ARUP Laboratories, a CLIA-certified laboratory. Results and interpretations are intended for clinical use, but there is a potential for delay in culturing and reporting if clinical indication or specimen type are unavailable at the onset. Stability constraints exists at 48 hours for ambient and refrigerated conditions, beyond which specimen validity may decline.

Test Details

New York Approved