NPM1 Mutation Status
UKAS Schedule of Accreditation, Accredited to ISO/IEC 17043:2010, Provider 7804
Mutations in the NPM1 gene are diagnostic/prognostic markers in Acute Myeloid Leukaemia.
PURPOSE OF PROGRAMME:
To assess a laboratories ability to accurately detect the NPM1 Mutation Status using molecular methods. NPM1 mutation load will reflect levels seen at diagnosis.
MATERIAL PROVIDED: Lyophilised cell lines and/or lyophilised patient samples
DISTRIBUTIONS PER YEAR: 3
SAMPLES PER DISTRIBUTION: 2 (Additional educational samples may also be issued).
FREQUENCY OF DISTRIBUTION: 4 monthly (July, November, March). Please note, trial schedules are a guide only and are subject to sample availability.
PROGRAMME OF ANALYSIS:
Results are entered online via the UK NEQAS LI website. Trials are live for 4 weeks. If you are unable to complete your trial analysis within the specified period please contact firstname.lastname@example.org
This programme is a qualitative scheme and so participants should answer 'mutation detected' or 'no mutation detected' to indicate the presence or absence of a NPM1 mutation in each sample and if positive the type of mutation detected. The presence/absence of the NPM1 mutation is determined from the consensus of all participants' results (modal result).
The scoring system is a rolling scheme that will identify unsatisfactory performance or persistent unsatisfactory performance of any participant. This is in order that UK NEQAS LI can provide support and guidance where needed, and ensure that the Genetics NQAAP are informed as appropriate. Please note that each programme will be scored independently. Each participant response is then compared against the consensus results. If the participant is out of consensus for one or both sample(s) a Criti
If a participant is awarded two Critical statuses out of three trials issued, then their overall status will escalate to persistent unsatisfactory performance. If a participant's status is elevated to persistent unsatisfactory performance then a further letter will be issued highlighting this and, for UK based laboratories, the Genetics NQAAP panel informed.
The External Quality Assessment Scheme for Leucocyte Immunophenotyping was established by Professor David Barnett in 1986 at Northern General Hospital, Sheffield. In 1990 the Service became known as the UK National External Quality Assessment Service for Leucocyte Immunophenotyping. UK NEQAS LI is part of the Sheffield Teaching Hospitals NHS Foundation Trust.