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ipsogen BCR-ABL1 Mbcr Kit CE

For quantitative detection of BCR-ABL Mbcr b2a2 or b3a2 transcripts using real-time PCR
  • Highly accurate and sensitive quantitative assay
  • EAC standardized assay for reproducible results
  • Compliance with EU IVD Directive 98/79/EC
  • Easy workflow with ready-to-use solutions
The ipsogen BCR-ABL1 Mbcr Kit is an in vitro molecular diagnostic kit for real-time PCR on the Rotor-Gene Q and other real-time PCR instruments. The kit provides reagents optimized for reliable and sensitive detection and quantitation of BCR-ABL Mbcr p210 Mbcr b2a2 or b3a2 transcripts, relative to ABL control gene expression, in bone marrow or peripheral blood samples of acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) patients previously diagnosed with a BCR-ABL Mbcr fusion gene event. The test is intended to evaluate the level of molecular response; results can be used for minimal residual disease follow-up. Major developments in technology and analytical performance are integrated into the ipsogen BCR-ABL1 Mbcr IS-MMR Kit CE, to provide sensitive and accurate results aligned with the International Scale, and allow assessment of Major Molecular Response (MMR).

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Cat No./ID: 670123
ipsogen BCR-ABL1 Mbcr Kit (24) CE
For 24 reactions: ABL Control Gene Standards, BCR-ABL Mbcr Fusion Gene Standards, Primer and Probe Mix ABL, Primers and Probe Mix BCR-ABL Mbcr Fusion Gene
Cat No./ID: 670125
ipsogen BCR-ABL1 Mbcr Kit (52) CE
For 52 reactions: ABL Control Gene Standards, BCR-ABL Mbcr Fusion Gene Standards, Primers and Probe Mix ABL, Primers and Probe Mix BCR-ABL Mbcr Fusion Gene

Product Details

0
BCR-ABL Mbcr fusion gene transcript.
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ABL control gene transcript.
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Accurate detection of BCR-ABL Mbcr standards.
BCR-ABL Mbcr standards (F1–F5): 101, 102, 103, 105, and 106 copies/5 µl.
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Reliable detection of ABL plasmid standards.
ABL standards (C1–C3): 103,104, and 105 copies/5 µl.
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In vitro diagnostic medical device.
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CE-IVD-marked.
Performance
To ensure highest sensitivity, the ipsogen BCR-ABL1 Mbcr Kit has been optimized to detect BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts and the ABL control gene using prediluted plasmid standards and primers and probe mixes (see figures Accurate detection of BCR-ABL Mbcr standards and Reliable detection of ABL plasmid standards).

Principle
The ipsogen BCR-ABL1 Mbcr Kit is a ready-to-use kit for the detection of BCR-ABL Mbcr p210 b2a2 or b3a2 fusion gene transcripts using real-time PCR. The kit is based on the amplification and detection of specific BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts, relative to ABL control gene expression, in total RNA extracted from bone marrow or peripheral blood samples of acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) patients previously diagnosed with a BCR-ABL Mbcr fusion gene event. The kit provides high levels of specificity, sensitivity, and reproducibility. The ipsogen BCR-ABL1 Mbcr Kit provides 5 standard dilutions for Mbcr and 3 standard dilutions for ABL. Use of the standards enables accurate quantification of transcripts. Specific primers and probe mixes and standard serial dilutions of control and fusion DNA are provided for the quantification of the BCR-ABL1 Mbcr genes and the ABL control gene according to Europe Against Cancer (EAC) recommendations (see figures BCR-ABL Mbcr fusion gene transcript and ABL control gene transcript).

Procedure
The first step is reverse transcription of total RNA in a sample into cDNA. The second step is the amplification of cDNA by real-time PCR. Using the ipsogen BCR-ABL1 Mbcr Kit allows detection and quantification of BCR-ABL Mbcr p210 b2a2 or b3a2 fusion gene and ABL transcripts. Simply start the reaction using the optimized protocols described in the kit handbook.

Applications
The ipsogen BCR-ABL1 Mbcr Kit enables sensitive and reliable detection and quantification of BCR-ABL Mbcr p210 b2a2 or b3a2 transcripts, relative to ABL control gene expression, for in vitro diagnostic use.

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Operating Software (3)

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Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
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To download Rotor-Gene AssayManager v2.1.1 after purchase:
    Click the Rotor-Gene AssayManager v2.1.1 Software header. On the next window, click Continue. Follow the on-screen instructions to install Rotor-Gene AssayManager v2.1.1.
    Rotor-Gene AssayManager v2.1.1 and license must be purchased prior to use.    

    IMPORTANT: In order to perform and analyze runs, at least one Rotor-Gene AssayManager v2.1.1 plug-in needs to be installed. Refer to your assay kit handbook for more information.

    IMPORTANT: To allow checksum integrity verification, use the value D24F10DEB7A1D60EE381E2AEA8789117D0980FCC.

To purchase a license key for Rotor-Gene AssayManager v2.1.1:
    1. After purchasing Rotor-Gene AssayManager v2.1.1 software and licenses, click the "Download" button and follow the onscreen instructions to install. After successful installation of the Rotor-Gene AssayManager v2.1.1 and a plug-in, a “key file” will be generated. This "key file" will be attached to the "Technical Support Form" in Step 5, below.   
    2. Go to the Technical Support Form. Make sure to include all required information and your Rotor-Gene Q or Rotor-Gene Q MDx serial number when filling out the form.       
    3. For Question 2, "Type of Request", select “Other”.
    4. For Question 4, “Your inquiry”, enter "Rotor-Gene AssayManager license request” and include your purchase order number, from your order confirmation.
    5. Include the "key file" from Step 1 as an attachment.
    6. Submit the form. QIAGEN Technical Services will respond via email with a license file within 1–2 working days.    
    7. After receiving your computer-specific Rotor-Gene AssayManager v2.1.1 license file, archive the license file locally on your computer.

IMPORTANT: The license file must always exist on the computer that has Rotor-Gene AssayManager v2.1.1 installed. The license file location should be protected and not subject to change.






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