therascreen BRAF V600E RGQ PCR Kit 変異検出キット RGQ 「キアゲン」

リアルタイム PCR を用いた BRAF 遺伝子の V600E 変異の検出

Products

The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
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therascreen BRAF V600E RGQ PCR Kit (24)

Cat. No. / ID:  874854

For 24 reactions: Control Reaction Mix, V600E Reaction Mix, BRAF Positive Control, Taq DNA Polymerase, Water for NTC, Water for Dilution
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Rotor-Gene Q MDx 5plex HRM

Cat. No. / ID:  900706

Real-time PCR cycler and High Resolution Melt analyzer with 5 channels (green, yellow, orange, red, crimson) plus HRM channel, laptop computer, software, accessories, 1-year warranty on parts and labor
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QIAamp DNA FFPE Tissue Kit (50)

Cat. No. / ID:  56404

For 50 DNA preps: 50 QIAamp MinElute Columns, Proteinase K, Buffers, Collection Tubes (2 ml) Use our next-generation QIAamp DNA FFPE Advanced Kits for improved performance.
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¥43,500
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Rotor-Gene AssayManager v2.1

Cat. No. / ID:  9024203

Software for routine testing in combination with Rotor-Gene Q and Rotor-Gene Q MDx instruments. IMPORTANT: Does not include license for use. License key must be purchased separately. Visit the Download Page for download, installation and licensing instructions.
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For up-to-date licensing information or Rotor-Gene Q instrument specific disclaimers, refer to the corresponding Rotor-Gene Q instrument user manual
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Rotor-Gene AssayManager v2.1 License (1)

Cat. No. / ID:  9025620

Single license for the installation of Rotor-Gene AssayManager v2.1 software on one computer. For installation on multiple computers, each computer requires an individual computer-specific license key.Visit the Download Page for software download, installation and licensing instructions.
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Features

  • BRAF 遺伝子変異検出コンパニオン診断薬
  • BRAF 遺伝子の V600E 変異の検出
  • 高感度、そして高い特異性
  • Sample to Insight® のシンプルなワークフロー
  • Rotor-Gene AssayManager® を使用した自動データ分析で、迅速かつ簡単な結果判定

Product Details

therascreen BRAF V600E 変異検出キット RGQ 「キアゲン」 は、BRAF遺伝子のV600E突然変異を検出する体外診断用医薬品です。この検査では、結腸・直腸がん(Colorectal Cancer, CRC)患者のホルマリン固定パラフィン包埋(Formalin-Fixed, Paraffin-Embedded, FFPE)腫瘍組織から抽出したDNAを解析します。これは、BRAFTOVI (エンコラフェニブ)、MEKTOVI (ビニメチニブ)及びセツキシマブ(遺伝子組換え)の3 剤併用療法、またはBRAFTOVI(エンコラフェニブ)及びセツキシマブ(遺伝子組換え)の2剤併用療法のいずれかによる治療が適する結腸・直腸がん(mCRC)への適応を判定するための補助を使用目的としています。

therascreen BRAF V600E 変異検出キット RGQ 「キアゲン」は、体外診断用医薬品(製造販売承認番号30200EZX00081000)です。

Performance

BEACON CRC 試験において、本品の臨床性能が評価されました。本試験は、BRAF V600E 変異陽性の治療切除不能な進行再発のCRC患者を対象に、エンコラフェニブ+セツキシマブ(遺伝子組換え)+ビニメチニブ(3 剤群)またはエンコラフェニブ+セツキシマブ(遺伝子組換え)(2剤群)と、イリノテカン及びセツキシマブ(遺伝子組換え)の併用投与、または、FOLFIRI 及びセツキシマブ(遺伝子組換え)の併用投与(対照群)を比較した、3 群多施設無作為化非盲検第III相試験です。

この試験は患者665 例(3 剤群224 例、2 剤群220 例、対照群221 例)を対象に行われました。試験の主要評価項目は、固形腫瘍の反応評価基準(Response Evaluation Criteria in Solid Tumors, RECIST v1.1)に従ったBICR (Blinded Independent Central Review)による全生存期間(Overall Survival, OS)と全奏効率(Overall Response Rate, ORR)でした。

本試験では、3 剤群と2 剤群のいずれにおいても、対照群と比較して統計学的に有意なOS とORR の改善が認められ、死亡リスクも各々48%(3 剤群)および40%(2 剤群)低下しました(3 剤群:HR 0.52、95% CI:0.39、0.70及び2 剤群:HR 0.60、95% CI:0.45、0.79)。

したがって、エンコラフェニブ、セツキシマブ(遺伝子組換え)及びビニメチニブの併用療法、またはエンコラフェニブ及びセツキシマブ(遺伝子組換え)の併用療法に対する患者適格性の判断においては、BRAF 変異状態を特定することに明らかな臨床的有益性があります。

Principle

therascreen BRAF V600E 変異検出キット RGQ 「キアゲン」は、変異検出用のV600E Reaction Mix とControl Reaction Mix の2 つの反応試薬から構成されており、BRAF 遺伝子のV600E変異の検出に使用されます。対立遺伝子に特異的な技術により、正確で再現性の高い変異の検出が可能です。ARMS プライマーとScorpions プローブを使用してDNA を選択的に増幅し、ロータージーン Q MDx 5plex HRM 装置によってシグナルを高い感度で検出します。結果判定は完全に自動化されています。コントロールとサンプル結果の両方が有効で、変異検出試験における⊿Ct値がカットオフ値以下の場合、V600E 変異検出と判定されます。

