ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit CE

For quantification of BCR-ABL1 Mbcr, MMR, MR4, and MR4.5 results reporting on the International Scale (IS)

S_1084_5_GEN_V2

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ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit (24) CE

Cat. No. / ID:  670923

For 24 reactions: Reverse transcriptase, RT mix, high positive RNA control, low positive RNA control, IS-MMR calibrator, Mbcr and ABL1 Single Plasmid Standards, Primers and Probe qPCR Mix ABL1, primers and probe qPCR mix BCR-ABL1 Mbcr fusion gene, Taq DNA polymerase
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ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit (24) CE
Rotor-Gene AssayManager v2.1 Software
The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit CE is intended for in vitro diagnostic use in Europe.

✓ 24/7 automatic processing of online orders

✓ Knowledgeable and professional Product & Technical Support

✓ Fast and reliable (re)-ordering

Features

  • MMR, MR4, and MR4.5 status reporting
  • Results directly aligned on the International Scale (IS)
  • An IS-MMR calibrator aligned with World Health Organization’s (WHO) reference material to prevent intra- and inter-lab variation in every run
  • High reliability using EAC technology and single plasmid standards
  • Ready-to-use solutions including all reagents for RT and qPCR, validated on Rotor-Gene Q MDx 5Plex HRM

Product Details

The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is a quantitative, in vitro diagnostic test for the measure of the BCR-ABL1 fusion gene b3a2 (e14a2) and b2a2 (e13a2) transcripts in total RNA extracted from whole blood.

The kit is intended to monitor deep molecular response in patients diagnosed with chronic phase Philadelphia chromosome positive (Ph+) p210 chronic myeloid leukemia (CML).

The kit is calibrated against the WHO International Genetic Reference Panel and runs on Rotor-Gene Q MDx 5plex HRM using real-time PCR technology. The kit provides all necessary reagents and is optimized for improved sensitive detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 transcripts, relative to ABL1 control gene expression.

Performance

To ensure the highest sensitivity and to achieve MR4.5 status, the ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit has been optimized to detect very low levels of BCR-ABL1 p210 b2a2 or b3a2 transcripts. The limit of detection (LOD) is 3.21 CNMbcr (corresponding to a LOD of 0.0030%) and the limit of blank (LOB) is 1.02 copies of BCR-ABL1 Mbcr transcript with ABL1CN = 100 000.

Principle

Theipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is a ready-to-use kit for the detection of BCR-ABL1 p210 b2a2 or b3a2 transcripts using real-time PCR. The kit is based on the amplification and detection of specific BCR-ABL1 p210 b2a2 or b3a2 transcripts, relative to ABL1 control gene expression, in total RNA. The kit provides high levels of specificity, sensitivity, and reproducibility. Each kit contains 4 standard dilutions for ABL1, and 5 standard dilutions for BCR-ABL1 Mbcr. Use of a single plasmid for BCR-ABL1 and ABL1 enables reproducible quantification of transcripts and limits variability. Primers and probe sets are designed according to Europe Against Cancer (EAC) recommendations. The kit also includes an IS-MMR calibrator allowing direct conversion of results to the International Scale at each run for accurate measurement of molecular responses, including major molecular response (MMR), MR4 and MR4.5 — also known as deep molecular response (DMR). The IS-MMR calibrator is included within every run to prevent intra- and inter-lab variation. High and low positive controls RNA are also included to monitor the reverse transcription and amplification steps of ABL1, and BCR-ABL1 Mbcr during transcript quantification.

Procedure

The ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit is provided with all necessary reagents for reverse transcription of total RNA into cDNA, followed by the amplification of cDNA by real-time PCR on Rotor-Gene Q MDx 5plex HRM, with the use of sensitive enzymes. Using this kit allows detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 and ABL1 transcripts. Simply start the reaction using the optimized protocols described in the kit handbook. Results analysis and interpretation is now automated and simplified with the Rotor-Gene AssayManager v2.1 software.

Applications

Theipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit enables sensitive and reliable detection and quantification of BCR-ABL1 p210 b2a2 or b3a2 transcripts, conversion of results to the International Scale (IS), MMR and MR4.5 reporting. The kit is CE marked and is intended to monitor deep molecular response in patients diagnosed with chronic phase Philadelphia chromosome positive (Ph+) p210 chronic myeloid leukemia (CML).

Resources

Operating Software (2)
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.





Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
Software User Guides (1)
For use with Rotor-Gene AssayManager v2.1 Gamma Plug-in
Instrument User Manuals (1)
For installation and setup of Rotor-Gene AssayManager v2.1
Safety Data Sheets (1)
Protocol Files (1)
Version 1.0.2
Certificates of Analysis (1)