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

Test Code

94148 (81156)

Includes

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

Preferred Specimen

!!!-LOOK ALIKE-SOUND ALIKE-!!!
SODIUM HEPARIN, Green Top
Tube will read "Sodium Heparin"

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

Set up: Daily; Report available: 2-3 days

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%.

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.