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Supporting information
It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic devices.

The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, supernatant, oral fluid, hemolysate, amniotic fluid, processed stool and plasma that are used for detecting and/or measuring analytes covered by the specific assays.

The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).", "Language": "en", "Country": "XR", "Code": "Intended Use" }, { "Name": "Product Purpose", "Value": "cobas® pure integrated solutions is an automated analyzer, intended for running qualitative and quantitative clinical chemistry and immunochemistry assays as well as ion selective measurements.

Supporting information
It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid in diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic devices.

The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, urine, cerebrospinal fluid, supernatant, oral fluid, hemolysate, amniotic fluid, processed stool and plasma that are used for detecting and/or measuring analytes covered by the specific assays.

The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only).", "Language": "en", "Country": "XR", "Code": "Product Purpose" } ] } } ] }

cobas® pure integrated solutions

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup><b> pure</b> integrated solutions

Simplicity meets Excellence

 

今日では、正確で迅速な診断の重要性がこれまで以上に認識されるようになっています。しかし、採血から最終的な検査結果が出るまでの過程では、臨床検査スタッフに高い水準の献身性、専門知識、努力が要求されます。

そのような状況にあるお客様を支援するため、ロシュは、品質の高さに定評のある革新的なソリューションを開発しました。

cobas®pure integrated solutionは、cobas®システムの新たな製品であり、高品質でありながら、日常業務の簡素化にも貢献します。cobas® pure*は、わずか2平方メートルの設置面積に生化学検査、免疫化学検査、ISE検査を組み合わせたシステムで、臨床的価値の高い独自のアッセイを多数含む幅広い検査項目から成る当社の幅広いメニューを、限られたスペースをやりくりしなければならない検査室に提供します。

日常業務をシンプルにするために、cobas®pureシステムにはオペレーターによる作業を削減する新機能が備わっており、スタッフの貴重な時間を節約できます。

cobas® pureにより、ロシュの大規模検査室向けの最新分析システムcobas®pro integrated solutionsに対し完全に標準化された結果と操作性が得られ、ネットワーク化した組織でシンプルかつ効果的な業務を実現します。

検査におけるあらゆる過程をシンプルにすることで、迅速かつ正確な診断が実現可能だからです。

 

*cobas® pureコバス® pure
(医療機器・製造販売届出番号:13B1X00201000081)

* 本製品の販売時期は、規制当局の承認スケジュールやビジネス戦略のために国によって異なります。

時計のアイコン

あなたの時間

 

オペレーターの作業時間を短縮

詳細を見る

空間のアイコン

あなたのスペース

 

わずか2 m2のスペースで、豊富なアッセイメニューを利用できます

詳細を見る

チームのアイコン

あなたのチーム

 

信頼性が高くシンプルな日常業務を実現します

詳細を見る

将来を表すアイコン

あなたの将来

 

検査室ソリューションをリードし、より高い臨床的価値を発信します

詳細を見る

医師の迅速な診断をサポート

 

患者や医師の満足度 や迅速な診断が重視されるようになり、医療システム全体で基準が引き上げられています。 こうした基準を満たすには、ピーク時でTATが短く予測可能な分析装置を選択することが重要となります。

予測可能な短いTATで、素早く結果を得る 

 

cobas®pure integrated solutionsは、あらゆるアッセイにおいて迅速かつ予測可能なターンアラウンドタイム(TAT)で結果が得られるように設計されています。

ロシュのイムノアッセイの93%は反応時間が 18分以下であり、STATアッセイの反応時間はわずか9分 となります。2

十分な見通しを確保するため、cobas®pure integrated solutionsでは、検体ごとの結果 が得られるまで時間、各検査の結果が得られるまでの時間、さらにはオーダーした全検査で最終結果 が得られるまでの時間を確認できます。

