Testing protocols

Performing a paroxysmal nocturnal haemoglobinuria (PNH) assay is complex and requires special attention when setting it up in the laboratory. The set-up of a good PNH protocol will facilitate:

  • Delivery of reliable and constant results over time.
  • Performance of high-sensitivity testing and avoidance of common mistakes.
  • Improved efficiency in the laboratory.

This section provides step-by-step instructions on how to establish optimal PNH assays in the most efficient way. These protocols are applicable to the wide range of instruments capable of analysis using a minimum of 4 and up to 6 colours.1,2 In addition to guidance on assay validation and the accurate reporting of results, our experts share advice on PNH testing pitfalls that frequently lead to suboptimal PNH diagnosis or misdiagnosis.

Protocols for 5-colour assays will be available soon. Please register on the portal to receive updates via newsletter

Testing considerations

Before and during PNH analysis, the following conditions should apply:

1: Pre-analytical considerations1,2

2: Analytical considerations1,2

3: Assay validation and quality control1,2

4: Clear reporting1,2

  • The report includes the PNH clone size in RBCs and white blood cells (WBCs; include data for granulocytes and monocytes, if possible) [see ‘report’ in 4-colour or 6-colour protocols].
  • Histograms/dot plots are included (see ‘report’ in 4-colour or 6-colour protocols).
  • The antibodies tested and assay sensitivity have been specified (see ‘report’ in 4-colour or 6-colour protocols).
  • The report does not contain misleading terminology (see ‘report’ in 4-colour or 6-colour protocols).
  • References
    1. Borowitz MJ et al; for Clinical Cytometry Society. Cytometry B Clin Cytom 2010; 78B: 211-230.
    2. Sutherland DR et al. Cytometry B Clin Cytom 2012; 82B: 195-208.

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