Programme objective: 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 neutrophils 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.
Clinical/scientific background: 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.
Suitability: These samples are suitable for flow cytometric analysis only, and they are not suitable for those who use other detection methods such as gel cards.
Sample type/distribution: The programme issues two samples per trial, these are of stabilised whole blood into which stabilised PNH material may be spiked to create PNH Clone Present samples, PNH Clone Absent samples are also issued. This programme issues samples a minimum of 5 times per annum and a maximum of 6.A trial schedule may be found here https://www.ukneqasli.co.uk/eqa-pt-programmes/trial-schedules/
Trial duration: Trials for this programme are live/open for 3 weeks. Please note, trials issued/closing in August or December are extended by 1 week. An automated email is sent 2 days prior to the trial closing, to any participant that has not returned results, warning them of the trial closure date.
Subcontracted areas: Pre-issue testing of samples for this programme are subcontracted to an approved accredited laboratory.
Updates to the programme for current or upcoming year: Further electronic exercises to be issued.
To register for this programme, please click here.