FastPlex™Human LeukemiaBCR-ABL (P210) Fusion Gene Detection Kit , Digital PCR Assay
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Package specification
24Test/Kit
 
Certification
CE-IVD
 
Storage        
Below -18°C
 
Intended use
This kit is used to quantify the proportion of BCR-ABL(P210) fusion gene in human peripheral blood specimens.
 
Detection of BCR-ABL(P210)  (e13a2, e14a2) transcript levels during tyrosine kinase inhibitor (TKI) therapy in patients with chronic myeloid leukemia (CML) to properly evaluate treatment response and monitor early relapse is important and positive for optimizing CML treatment.
Test Principle
 
Total RNA was extracted from peripheral blood, reverse transcribed, and PCR reaction solution was configured using the transcribed cDNA as a template. A pair of primers specific for the BCR-ABL 210 fusion gene and a specific fluorescent probe (labeled with the reporter fluorophore FAM and quenched fluorophore) were added to the PCR reaction solution, along with a pair of primers specific for the ABL gene and a specific fluorescent probe (labeled with the reporter fluorophore HEX and quenched fluorophore). When the fluorescent probe is intact, the fluorescent signal emitted by the reporter motif is absorbed by the quenched fluorescent motif; during PCR amplification, the 5'-3' exonuclease activity of Taq enzyme degrades the probe enzymatically, which separates the reporter fluorescent motif (FAM or HEX) from the quenched fluorescent motif, thus allowing the reporter fluorescent motif to display fluorescence.
 
Digital PCR is the dispersion of the configured PCR reaction solution in thousands of droplets. At the end of the PCR reaction, the total amount of template for the BCR-ABL 210 fusion gene and the total amount of template for the ABL gene in the PCR reaction solution are reduced by collecting and counting the fluorescence signals of all droplets, performing a Poisson distribution calculation, and combining the conversion factor (CF) of each laboratory to calculate the %IS value, which is then used to guide the MR level by the %IS value reaction (see below for the calculation formula). clinical treatment and adjustment of the treatment plan.
 
Kit components
 
The components of this kit are detailed in the table below.
 
Item
Main components
Volume (uL)
Qty (tube)
Reverse transcriptase
Reverse transcriptase
36
1 
Reverse Transcription Reaction Solution
Reverse transcription buffer, RNaseIn, dNTPs, reverse transcription primers
204
1 
BCR-ABL 210 Premix Reaction Solution
PCR buffer, MgCl2, dNTPs, primers, probes
1512
1 
BCR-ABL 210 amplification enzyme
DNA polymerase
24
1 
BCR-ABL 210 10% IS Positive Control
Cell line RNA
20
3 
BCR-ABL 210 0.1% IS Positive Control
Cell line RNA
20
3 
BCR-ABL 210 Negative Control
Cell line RNA
60
1 
 
Note: Components in kits of different lot numbers should not be used interchangeably.