GeneProof BCR/ABL Detection PCR Kit

CE IVD

PRODUCT DETAIL

The PCR kit is designed for qualitative detection of the BCR/ABL fusion gene by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

Method consists in amplification and detection of target sequences using allele specific fluorophore labelled probes. The fusion gene BCR/ABL variants are distinguished by using different fluorophores. The Major variant (Mbcr, p210) target sequence is detected in FAM fluorescent channel, the Minor variant (mbcr, p190) in the Cy5 fluorescent channel and the Micro variant (μBCR, p230) in the Texas Red channel. To control sample quality, RNA extraction process and RT-PCR process the kit uses the mRNA detection of the gene for human ABL. Amplification of this control mRNA is visualized in the HEX channel. This detection technology of the naturally occurring human mRNA provides control of the whole diagnostic process, i.e. sample quality (sample RNA degradation), RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into
cDNA) and PCR amplification efficiency (PCR inhibition). The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics and provides qualitative detection.

 

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TECHNICAL SPECIFICATION 

Technology one-step RT real-time PCR
Type of Analysis qualitative
Target Sequence BCR/ABL fusion gene
Specificity

Major (b3a2, b2a2), Minor (e1a2), Micro (c3a2)

Sensitivity

0.01 % BCR/ABL positive cells

Extraction / Inhibition Control

control of PCR inhibition and quality of RNA extraction

Validated Specimen whole blood, bone marrow
Storage -20 ± 5 °C
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System

Validated Instruments

croBEE Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5, Texas Red
Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
Certification CE IVD for in vitro Diagnostics Use

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof BCR/ABL Detection PCR Kit IN DEVELOPMENT One-Step RT real-time PCR IN DEVELOPMENT