Pilot Paroxysmal Nocturnal Haemoglobinuria High Resolution (Not Accredited)

This programme is designed for use by laboratories undertaking High Resolution PNH diagnosis using flow cytometry and it is not suitable for those who use other detection methods. Routine PNH analysis is defined as identifying PNH populations of 1% or above, whilst high sensitivity assays are able to detect populations as low as 0.01%. The High Resolution programme will be designed to reflect this using samples with very small clone sizes. It will operate as a distinct programme with separate samples but the report format, scoring system and frequency of distribution will be the same as the routine PNH programme.

Samples are to be analysed by flow cytometry only. Laboratories are requested to report the percentage of PNH erythrocytes (total, type II and type III) and the percentage of PNH granulocytes in each sample. Additionally they are asked to record whether a clone is present or absent.

Two samples are issued per trial and this programme issues samples a minimum of 3 times per annum and a maximum of 4.