Paroxysmal Nocturnal Hemoglobinuria (PNH)

Also known as: PNH

Clinical Use

Use

The following markers are utilized to test neutrophils and/or monocytes: CD24, CD15, CD45, FLAER, CD64, CD14. If a PNH clone is identified, the following markers are used to test red blood cells: glycophorin A, CD59.

Special Instructions

Not provided.

Limitations

The test is developed by LabCorp and its performance characteristics are established internally, however, it is not FDA-approved. The assay's sensitivity typically ranges from 0.01% to 0.1%, with detection dependent on the number of cells and events acquired. It is important to correlate test results with clinical and laboratory data for accurate diagnosis. Specimens older than 48 hours or with fewer than 1,000 WBC/µL could lead to incomplete RBC analysis.

Test Details

Methodology

Cell-based / Cytometry (Flow Cytometry)

Biomarkers

8 targets

CD14CD15CD24CD45CD59CD64FLAERglycophorin A

LOINC Codes

Result Codes

33664-4 - CD59 Cells Bld Ql
8251-1 - Service Cmnt-Imp
31208-2 - Specimen source
33194-2 - Viable cells NFr Spec
53831-4 - CD59 deficient Granulocytes NFr Bld
60554-3 - CD59 deficient Monocytes NFr Bld
49031-8 - CD59 RBC/RBC NFr Bld
72486-4 - Lab director name Provider
80563-0 - Report

Result Turnaround Time

2-7 days

Specimen

Whole Blood

Volume

4 mL

Minimum Volume

2 mL

Container

Green-top (sodium heparin) tube (preferred) or lavender-top (EDTA)

Collection Instructions

Draw Monday through Thursday only. Specimens must arrive at Integrated Oncology within 48 hours of collection. Ship immediately with a cool pack. Do not freeze.

Storage Instructions

Refrigerate; stable at room temperature up to 48 hours; refrigerated up to 48 hours.

Causes for Rejection

Samples with less than 1,000 WBC/µL may only have RBC analysis reported; specimens received for testing greater than 48 hours old and viability less than 80%; frozen specimen; broken container; fixed tissue; bone marrow; insufficient sample; sample greater than 48 hours old.