IMED License

t(4;11) KMT2A::AFF1 fusion detection kit

Features:

  • One-Step Reaction: Performed in a single-step reaction (no cDNA synthesis required).
  • 100% Diagnostic Sensitivity and Specificity: Achieves 100% diagnostic sensitivity and specificity.
  • Includes Controls: Contains internal, positive, and negative controls to validate the extraction and PCR process.
  • Rapid Results: Delivers results in the shortest possible time (90 minutes).

Description

t(4;11) KMT2A::AFF1 Fusion Detection rRT-PCR Kit

The mixed-lineage leukemia (MLL) gene, now known as KMT2A, is located on chromosome 11q23 and undergoes rearrangement in a subset of acute leukemias. This genetic alteration is observed in approximately 10% of acute lymphoblastic leukemia (ALL) cases and about 3% of acute myeloid leukemia (AML) cases.

This gene can fuse with various partners, the most common being AF4 or AFF1, located on chromosome 4q21. This fusion accounts for about 36% of KMT2A (MLL-rearranged) leukemias and 57% of MLL-r ALL cases.

The t(4;11) translocation results in the formation of the KMT2A::AFF1 fusion and has been reported in 5-10% of ALL cases, particularly in children. This genetic abnormality is most prevalent in infants under six months old, constituting approximately 50% of ALL cases in this age group. These patients often present with a Pro B-ALL immunophenotype.

The incidence of this translocation in AML, mainly in M4 and M5 subtypes, is rare.

Leukemias with KMT2A rearrangement (MLL-r) are typically characterized by sudden onset, very rapid progression, and aggressive behavior, carrying a poorer prognosis compared to non-MLL-r cases.

Despite advancements in chemotherapy and hematopoietic stem cell transplantation methods, therapeutic responses in infant, pediatric, and adult patients with this type of leukemia remain unsatisfactory.

The t(4;11) KMT2A::AFF1 Fusion Detection rRT-PCR Kit

Developed by Amir Peyvand Research and Development (AP-RAD), this kit is designed for the rapid, sensitive, and specific detection of the KMT2A::AFF1 fusion. It serves as a valuable tool for accurately diagnosing patients with this translocation and enabling timely selection of appropriate therapeutic strategies.

اطلاعات کیت
Description Real-Time Amplification Kit with Genomic RNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status IUO
Storage & Transfer Condition (˚C) 20-
Number of Reactions 25
Controls Positive & Negative
Applicable Instruments All Type of Real-Time PCR Machines with FAM and JOE Channels
Result Display Time 1.5hours
Validated Specimens Peripheral Blood
Bone Marrow Aspirate
Sample Volume 2µL
Analytical Sensitivity (Copy/µL)s 0.3Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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