IMED License

PML::RARA Fusion Detection Kit

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)
  • Differential detection of bcr1, bcr2, and bcr3 isoforms of the PML:RARA fusion in three reactions

Description

PML::RARA Fusion Detection rRT-PCR Kit (Real-time) | PML::RARA Fusion Detection Kit

The chromosomal translocation t(15;17), which results in the fusion of the PML gene on chromosome 15 with the RARA gene on chromosome 17, is the cause of Acute Promyelocytic Leukemia (APL). APL is a subtype of Acute Myeloid Leukemia (AML – morphology M3) and is considered one of the most dangerous types of leukemia because it is associated with severe coagulation disorders and, without rapid diagnosis, can lead to early patient death.

Rapid and accurate diagnosis of this disease plays a vital role in reducing mortality; as timely initiation of specific treatments such as ATRA and arsenic trioxide can transform APL from a potentially fatal condition into one of the most treatable types of leukemia.

The PML::RARA fusion can produce three different isoforms depending on the breakpoint location in the PML gene:

  • bcr1 (PML::RARA L – Long): Breakpoint in intron 6
  • bcr2 (PML::RARA V – Variant): Breakpoint in exon 6
  • bcr3 (PML::RARA S – Short): Breakpoint in intron 3

Accurate identification of these isoforms holds great value in molecular interpretation, disease monitoring (MRD), and treatment decision-making.

ap-rad, utilizing proprietary design and Real-Time PCR technology, has produced the PML::RARA Fusion Detection rRT-PCR Kit. This kit is designed and manufactured with the following objectives:

  • Rapid, sensitive, and specific detection of the PML::RARA fusion
  • Precise differentiation of the three isoforms bcr1, bcr2, and bcr3
  • Application in initial diagnosis, molecular confirmation of APL, and monitoring treatment response

It is considered a reliable tool for specialized molecular diagnostic laboratories in the field of hematology.

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 15µL
Analytical Sensitivity (Copy/µL)s 0.5Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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