IMED License

PML::RARA (Acute Promyelocytic Leukemia (APL)) 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 (120 minutes)

  • Detection of 3 PML::RARA fusion isoforms in one reaction

Description

PML::RARA Detection rRT-PCR Kit | PML::RARA Detection Kit by rRT-PCR Method

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) with M3 cytomorphology and is recognized as one of the highest-risk types of AML. If not diagnosed and treated promptly, it is associated with a high risk of mortality due to severe coagulopathies. Therefore, accuracy and speed in diagnosing this disease are of vital importance. The timely initiation of effective treatments can transform APL from a very high-risk malignancy into one of the most treatable types of leukemia.

Depending on the location of the breakpoint in the PML gene (intron 6, exon 6, or intron 3), the PML::RARA fusion can occur in three different isoforms: bcr1 (PML::RARA L or Long), bcr2 (PML::RARA V or Variant), and bcr3 (PML::RARA S or Short). Accurate identification of these isoforms is important in disease diagnosis and monitoring.

ap-rad, with the aim of rapid, sensitive, and specific detection of the PML::RARA fusion and the simultaneous differentiation of bcr1, bcr2, and bcr3 isoforms, has designed and manufactured the PML::RARA Detection rRT-PCR Kit. This kit provides an efficient tool for the early diagnosis and clinical management of patients with APL.

اطلاعات کیت
Description Real-Time Amplification Kit with Genomic RNA Extraction of Specimen
Method Real-Time
Type Qualitative
Regulatory Status IVD
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 2hours
Validated Specimens Peripheral Blood
Bone Marrow Aspirate
Sample Volume 5µL
Analytical Sensitivity (Copy/µL)s 0.5Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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