IMED License

RUNX1::RUNX1T1 Fusion Detection Kit by Real-Time PCR Method

Features:

  • Performed in a one-step reaction (no need for cDNA synthesis)

  • 100% diagnostic sensitivity and specificity

  • Contains internal, positive, and negative controls to confirm the extraction process and PCR test

  • Results obtained in the shortest possible time (90 minutes)

Description

t(8;21) RUNX1::RUNX1T1 Fusion Detection rRT-PCR Kit | RUNX1::RUNX1T1 Fusion Real-Time PCR Detection Kit

The chromosomal translocation t(8;21)(q22;q22) is one of the most common cytogenetic abnormalities in Acute Myeloid Leukemia (AML), particularly in the FAB-M2 subtype. This translocation results in the fusion of the RUNX1 (AML1) gene on chromosome 21 with the RUNX1T1 (ETO) gene on chromosome 8, creating the RUNX1::RUNX1T1 fusion. This fusion plays a key role in the pathogenesis of AML and disrupts the normal maturation of myeloid cells.

The presence of t(8;21) is usually associated with a relatively good prognosis and a favorable response to certain specific treatments. This abnormality accounts for approximately 7% of de novo AML cases and is more commonly observed in younger patients. In the AML-M2 subtype, approximately 20-40% of affected patients have this translocation. Additionally, t(8;21) has also been reported in cases of AML-M1, AML-M4, as well as therapy-related acute myeloid leukemia (t-AML).

Accurate detection of the RUNX1::RUNX1T1 fusion has significant clinical importance because it:

  • Facilitates patient prognosis assessment.

  • Plays a key role in treatment selection and monitoring of treatment response (MRD).

  • Enables rapid diagnosis in the acute phase of the disease and the implementation of effective treatment.

ap-rad, aiming to provide an accurate and efficient tool for the molecular diagnosis of hematology, has designed and manufactured the t(8;21) RUNX1::RUNX1T1 Fusion Detection rRT-PCR Kit. Utilizing rRT-PCR technology, this kit enables:

  • Rapid, sensitive, and highly specific detection of the RUNX1::RUNX1T1 fusion

  • Early detection of cytogenetic abnormalities in AML

  • Application in diagnosis, molecular interpretation, and treatment monitoring

for specialized laboratories, making it a reliable tool for the accurate diagnosis of AML based on t(8;21).

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 1Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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