BCR-ABL Universal Real-Time PCR Kit

Qualitative Detection of BCR-ABL1 Major, Minor & Micro + Quantitative Measurement of Major (p210)

The BCR-ABL Universal Real-Time PCR Kit is a CE-IVD molecular diagnostic test designed for comprehensive detection of BCR-ABL1 fusion transcripts associated with the Philadelphia chromosome (t(9;22)).

It enables laboratories to perform both:

This universal format supports CML diagnostic confirmation and follow-up in a single standardized RT-PCR workflow.

Product Overview

The BCR-ABL Universal Real-Time PCR Kit is an in vitro diagnostic (IVD) assay based on real-time RT-PCR technology. It is intended for testing RNA extracted from peripheral blood or bone marrow (EDTA samples). The assay combines qualitative and quantitative reporting in one consolidated kit.

This integrated approach enables robust reporting for:

Why BCR-ABL Universal Testing Matters

The BCR-ABL1 fusion gene (Philadelphia chromosome) is strongly linked to Chronic Myeloid Leukemia (CML), and may also be detected in certain cases of Acute Lymphoblastic Leukemia (ALL) and rarely AML.

However, clinical reporting often requires:

The Universal Kit supports both diagnostic and monitoring requirements, helping laboratories deliver:

Targets Detected

Qualitative Targets (Detection + Differentiation)
  • BCR-ABL1 Major (p210)
    e13a2, e14a2
  • BCR-ABL1 Minor (p190)
    e1a2
  • BCR-ABL1 Micro (p230)
    e19a2
Quantitative Target
  • BCR-ABL1 Major (p210) only
    Copy number measurement supported using QS calibration standards
Internal Control
  • ABL1 Gene
    Ensures sample integrity and assay performance.

Applications

The kit is ideal for clinical molecular laboratories performing:

BCR-ABL Universal
  • BCR-ABL1 transcript detection (Major / Minor / Micro)
  • Confirmatory molecular diagnosis of Philadelphia chromosome-positive leukemias
  • Transcript classification to support clinical interpretation
  • BCR-ABL1 p210 baseline transcript burden estimation
  • Longitudinal monitoring of Major (p210) molecular response
  • Integration into hematology and oncology molecular workflows

Key Features & Benefits

Universal BCR-ABL1 Real-Time PCR Testing (Major + Minor + Micro)

Single kit designed for qualitative identification and differentiation of all clinically relevant BCR-ABL1 fusion transcript categories.

Quantitative Monitoring of Major (p210)

Supports BCR-ABL1 p210 transcript quantification to enable baseline burden reporting and follow-up monitoring.

Standardized Quantification Using QS Controls

Includes three Quantification Standards (QS1-QS3 dilutions) supporting reliable copy number estimation and standard curve-based calculation.

High Specificity with Probe-Based Detection

Real-time RT-PCR using fluorescent probes:

Internal Control for Quality Assurance

ABL1 confirms RNA integrity and assay validity, strengthening confidence in every reported result.

Optimized for Fast & Automated Workflow

Compatible with OnePCR-Rapi-Q Ultra-Fast POC System enabling streamlined molecular testing in hematology labs.

Sample Types & Reporting Output

Sample Types

Validated for use with:

  • Peripheral Blood (EDTA)
  • Bone Marrow (EDTA)
Reporting Output

The test provides clear actionable output for clinicians and labs, including:

  • Positive / Negative qualitative interpretation (per transcript category)
  • Ct values for BCR-ABL1 targets and ABL1 internal control
  • Amplification curves
  • Standard curve suitability criteria (for quantification of Major p210)
  • Copy number reporting support and normalized calculation guidance
  • Result export options (USB / Bluetooth; system dependent)

Compatible System

With OnePCR® Ultra-Fast POC System

Designed for automated workflow including extraction and amplification.

OnePCR® workflow
  • Collect EDTA blood / bone marrow sample
  • Load 200 µl sample into Cartridge-1
  • Reconstitute Cartridge-2 tubes (RM + QS) using provided buffer
  • Load cartridges into the system
  • Fully automated extraction + RT-PCR run
  • Results displayed with Ct values, curves and interpretation

Storage & Stability

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
BCR-ABL Universal Real-Time PCR Kit G2M802721 G610030-1 24 Tests

Why Choose the BCR-ABL Universal Real-Time PCR Kit

If your lab requires a single solution for comprehensive BCR-ABL real-time PCR testing, this Universal kit delivers:

  • qualitative detection of Major (p210), Minor (p190) and Micro (p230) transcripts
  • quantitative monitoring of Major (p210) for CML follow-up
  • internal control-based validation (ABL1)
  • QS-supported standardized quantification
  • simplified workflow for both diagnosis and monitoring using one universal kit

Resources to get started

Download useful documents and technical information for the BCR-ABL Universal Real-Time PCR Kit.

Product Brochure
IFU (Instructions for Use)
Report File

Product Enquiry Form

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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