IMED License

Diagnostic kit for the t(12;21) ETV6::RUNX1 fusion

Features:

  • Single‑step reaction without the need for cDNA synthesis
  • 100% diagnostic sensitivity and specificity
  • Includes internal, positive, and negative controls to validate the extraction process and PCR performance
  • Results obtained in the shortest possible time (90 minutes)

Description

English Translation (Professional & Medical Grade)

t(12;21) ETV6::RUNX1 Fusion Detection rRT‑PCR Kit (Real‑time) | کیت تشخیص فیوژن t(12;21) ETV6::RUNX1

Acute lymphoblastic leukemia (ALL) is the most common type of childhood malignancy, accounting for more than 20% of all pediatric cancers. This disease arises from the transformation and uncontrolled proliferation of immature lymphoid progenitor cells in the bone marrow and thymus.

One of the most important and frequently occurring genetic alterations in ALL is the translocation between chromosomes 12 and 21, which results in the formation of the ETV6::RUNX1 (TEL::AML1) fusion gene. This genetic rearrangement is detected in approximately 17–25% of children with B‑cell precursor ALL (BCP‑ALL) and represents one of the most common recurrent translocations in this group.

Although the reported frequency varies across countries, its age‑related distribution is well‑established:

  • Highest incidence in children aged 1 to 12 years (with a peak at 2–5 years)
  • Not observed in infants younger than one year
  • Rare in adults, reported in approximately 1.4% to 4.4%

Due to its significant role in prognosis and treatment selection, this translocation is highly important for accurate and rapid diagnosis.


ETV6::RUNX1 Fusion Detection Kit

The t(12;21) ETV6::RUNX1 Fusion Detection Kit, produced by AmirPayvand Research and Development (AP‑RAD), is designed for the rapid, sensitive, and specific identification of the ETV6::RUNX1 fusion.

This kit enables precise detection of patients carrying this translocation and plays a crucial role in the management and therapeutic monitoring of individuals diagnosed with ALL.

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-
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 0.1Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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