BCR::ABL1 Minor Quantification (Accredited)

Programme objective: To assess a laboratory's ability to accurately quantify the minor (p190) BCR::ABL1 (e1a2) transcript at clinically relevant disease monitoring levels, using molecular methods.

Clinical/scientific background: BCR::ABL1 rearrangements at the minor breakpoint cluster region (m-BCR), leading to production of the p190 fusion protein, are most frequently associated with Ph-positive Acute Lymphocytic Leukaemia (ALL) and a subset of Chronic Myeloid Leukaemia (CML) patients. Quantification of minor BCR::ABL1 transcript (e1a2) levels can be utilised to monitor patient response to treatment and disease recurrence. 

Suitability: Any RNA/cDNA based molecular genetic approach to BCR::ABL1 minor transcript quantification.

Sample type/distribution: Two lyophilised cell line-based samples are issued three times per annum. Trial schedule can be found here: https://www.uknegasli.co.uk/ega-pt-programmes/trial-schedules/

Participants are asked to submit quantitative results as % ratio BCR::ABL1/reference gene together with details of their methodology. Instructions for the storage, reconstitution and use of the lyophilised samples are included with each sample distribution.

Trial duration: Trials for this programme are live/open for a minimum of 4 weeks. Please note that 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 and post-closure testing of samples for this programme are currently subcontracted, although the final decision about sample suitability lies with the EQA provider; no other activities in relation to this EQA programme are subcontracted.

Updates to the programme for current or upcoming year: Following the successful accreditation of the BCR::ABL1 Minor Quantification programme by UKAS (ISO 17043) and the increase in the number of trial issues from two to three per annum, we have now automated the data entry, analysis and reporting processes for the this programme allowing for the implementation of formal performance monitoring.

To register for this programme, please click here. 

UK NEQAS LI facilitates access to the Cepheid maintained document(s), which includes guidance on the recommended sample preparation process protocol for our lyophilised EQA/PT material, for the convenience of participants utilising the Cepheid GeneXpert system.   By hosting such information on our website, UK NEQAS LI are in no way endorsing the use of any particular assay kit/reagent, method, platform or technology.