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      臨床検査用 BD FACSLyric™ フローサイトメーター

      BD FACSLyric™ フローサイトメーターの性能、自動化、標準化は臨床検査に貢献します

      Testimonials Journal Publication

      Overview

       自動化により検査室のワークフローを合理化し、効率性と生産性を実現

       

      • 再現性の高い結果は自動化された標準化を実現します。

       

      BD FACSLyric™ フローサイトメーターがどのように検査室に変革をもたらすかご覧ください。

       

      販売名: BD FACSLyric フローサイトメーター
      医療機器製造販売届出番号:13B1X10407000161

       
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      FEATURES

      The BD FACSLyric™ Flow Cytometry System—A Next-Generation Flow Cytometer

      BD FACSLyric™ フローサイトメーターは、他のすべてのBD装置と同様、BDのエキスパートによるトレーニング、サービス、サポートをお届けします。

      BD FACSLyric™ フローサイトメーターの特徴

      • 4、6、8、10、12カラーモデルを揃えており、検査室/研究室のニーズの変化に合わせてアップグレード可能
      • 最大3つのレーザー（Blue、Red、Violet）と12色の蛍光チャンネルと14のパラメーター
      • 最大35,000イベント/秒の速度でデータを取得
      • BD® CS&Tビーズを使用したシングルチューブでの自動QC
      • 60日ごとに必要な蛍光補正を行うだけで、測定可能
      • 21種類のローディングオプション：BD FACS™ユニバーサルローダーを用いることで、各種ウェルプレート、チューブに対応
      • BD FACSuite™ Clinical ソフトウェアを搭載し、パスワード保護、監査証跡、電子署名、IQ/OQ手順を提供し、米国FDA 21 CFR Part 11に適合
      • BD FACSLink™  システムとBD Assurity Linc™ リモートサポートシステムは、お客様のワークフローを効率化し、シームレスにすることで、生産性を向上

       

      BD FACSLyric™ フローサイトメーターのパンフレットをご覧ください。

      BD FACSLyric™  フローサイトメーターの自動セットアップと自動蛍光補正でシンプルになったワークフローをご体験ください。

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      パフォーマンス

      機器内・機器間の差をなくし標準化を実現するフローサイトメーター

      BD FACSLyric™ フローサイトメーターは、分解能と分離能を発揮し、dimな細胞やレアな細胞集団をより簡単に分離することができます。

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      dimな細胞群やレアポピュレーションの分離を簡単にします。

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      すべてのパラメーターでStain Index指数が8～190％向上し、より良い分離を可能とし、結果、より迅速な分析と簡単なゲーティングを実現します。

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      ユニバーサルセットアップ機能は、検査室内や施設間の機器セットアップを標準化します。データ、アイデア、IVD、プロトコルを施設内および施設間で共有・交換することができます。

       

       

       

      Highly reproducible results between instruments drive standardization

       

      BD FACSLyric™ System Variance (CVs)
      15 BD FACSLyric™ Systems: Lyse/Wash settings and BD FC® Beads
      Blue Laser %CV
      FITC 4.2
      PE 4.4
      PE-Cy7 4.8
      PerCP 10.2
      PerCP-Cy5.5 7.9
      Red Laser %CV
      APC 5.3
      APC-Cy7 4.1
      APC-H7 3.9
      APC-R700 4.2
         
      Violet Laser %CV
      BD Horizon™ V450 11.1
      BD Horizon™ V500 11
      BD Horizon™ BV605 13.6
      BD Horizon™ BV711 7.5
      BD Horizon™ BV786 15.3

       

      Between-instrument reproducibility of target MFI values on the BD FACSLyric™ System

      Lyse/wash assay settings were imported across 15 instruments to show effects of standardization on beads. The CVs of the fluorescence intensity across all channels varies by less than 15.3%. Daily QC with one lot of BD® Cytometer Setup & Tracking Beads was run on fifteen BD FACSLyric™ Flow Cytometers. For each instrument, the PMTV gains were automatically adjusted to meet the target values. BD® FC Beads acquired on each BD FACSLyric™ Instrument. The MFI of positive populations was measured for all parameters across all instruments. The %CV is shown. The data for this internal study were acquired using BD® FC Beads across 15 BD FACSLyric™ Instruments. Greater between-instrument variability could be observed when running biological samples, when using non BD reagents or when comparing fewer instruments. 


      BD FACSLyric Variance(CVs)
      15 BD FACSLyric Systems: Lyse/Wash settings and BD FC beads
      Blue Laser %CV
      FITC 4.2
      PE 4.4
      PE-Cy7 4.8
      PerCP 10.2
      PerCP-Cy5.5 7.9
      Red laser %CV
      APC 5.3
      APC-Cy7 4.1
      APC-H7 3.9
      APC-R700 4.2
         
      Violet laser %CV
      BD Horizon™ V450 11.1
      BD Horizon™ V500 11
      BD Horizon™ BV605 13.6
      BD Horizon™ BV711 7.5
      BD Horizon™ BV786 15.3
       

      Between-instrument reproducibility of target MFI values on the BD FACSLyric

      Lyse/wash assay settings were imported across 15 instruments to show effects of standardization on beads. The CVs of the fluorescence intensity across all channels varies by less than 15.3%. (Figure 5) Daily QA with one lot of BD CS&T beads was run on fifteen BD FACSLyric cytometers. For each instrument, the PMTV gains were automatically adjusted to meet the target values. BD FC beads acquired on each BD FACSLyric instrument. The MFI of positive populations was measured for all parameters across all instruments. The %CV is shown.
       

