IMED License

One‑Step Qualitative Detection Kit for BCR::ABL p190 Fusion

Features:

  • Includes internal, positive, and negative controls to verify extraction efficiency and PCR performance
  • 100% diagnostic accuracy and specificity
  • Results obtained in the shortest possible time (90 minutes)

Description

BCR-ABL p190 Detection rRT-PCR Kit (Real-time) | One‑Step Qualitative Detection Kit for BCR::ABL p190 Fusion

The One‑Step Qualitative Detection Kit for BCR::ABL p190 Fusion is one of the specialized, high‑quality products of AmirPeyvand Research and Development (AP‑RAD), developed in line with the company’s commitment to producing precise, sensitive, and reliable molecular diagnostic kits.

Chronic Myeloid Leukemia (CML) results from a reciprocal translocation between chromosomes 9 and 22. In this genetic rearrangement, the ABL oncogene from chromosome 9 is translocated to the BCR region on chromosome 22. The resulting chromosome, known as the Philadelphia chromosome, leads to the production of an abnormal, constitutively active tyrosine kinase protein, which in turn causes the uncontrolled proliferation of white blood cells in the bone marrow. Currently, the most sensitive and accurate method for identifying CML is the qualitative reverse transcription polymerase chain reaction (RT‑PCR).

In addition to being the primary hallmark of CML, the Philadelphia chromosome (Ph) is also observed in a subset of patients with Acute Lymphoblastic Leukemia (ALL), both in children and adults. In some cases, due to gene breakpoint variations, exon 1 of the BCR gene (e1) fuses with exon 2 of the ABL gene (a2), forming the e1‑a2 fusion. This fusion produces the chimeric BCR::ABL protein with a molecular weight of 190 kDa (p190), which plays a key role in the pathogenesis of Ph+ ALL.

The AmirPeyvand One‑Step Qualitative BCR::ABL p190 Fusion Detection Kit is designed to provide rapid, sensitive, and specific detection of the BCR::ABL p190 fusion. This kit serves as a reliable tool for use in clinical diagnostic laboratories, hematology units, and molecular genetics laboratories. It enables accurate identification of affected patients and contributes significantly to diagnosis, monitoring, and therapeutic decision‑making.

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 1.5Copy/µL
Analytical Specificity 100%
Clinical Sensitivity 100%
Clinical Specificity 100%
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