9分

9分

9分

18分

9分

27分

機器の前の女性

機器の準備時間と作業負担の削減によるメリット

メンテナンス作業の負担を減らすことで、スタッフの作業時間を節約します

 

cobas®pure integrated solutionsでは、メンテナンス作業を最大限削減できるようあらゆる努力がなされています。新しいスマートなコンセプトとして自動メンテナンスを導入することで、メンテナンス作業をバックグラウンドで自動的に実行し、日々のメンテナンスにかかる作業負担をわずか5分間に軽減します。1

cobas®AutoCalによる時間とコストの節約

 

cobas®pure integrated solutionsの生化学検査モジュールは、AutoCal機能を搭載することでキャリブレーションを大幅に簡素化します。cobas® AutoCalを用いれば、多くの生化学項目において、検査用の新しい試薬ロットが自動的に補正されるため、手動でキャリブレーションする必要はありません。これにより、キャリブレーション頻度が56%減少し、1年で最大105時間の作業時間を短縮できます。*3

 

* 一般的な中規模検査室の日常業務において、cobas® 6000アナライザシリーズ(cobas c 501モジュール、cobas e 601モジュール)と比較した場合。

生化学と免疫を一つの装置に統合

検体管のアイコン

1本の

検体管ですべての生化学 & 免疫化学検査を実施

結果のアイコン

1セット

だけの結果の追跡で済みます

アナライザのアイコン

1つの

プラットフォームで管理し、トレーニング対象も1つで済みます

ソフトウェアのアイコン

1つの

ユーザーインターフェースでインタラクティブな操作

パートナーのアイコン

1社の

メーカーとパートナー連携

機器を操作する女性

3種のコンパクトな機器構成*

免疫化学検査システムの構成
免疫化学検査システムの構成
 

設置スペース 1.2 m2

 

cobas e 402

Hybridシステムの構成
Hybridシステムの構成
 

設置スペース 2.0 m2

生化学検査システムの構成
生化学検査システムの構成
 

設置スペース 1.2 m2

 

cobas c 303

*ここで示した幅及び奥行きの寸法は、床面積(設置スペース)のサイズです4

試薬をロードする女性

進化した試薬カセットにより生産性を向上

すぐに使用可能な試薬

 

cobas®pureは、最新世代の試薬であるRoche - cobas e pack green、cobas c pack greenを使用しています。これらの試薬では、調製、ミキシング、待ち時間、事前開封の作業が不要です。作業者は冷蔵庫から試薬を取り出し 、そのまま各分析モジュールに架設できます。

調製不要のアイコン

調製不要

ミキシング不要のアイコン

ミキシング不要

待ち時間不要のアイコン

待ち時間不要

事前開封不要のアイコン

事前開封不要

矢印のアイコン

冷蔵庫から取り出し

矢印のアイコン

分析モジュールに架設

業界をリードするオンボード安定性

 

スペースを有効活用することで、少ないスペースで生産性を向上します。免疫化学検査用試薬の平均オンボード安定性は110日であり、98%の試薬が4ヵ月のオンボード安定性を示します。生化学検査の平均オンボード安定性は137日であり、57%の試薬が6ヵ月のオンボード安定性を示します。5,6

免疫試薬5

 

  • 最長4ヵ月のオンボード安定性
  • 従来のシステムと比較して、平均約3倍長いオンボード安定性
cobas e pack green

cobas e  pack green

生化学試薬6

 

  • 最大6ヵ月持続するオンボード安定性
  • 従来のシステムと比較して、平均約2倍長いオンボード安定性
cobas c pack green

cobas c pack green

信頼性と安全性の高いソリューションでチームに自信を

 

ダウンタイムや検査結果に対する信頼の欠如は、検査室において 最もストレスのかかることの一つです。このような事態により、時間ばかりかかる手作業での回避策や検体の再提出に注意を向けなければならなくなると、 スタッフのモラルや モチベーションに影響します。

さらに、結果の質や検査室の評判に対するリスクもあります。 cobas®pure integrated solutionsは、優れた システムアーキテクチャによる卓抜した信頼性と様々な安全機能により自信を持てる結果を提供できるよう設計されています。

シールドのアイコン

世界75,000以上の分析ユニットの既存のポートフォリオの99%の稼働時間7 

結果の安全性1

 

ディスポーザブルチップ/カップ

cobas® pure免疫化学検査分析ユニットでは、ディスポーザブルチップ とカップを採用することで、検体のキャリーオーバーリスクを完全に排しています。

 

