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Paroxysmal Nocturnal Hemoglobinuria (PNH) with FLAER (High Sensitivity)
Test CodePNHIF
Alias/See Also
LAB3313
CPT Codes
<p>88184, 88185 (x6), 88187</p>
Includes
Antibodies directed against CD45, glycophorin A, CD59, CD24, CD14, CD15, CD64, as well as FLAER.
Preferred Specimen
Specimen Type: Whole blood
Collection Container/Type
Preferred: Green top (Sodium heparin)
Acceptable: Yellow top (ACD), Lavender top (EDTA)
Specimen Volume: 5-10 mL
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)
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.
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
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%.
Performing Laboratory
Quest Diagnostics Nichols Institute 14225 Newbrook Drive Chantilly, VA 20153
Last Updated: February 17, 2023