Procedure

QIAamp DNA FFPE Tissue Kit を使用してCRC腫瘍組織からDNA を抽出し、次いで、ロータージーン Q MDx 5plex HRM 装置で高感度リアルタイム PCR を行う、シンプルで簡単な検査ワークフローです。Rotor-Gene AssayManager は、変異を迅速かつ正確に判断し、検体中のV600E 変異有無を判定します。

Applications

therascreen BRAF V600E 変異検出キット RGQ 「キアゲン」は、BRAF 遺伝子のV600E 変異を検出する体外診断用医薬品です。これは、コンパニオン診断薬として薬事承認されており、BRAFTOVI (エンコラフェニブ)、MEKTOVI (ビニメチニブ)及びセツキシマブ(遺伝子組換え)、またはBRAFTOVI (エンコラフェニブ)及びセツキシマブ(遺伝子組換え)による治療が適切な結腸・直腸がん患者の特定に寄与します。

Resources

パンフレット (6)
Sample to Insight solutions for successful molecular analysis
High-quality, nucleic acid purification for successful PCR and NGS experiments.
Second edition — innovative tools
FFPE サンプルの分子解析における重要なファクター
Critical factors for molecular analysis of FFPE samples
オペレーティング・ソフトウェア (3)
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.





For use on the Rotor-Gene Q. Rotor-Gene Q software 2.3.5 is compatible with Windows 7 and Windows 10 operating systems
Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
追加リソース (1)
MSDS (2)
Download Safety Data Sheets for QIAGEN product components.
Download Safety Data Sheets for QIAGEN product components.
ソフトウェアユーザーガイド (1)
For use with Rotor-Gene AssayManager v2.1 Gamma Plug-in
機器ユーザーマニュアル (2)
For use with Rotor-Gene AssayManager v2.1 Software
For installation and setup of Rotor-Gene AssayManager v2.1
プロトコール (1)
Certificates of Analysis (1)
Additional Resources (1)
Brochures & Guides (6)
High-quality, nucleic acid purification for successful PCR and NGS experiments.
Second edition — innovative tools
Sample to Insight solutions for successful molecular analysis
Critical factors for molecular analysis of FFPE samples
FFPE サンプルの分子解析における重要なファクター
Instrument User Manuals (2)
For installation and setup of Rotor-Gene AssayManager v2.1
For use with Rotor-Gene AssayManager v2.1 Software
Software User Guides (1)
For use with Rotor-Gene AssayManager v2.1 Gamma Plug-in
Protocol Files (1)
Operating Software (3)
For use on the Rotor-Gene Q. Rotor-Gene Q software 2.3.5 is compatible with Windows 7 and Windows 10 operating systems
Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
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.





FAQ

I received a kit containing the MinElute columns; however, they were left out for a while and not stored at 2–8°C upon receipt. Can I still use them?

The MinElute spin columns included in the following kits should be stored at 2–8°C upon arrival: AllPrep DNA/RNA Micro, EpiTect Fast DNA Bisulfite, EpiTect Fast FFPE Bisulfite, EpiTect Fast LyseAll Bisulfite, EpiTect Plus DNA Bisulfite, EpiTect Plus FFPE Bisulfite, EpiTect Plus LyseAll Bisulfite, exoRNeasy Serum/plasma Maxi, exoRNeasy Serum/Plasma Midi, GeneRead DNA FFPE, GeneRead rRNA Depletion, GeneRead Size Selection, MinElute Gel Extraction, MinElute PCR Purification, MinElute Reaction Cleanup, miRNeasy FFPE, miRNeasy Micro, miRNeasy Serum/Plasma, QIAamp DNA FFPE, QIAamp DNA Investigator, QIAamp DNA Micro, QIAamp MinElute Media, QIAamp MinElute Virus Spin, QIAamp MinElute Virus Vacuum, RNeasy FFPE, RNeasy Micro, RNeasy Plus Micro.

Short-term storage (up to 4 weeks) at room temperature (15–25°C) does not affect the performance. However, for optimal performance and quality, storage temperature should not exceed 25°C.

FAQ ID - 3560
What is the composition of elution buffer ATE in the QIAamp DNA Investigator kit, QIAamp DNA FFPE Tissue kit and the QIAamp Fast DNA Stool Mini kit?

The composition of Buffer ATE is:

- 10 mM Tris-Cl pH 8.3

- 0.1 mM EDTA

- 0.04% NaN3 (sodium-azide)

FAQ ID -3122
What can be used as an alternative to the A260 measurement for quantification of small amounts of RNA and DNA?

Small amounts of RNA and DNA may be difficult to measure spectrophotometrically. Fluorometric measurements, or quantitative RT-PCR and PCR are more sensitive and accurate methods to quantify low amounts of RNA or DNA.

Fluorometric measurements are carried out using nucleic acid binding dyes, such as RiboGreen® RNA Quantitation Reagent for RNA, and PicoGreen® DNA Quantitation Reagent for DNA (Molecular Probes, Inc.).

FAQ ID -728