AffiCHECK® BCR-ABL1 p190 Control Panel

AffiCHECK® BCR-ABL1 p190 Control Panel 

Intended Use

The AffiCHECK® BCR-ABL1 p190 Control Panel stands as a vital reference material, meticulously designed to oversee and quantify the detection of the p190 BCR-ABL1 translocation mRNA transcript and the ABL1 endogenous control mRNA transcript. This oversight occurs during analysis using the advanced Xpert® BCR-ABL Ultra p190 assay on the sophisticated Cepheid GeneXpert® Instrument Systems.

At the heart of this examination lies the notorious Philadelphia chromosome, formed by an intricate translocation between chromosome 9's ABL1 gene and chromosome 22's BCR gene, denoted as t(9;22). This genetic anomaly culminates in the creation of the fusion gene BCR-ABL1, a hallmark present in a majority of chronic myelogenous leukemia (CML) cases and "Philadelphia positive" acute lymphoblastic leukemia of B-cell lineage (Ph+ALL)1.

Depending on the breakpoint within the BCR region, various BCR-ABL protein isoforms emerge, all encompassing exons 2-11 of the ABL1 gene but varying in the length of their BCR component. Predominantly, the major p210 and minor p190 translocations manifest, corresponding to a 210kD protein and a 190kD protein, respectively2. The primary p210 BCR-ABL1 translocation characterizes CML, while the secondary p190 BCR-ABL1 occurs in the majority of B-cell acute lymphoblastic leukemia patients3.

Monitoring BCR-ABL1 transcripts in patient blood is pivotal for evaluating treatment response and disease progression. This quantitative analysis serves as a critical tool in the clinical arsenal, aiding clinicians in assessing therapy efficacy and disease management for CML and Ph+ALL patients.

Principal

The AffiCHECK® BCR-ABL1 p190 Control Panel conteins five distinct elements, each harboring an incremental concentration of BCR-ABL1 (e1a2) RNA transcript alongside a fixed amount of ABL1 RNA transcript. These elements yield five levels, ranging from 0% to 10%, with the 0% level exclusively containing ABL1 RNA transcript. The precise ratio between e1a2 RNA and ABL1 RNA has undergone meticulous confirmation using digital PCR technology.

Employing consistent reference materials consistently across different batches proves instrumental for laboratories in detecting shifts, patterns, and potential irregularities triggered by fluctuations within the testing framework. This method fosters reliability and precision, aiding in the continuous evaluation and enhancement of the laboratory's testing procedures.

Compenents

The AffiCHECK® BCR-ABL1 p190 Control Panel is packaged in a set of 10 exclusive single-use vials, presenting two vials per ratio level. Each vial encapsulates 4 mL of precisely engineered RNA transcripts, suspended within a stabilizing matrix infused with a non-infectious solution containing buffers and preservatives. Specifically, the 0% level is solely composed of ABL1 RNA transcript, while the 0.02%, 0.1%, 1%, and 10% levels showcase a varied blend of BCR-ABL1 RNA transcript and ABL1 RNA transcript ratios.

Storage conditions

AffiCHECK® BCR-ABL1 p190 Control Panel must be sored at -20°C. Unopened package remains stable until the indicated expiration date.