IMED License

BCR::ABL p190 Fusion Detection Kit

Features:

  1. Performed in a one-step reaction (no need for cDNA synthesis)
  2. 100% diagnostic sensitivity and specificity
  3. Contains internal, positive, and negative controls to confirm the extraction process and PCR test
  4. Results obtained in the shortest possible time (180 minutes)

Description

BCR::ABL p190 Detection RT-PCR Kit (Conventional) | BCR::ABL p190 Fusion Detection Kit

The Philadelphia Chromosome (Ph) is one of the most common chromosomal abnormalities in hematologic malignancies and is recognized as the primary indicator in Chronic Myeloid Leukemia (CML). This genetic alteration is also observed in a percentage of patients with Acute Lymphoblastic Leukemia (ALL), and its detection plays a crucial role in selecting the treatment approach and monitoring response to therapy.

In some patients, following point breaks on chromosomes, exon e1 of the BCR gene joins to exon 2 of the ABL gene, known as the e1-a2 junction. The result of this fusion is the production of the BCR::ABL p190 chimeric protein with an approximate molecular weight of 190 kilodaltons. This type of fusion is primarily associated with Ph-positive ALL, and its accurate detection is particularly important for determining prognosis and selecting targeted therapy.

The Real-Time RT-PCR technique, as the gold standard for the molecular diagnosis of gene fusions, enables the precise and sensitive detection of this rearrangement.

ap-rad, relying on the specific design of molecular primers and probes, has developed the BCR::ABL p190 Detection RT-PCR Kit. This kit is designed and manufactured with the following objectives:

  • Rapid, sensitive, and specific detection of the BCR::ABL p190 fusion
  • Precise differentiation of this fusion type from other BCR::ABL rearrangements
  • Usability in molecular diagnostic laboratories and healthcare centers

It enables the monitoring of patients suspected of having ALL or CML and the follow-up of their treatment response with the highest accuracy.

اطلاعات کیت
Description Conventional Amplification Kit with Genomic RNA Extraction of Specimen
Method Conventional
Type Qualitative
Regulatory Status RUO
Storage & Transfer Condition (˚C) 20-
Number of Reactions 25
Controls Positive & Negative
Applicable Instruments All Type of Thermal Cycler PCR Machines
Result Display Time 3hours
Validated Specimens Peripheral Blood
Bone Marrow Aspirate
Sample Volume 2µL
Analytical Sensitivity (Copy/µL)s 0.4Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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