About Chronic myelogenous leukemia (CML)
Chronic myelogenous leukemia(CML)is a malignant disease of hematopoietic stem cells characterized by myeloid proliferation.It is also called chronic myeloid leukemia(CML).The annual incidence of CML worldwide is(1-2)/100,000,account- ing for 15%-20%of all adult leukemias.
Chronic myeloid leukemia(CML)has a mature program from disease diagnosis to treatment and efficacy monitoring.TKI treatment has increased the 10-year survival rate of CML patients to 85%to 90%. Patients not only pursue major molecular response(MMR),but also emphasize early molecular response (EMR) and stable deep molecular response(DMR).
Clinical practice shows that molecular response evaluation of CML patients can be achieved by monitoring minimal residual disease (MRD)at the molecular level. Therefore,standardized molecular MRD monitoring of CML patients is crucial to evaluate whether the best treatment effect is achieved.MRD detection at the appropriate time point has become a routine method in the treatment of CML.
Elevate your Chronic Myeloid Leukemia monitoring with the Rainsure's
BCR-ABL%IS Kit
Absolute Quantification
No standard calibration curve required.Direct quantification of Molecular
High Sensitivity
Measure MR value down to MR 5.0 level
Simple Workflow
Automatic digital PCR system without complex manual operation
Standardized Interpreted Output
Direct reporting on the International Scale(%IS)and Molecular Response(MR) Values
20,000 Available drop-lets can be achieved stably
The assay reportable range of linearity is from MR 0.3 (50%IS) to MR5.0(0.001%IS)
Performance
RainSure BCR-ABL Fusion Gene Detection Kit shows concordance with WHO reference standard and competitor A
| Sample Number | RainSure dPCR BCR-ABL Copy Number(copies/uL) | RainSure dPCR ABL Copy Number(copies/uL) | RainSure dPCR Mutation Ratio(%) | RT-PCR BCR-ABL Copy Number | RT-PCR ABL Copy Number | RT-PCR Mutation Ratio |
| M20-29208 | 10.16 | 170720 | 0.00595 | 0 | 302000 | 0 |
| M20-28822 | 1.84 | 397600 | 0.00046 | 0 | 526000 | 0 |
| M2020106 | 35360.00 | 505120 | 7.00032 | 212000 | 923000 | 22.965 |
| M202011246 | 493520.00 | 714080 | 69.11270 | 1360000 | 757000 | 179.000 |
| M2021-00470 | 1.84 | 388720 | 0.00047 | 0 | 250000 | 0 |
RainSure BCR-ABL Fusion Gene Detection Kit shows higher precision and sensitivity compared to RT-PCR BCR-ABL kit
Ordering Information
| 3.02.01.4130 | Human BCR-ABL (P210) Fusion Gene Detection Kit (Digital PCR) | 24 rxn |
| 3.02.03.0001 | BCRABL p210/p190 digital PCR one-tube quant test | 24 rxn |
| 3.04.01.4004 | Digital PCR cartridge | 12 pcs |
| 3.04.01.4005 | Digital PCR cartridge sealing cover | 12 pcs |
| 3.02.01.4063 | Generation Oil for probes | 24 rxn |
| 3.04.01.4003 | Heating transfer film | 12 pcs |
Required system
| PCR Amplifying Apparatus | 1 unit |
| Model: SG8-3000/SG-2000/SG32-3000 | |
| Biochip Scanner | 1 unit |
| Model: DScanner4-1000/DScanner5-1000 | |
| All-in-one System | 1 unit |
| Model: RS32 |
