BCR::ABL1 Major Quantification (Accredited)

Programme objective To assess a laboratory’s ability to accurately quantify the major (p210) BCR::ABL1 transcript at clinically relevant disease monitoring levels, using molecular methods.

Clinical/scientific background The quantification of the BCR::ABL1 transcript through molecular diagnostic techniques, such as reverse transcriptase quantitative PCR (RT-PCR) and digital PCR (RTdPCR), is essential for managing patients with chronic myeloid leukaemia (CML) and other BCR::ABL1positive leukemia. These techniques are pivotal in monitoring the response to tyrosine kinase inhibitor (TKI) therapy, which is critical for improving patient outcomes.

Recent scientific updates and guideline revisions, including those from the European LeukemiaNet (ELN), emphasise the significance of achieving a major molecular response (MMR), defined as BCR::ABL1 levels ≤ 0.1% on the International Scale (IS). Achieving deeper molecular responses, such as MR 4.0 and MR 4.5, which correspond to BCR::ABL1^IS levels of ≤0.01% and ≤0.0032% respectively, are indicative of measurable residual disease and can influence decisions regarding the modification or cessation of therapy in stable patients.

Suitability  Participation in this External Quality Assessment (EQA) programme is open to laboratories employing any RNA-based molecular genetic approach for the quantification of the BCR::ABL1 major transcript (e14a2, p210).

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 400.

Sample type/distribution Two lyophilised cell line-based samples are issued three times per annum, plus additional samples e.g. rare transcript or <MR 4.0 samples. Trial schedule can be found here: https://www.ukneqasli.co.uk/eqa-pt-programmes/trial-schedules/

Trial duration Standardly trials for this programme are live/open for a minimum of 4 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 and post-closure testing of samples for this programme are 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 please note that we plan to include scored e13a2 positive samples to supplement the e14a2 positive samples. In addition to this we hope to issue educational samples at MR4.0 or lower.

To register for this programme, please click here.

Related Documents

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.