PML-RARA bcr1,2,3 One-Step Detection Kit
Cat Number: LEUK4-QRT24
The PML-RARA One-Step Detection Kit is a highly sensitive and specific molecular diagnostic tool designed for the detection and quantification of PML-RARA fusion transcripts optimized for both screening and monitoring residual or recurrent Acute Promyelocytic Leukemia (APL).
- Analytical sensitivity of 10-5
- One –step cDNA synthesis
- 24 tests per kit
- Less than 2-hour turnaround time
- Works with peripheral blood or bone marrow
- For research use (RUO) in the U.S
- For in vitro diagnostic use (IVD) in the European Union
Chromosomal translocations are critical genetic alterations in leukemia, serving as essential biomarkers for disease classification, prognosis, and monitoring. One of the most well-characterized translocations in acute promyelocytic leukemia (APL) involves the fusion of the PML gene on chromosome 15 and the RARA gene on chromosome 17. This translocation, t(15;17)(q24;q21), results in the formation of the PML-RARA fusion gene, which disrupts normal retinoic acid signaling and promotes leukemogenesis. Three primary PML-RARA isoforms—bcr1, bcr2, and bcr3—are detected in APL, with frequencies of approximately 55%, 5%, and 40%, respectively.
The presence of the PML-RARA fusion gene is a hallmark of APL, making it a crucial target for disease diagnosis and monitoring. Detecting and quantifying these fusion transcripts enables clinicians to assess disease burden, monitor minimal residual disease (MRD), and detect early molecular relapse, facilitating timely therapeutic interventions.
The LEUK4-QRT24 PML-RARA One-Step Detection Kit is a highly sensitive and specific real-time PCR-based assay designed to detect and quantify PML-RARA fusion transcripts in RNA extracted from blood or bone marrow samples. The assay utilizes a FAM-labeled hydrolysis probe to detect PML-RARA, along with a Cal Fluor Orange 560 (VIC equivalent)-labeled probe targeting the ABL gene as an internal control. This dual-target design enables accurate fusion gene quantification using the comparative Ct method (Pfaffl method), eliminating the need for external reference standards.
The use of optimized primers and reagents ensures highly efficient and reproducible cDNA synthesis in a single-tube reaction, enhancing sensitivity and specificity.
A low positive control for the PML-RARA One-Step Detection Kit is available and sold separately to support assay validation and performance monitoring.
The PML-RARA bcr1,2,3 One-Step Detection Kit follows a simple and easy to use process. It can be completed in 2 hours.
EntroGenʼs PML-RARA bcr1,2,3 One-Step Detection Kit requires a real-time PCR instrument capable of detecting FAM and VIC fluorescent probes. This test includes reagents required for PCR amplification/detection, as well as validated reaction controls.
The PML-RARA bcr1,2,3 One-Step Detection Kit features a streamlined workflow. It includes first-strand cDNA synthesis and subsequent real-time PCR in a single tube.
The kit does not include reagents or columns for RNA isolation.
