PNH is an acquired stem cell disorder affecting all blood cell lines that has severe implications to both the life expectancy and quality of life affected individuals. In addition treatment of the disorder is expensive. For these reasons PNH testing by flow cytometry is classed as a critical clinical diagnostic test.
This programme is designed for use by laboratories undertaking PNH diagnosis using flow cytometry and it is not suitable for those who use other detection methods.
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 total clone size as a percentage for both PNH granulocytes and PNH monocytes in each sample. Additionally they are asked to record whether a clone is present or absent. If a cell population is not routinely tested then this option must be selected. Participants are also requested to provide information relating to gating and GPI linked antibodies and should also state their level of sensitivity for the assay for each cell population analysed.
Two samples are issued per trial and this programme issues samples a minimum of 5 times per annum and a maximum of 6.
Pre issue testing of samples for this programme is subcontracted, although the final decision about sample suitability lies with the EQA provider; no other activities in relation to this EQA programme are subcontracted.