      The data for this internal study was acquired using BD FC Beads across 15 instruments. Greater between-instrument variability could be observed when running biological samples, when using non-BD reagents or when comparing fewer instruments.

       

       

      APPLICATIONS

      CD4カウント、その他の免疫学的評価

      HIVなどの免疫不全の患者やその疑いのある患者の測定

      検査室のワークフローの効率化と標準化により、臨床検査における精度の向上を実現
      • BD FACSuite™ クリニカルソフトウェアは、4カラーおよび6カラーのT、B、NK細胞分析用のプレ設定されたテンプレートを備えており、再現性の高い結果を提供します。
      • 各試薬は、蛍光標識された複数のモノクローナル抗体が含まれ、染色の品質を確保するために適切な力価で混合されたカクテルになっています。

      BD FACSLyric™ フローサイトメーターの製品情報シートをご覧ください。

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      "BD is positioned with BD® CS&T and BD® FC Bead technology to enable instrument standardization simply from day to day, instrument to instrument, and lab to lab."

      Portrait of Dr. Wang for product testimonial.

      "BD is positioned with BD® CS&T and BD® FC Bead technology to enable instrument standardization simply from day to day, instrument to instrument, and lab to lab."

      Dr. Lili Wang
      NIST
      Gaithersburg, MD

      “The consistency and the regulatory compliance of FACSLyric [Flow Cytometer]’s output is what really drew us to the platform. It is currently unmatched by other flow cytometers in its ability to generate reliable, repeatable results across tests and instruments—even for the most complex assays we deal with day to day. We’ve found it particularly beneficial for multiparameter testing for CAR T cells and immunophenotyping.”

      Portrait of Dr Kromminga for product testimonial.

      “The consistency and the regulatory compliance of FACSLyric [Flow Cytometer]’s output is what really drew us to the platform. It is currently unmatched by other flow cytometers in its ability to generate reliable, repeatable results across tests and instruments—even for the most complex assays we deal with day to day. We’ve found it particularly beneficial for multiparameter testing for CAR T cells and immunophenotyping.”

      Dr. Arno Kromminga
      Chief Scientific Officer, BioAgilytix
      Europe

      “The assay portability of BD FACSLyric is the key to efficient method transfer and high data reproducibility. It represents a clear advantage in a regulated environment, where conditions must be met to produce valid results of a guaranteed level of quality. Functional immune cell–based assays and cytokine quantification in preclinical and clinical drug development is a particularly important area where BD FACSLyric offers clear technical advantages.”

      Portrait of Dr Moser for product testimonial.

      “The assay portability of BD FACSLyric is the key to efficient method transfer and high data reproducibility. It represents a clear advantage in a regulated environment, where conditions must be met to produce valid results of a guaranteed level of quality. Functional immune cell–based assays and cytokine quantification in preclinical and clinical drug development is a particularly important area where BD FACSLyric offers clear technical advantages.”

      Dr. René Moser
      Chief Executive Officer & Chief Scientific Officer, IBR Inc.
      Switzerland

      “The BD FACSLyric is a system for everyday work that every technician can use.”

      Portrait of Dr Hoffmann for product testimonial.

      “The BD FACSLyric is a system for everyday work that every technician can use.”

      Dr. Dennis Hoffman
      Labor Wisplinghoff
      Cologne, Germany
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      臨床検査用 BD FACSLyric™ フローサイトメーター

      BD FACSLyric™ フローサイトメーターの性能、自動化、標準化は臨床検査に貢献します

      お問い合わせ
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      RESOURCES
      Expand All Collapse All
      Journal Publication

      Omana-Zapata I, Mutschmann C, Schmitz J, et al. Accurate and reproducible enumeration of T-, B- and NK lymphocytes using the BD FACSLyric 10-Color System: a multisite clinical evaluation. PLoS One. 2019;14(1):e0211207. doi: 10.1371/journal.pone.0211207. 

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      Class 1 Laser Product. 

       Cy™ is a trademark of GE Healthcare. Cy™ dyes are subject to proprietary rights of GE Healthcare and Carnegie Mellon University, and are made and sold under license from GE Healthcare only for research and in vitro diagnostic use. Any other use requires a commercial sublicense from GE Healthcare, 800 Centennial Avenue, Piscataway, NJ 08855-1327, USA.
       The BD FACSLyric™ Flow Cytometer is for In Vitro Diagnostic Use with BD FACSuite™ Clinical Application for up to 6 colors. 7 to 12 colors are for Research Use Only. 


       BD FACSuite™ Clinical Application is for In Vitro Diagnostic Use. BD FACSuite™ Application is for Research Use Only. 

      Sales Name: BD FACSLyric Flow Thyometer Notification Number: 07B1X00003000161

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