Paroxysmal Nocturnal Hemoglobinuria (PNH) with FLAER (High Sensitivity)
Test Summary
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%.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5-10 mL whole blood collected in a sodium heparin (green-top) tube
Minimum Volume
3 mL
Instructions
N/A
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
Whole blood collected in: ACD-A (yellow-top) tube or EDTA (lavender-top) tube
Unacceptable Specimens
N/A
Order Code
PNHFL
EPIC (Premier) Code
LAB6384
Includes
Antibodies directed against CD45, glycophorin A, CD59, CD24, CD14, CD15, CD64, as well as FLAER.
CPT Code
- 88184
- 88185 (x7)
- 88187 - This test code is for non-New York patient testing. For New York patient testing
Billing Code
- 670786
- 670787
- 670788
CPT Statement
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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 3 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5-10 mL whole blood collected in a sodium heparin (green-top) tube
Minimum Volume
3 mL
Instructions
N/A
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Room temperature: 72 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
Whole blood collected in: ACD-A (yellow-top) tube or EDTA (lavender-top) tube
Unacceptable Specimens
N/A
Billing
CPT Code
- 88184
- 88185 (x7)
- 88187 - This test code is for non-New York patient testing. For New York patient testing
Billing Code
- 670786
- 670787
- 670788
CPT Statement
Result Information
Methodology
Flow Cytometry (FC)
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 3 days