Paroxysmal Nocturnal Haemoglobinuria (Accredited)

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: Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any Flow Cytometric approach for the detection of PNH clone in a sample.

These samples are suitable for flow cytometricanalysis only, and they are not suitable for those who use other detection methods such as gel cards.

All EQA programme communications, data entry, and reports will be conducted exclusively in the English language. Participants must ensure proficiency in English to fully engage in the programme.

The programme welcomes participation from diverse sectors including:

Clinical Healthcare Laboratories
Academic and Research Institutions
In Vitro Diagnostics (IVD) Manufacturers
Pharmaceutical companies

Minimum participation level 30, maximum participation level 300.

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 4 times per annum and a maximum of 6, subject to sample availability. 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 is subcontracted to an approved accredited laboratory.

Updates to the programme for current or upcoming year: Each year we quote a minimum and a maximum number of possible trial distributions that will be issued on our website, subject to sample availability. Historically, we have consistently achieved the maximum number of distributions. In 2025-2026 due to staffing shortage, we are unlikely to hit the maximum number of distributions, as we have in previous years and trials may not be equally distributed throughout the year i.e; bimonthly. We will return to the full trial distribution schedule in 2026-2027. Please accept our apologies for this short-term decrease in our services.

To register for this programme, please click here.