GeneProof BCR/ABL Detection PCR Kit
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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|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|
|External Quality Assessment||regularly tested by Institute of Hematology and Blood Transfusion (IHBT) Prague External Quality Assessment panels - results at www.geneproof.com|
|Certification||CE IVD for in vitro Diagnostics Use|
|Product name||Cat. No.||Technology||Package|
|GeneProof BCR/ABL Detection PCR Kit||IN DEVELOPMENT||One-Step RT real-time PCR||IN DEVELOPMENT|