Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, WBC

Casandra

Casandra Test Code AR35678Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 2005003CPT Code 86356

Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, WBC

Also known as: PNH WBC

Clinical Use

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Use

This test is used to quantify or monitor the paroxysmal nocturnal hemoglobinuria (PNH) clone size in white blood cells (WBC). It is recommended as the preferred initial diagnostic test for PNH and monitors the effectiveness of treatments, such as Eculizumab, by measuring the PNH clone size in leukocytes, which is crucial for managing patients with PNH, aplastic anemia, and myelodysplastic syndromes.

Special Instructions

This test is not approved for New York State clients. New York State clients must use the Paroxysmal Nocturnal Hemoglobinuria Panel (ARUP test code 2005006) on whole blood specimens. Repeat testing frequency depends on clinical and hematological changes and is suggested at least annually for routine monitoring.

Limitations

The assay provides the most accurate measurement of the PNH clone size using WBC. However, the sensitivity may be lower in severely pancytopenic patients. The lower limits of quantification are 0.02 percent for PNH PMNs and 0.5 percent for PNH monocytes. The lower limits of detection are 0.008 percent for PMNs and 0.2 percent for monocytes. The presence of subclinical PNH populations in myelodysplastic bone marrow disorders may correlate with positive immunotherapeutic responses.

Test Details