キャリーオーバー回避プログラム

cobas® pureの生化学分析モジュールの検体プローブは、 検体を調製する毎に、脱イオン水で内部と外部を 洗浄します。さらに、検体のキャリーオーバーに敏感な項目については、 特殊洗浄をプログラムすることで、試薬プローブ、 検体プローブ、反応セルを塩基性および酸性の洗浄液で追加洗浄することができます。

 

超音波ミキシング

cobas® pure 生化学分析ユニットは、検体と試薬を非接触で混合する超音波ミキシング を採用することで、攪拌時のキャリーオーバー のリスクを排します。

高い信頼性

 

cobas® pure integrated solutionsは、ロシュが誇る信頼性 を提供できるよう設計されています。全世界で75,000台以上の分析ユニットを擁する cobas®ソリューションファミリーは、99%以上 の稼働時間*を実現しています。7 信頼性の高い装置を持つことは、サービスの中断 やトラブル対応に費やす時間を削減し、 予測可能なTATで生産性をより向上させることにつながります。

 

*稼働時間: システムが稼働している時間に対して予定外の出来事によってシステム が稼働していない時間の割合。計算:
(365日/修理訪問のない期間の平均)×(修理訪問の平均時間+移動時間)7

アナライザを見ている検査室スタッフ

標準化されたソリューションにより業務を効率化

 

検査室の標準化によってワークフロー、システム、試薬を統合することで、 より少ない機器でより多くの作業を行うことができます。 また、標準化によって、ネットワーク連携のための効率的で互換性のある ソリューションが実現します。

標準化による主なメリット

 

結果のスピードアップと精度の向上

同じ試薬や検出技術を使用することで、基準値が標準化され、結果のスピードアップと精度の向上につながります。

 

トレーニングとスタッフ割り当てがシンプルに

cobas®システム共通のユーザーインターフェースを採用することにより、トレーニングがシンプルになり、医療機関がより大きな統合医療ネットワークに統合されても、スタッフを柔軟に配置することができます。

 

患者管理の最適化

時間や場所が異なっても一貫した結果が得られるため、最適な患者管理が可能になります。

試薬パックのアイコン

同じ
試薬

アイコン 検出技術

同じ
テクノロジー

アイコン インターフェース

共通の
ユーザーインターフェース

アイコン 基準値

同じ
基準値

アッセイポートフォリオの集中的な革新

 

エビデンスベースの拡大

認識を高め、変革へのアクセスを広げるために、臨床試験を通して既存アッセイのエビデンスベースを拡大します。

 

既存アッセイに対する新しい主張

より広い用途のための既存アッセイに対する新しい主張の作成。

 

新たなアッセイの発見

臨床医が患者の転帰を改善するのを助けるための、アンメットメディカルニーズの領域におけるメニューの拡大。

 

個別化医療を臨床診療に取り入れる

より良い患者ケアをサポートし、医療経済に貢献しつつ、検査室が医療上の意思決定においてより大きな役割を果たすことが可能となります。

臨床的価値

より大きな成果をもたらす
臨床的価値

並外れたアッセイ品質への尽力

 

高度なアッセイデザイン
  • 測定範囲全体にわたる優れた精度
  • 重要な領域での高い感度
  • より広い測定範囲、より少ない希釈と反復

 

一貫性があり標準化された結果
  • すべてのプラットフォームにわたって一貫した検査結果
  • 優れたロット間一貫性
  • 勧告法に対して標準化されたアッセイ

 

利便性のためのデザイン
  • 短時間かつ予測可能なアッセイTAT
  • 少ない検体量
  • 試薬調製は必要ありません
  1. cobas pure integrated solutionsのユーザーガイド
  2. エクルーシスアッセイメニューcobas pureー分析(ソースメソッドシートcobas e pack green色)
  3. cobas pure – AutoCal 推定時間削減 – 内部計算
  4. cobas pure – 設置スペースサイズ – 社内文書
  5. エクルーシスアッセイメニューcobas pure – 分析(ソースメソッドシートcobas e pack green、CMPデータベース)
  6. 生化学検査メニュー cobas pure – 分析(ソースメソッドシートcobas c pack green)
  7. ロシュダイアグノスティックス社内報告Data On File – GCSレポート/製品レポートQ1/2020、TableauによるCPS Finance Report、ICB Q1/2020

概説

注文情報

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