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微生物検査
移動式蛍光免疫測定装置 SOFIA™ 2アナライザー
オーソ・クリニカル・ダイアグノスティックス株式会社
届出番号：13B3X10182000023
Item 1 of 5
特長
- 01
- 免疫蛍光法による高感度の測定装置
- 02
- 自動判定モード：最短3分から自動判定
- 03
- 連続判定モード：多検体バッチにて連続判定
- 04
- AC電源および内臓バッテリーで検査可能
- 05
- 「検体検査の質の確保」をサポート
製品概要
本装置は、呼吸器感染症の原因病原体を検出するためのキットを判定するPOCT対応機器です。
測定可能項目
・インフルエンザウイルス A/B抗原
・A群β溶血性連鎖球菌抗原
・RSウイルス抗原
2つの測定モードでワークフローを効率化
・自動測定モード ➡ 複数の業務で多忙な現場をサポート
検体滴下後のカセットを装置にセット後、自動で測定・判定・結果表示
項目により、3分、5分、8分、10分、15分で判定を複数回実施、最短3分で測定結果表示
・連続判定モード ➡ 流行時に多くの患者様をバッチ処理する現場をサポート
装置外でインキュベーションを行い、読み取りのみを装置で実施することにより、効率的に測定が可能
装置による判定時間は10秒
「検体検査の質の確保」をサポート
・校正用キャリブレーターカセットによるキャリブレーションにより正確性を担保
・陽性・陰性コントロールスワブをキットに同梱、定期的な内部精度管理をサポート
仕様・スペック
| Sofia™2アナライザー | サイズ： 12cm（W）× 22cm（D）× 12cm（H） 重 量： 約1.0kg 電 源： AC100-240V / リチウムポリマー充電式電池 画 面： 4インチカラー液晶ディスプレー 通 信： RJ45コネクター 環 境： 温度：15～30℃ 湿度：20～85％（結露なし） |
|---|---|
| Sofiaアナライザー用Influenza A+B FIA | 承認番号： 22900EZ100002000 判定時間： 陽性判定：3分から可能、陰性判定15分 検 体： 鼻腔ぬぐい液 |
| Sofiaアナライザー用Strep A+ FIA | 承認番号： 22800EZ100001000 判定時間： 陽性判定：3分から可能、陰性判定5分 検 体： 咽頭ぬぐい液 |
| Sofiaアナライザー用RSV FIA | 承認番号： 22800EZ100002000 判定時間： 陽性判定：3分から可能、陰性判定15分 検 体： 鼻咽頭ぬぐい液 |
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