PML-RARA Real-Time PCR Kit
Qualitative detection and differentiation of PML-RARA fusion transcripts (bcr1, bcr2, bcr3) for confirmatory diagnosis of Acute Promyelocytic Leukemia.
Qualitative Detection & Differentiation of PML-RARA Fusion Transcripts (bcr1, bcr2, bcr3) in Acute Promyelocytic Leukemia
The PML-RARA-Q Real-Time PCR Kit is a CE-IVD molecular diagnostic assay designed for multiplex detection and differentiation of PML-RARA fusion transcripts, the defining genetic abnormality in Acute Promyelocytic Leukemia (APL).
This assay enables rapid molecular confirmation of APL, supporting early initiation of life-saving targeted therapy and timely clinical decision-making through a standardized real-time RT-PCR workflow.
Product Overview
The PML-RARA-Q Real-Time PCR Kit is an in vitro diagnostic (IVD) assay based on real-time RT-PCR technology for the qualitative detection of PML-RARA fusion transcripts in human clinical samples.
APL is characterized by a chromosomal translocation: t(15;17) → PML gene (Chr 15) + RARA gene (Chr 17).
This fusion results in three clinically relevant breakpoint isoforms, all covered by the assay: bcr1, bcr2 (variant form), and bcr3.
- The assay includes an ABL1 internal control to ensure assay validity and RNA integrity.
- This multiplex approach enables accurate fusion transcript identification for confirmatory leukemia diagnostics.
Why PML-RARA Testing Matters
Acute Promyelocytic Leukemia (APL) is a distinct subtype of AML (AML-M3) requiring urgent molecular diagnosis due to its association with life-threatening coagulopathy.
Detection is essential to
- Confirm APL diagnosis
- Differentiate APL from other AML subtypes
- Initiate targeted therapy (ATRA / arsenic trioxide)
- Guide risk stratification and treatment planning
Breakpoint distribution
Targets Detected
Fusion Transcript Targets
Internal Control
Ensures RNA quality and assay performance validation.
Applications
The kit is ideal for clinical molecular laboratories performing:
- PML-RARA fusion transcript testing
- Molecular confirmation of Acute Promyelocytic Leukemia (APL)
- Breakpoint isoform differentiation (bcr1 / bcr2 / bcr3)
- Leukemia subtype classification
- Oncology molecular diagnostic workflows
- Rapid therapy-guiding genetic testing
Key Features & Benefits
Multiplex Detection of All Major PML-RARA Isoforms
Single assay detects and differentiates bcr1, bcr2, and bcr3 transcripts for comprehensive APL confirmation.
Three-Tube Multiplex Real-Time PCR Design
Isoform-specific ready mixes enable precise breakpoint identification.
Automated Sample-to-Result Workflow
Compatible with Genes2Me rapid PCR platforms for streamlined molecular oncology testing.
Rapid Molecular Confirmation of APL
Supports urgent diagnosis where early therapy initiation is clinically critical.
Internal Control for Quality Assurance
ABL1 validates extraction, amplification, and sample integrity.
Sample Types & Reporting Output
Sample Types
Validated for use with:
Reporting Output
The assay provides clear qualitative reporting, including:
- Isoform-specific positive / negative result
- Ct values
- Amplification curves
- Internal control validation
- Exportable reports (USB / Bluetooth; system dependent)
Compatible System
OnePCR-Rapi-Q Ultra-Fast POC System
Designed for automated workflow including extraction and amplification.
- Collect peripheral blood / bone marrow sample
- Load 200 µl sample into Cartridge-1
- Reconstitute Ready Mix tubes (bcr1 / bcr2 / bcr3)
- Insert cartridges / tubes into system
- Automated RNA extraction + RT-PCR amplification
- Results displayed with isoform differentiation and Ct curves
Storage & Stability
Ordering Information
| Commercial Name | Old Cat No. | New Cat No. | Pack Size |
|---|---|---|---|
| PML-RARA-Q Real-Time PCR Kit | G2M708821R | G610024-3 | 24 Tests |
Why Choose the PML-RARA-Q Real-Time PCR Kit?
If your lab requires a reliable APL molecular diagnostic PCR kit, this assay delivers:
- Multiplex detection of bcr1, bcr2, bcr3 isoforms
- Rapid confirmation of PML-RARA fusion
- Internal control–validated results
- Probe-based high-specificity PCR chemistry
- Compatibility with fast automated PCR systems
- Suitability for urgent leukemia diagnostics
