TEST:

Quantidex qPCR BCR-ABL IS Kit

"Bio-Techne Corporation...has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR."

The results were highly correlated over the full range of values obtained. Some bias was observed, with unknown origin or significance. This is a similar bias between methods previously observed for leukemic translocation marker BCR::ABL1 RNA prior to international harmonization efforts for standardized measurement with international primary reference materials.

The analytical validation showed that the modified FDA-cleared assay performed with high precision, accuracy, linear range, and analytical sensitivity, and results highly correlated with our LDP.

The 2 kits were highly correlated over the full range of values obtained. Some bias was observed, arising from differences in quantifying e13a2. Qualitative agreement of detection was high, but interpretation was complicated by replicate-discrepant BCR-ABL1 results

Twelve patients with ≥3 different time points were part of this cohort, and several patients showed MR (MR >2) or major MR (MR >3) after TKI initiation (imatinib, dasatinib, nilotinib). ddPCR and RT-qPCR are comparable methods, with ddPCR showing MR values that trended slightly higher than RT-qPCR, though this did not significantly change clinical status. Both assays also showed sensitive MRD detection in patients with CML.

Single- and multi-site precision studies demonstrated a maximum standard deviation of 0.13 MR (30% CV within the assay range between MR0.7 and MR3.7). The performance of this BCR-ABL1 monitoring test meets all of the clinical guideline recommendations for sensitivity and IS reporting for the management of chronic myeloid leukemia patients.