Paroxysmal Nocturnal Hemoglobinuria (PNH) with FLAER (High Sensitivity)

Message
LIMITED STABILTY PROCESSING.
No collections Friday-Sunday
Sample MUST arrive at QNI lab Monday-Thursday ONLY. Contact QNI CSR via phone with tracking.


Test Code
FC PNHFLAER


Quest Code
94148


CPT Codes
88184, 88185 (x7), 88187<br><strong>This test is not available for New York patient testing.</strong>

Includes
Antibodies directed against CD45, glycophorin A, CD59, CD24, CD14, CD15, CD64, as well as FLAER.


Preferred Specimen
5-10 mL whole blood collected in a sodium heparin (green-top) tube


Minimum Volume
3 mL


Other Acceptable Specimens
Whole blood collected in: ACD-A (yellow-top) tube or EDTA (lavender-top) tube


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 72 hours
Refrigerated: Unacceptable
Frozen: Unacceptable


Methodology
Flow Cytometry (FC)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
A.M. Sets up 7 days a week.


Reference Range
See Laboratory Report


Clinical Significance
The high sensitivity and quantitative flow cytometry assay is used in the diagnosis and follow-up of patients with paroxysmal nocturnal hemoglobinuria (PNH). FLAER as well as antibodies directed against glycosylphosphosphatidylinositol (GPI)-linked antigens are used to evaluate for the presence of (GPI)-deficient cell populations down to a level of 0.01%.


Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.